Prostate Cancer
Conditions
Brief summary
This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume. The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.
Interventions
DRUGDegarelix
The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
DRUGGoserelin
Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
DRUGBicalutamide
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.
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
1. Patient has given written informed consent 2. Patient is 18 years or older 3. Patient has histologically confirmed prostate cancer 4. Patient has a serum prostate-specific antigen (PSA) level at screening \>2 ng/mL 5. The prostate size is \>30 cubic centimetres (cc), measured by TRUS 6. Patient has had a bone-scan within 12 weeks before inclusion 7. Patient must be able to undergo transrectal examinations 8. Patient has an estimated life expectancy of at least 12 months
Exclusion criteria
1. Any previous treatments for prostate cancer 2. Previous trans-urethral resection of the prostate (TURP) 3. Is not considered a candidate for medical castration 4. Use of urethral catheter 5. Is currently treated with a 5-alpha reductase inhibitor 6. Is currently treated with an alpha-adrenoceptor antagonist 7. Treatment with botulinum toxin A (Botox) 8. Require radiotherapy during the trial 9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema 10. Hypersensitivity towards any component of the investigational products or excipients 11. Previous history or presence of another malignancy 12. A clinically significant disorder 13. A corrected QT interval over 450 msec 14. Mental incapacity or language barrier precluding adequate understanding or co-operation 15. Receipt of an investigational drug within the last 28 days proceeding screening 16. Previous participation in any degarelix trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) | After treatment of 12 weeks compared to Baseline | TRUS is a method of measuring the size of the prostate. |
| Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) | After treatment of 12 weeks compared to Baseline | TRUS is a method of measuring the size of the prostate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Testosterone Levels During the Study | At 4, 8, and 12 weeks compared to baseline. | — |
| Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study | At 4, 8, and 12 weeks compared to baseline. | — |
| Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | After treatment of 4, 8, and 12 weeks compared to Baseline | The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). |
| Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8 | After treatment of 4 and 8 weeks compared to Baseline | TRUS is a method of measuring the size of the prostate. |
| Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Baseline to 12 weeks of 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. |
| Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | Baseline to 12 weeks of treatment | The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study. |
| Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII) | After treatment of 4, 8, and 12 weeks compared to Baseline | The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16. |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | After treatment of 4, 8, and 12 weeks compared to Baseline | The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic. |
Countries
Belgium, Denmark, Finland, Italy, Norway, Portugal, Sweden, Turkey (Türkiye)
Participant flow
Recruitment details
The participants were recruited by outpatient urologists. 180 participants were to be randomised in a 1:1 ratio to one of two treatment groups (90 participants were to be treated with degarelix; 90 participants were to be treated with goserelin plus bicalutamide). The recruitment period was August 2009 - December 2010.
Pre-assignment details
The apparent skewed number of actual participants in the two groups is due to the fact that randomisation was done in blocks per site rather than per study.
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 240 mg/80 mg The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | 82 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.
On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin. | 97 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Practical reasons | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 3 |
Baseline characteristics
| Characteristic | Total | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Degarelix 240 mg/80 mg |
|---|---|---|---|
| Age Continuous | 72.5 years STANDARD_DEVIATION 7.39 | 73.0 years STANDARD_DEVIATION 7.1 | 71.9 years STANDARD_DEVIATION 7.71 |
| Benign Prostatic Hyperplasia Impact Index (BPHII) | 4.80 scores on a scale STANDARD_DEVIATION 3.49 | 4.58 scores on a scale STANDARD_DEVIATION 3.58 | 5.06 scores on a scale STANDARD_DEVIATION 3.39 |
| Body Mass Index | 26.6 kilogram per square meter STANDARD_DEVIATION 3.88 | 26.5 kilogram per square meter STANDARD_DEVIATION 3.72 | 26.8 kilogram per square meter STANDARD_DEVIATION 4.07 |
| Body Weight | 79.7 kilogram STANDARD_DEVIATION 12.2 | 79.7 kilogram STANDARD_DEVIATION 12.2 | 79.7 kilogram STANDARD_DEVIATION 12.4 |
| Gleason Score Gleason Score 2-4 | 2 participants | 1 participants | 1 participants |
| Gleason Score Gleason Score 5-6 | 31 participants | 15 participants | 16 participants |
| Gleason Score Gleason Score 7-10 | 146 participants | 81 participants | 65 participants |
| Prostate Volume | 52.1 milliliter STANDARD_DEVIATION 21.1 | 49.9 milliliter STANDARD_DEVIATION 15.5 | 54.8 milliliter STANDARD_DEVIATION 26 |
| Quality of Life (QoL) Related to Urinary Symptoms | 2.79 scores on a scale STANDARD_DEVIATION 1.64 | 2.73 scores on a scale STANDARD_DEVIATION 1.66 | 2.85 scores on a scale STANDARD_DEVIATION 1.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 179 Participants | 97 Participants | 82 Participants |
| Region of Enrollment Belgium | 4 participants | 2 participants | 2 participants |
| Region of Enrollment Denmark | 28 participants | 15 participants | 13 participants |
| Region of Enrollment Finland | 31 participants | 17 participants | 14 participants |
| Region of Enrollment Italy | 42 participants | 22 participants | 20 participants |
| Region of Enrollment Norway | 12 participants | 8 participants | 4 participants |
| Region of Enrollment Portugal | 11 participants | 7 participants | 4 participants |
| Region of Enrollment Sweden | 23 participants | 12 participants | 11 participants |
| Region of Enrollment Turkey | 28 participants | 14 participants | 14 participants |
| Serum Protsate-Specific Antigen (PSA) Levels | 20.2 nanograms per milliliter | 15.6 nanograms per milliliter | 27.8 nanograms per milliliter |
| Serum Testosterone Levels | 4.23 nanograms per milliliter | 4.33 nanograms per milliliter | 4.08 nanograms per milliliter |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 179 Participants | 97 Participants | 82 Participants |
| Stage of Prostate Cancer Localized | 56 participants | 32 participants | 24 participants |
| Stage of Prostate Cancer Locally Advanced | 53 participants | 23 participants | 30 participants |
| Stage of Prostate Cancer Metastatic | 53 participants | 31 participants | 22 participants |
| Stage of Prostate Cancer Not Classifiable | 17 participants | 11 participants | 6 participants |
| Total International Prostate Symptom Score (IPSS) | 13.8 scores on a scale STANDARD_DEVIATION 7.15 | 13.4 scores on a scale STANDARD_DEVIATION 7.36 | 14.3 scores on a scale STANDARD_DEVIATION 6.91 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 84 | 47 / 98 |
| serious Total, serious adverse events | 1 / 84 | 7 / 98 |
Outcome results
Primary
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)
TRUS is a method of measuring the size of the prostate.
Time frame: After treatment of 12 weeks compared to Baseline
Population: Full Analysis Set (FAS), Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Degarelix 240 mg/80 mg | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) | -37.2 milliliter | Standard Deviation 16.8 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) | -39.0 milliliter | Standard Deviation 17.7 |
Comparison: Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.p-value: 0.3695% CI: [-2.78, 7.52]ANCOVA
Primary
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)
TRUS is a method of measuring the size of the prostate.
Time frame: After treatment of 12 weeks compared to Baseline
Population: Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Degarelix 240 mg/80 mg | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) | -37.3 milliliter | Standard Deviation 16.8 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) | -39.0 milliliter | Standard Deviation 18.4 |
Comparison: Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.p-value: 0.4195% CI: [-3.1, 7.58]ANCOVA
Secondary
Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)
The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16.
Time frame: After treatment of 4, 8, and 12 weeks compared to Baseline
Population: FAS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 240 mg/80 mg | Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII) | Week 4 | -0.78 scores on a scale | Standard Deviation 2.03 |
| Degarelix 240 mg/80 mg | Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII) | Week 8 | -0.88 scores on a scale | Standard Deviation 2.73 |
| Degarelix 240 mg/80 mg | Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII) | Week 12 | -1.28 scores on a scale | Standard Deviation 2.62 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII) | Week 4 | -0.70 scores on a scale | Standard Deviation 2.34 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII) | Week 8 | -1.09 scores on a scale | Standard Deviation 2.48 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII) | Week 12 | -1.16 scores on a scale | Standard Deviation 2.67 |
Secondary
Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8
TRUS is a method of measuring the size of the prostate.
Time frame: After treatment of 4 and 8 weeks compared to Baseline
Population: FAS, Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 240 mg/80 mg | Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8 | Week 4 | -19.2 milliliter | Standard Deviation 15.2 |
| Degarelix 240 mg/80 mg | Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8 | Week 8 | -33.1 milliliter | Standard Deviation 14.8 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8 | Week 4 | -21.2 milliliter | Standard Deviation 17.7 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8 | Week 8 | -33.2 milliliter | Standard Deviation 20.6 |
Secondary
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit
The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').
Time frame: After treatment of 4, 8, and 12 weeks compared to Baseline
Population: FAS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 240 mg/80 mg | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | Week 4 | -0.46 scores on a scale | Standard Deviation 1.43 |
| Degarelix 240 mg/80 mg | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | Week 8 | -0.83 scores on a scale | Standard Deviation 1.62 |
| Degarelix 240 mg/80 mg | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | Week 12 | -0.99 scores on a scale | Standard Deviation 1.64 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | Week 4 | -0.56 scores on a scale | Standard Deviation 1.3 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | Week 8 | -0.79 scores on a scale | Standard Deviation 1.37 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | Week 12 | -1.01 scores on a scale | Standard Deviation 1.38 |
Secondary
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12
The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Time frame: After treatment of 4, 8, and 12 weeks compared to Baseline
Population: FAS, Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 240 mg/80 mg | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Week 4 | -2.09 scores on a scale | Standard Deviation 4.36 |
| Degarelix 240 mg/80 mg | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Week 8 | -3.55 scores on a scale | Standard Deviation 5.95 |
| Degarelix 240 mg/80 mg | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Week 12 | -4.39 scores on a scale | Standard Deviation 6.66 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Week 4 | -1.36 scores on a scale | Standard Deviation 5.86 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Week 8 | -3.13 scores on a scale | Standard Deviation 6.06 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | Week 12 | -2.74 scores on a scale | Standard Deviation 6.37 |
Secondary
Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study
Time frame: At 4, 8, and 12 weeks compared to baseline.
Population: FAS.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 240 mg/80 mg | Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study | Week 4 | -20.25 nanograms per milliliter |
| Degarelix 240 mg/80 mg | Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study | Week 8 | -22.5 nanograms per milliliter |
| Degarelix 240 mg/80 mg | Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study | Week 12 | -25.15 nanograms per milliliter |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study | Week 4 | -12.10 nanograms per milliliter |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study | Week 8 | -14.6 nanograms per milliliter |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study | Week 12 | -13.1 nanograms per milliliter |
Secondary
Change in Serum Testosterone Levels During the Study
Time frame: At 4, 8, and 12 weeks compared to baseline.
Population: FAS.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 240 mg/80 mg | Change in Serum Testosterone Levels During the Study | Week 12 | -4.09 nanograms per milliliter |
| Degarelix 240 mg/80 mg | Change in Serum Testosterone Levels During the Study | Week 4 | -3.91 nanograms per milliliter |
| Degarelix 240 mg/80 mg | Change in Serum Testosterone Levels During the Study | Week 8 | -3.97 nanograms per milliliter |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change in Serum Testosterone Levels During the Study | Week 8 | -4.24 nanograms per milliliter |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change in Serum Testosterone Levels During the Study | Week 12 | -4.23 nanograms per milliliter |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change in Serum Testosterone Levels During the Study | Week 4 | -4.17 nanograms per milliliter |
Secondary
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Time frame: Baseline to 12 weeks of treatment
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 | S-Alanine aminotransferase (IU/L) >3xULN | 1 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Red blood cell count (10^12/L) <=3.5 | 1 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alkaline phosphatase (IU/L) >3xULN+25% increase | 0 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haematocrit (Ratio) <=0.37 | 13 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Aspartate aminotransferase (IU/L) >3xULN | 0 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haemoglobin (g/L) <=115 | 2 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Cholesterol (mmol/L) >=8.0 | 2 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-White blood cell count (10^9/L) <=2.8 | 3 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Glutamyltransferase (IU/L) >3xULN | 1 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Urea nitrogen (mmol/L) >=10.7 | 10 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Potassium (mmol/L) >=5.8 | 3 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Urea nitrogen (mmol/L) >=10.7 | 3 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haemoglobin (g/L) <=115 | 1 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Glutamyltransferase (IU/L) >3xULN | 0 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Potassium (mmol/L) >=5.8 | 3 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Red blood cell count (10^12/L) <=3.5 | 0 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-White blood cell count (10^9/L) <=2.8 | 1 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alanine aminotransferase (IU/L) >3xULN | 2 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Alkaline phosphatase (IU/L) >3xULN+25% increase | 1 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Aspartate aminotransferase (IU/L) >3xULN | 2 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Cholesterol (mmol/L) >=8.0 | 0 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haematocrit (Ratio) <=0.37 | 16 participants |
Secondary
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
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.
Time frame: Baseline to 12 weeks of treatment
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 | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 1 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 2 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 0 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | 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 | Body weight increase of >=7 percent | 2 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight increase of >=7 percent | 3 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Diastolic blood pressure >=105 and increase >=15 | 1 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure >=180 and increase >=20 | 4 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate <=50 and decrease >=15 | 0 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Heart rate >=120 and increase >=15 | 0 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Body weight decrease of >=7 percent | 5 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |