Prostate Cancer
Conditions
Brief summary
The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.
Detailed description
This was an open-label, randomized, parallel-arm, multicenter study to determine if degarelix intermittent therapy was non-inferior to continuous androgen deprivation therapy (combination of treatment groups receiving continuous degarelix and leuprolide therapy, respectively) in maintaining PSA levels at ≤ 4.0 ng/mL at 14 months. The study consisted of two phases, Phase A and B. During Phase A, patients in the degarelix intermittent and degarelix continuous arms received 7 months of therapy with degarelix one-month depot formulation and patients in the leuprolide continuous arm received leuprolide one-month depot injection (7.5 mg) followed by two 3-month depot (22.5 mg) injections. After 7 months of treatment, patients with a PSA ≤2 ng/mL continued into Phase B. During Phase B, patients in the degarelix intermittent arm had a 7-month off-treatment period. Patients randomized to the degarelix continuous arm and the leuprolide continuous arm continued to receive degarelix or leuprolide depot as in Phase A for the remainder of the 14 months.
Interventions
DRUGDegarelix
Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.
DRUGLeuprolide
Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older. * Raising PSA after prior treatment failure of localized prostate cancer. * Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy. * Has a screening testosterone within normal range (≥1.5 ng/mL). * Has Eastern Cooperative Oncology Group score of ≤2. * Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs. * Life expectancy of at least 15 months.
Exclusion criteria
* Taken hormone therapy in the last 6 months prior to entering this study. * Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial. * Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema. * Has hypersensitivity towards any component of the study drug. * Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last five years. * Has abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial. * Has a clinically significant medical condition (other than prostate cancer) including but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator. * Has an intellectual incapacity or language barriers precluding adequate understanding or co-operation. * Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial. * Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit. * Has previously participated in any Degarelix trial. * Is part of an ongoing trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL | At 14 month | Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Serum PSA Levels | Phase A Visit 1-8 and Phase B Visit 9-15. | Percent change from Baseline in serum PSA levels during the study period was measured. |
| Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | During 14 months | The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Physical well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the physical well-being sub scale ranges from 0 to 28. Higher scores represent better QoL. |
| Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | During 14 months | The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Emotional well-being consist of 6 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the emotional well-being sub scale ranges from 0 to 24. Higher scores represent better QoL.Higher scores represent better QoL. |
| Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | During 14 months | The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Social well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the social well-being sub scale ranges from 0 to 28. Higher scores represent better QoL. |
| Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | During 14 months | The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Functional well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the functional well-being sub scale ranges from 0 to 28. Higher scores represent better QoL. |
| Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | During 14 months | The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Additional concerns consist of 12 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the additional concerns ranges from 0 to 48. Higher scores represent better QoL. |
| Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | During 14 months | The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Total FACT-P scores ranges from 0 to 156. Higher scores represent better QoL. |
| Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | During 14 months | The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Sexual drive domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the sexual drive domain ranges from 0 to 8. A higher scores represent better sexual function. |
| Change From Baseline in Sexual Function as Assessed by the SFI: Erection | During 14 months | The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Erection domain consist of 3 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the erection domain ranges from 0 to 12. A higher scores represent better sexual function. |
| Absolute Change From Baseline in Serum PSA Levels | Phase A Visit 1-8 and Phase B Visit 9-15. | Absolute change from Baseline in serum PSA levels during the study period was measured. |
| Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | During 14 months | The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Problem assessment domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the problem assessment domain ranges from 0 to 8. A higher scores represent better sexual function. |
| Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | During 14 months | The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Overall satisfaction domain consist of single question and is scored on a scale of 0-4 (0=minimum, 4=maximum). A higher score represent better sexual function. |
| Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | During 14 months | The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Total SFI score ranges from 0 to 44. A higher scores represent better sexual function. |
| Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL | At 14 months | Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period. |
| Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group | During Phase B | The time to testosterone \>0.5 ng/mL level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix) |
| Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level | During Phase B | The time to return to normal range (≥1.5 ng/mL) or Baseline testosterone level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix). |
| Absolute Change From Baseline in Serum Testosterone Levels | Phase A Visit 1-8 and Phase B Visit 9-15. | Absolute Change From Baseline in Serum Testosterone Levels was measured. |
| Percent Change From Baseline in Serum Testosterone Levels | Phase A Visit 1-8 and Phase B Visit 9-15. | Percent change from Baseline in serum testosterone levels was measured. |
| Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | During 14 months | The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Ejaculation domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the ejaculation domain ranges from 0 to 8. A higher scores represent better sexual function. |
Countries
United States
Participant flow
Pre-assignment details
Of the total 409 patients enrolled, six patients were not dosed either due to randomisation error, failing eligibility criteria or consent withdrawal after being randomised.
Participants by arm
| Arm | Count |
|---|---|
| DI (Degarelix Intermittent) Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.
During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.
Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period. | 175 |
| DC (Degarelix Continuous) Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.
Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall
Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses). | 50 |
| LC (Leuprolide Continuous) Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer's labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each) | 178 |
| Total | 403 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 14 | 5 | 18 |
| Overall Study | Lost to Follow-up | 1 | 0 | 3 |
| Overall Study | Other (not meeting above criteria) | 5 | 1 | 2 |
| Overall Study | Physician Decision | 2 | 0 | 3 |
| Overall Study | Protocol Violation | 5 | 0 | 8 |
| Overall Study | PSA failure (>2 ng/mL) at Visit 8 | 10 | 4 | 7 |
| Overall Study | PSA failure (>2 ng/mL) on other visit | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 2 |
Baseline characteristics
| Characteristic | DI (Degarelix Intermittent) | Total | LC (Leuprolide Continuous) | DC (Degarelix Continuous) |
|---|---|---|---|---|
| Age, Continuous | 71.9 Years STANDARD_DEVIATION 8.89 | 71.5 Years STANDARD_DEVIATION 8.59 | 71.0 Years STANDARD_DEVIATION 8.44 | 71.7 Years STANDARD_DEVIATION 8.14 |
| Body Mass Index (BMI) | 28.9 Kg/m^2 STANDARD_DEVIATION 5.45 | 29.2 Kg/m^2 STANDARD_DEVIATION 5.16 | 29.6 Kg/m^2 STANDARD_DEVIATION 4.94 | 29.2 Kg/m^2 STANDARD_DEVIATION 4.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 35 Participants | 14 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 158 Participants | 368 Participants | 164 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 1.77 Meter STANDARD_DEVIATION 0.089 | 1.76 Meter STANDARD_DEVIATION 0.085 | 1.76 Meter STANDARD_DEVIATION 0.08 | 1.74 Meter STANDARD_DEVIATION 0.089 |
| Prostate Specific Antigen (PSA) | 16.4 ng/mL STANDARD_DEVIATION 66.3 | 13.8 ng/mL STANDARD_DEVIATION 48 | 10.7 ng/mL STANDARD_DEVIATION 24.4 | 15.6 ng/mL STANDARD_DEVIATION 32.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 5 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 79 Participants | 38 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 140 Participants | 316 Participants | 137 Participants | 39 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 175 Participants | 403 Participants | 178 Participants | 50 Participants |
| Testosterone | 3.65 ng/mL STANDARD_DEVIATION 1.43 | 3.73 ng/mL STANDARD_DEVIATION 1.52 | 3.76 ng/mL STANDARD_DEVIATION 1.58 | 3.90 ng/mL STANDARD_DEVIATION 1.59 |
| Weight | 90.3 Kg STANDARD_DEVIATION 19.4 | 90.8 Kg STANDARD_DEVIATION 17.9 | 91.9 Kg STANDARD_DEVIATION 16.9 | 88.4 Kg STANDARD_DEVIATION 15.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 159 / 175 | 47 / 50 | 158 / 178 |
| serious Total, serious adverse events | 26 / 175 | 6 / 50 | 18 / 178 |
Outcome results
Primary
Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL
Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.
Time frame: At 14 month
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DI (Degarelix Intermittent) | Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL | 100 Percentage of patients |
| Total Continuous | Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL | 98.4 Percentage of patients |
95% CI: [-0.19, 3.33]
Secondary
Absolute Change From Baseline in Serum PSA Levels
Absolute change from Baseline in serum PSA levels during the study period was measured.
Time frame: Phase A Visit 1-8 and Phase B Visit 9-15.
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 6 (Month 5) | -7.19 ng/mL | Standard Deviation 11 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 3 (Month 2) | -6.94 ng/mL | Standard Deviation 10.8 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 11 (Month 10) | -7.07 ng/mL | Standard Deviation 10.9 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 7 (Month 6) | -7.21 ng/mL | Standard Deviation 10.9 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 2 (Month 1) | -6.39 ng/mL | Standard Deviation 10.2 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 10 (Month 9) | -7.18 ng/mL | Standard Deviation 11 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 8 (Month 7) | -7.24 ng/mL | Standard Deviation 11 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 13 (Month 12) | -6.81 ng/mL | Standard Deviation 11 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 9 (Month 8) | -7.25 ng/mL | Standard Deviation 11 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 4 (Month 3) | -7.07 ng/mL | Standard Deviation 10.9 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 15 (Month 14) | -6.74 ng/mL | Standard Deviation 11 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 1 (Day 0) | NA ng/mL | — |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 5 (Month 4) | -7.16 ng/mL | Standard Deviation 11 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 14 (Month 13) | -6.79 ng/mL | Standard Deviation 11 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 12 (Month 11) | -6.96 ng/mL | Standard Deviation 10.9 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 12 (Month 11) | -14.9 ng/mL | Standard Deviation 33.9 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 1 (Day 0) | -0.91 ng/mL | — |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 2 (Month 1) | -14.3 ng/mL | Standard Deviation 34.8 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 3 (Month 2) | -14.8 ng/mL | Standard Deviation 34.9 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 4 (Month 3) | -15 ng/mL | Standard Deviation 35 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 5 (Month 4) | -15.1 ng/mL | Standard Deviation 35.2 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 6 (Month 5) | -15.1 ng/mL | Standard Deviation 35.2 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 7 (Month 6) | -15.1 ng/mL | Standard Deviation 35.2 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 8 (Month 7) | -15.1 ng/mL | Standard Deviation 35.2 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 9 (Month 8) | -15 ng/mL | Standard Deviation 34.7 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 10 (Month 9) | -15 ng/mL | Standard Deviation 34.7 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 11 (Month 10) | -14.9 ng/mL | Standard Deviation 34.3 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 13 (Month 12) | -14.8 ng/mL | Standard Deviation 33.9 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 14 (Month 13) | -14.8 ng/mL | Standard Deviation 33.9 |
| Total Continuous | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 15 (Month 14) | -14.8 ng/mL | Standard Deviation 33.9 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 6 (Month 5) | -8.59 ng/mL | Standard Deviation 15.9 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 14 (Month 13) | -8.59 ng/mL | Standard Deviation 16 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 11 (Month 10) | -8.63 ng/mL | Standard Deviation 15.9 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 5 (Month 4) | -8.51 ng/mL | Standard Deviation 15.8 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 4 (Month 3) | -8.44 ng/mL | Standard Deviation 15.7 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 12 (Month 11) | -8.64 ng/mL | Standard Deviation 15.9 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 3 (Month 2) | -8.12 ng/mL | Standard Deviation 15.4 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 1 (Day 0) | NA ng/mL | — |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 13 (Month 12) | -8.64 ng/mL | Standard Deviation 15.9 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 8 (Month 7) | -8.64 ng/mL | Standard Deviation 15.9 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 2 (Month 1) | -6.38 ng/mL | Standard Deviation 13.2 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 9 (Month 8) | -8.64 ng/mL | Standard Deviation 15.9 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase A, Visit 7 (Month 6) | -8.64 ng/mL | Standard Deviation 15.9 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 15 (Month 14) | -8.6 ng/mL | Standard Deviation 15.9 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum PSA Levels | Phase B, Visit 10 (Month 9) | -8.64 ng/mL | Standard Deviation 15.9 |
Secondary
Absolute Change From Baseline in Serum Testosterone Levels
Absolute Change From Baseline in Serum Testosterone Levels was measured.
Time frame: Phase A Visit 1-8 and Phase B Visit 9-15.
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 11 (Month 10) | -3.0 ng/mL | Standard Deviation 1.76 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 6 (Month 5) | -3.67 ng/mL | Standard Deviation 1.41 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 14 (Month 13) | -2.1 ng/mL | Standard Deviation 1.81 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 10 (Month 9) | -3.41 ng/mL | Standard Deviation 1.6 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 7 (Month 6) | -3.66 ng/mL | Standard Deviation 1.41 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 3 (Month 2) | -3.67 ng/mL | Standard Deviation 1.4 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 9 (Month 8) | -3.63 ng/mL | Standard Deviation 1.44 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 8 (Month 7) | -3.66 ng/mL | Standard Deviation 1.42 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 15 (Month 14) | -1.77 ng/mL | Standard Deviation 2.27 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 13 (Month 12) | -2.18 ng/mL | Standard Deviation 1.8 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 4 (Month 3) | -3.68 ng/mL | Standard Deviation 1.4 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 2 (Month 1) | -3.64 ng/mL | Standard Deviation 1.4 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 12 (Month 11) | -2.57 ng/mL | Standard Deviation 1.78 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 5 (Month 4) | -3.67 ng/mL | Standard Deviation 1.41 |
| DI (Degarelix Intermittent) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 1 (Day 0) | NA ng/mL | — |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 6 (Month 5) | -3.78 ng/mL | Standard Deviation 1.44 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 1 (Day 0) | -2.97 ng/mL | — |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 2 (Month 1) | -3.77 ng/mL | Standard Deviation 1.43 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 3 (Month 2) | -3.77 ng/mL | Standard Deviation 1.44 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 4 (Month 3) | -3.78 ng/mL | Standard Deviation 1.43 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 5 (Month 4) | -3.78 ng/mL | Standard Deviation 1.44 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 12 (Month 11) | -3.74 ng/mL | Standard Deviation 1.43 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 7 (Month 6) | -3.77 ng/mL | Standard Deviation 1.44 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 8 (Month 7) | -3.78 ng/mL | Standard Deviation 1.43 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 9 (Month 8) | -3.76 ng/mL | Standard Deviation 1.44 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 10 (Month 9) | -3.76 ng/mL | Standard Deviation 1.44 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 11 (Month 10) | -3.75 ng/mL | Standard Deviation 1.44 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 13 (Month 12) | -3.72 ng/mL | Standard Deviation 1.43 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 14 (Month 13) | -3.73 ng/mL | Standard Deviation 1.42 |
| Total Continuous | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 15 (Month 14) | -3.71 ng/mL | Standard Deviation 1.42 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 10 (Month 9) | -3.78 ng/mL | Standard Deviation 1.56 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 5 (Month 4) | -3.74 ng/mL | Standard Deviation 1.61 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 14 (Month 13) | -3.77 ng/mL | Standard Deviation 1.57 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 11 (Month 10) | -3.77 ng/mL | Standard Deviation 1.57 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 4 (Month 3) | -3.77 ng/mL | Standard Deviation 1.55 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 12 (Month 11) | -3.78 ng/mL | Standard Deviation 1.55 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 3 (Month 2) | -3.77 ng/mL | Standard Deviation 1.56 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 1 (Day 0) | NA ng/mL | — |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 13 (Month 12) | -3.78 ng/mL | Standard Deviation 1.56 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 8 (Month 7) | -3.78 ng/mL | Standard Deviation 1.55 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 7 (Month 6) | -3.77 ng/mL | Standard Deviation 1.56 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 2 (Month 1) | -3.7 ng/mL | Standard Deviation 1.56 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 9 (Month 8) | -3.78 ng/mL | Standard Deviation 1.56 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase A, Visit 6 (Month 5) | -3.78 ng/mL | Standard Deviation 1.55 |
| LC (Leuprolide Continuous) | Absolute Change From Baseline in Serum Testosterone Levels | Phase B, Visit 15 (Month 14) | -3.78 ng/mL | Standard Deviation 1.56 |
Secondary
Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns
The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Additional concerns consist of 12 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the additional concerns ranges from 0 to 48. Higher scores represent better QoL.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase A, Month 7 | -0.89 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 13 | -0.91 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 8 | -1.29 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 9 | -0.97 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 11 | -0.80 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 14 | -0.81 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 12 | -0.75 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase A, Month 3 | -1.14 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 10 | -0.86 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase A, Month 3 | -0.92 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 14 | -0.67 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 9 | -1.64 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 11 | -0.56 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 8 | -1.03 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 13 | -0.96 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 10 | -0.80 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 12 | -1.20 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase A, Month 7 | -1.34 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 11 | -0.58 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 12 | -0.75 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 13 | -0.86 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 14 | -0.27 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase A, Month 3 | -0.51 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase A, Month 7 | -1.03 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 8 | -0.63 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 9 | -0.90 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 10 | -0.70 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 12 | -0.84 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 9 | -1.06 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase A, Month 3 | -0.60 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 14 | -0.35 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 11 | -0.57 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 10 | -0.72 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 13 | -0.88 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase B, Month 8 | -0.72 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns | Phase A, Month 7 | -1.10 Scores on a scale |
Secondary
Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being
The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Emotional well-being consist of 6 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the emotional well-being sub scale ranges from 0 to 24. Higher scores represent better QoL.Higher scores represent better QoL.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 12 | 0.99 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 11 | 0.82 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 14 | 0.40 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 9 | 0.75 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 8 | 0.65 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase A, Month 7 | 0.67 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 13 | 0.74 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 10 | 1.09 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase A, Month 3 | 0.69 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 10 | 0.00 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 12 | 1.07 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 11 | 0.94 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase A, Month 7 | 0.57 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase A, Month 3 | 1.31 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 8 | 0.95 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 14 | 0.86 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 13 | 0.52 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 9 | 1.11 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 10 | 0.98 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase A, Month 3 | 0.76 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase A, Month 7 | 0.90 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 8 | 1.11 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 9 | 1.16 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 11 | 1.05 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 12 | 1.23 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 13 | 1.14 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 14 | 1.12 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 12 | 1.20 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 9 | 1.15 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 8 | 1.08 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 14 | 1.06 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 13 | 1.01 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase A, Month 7 | 0.83 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 11 | 1.03 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase B, Month 10 | 0.77 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being | Phase A, Month 3 | 0.88 Scores on a scale |
Secondary
Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being
The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Functional well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the functional well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 12 | -0.92 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 11 | -1.25 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 14 | -1.02 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 9 | -1.14 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 8 | -1.18 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase A, Month 7 | -1.41 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 13 | -1.49 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 10 | -1.35 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase A, Month 3 | -0.96 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 10 | -0.89 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 12 | -1.49 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 11 | -0.80 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase A, Month 7 | -0.78 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase A, Month 3 | -0.88 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 8 | -1.08 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 14 | -1.95 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 13 | -2.22 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 9 | -1.07 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 10 | -1.42 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase A, Month 3 | -0.29 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase A, Month 7 | -1.24 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 8 | -0.73 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 9 | -1.23 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 11 | -1.24 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 12 | -0.73 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 13 | -0.96 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 14 | -0.84 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 12 | -0.89 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 9 | -1.20 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 8 | -0.80 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 14 | -1.07 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 13 | -1.22 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase A, Month 7 | -1.15 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 11 | -1.15 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase B, Month 10 | -1.31 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being | Phase A, Month 3 | -0.42 Scores on a scale |
Secondary
Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being
The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Social well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the social well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase A, Month 3 | -0.18 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 11 | 0.20 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 12 | -0.16 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 14 | 0.28 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 8 | -0.33 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase A, Month 7 | 0.00 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 9 | -0.02 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 13 | -0.02 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 10 | 0.36 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 10 | -1.00 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 12 | -1.34 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 8 | -0.52 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 11 | -1.09 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase A, Month 7 | -0.30 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 9 | -0.95 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase A, Month 3 | -0.06 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 14 | -0.68 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 13 | -1.35 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 10 | -1.15 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase A, Month 3 | -0.36 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 9 | -1.10 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase A, Month 7 | -0.46 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 8 | -0.41 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 11 | -0.83 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 12 | -0.85 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 13 | -0.72 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 14 | -0.55 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 12 | -0.95 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 9 | -1.07 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 8 | -0.43 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 14 | -0.58 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 13 | -0.85 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase A, Month 7 | -0.43 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 11 | -0.88 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase B, Month 10 | -1.12 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being | Phase A, Month 3 | -0.30 Scores on a scale |
Secondary
Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score
The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Total FACT-P scores ranges from 0 to 156. Higher scores represent better QoL.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 12 | -0.95 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 11 | -1.18 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 14 | -1.36 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 9 | -1.61 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 8 | -1.75 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase A, Month 7 | -2.03 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 13 | -1.74 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 10 | -0.89 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase A, Month 3 | -1.86 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 10 | -4.56 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 12 | -3.97 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 11 | -3.27 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase A, Month 7 | -2.64 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase A, Month 3 | -1.89 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 8 | -3.12 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 14 | -4.28 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 13 | -5.62 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 9 | -3.49 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 10 | -3.16 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase A, Month 3 | -1.23 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase A, Month 7 | -2.38 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 8 | -1.69 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 9 | -2.84 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 11 | -2.48 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 12 | -1.60 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 13 | -1.85 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 14 | -1.65 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 12 | -2.09 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 9 | -2.98 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 8 | -1.99 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 14 | -2.20 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 13 | -2.64 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase A, Month 7 | -2.43 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 11 | -2.65 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase B, Month 10 | -3.45 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score | Phase A, Month 3 | -1.37 Scores on a scale |
Secondary
Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being
The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Physical well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the physical well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 12 | -0.91 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 11 | -1.00 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 14 | -1.04 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 9 | -1.24 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 8 | -0.96 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase A, Month 7 | -1.41 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 13 | -1.00 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 10 | -1.05 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase A, Month 3 | -1.47 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 10 | -2.08 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 12 | -1.62 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 11 | -1.77 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase A, Month 7 | -1.48 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase A, Month 3 | -1.63 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 8 | -1.92 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 14 | -1.90 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 13 | -2.10 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 9 | -1.85 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 10 | -1.68 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase A, Month 3 | -1.41 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase A, Month 7 | -1.67 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 8 | -1.74 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 9 | -1.77 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 11 | -1.53 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 12 | -1.32 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 13 | -1.40 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 14 | -1.45 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 12 | -1.39 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 9 | -1.79 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 8 | -1.78 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 14 | -1.55 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 13 | -1.55 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase A, Month 7 | -1.63 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 11 | -1.58 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase B, Month 10 | -1.76 Scores on a scale |
| Total Continuous | Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being | Phase A, Month 3 | -1.46 Scores on a scale |
Secondary
Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive
The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Sexual drive domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the sexual drive domain ranges from 0 to 8. A higher scores represent better sexual function.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase A, Month 3 | -1.57 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase A, Month 7 | -1.71 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 9 | -1.72 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 11 | -1.59 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 13 | -1.44 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 14 | -1.30 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 14 | -1.65 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 11 | -1.52 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase A, Month 3 | -1.57 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 9 | -1.51 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase A, Month 7 | -1.39 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 13 | -1.55 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase A, Month 7 | -1.67 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 9 | -1.62 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 11 | -1.65 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 14 | -1.72 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 13 | -1.72 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase A, Month 3 | -1.27 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 13 | -1.69 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 14 | -1.71 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase A, Month 7 | -1.61 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 11 | -1.63 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase A, Month 3 | -1.33 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive | Phase B, Month 9 | -1.60 Scores on a scale |
Secondary
Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation
The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Ejaculation domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the ejaculation domain ranges from 0 to 8. A higher scores represent better sexual function.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase A, Month 3 | -1.04 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase A, Month 7 | -1.23 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 9 | -1.24 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 11 | -0.94 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 13 | -0.89 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 14 | -0.79 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 14 | -1.17 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 11 | -1.24 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase A, Month 3 | -0.90 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 9 | -1.06 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase A, Month 7 | -0.80 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 13 | -1.07 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase A, Month 7 | -1.08 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 9 | -0.94 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 11 | -0.93 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 14 | -0.97 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 13 | -1.12 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase A, Month 3 | -0.87 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 13 | -1.11 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 14 | -1.01 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase A, Month 7 | -1.02 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 11 | -1.00 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase A, Month 3 | -0.88 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation | Phase B, Month 9 | -0.97 Scores on a scale |
Secondary
Change From Baseline in Sexual Function as Assessed by the SFI: Erection
The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Erection domain consist of 3 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the erection domain ranges from 0 to 12. A higher scores represent better sexual function.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase A, Month 3 | -1.32 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase A, Month 7 | -1.43 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 9 | -1.52 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 11 | -1.15 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 13 | -0.97 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 14 | -0.90 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 14 | -1.43 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 11 | -1.34 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase A, Month 3 | -0.91 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 9 | -1.07 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase A, Month 7 | -1.06 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 13 | -1.36 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase A, Month 7 | -1.34 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 9 | -1.46 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 11 | -1.28 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 14 | -1.26 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 13 | -1.33 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase A, Month 3 | -1.21 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 13 | -1.34 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 14 | -1.29 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase A, Month 7 | -1.28 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 11 | -1.30 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase A, Month 3 | -1.14 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Erection | Phase B, Month 9 | -1.38 Scores on a scale |
Secondary
Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life
The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Overall satisfaction domain consist of single question and is scored on a scale of 0-4 (0=minimum, 4=maximum). A higher score represent better sexual function.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase A, Month 3 | -0.32 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase A, Month 7 | -0.28 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 9 | -0.33 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 11 | -0.15 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 13 | -0.11 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 14 | -0.12 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 14 | -0.70 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 11 | -0.47 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase A, Month 3 | -0.18 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 9 | -0.34 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase A, Month 7 | -0.37 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 13 | -0.57 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase A, Month 7 | -0.40 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 9 | -0.41 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 11 | -0.41 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 14 | -0.37 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 13 | -0.42 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase A, Month 3 | -0.27 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 13 | -0.45 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 14 | -0.44 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase A, Month 7 | -0.39 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 11 | -0.42 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase A, Month 3 | -0.25 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life | Phase B, Month 9 | -0.39 Scores on a scale |
Secondary
Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment
The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Problem assessment domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the problem assessment domain ranges from 0 to 8. A higher scores represent better sexual function.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase A, Month 3 | -0.26 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase A, Month 7 | -0.90 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 9 | -0.56 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 11 | 0.09 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 13 | -0.15 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 14 | -0.31 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 14 | -1.68 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 11 | -0.53 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase A, Month 3 | -0.58 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 9 | -0.71 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase A, Month 7 | -0.88 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 13 | -1.63 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase A, Month 7 | -0.57 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 9 | -0.64 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 11 | -0.98 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 14 | -0.89 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 13 | -1.07 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase A, Month 3 | -0.36 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 13 | -1.19 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 14 | -1.05 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase A, Month 7 | -0.63 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 11 | -0.89 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase A, Month 3 | -0.40 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment | Phase B, Month 9 | -0.66 Scores on a scale |
Secondary
Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score
The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Total SFI score ranges from 0 to 44. A higher scores represent better sexual function.
Time frame: During 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 13 | -3.37 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase A, Month 3 | -4.07 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 14 | -3.27 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 9 | -4.97 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase A, Month 7 | -5.20 Scores on a scale |
| DI (Degarelix Intermittent) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 11 | -3.56 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 13 | -5.59 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 11 | -4.62 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 14 | -5.93 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase A, Month 7 | -4.28 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase A, Month 3 | -3.93 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 9 | -4.35 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 9 | -4.62 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase A, Month 3 | -3.69 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase A, Month 7 | -4.57 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 11 | -4.74 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 13 | -5.15 Scores on a scale |
| LC (Leuprolide Continuous) | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 14 | -4.68 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 14 | -4.94 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 13 | -5.24 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase A, Month 7 | -4.51 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase A, Month 3 | -3.74 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 11 | -4.71 Scores on a scale |
| Total Continuous | Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score | Phase B, Month 9 | -4.56 Scores on a scale |
Secondary
Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL
Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period.
Time frame: At 14 months
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DI (Degarelix Intermittent) | Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL | 100 Percentage of patients |
| Total Continuous | Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL | 97.6 Percentage of patients |
| LC (Leuprolide Continuous) | Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL | 98.7 Percentage of patients |
Secondary
Percent Change From Baseline in Serum PSA Levels
Percent change from Baseline in serum PSA levels during the study period was measured.
Time frame: Phase A Visit 1-8 and Phase B Visit 9-15.
Population: Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 6 (Month 5) | -94.2 Percent change | Standard Deviation 9.31 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 3 (Month 2) | -90.4 Percent change | Standard Deviation 12.2 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 11 (Month 10) | -91.9 Percent change | Standard Deviation 13.4 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 7 (Month 6) | -94.8 Percent change | Standard Deviation 8.34 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 2 (Month 1) | -80.8 Percent change | Standard Deviation 24.4 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 10 (Month 9) | -93.6 Percent change | Standard Deviation 11.5 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 8 (Month 7) | -95.4 Percent change | Standard Deviation 7.13 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 13 (Month 12) | -84.2 Percent change | Standard Deviation 24.9 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 9 (Month 8) | -95.7 Percent change | Standard Deviation 6.97 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 4 (Month 3) | -92.8 Percent change | Standard Deviation 9.9 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 15 (Month 14) | -80.8 Percent change | Standard Deviation 26.4 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 1 (Day 0) | NA Percent change | — |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 5 (Month 4) | -94.1 Percent change | Standard Deviation 8.45 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 14 (Month 13) | -82.8 Percent change | Standard Deviation 24.9 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 12 (Month 11) | -88 Percent change | Standard Deviation 22.7 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 12 (Month 11) | -95.1 Percent change | Standard Deviation 11.9 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 1 (Day 0) | -39.6 Percent change | — |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 2 (Month 1) | -84.5 Percent change | Standard Deviation 11.8 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 3 (Month 2) | -92.4 Percent change | Standard Deviation 8.23 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 4 (Month 3) | -94.5 Percent change | Standard Deviation 7.37 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 5 (Month 4) | -95.5 Percent change | Standard Deviation 7.05 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 6 (Month 5) | -95.7 Percent change | Standard Deviation 7.8 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 7 (Month 6) | -95.8 Percent change | Standard Deviation 8.64 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 8 (Month 7) | -95.4 Percent change | Standard Deviation 10.8 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 9 (Month 8) | -95.5 Percent change | Standard Deviation 10.3 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 10 (Month 9) | -95.6 Percent change | Standard Deviation 10.6 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 11 (Month 10) | -95.7 Percent change | Standard Deviation 9.46 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 13 (Month 12) | -95.1 Percent change | Standard Deviation 10.6 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 14 (Month 13) | -95.1 Percent change | Standard Deviation 10.4 |
| Total Continuous | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 15 (Month 14) | -94.4 Percent change | Standard Deviation 12.9 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 6 (Month 5) | -94.5 Percent change | Standard Deviation 7.52 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 14 (Month 13) | -93.1 Percent change | Standard Deviation 25.9 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 11 (Month 10) | -93.1 Percent change | Standard Deviation 24.9 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 5 (Month 4) | -93.4 Percent change | Standard Deviation 9.39 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 4 (Month 3) | -92.3 Percent change | Standard Deviation 7.67 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 12 (Month 11) | -94.4 Percent change | Standard Deviation 23.5 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 3 (Month 2) | -87.3 Percent change | Standard Deviation 12.3 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 1 (Day 0) | NA Percent change | — |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 13 (Month 12) | -94.5 Percent change | Standard Deviation 23.5 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 8 (Month 7) | -95.5 Percent change | Standard Deviation 7.62 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 2 (Month 1) | -62.8 Percent change | Standard Deviation 31.2 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 9 (Month 8) | -95.2 Percent change | Standard Deviation 12.3 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase A, Visit 7 (Month 6) | -95.3 Percent change | Standard Deviation 7.23 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 15 (Month 14) | -93.7 Percent change | Standard Deviation 25.8 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum PSA Levels | Phase B, Visit 10 (Month 9) | -94.3 Percent change | Standard Deviation 23.2 |
Secondary
Percent Change From Baseline in Serum Testosterone Levels
Percent change from Baseline in serum testosterone levels was measured.
Time frame: Phase A Visit 1-8 and Phase B Visit 9-15.
Population: Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 10 (Month 9) | -88.7 Percent change | Standard Deviation 24.7 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 6 (Month 5) | -97.3 Percent change | Standard Deviation 4.42 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 14 (Month 13) | -51.9 Percent change | Standard Deviation 43.1 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 9 (Month 8) | -95.6 Percent change | Standard Deviation 9.69 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 7 (Month 6) | -96.8 Percent change | Standard Deviation 7.01 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 13 (Month 12) | -54.7 Percent change | Standard Deviation 41.5 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 8 (Month 7) | -96.9 Percent change | Standard Deviation 6.34 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 3 (Month 2) | -97.3 Percent change | Standard Deviation 2.46 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 1 (Day 0) | NA Percent change | — |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 12 (Month 11) | -65.4 Percent change | Standard Deviation 37.7 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 4 (Month 3) | -97.5 Percent change | Standard Deviation 2.06 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 15 (Month 14) | -44 Percent change | Standard Deviation 66.1 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 11 (Month 10) | -77 Percent change | Standard Deviation 34.8 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 5 (Month 4) | -97.2 Percent change | Standard Deviation 4.26 |
| DI (Degarelix Intermittent) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 2 (Month 1) | -96.4 Percent change | Standard Deviation 5.26 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 2 (Month 1) | -97.4 Percent change | Standard Deviation 2.31 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 1 (Day 0) | -95.8 Percent change | — |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 3 (Month 2) | -97.5 Percent change | Standard Deviation 1.9 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 4 (Month 3) | -97.8 Percent change | Standard Deviation 1.41 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 5 (Month 4) | -97.7 Percent change | Standard Deviation 1.58 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 6 (Month 5) | -97.6 Percent change | Standard Deviation 2.49 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 7 (Month 6) | -97.6 Percent change | Standard Deviation 2.03 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 8 (Month 7) | -97.5 Percent change | Standard Deviation 2.54 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 9 (Month 8) | -97.1 Percent change | Standard Deviation 3.09 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 10 (Month 9) | -97 Percent change | Standard Deviation 3.14 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 11 (Month 10) | -97 Percent change | Standard Deviation 3.74 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 12 (Month 11) | -96.7 Percent change | Standard Deviation 3.43 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 13 (Month 12) | -96 Percent change | Standard Deviation 5.56 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 14 (Month 13) | -96.5 Percent change | Standard Deviation 3.7 |
| Total Continuous | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 15 (Month 14) | -95.8 Percent change | Standard Deviation 4.8 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 10 (Month 9) | -97.7 Percent change | Standard Deviation 1.7 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 4 (Month 3) | -97.5 Percent change | Standard Deviation 1.76 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 14 (Month 13) | -97.4 Percent change | Standard Deviation 4.64 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 11 (Month 10) | -97.5 Percent change | Standard Deviation 3.49 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 3 (Month 2) | -97.7 Percent change | Standard Deviation 1.44 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 15 (Month 14) | -97.7 Percent change | Standard Deviation 1.56 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 12 (Month 11) | -97.9 Percent change | Standard Deviation 1.36 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 7 (Month 6) | -97.9 Percent change | Standard Deviation 1.46 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 2 (Month 1) | -95.5 Percent change | Standard Deviation 4.22 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 8 (Month 7) | -97.7 Percent change | Standard Deviation 1.67 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 6 (Month 5) | -97.8 Percent change | Standard Deviation 1.36 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 1 (Day 0) | NA Percent change | — |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 9 (Month 8) | -97.8 Percent change | Standard Deviation 1.43 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase A, Visit 5 (Month 4) | -96.2 Percent change | Standard Deviation 14 |
| LC (Leuprolide Continuous) | Percent Change From Baseline in Serum Testosterone Levels | Phase B, Visit 13 (Month 12) | -97.8 Percent change | Standard Deviation 1.45 |
Secondary
Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level
The time to return to normal range (≥1.5 ng/mL) or Baseline testosterone level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix).
Time frame: During Phase B
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DI (Degarelix Intermittent) | Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level | 168 Days |
Secondary
Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group
The time to testosterone \>0.5 ng/mL level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix)
Time frame: During Phase B
Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DI (Degarelix Intermittent) | Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group | 112.0 Days |