Prostate Cancer
Conditions
Brief summary
The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients. Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.
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 second and third doses of goserelin were administered on Days 31 and 59, respectively.
DRUGBicalutamide
On Day 0, three days before the first dose of goserelin on Day 3, patients began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 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
* Patient has given written informed consent before any trial-related activity is performed * Has a confirmed prostate cancer in which this type of treatment is needed.
Exclusion criteria
* Previous treatment for prostate cancer * Previous trans-urethral resection of the prostate * Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist. * Patients in need of external beam radiotherapy to be started at the same time as hormone therapy * Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk) * History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. * Hypersensitivity towards any component of the investigational product * Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer. * Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 | After treatment of 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit | After treatment of 4, 8 and 12 weeks compared to Baseline | Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec) |
| Change From Baseline in Residual Volume (Vresidual) at Each Visit | After treatment of 4, 8 and 12 weeks compared to Baseline | Uroflowmetry was used to quantify the residual volume (Vresidual; mL) |
| Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 | After 12 weeks treatment compared to Baseline | TRUS is a method of measuring the size of the prostate. |
| Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit | After treatment of 4, 8 and 12 weeks compared to Baseline | — |
| Change From Baseline in Total IPSS at Weeks 4 and 8 | After treatment of 4 and 8 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. |
| 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'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL. |
| 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 on participant with one abnormal value are presented, many more variables were included in the trial. |
| Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit | After treatment of 4, 8 and 12 weeks compared to Baseline | — |
Countries
Germany, Spain, United Kingdom
Participant flow
Recruitment details
The participants were recruited by outpatient urologists. 280 participants were to be randomised in a 3:1 ratio to one of two treatment groups (210 patients were to be treated with degarelix; 70 patients were to be treated with goserelin plus bicalutamide). The trial was stopped early due to poor recruitment.
Participants by arm
| Arm | Count |
|---|---|
| Degarelix 240 mg/80 mg Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL) | 27 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) Goserelin (3.6 mg) + bicalutamide (50 mg) | 13 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Selection Criteria Not Met | 2 | 0 |
Baseline characteristics
| Characteristic | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Total | Degarelix 240 mg/80 mg |
|---|---|---|---|
| Age Continuous | 71.0 years STANDARD_DEVIATION 8.39 | 70.3 years STANDARD_DEVIATION 8.49 | 69.9 years STANDARD_DEVIATION 8.68 |
| Body mass index | 26.8 kilogram per square meter STANDARD_DEVIATION 3.75 | 26.7 kilogram per square meter STANDARD_DEVIATION 3.91 | 26.7 kilogram per square meter STANDARD_DEVIATION 4.06 |
| Body weight | 78.2 kilogram STANDARD_DEVIATION 8.5 | 80.3 kilogram STANDARD_DEVIATION 12.5 | 81.4 kilogram STANDARD_DEVIATION 14 |
| Gleason Score 2-4 | 0 participants | 0 participants | 0 participants |
| Gleason Score 5-6 | 0 participants | 2 participants | 2 participants |
| Gleason Score 7-10 | 13 participants | 38 participants | 25 participants |
| 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 | 1 Participants | 1 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 | 12 Participants | 39 Participants | 27 Participants |
| Region of Enrollment Germany | 7 participants | 20 participants | 13 participants |
| Region of Enrollment Spain | 4 participants | 8 participants | 4 participants |
| Region of Enrollment United Kingdom | 2 participants | 12 participants | 10 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 40 Participants | 27 Participants |
| Stage of Prostate Cancer Localized | 0 participants | 4 participants | 4 participants |
| Stage of Prostate Cancer Locally Advanced | 1 participants | 5 participants | 4 participants |
| Stage of Prostate Cancer Metastatic | 4 participants | 14 participants | 10 participants |
| Stage of Prostate Cancer Not Classifiable | 8 participants | 17 participants | 9 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 27 | 7 / 13 |
| serious Total, serious adverse events | 0 / 27 | 1 / 13 |
Outcome results
Primary
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 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 12 weeks compared to Baseline
Population: Full Analysis Set (FAS) + Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Degarelix 240 mg/80 mg | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 | -11.2 score on scale | Standard Deviation 8.29 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 | -7.69 score on scale | Standard Deviation 7.61 |
Comparison: Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.p-value: 0.197395% CI: [-7.51, 1.61]ANCOVA
Comparison: Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.p-value: 0.039895% CI: [-11.5, -0.291]ANCOVA
Secondary
Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit
Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)
Time frame: After treatment of 4, 8 and 12 weeks compared to Baseline
Population: FAS, LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 240 mg/80 mg | Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit | Week 4 | 3.63 mL/sec | Standard Deviation 7.82 |
| Degarelix 240 mg/80 mg | Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit | Week 8 | 4.74 mL/sec | Standard Deviation 6.6 |
| Degarelix 240 mg/80 mg | Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit | Week 12 | 3.62 mL/sec | Standard Deviation 7.37 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit | Week 4 | 3.55 mL/sec | Standard Deviation 3.8 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit | Week 8 | 3.52 mL/sec | Standard Deviation 3.58 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit | Week 12 | 2.07 mL/sec | Standard Deviation 4.57 |
Comparison: Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.p-value: 0.815195% CI: [-5.33, 4.22]ANCOVA
Comparison: Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.p-value: 0.45595% CI: [-2.46, 5.38]ANCOVA
Comparison: Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.p-value: 0.318695% CI: [-2.04, 6.08]ANCOVA
Secondary
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12
TRUS is a method of measuring the size of the prostate.
Time frame: After 12 weeks treatment compared to Baseline
Population: FAS, Observed Cases (OC).
| 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 | -22.4 mL | Standard Deviation 14.8 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 | -13.4 mL | Standard Deviation 10 |
Comparison: Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.p-value: 0.101895% CI: [-17.3, 1.64]ANCOVA
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'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.
Time frame: After treatment of 4, 8 and 12 weeks compared to Baseline
Population: FAS, OC.
| 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 | -0.96 score on scale | Standard Deviation 0.92 |
| Degarelix 240 mg/80 mg | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | Week 8 | -1.54 score on scale | Standard Deviation 1.42 |
| Degarelix 240 mg/80 mg | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | Week 12 | -1.77 score on scale | Standard Deviation 1.73 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | Week 4 | -0.54 score on scale | Standard Deviation 1.51 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | Week 8 | -0.73 score on scale | Standard Deviation 2.2 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | Week 12 | -0.55 score on scale | Standard Deviation 1.69 |
Secondary
Change From Baseline in Residual Volume (Vresidual) at Each Visit
Uroflowmetry was used to quantify the residual volume (Vresidual; mL)
Time frame: After treatment of 4, 8 and 12 weeks compared to Baseline
Population: FAS, LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 240 mg/80 mg | Change From Baseline in Residual Volume (Vresidual) at Each Visit | Week 4 | -36.2 mL | Standard Deviation 148 |
| Degarelix 240 mg/80 mg | Change From Baseline in Residual Volume (Vresidual) at Each Visit | Week 8 | -43.8 mL | Standard Deviation 133 |
| Degarelix 240 mg/80 mg | Change From Baseline in Residual Volume (Vresidual) at Each Visit | Week 12 | -50.7 mL | Standard Deviation 135 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Residual Volume (Vresidual) at Each Visit | Week 4 | -19.8 mL | Standard Deviation 63.5 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Residual Volume (Vresidual) at Each Visit | Week 8 | -19.6 mL | Standard Deviation 85.4 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Residual Volume (Vresidual) at Each Visit | Week 12 | -13.4 mL | Standard Deviation 85.8 |
Comparison: Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.p-value: 0.562795% CI: [-37.8, 68.2]ANCOVA
Comparison: Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.p-value: 0.828495% CI: [-49.1, 60.9]ANCOVA
Comparison: Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.p-value: 0.598495% CI: [-34.4, 58.8]ANCOVA
Secondary
Change From Baseline in Total IPSS at Weeks 4 and 8
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 and 8 weeks compared to Baseline
Population: FAS, LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Degarelix 240 mg/80 mg | Change From Baseline in Total IPSS at Weeks 4 and 8 | Week 4 | -7.31 score on scale | Standard Deviation 5.83 |
| Degarelix 240 mg/80 mg | Change From Baseline in Total IPSS at Weeks 4 and 8 | Week 8 | -9.46 score on scale | Standard Deviation 6.94 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Total IPSS at Weeks 4 and 8 | Week 4 | -4.62 score on scale | Standard Deviation 5.49 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Change From Baseline in Total IPSS at Weeks 4 and 8 | Week 8 | -8.08 score on scale | Standard Deviation 9 |
Comparison: Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.p-value: 0.229895% CI: [-6.58, 1.64]ANCOVA
Comparison: Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.p-value: 0.691795% CI: [-5.98, 4.02]ANCOVA
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 on participant with one abnormal value are presented, many more variables were included in the trial.
Time frame: Baseline to 12 weeks of treatment
Population: FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Platelet count (10^9/L) <=75 | 1 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Potassium (mmol/L) >=5.8 | 0 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Calcium (mmol/L) <=1.8 | 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 | 1 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haematocrit (Ratio) <=0.37 | 5 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 | 2 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Haematocrit (Ratio) <=0.37 | 1 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | B-Platelet count (10^9/L) <=75 | 0 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | S-Calcium (mmol/L) <=1.8 | 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 | 1 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: FAS. One participant in the degarelix group did not have any assessment of vital signs or body weight (the number of participants in this group is thus 26).
| 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 | 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 | Systolic blood pressure <=90 and decrease >=20 | 0 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 | 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 | 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 decrease of >=7 percent | 1 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 | 1 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 | 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 <=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 <=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 | 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 | 0 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 |
| 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 | Systolic blood pressure >=180 and increase >=20 | 0 participants |
Secondary
Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit
Time frame: After treatment of 4, 8 and 12 weeks compared to Baseline
Population: FAS, OC.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 240 mg/80 mg | Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit | Week 4 | 26 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit | Week 8 | 25 participants |
| Degarelix 240 mg/80 mg | Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit | Week 12 | 27 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit | Week 4 | 12 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit | Week 8 | 12 participants |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit | Week 12 | 12 participants |
Secondary
Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit
Time frame: After treatment of 4, 8 and 12 weeks compared to Baseline
Population: FAS, LOCF.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 240 mg/80 mg | Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit | Week 4 | -85.72 percentage |
| Degarelix 240 mg/80 mg | Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit | Week 8 | -89.2 percentage |
| Degarelix 240 mg/80 mg | Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit | Week 12 | -93.87 percentage |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit | Week 4 | -93.44 percentage |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit | Week 8 | -97.26 percentage |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) | Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit | Week 12 | -97.78 percentage |