Prostate Cancer
Conditions
Brief summary
The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.
Detailed description
The participants received one or more treatment cycles of seven monthly degarelix doses during the induction period(s). The off-treatment period(s) started when prostate-specific antigen (PSA) ≤4 ng/mL and lasted up to 24 months based on PSA levels. A visit was scheduled on a monthly basis during the induction treatment periods, and every two months during the off-treatment periods. During the off-treatment periods, degarelix treatment was re-initiated when PSA \>4 ng/mL. The maximum of degarelix IAD treatment cycles that a participant could receive was limited to three.
Interventions
DRUGDegarelix 240 mg / 80 mg
For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient. * Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), and is in need of androgen deprivation treatment. * Patients with Locally Advanced or Metastatic Prostate Cancer - Screening PSA level (measured at a central laboratory) must be \>4 ng/mL and ≤50 ng/mL. * Patients with Localised Prostate Cancer or Patients with Previous Therapy with Curative Intention and a Rising PSA - PSA doubling time (based on patient records at the trial site) must be \<24 months. There is no minimum PSA level required and the maximum PSA must be ≤50 ng/mL. * Is a male patient aged 18 years or older. * Has an Eastern Cooperative Oncology Group score of ≤2. * Has a life expectancy of at least 24 months.
Exclusion criteria
* Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including gonadotropin releasing hormone (GnRH) receptor agonists, GnRH antagonists, anti-androgens, 5-alpha reductase inhibitors and estrogens). However, for patients having undergone prostatectomy or radiotherapy with curative intention, then neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to Screening Visit. * Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy. * Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema. * Has hypersensitivity towards any component of the investigational medicinal product. * Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin. * Has a known or suspected clinically significant liver and/or biliary disease. * Has a history of or risk factors for Torsades de Pointes * At time of inclusion receives concomitant medications that might prolong the QT interval. * Has any clinically significant laboratory abnormalities which in the judgment of the investigator would affect the patient's health or the outcome of the trial. * Has a clinically significant disorder (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 severe kidney failure (creatinine clearance \<30 mL/min), based on the serum creatinine value at Screening Visit and calculated by Cockcroft-Gault algorithm (only valid in France). * Has a mental incapacity or language barriers precluding adequate understanding or co operation. * Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial. * Has previously participated in any degarelix trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment | Up to 24 months after end of induction period | Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment | Up to 24 months after end of induction period | Blood samples for analyses of serum testosterone levels were collected at the Screening Visit, Month 4 and 7 of the induction period of Cycle 1 and the corresponding visits of any additional treatment cycles, every two months during the off-treatment period(s), and at the End-of-Trial Visit. Analyses were performed using Liquid-Liquid Extraction and Liquid Chromatography-Mass Spectrometry/Mass Spectrometry. |
| Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD | 7 months | — |
| Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Up to 31 months | The EORTC QLQ-PR25 employs a modular approach towards assessing cancer patients´ health-related Quality of Life (QoL) and assesses urinary, bowel, and sexual symptoms and functioning, and the side-effects of hormonal treatment. It consists of 25 questions distributed on six domains (number of items per domain, ranges from x to y: urinary symptoms (8, 0-100), bother due to use of incontinence aid (1, 0-100), bowel symptoms (4, 0-100), hormonal treatment-related symptoms (6, 0-100), sexual activity (2, 0-100), and sexual functioning (4, 0-100). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual). |
| Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD | 7 months | — |
| Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment | Up to 3 x 31 months | This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. |
| Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment | Up to 3 x 31 months | This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. ULN=Upper limit of normal. |
| Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Up to 31 months | The IIEF scale addresses the relevant domains of male sexual function (i.e. erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). The IIEF scale is psychometrically sound, and has been linguistically validated in multiple languages. The IIEF scale demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. It consists of the following domains (number of items per domain; ranges from x to y: erectile function (6; 1-30), orgasmic function (2; 0-10), sexual desire (2; 2-10), intercourse satisfaction (3; 0-15) and overall satisfaction (2; 2-10). For all domains, a higher score represents a better sexual function. |
Countries
Belgium, France, Germany, Italy, Netherlands, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 240 mg / 80 mg Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections. | 213 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Miscellaneous reasons | 20 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Degarelix 240 mg / 80 mg |
|---|---|
| Age, Continuous | 73.1 years STANDARD_DEVIATION 7.73 |
| Baseline EORTC QLQ-PR25 Scores during Cycle 1 Bother due to Incontinence aid | 18.5 units on a scale STANDARD_DEVIATION 28 |
| Baseline EORTC QLQ-PR25 Scores during Cycle 1 Bowel Symptoms | 4.05 units on a scale STANDARD_DEVIATION 9.65 |
| Baseline EORTC QLQ-PR25 Scores during Cycle 1 Hormonal Treatment-related Symptoms | 7.09 units on a scale STANDARD_DEVIATION 10.4 |
| Baseline EORTC QLQ-PR25 Scores during Cycle 1 Sexual Activity | 58.0 units on a scale STANDARD_DEVIATION 26.8 |
| Baseline EORTC QLQ-PR25 Scores during Cycle 1 Sexual Functioning | 25.8 units on a scale STANDARD_DEVIATION 26.7 |
| Baseline EORTC QLQ-PR25 Scores during Cycle 1 Urinary Symptoms | 23.1 units on a scale STANDARD_DEVIATION 16 |
| Baseline IIEF Scores during Cycle 1 Erectile Function | 7.02 units on a scale STANDARD_DEVIATION 8.96 |
| Baseline IIEF Scores during Cycle 1 Intercourse Satisfaction | 2.65 units on a scale STANDARD_DEVIATION 4.2 |
| Baseline IIEF Scores during Cycle 1 Orgasmic Function | 2.31 units on a scale STANDARD_DEVIATION 3.43 |
| Baseline IIEF Scores during Cycle 1 Overall Satisfaction | 5.17 units on a scale STANDARD_DEVIATION 2.91 |
| Baseline IIEF Scores during Cycle 1 Sexual Desire | 4.22 units on a scale STANDARD_DEVIATION 2.26 |
| Median Baseline Serum Prostate-specific Antigen Levels | 7.9 ng/mL |
| Median Baseline Serum Testosterone Levels | 4.09 ng/mL |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 212 Participants |
| Region of Enrollment Belgium | 26 participants |
| Region of Enrollment France | 43 participants |
| Region of Enrollment Germany | 63 participants |
| Region of Enrollment Italy | 32 participants |
| Region of Enrollment Netherlands | 25 participants |
| Region of Enrollment Spain | 24 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 213 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 185 / 216 |
| serious Total, serious adverse events | 51 / 216 |
Outcome results
Primary
Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment
Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.
Time frame: Up to 24 months after end of induction period
Population: FAS, Off-treatment Cycle 1, i.e. a subset of all FAS participants who completed the 7 months' induction treatment period of the first cycle and were enrolled in the off-treatment period (of the first cycle) and had at least one efficacy assessment (i.e. PSA or testosterone determination) during the off-treatment period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 240 mg / 80 mg | Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment | 392 days |
Secondary
Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment
Blood samples for analyses of serum testosterone levels were collected at the Screening Visit, Month 4 and 7 of the induction period of Cycle 1 and the corresponding visits of any additional treatment cycles, every two months during the off-treatment period(s), and at the End-of-Trial Visit. Analyses were performed using Liquid-Liquid Extraction and Liquid Chromatography-Mass Spectrometry/Mass Spectrometry.
Time frame: Up to 24 months after end of induction period
Population: FAS, Off-treatment Cycle 1.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 240 mg / 80 mg | Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment | 112 days |
Secondary
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment
This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. ULN=Upper limit of normal.
Time frame: Up to 3 x 31 months
Population: Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment | S-Creatinine, ≥177 (µmol/L) | 1 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment | S-Glutamyltransferase, >3xULN | 1 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment | S-Potassium, ≥5.8 mmol/L) | 3 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment | S-Total Bilirubin, >1.5xULN | 1 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment | S-Alanine Aminotransferase, >3xULN | 2 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment | S-Alkaline Phosphatase, >3xULN and 25% increase | 1 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment | S-Aspartate Aminotransferase, >3xULN | 2 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment | S-Calcium, ≤1.8 mmol/L | 1 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment | S-Urea Nitrogen, >10.7 mmol/L | 24 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment | S-Sodium, ≤130 mmol/L | 1 participants |
Secondary
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial.
Time frame: Up to 3 x 31 months
Population: Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment | Heart rate ≤50 and decrease ≥15 | 4 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment | Heart rate ≥120 and increase ≥15 | 0 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment | Body weight decrease of ≥7 percent | 14 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment | Systolic blood pressure ≤90 and decrease ≥20 | 4 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment | Systolic blood pressure ≥180 and increase ≥20 | 13 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment | Diastolic blood pressure ≤50 and decrease ≥15 | 2 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment | Diastolic blood pressure ≥105 and increase ≥15 | 8 participants |
| Degarelix 240 mg / 80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment | Body weight increase of ≥7 percent | 23 participants |
Secondary
Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD
Time frame: 7 months
Population: FAS, Cycle 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degarelix 240 mg / 80 mg | Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD | 210 participants |
Secondary
Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD
Time frame: 7 months
Population: FAS, Cycle 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Degarelix 240 mg / 80 mg | Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD | -90.8 percentage of baseline | Standard Deviation 16.6 |
Secondary
Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
The EORTC QLQ-PR25 employs a modular approach towards assessing cancer patients´ health-related Quality of Life (QoL) and assesses urinary, bowel, and sexual symptoms and functioning, and the side-effects of hormonal treatment. It consists of 25 questions distributed on six domains (number of items per domain, ranges from x to y: urinary symptoms (8, 0-100), bother due to use of incontinence aid (1, 0-100), bowel symptoms (4, 0-100), hormonal treatment-related symptoms (6, 0-100), sexual activity (2, 0-100), and sexual functioning (4, 0-100). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
Time frame: Up to 31 months
Population: FAS, Cycle 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Treatment-related Symptoms, End of Cycle 1 | 13.2 units on a scale | Standard Deviation 13 |
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Sexual Activity, End of Induction | 55.1 units on a scale | Standard Deviation 27.2 |
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Sexual Activity, End of Cycle 1 | 56.7 units on a scale | Standard Deviation 26.6 |
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Sexual Functioning, End of Induction | 10.9 units on a scale | Standard Deviation 17.7 |
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Sexual Functioning, End of Cycle 1 | 17.7 units on a scale | Standard Deviation 22.6 |
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Urinary Symptoms, End of Induction | 24.5 units on a scale | Standard Deviation 18 |
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Urinary Symptoms, End of Cycle 1 | 21.2 units on a scale | Standard Deviation 16.7 |
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Bother, End of Induction | 17.9 units on a scale | Standard Deviation 29.1 |
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Bother, End of Cycle 1 | 31 units on a scale | Standard Deviation 34.4 |
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Bowel Symptoms, End of Induction | 4.84 units on a scale | Standard Deviation 10.2 |
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Bowel Symptoms, End of Cycle 1 | 4.98 units on a scale | Standard Deviation 8.34 |
| Degarelix 240 mg / 80 mg | Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Treatment-related Symptoms, End of Induction | 17.6 units on a scale | Standard Deviation 14.5 |
Secondary
Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD
The IIEF scale addresses the relevant domains of male sexual function (i.e. erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). The IIEF scale is psychometrically sound, and has been linguistically validated in multiple languages. The IIEF scale demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. It consists of the following domains (number of items per domain; ranges from x to y: erectile function (6; 1-30), orgasmic function (2; 0-10), sexual desire (2; 2-10), intercourse satisfaction (3; 0-15) and overall satisfaction (2; 2-10). For all domains, a higher score represents a better sexual function.
Time frame: Up to 31 months
Population: FAS, Cycle 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 240 mg / 80 mg | Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Erectile Function, End of Induction | 3.1 units on a scale | Standard Deviation 5 |
| Degarelix 240 mg / 80 mg | Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Erectile Function, End of Cycle 1 | 5.35 units on a scale | Standard Deviation 8.21 |
| Degarelix 240 mg / 80 mg | Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Orgasmic Function, End of Induction | 0.665 units on a scale | Standard Deviation 1.81 |
| Degarelix 240 mg / 80 mg | Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Orgasmic Function, End of Cycle 1 | 1.76 units on a scale | Standard Deviation 3.03 |
| Degarelix 240 mg / 80 mg | Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Sexual Desire, End of Induction | 2.84 units on a scale | Standard Deviation 1.47 |
| Degarelix 240 mg / 80 mg | Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Sexual Desire, End of Cycle 1 | 3.77 units on a scale | Standard Deviation 2.17 |
| Degarelix 240 mg / 80 mg | Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Intercourse Satisfaction, End of Induction | 0.801 units on a scale | Standard Deviation 2.21 |
| Degarelix 240 mg / 80 mg | Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Intercourse Satisfaction, End of Cycle 1 | 2.01 units on a scale | Standard Deviation 3.69 |
| Degarelix 240 mg / 80 mg | Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Overall Satisfaction, End of Induction | 4.5 units on a scale | Standard Deviation 2.9 |
| Degarelix 240 mg / 80 mg | Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD | Overall Satisfaction, End of Cycle 1 | 4.97 units on a scale | Standard Deviation 3.12 |