Trial Outcomes & Findings for Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer (NCT NCT00833248)

NCT ID: NCT00833248

Last Updated: 2012-10-04

Results Overview

TRUS is a method of measuring the size of the prostate.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 246 participants
• Primary outcome timeframe: After treatment of 12 weeks compared to Baseline
• Results posted on: 2012-10-04

Participant Flow

The participants were recruited by outpatient urologists, radiotherapists or oncologists. A total of 240 patients were to be randomised in a 3:1 ratio to one of two treatment groups (180 participants were to be treated with degarelix; 60 participants were to be treated with goserelin+bicalutamide). The recruitment period was April 2009 - June 2011.

Participant milestones

Measure	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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Overall Study STARTED	181	65
Overall Study Full Analysis Set (FAS)	180	64
Overall Study Per Protocol (PP) Analysis Set	164	57
Overall Study Safety Analysis Set	181	64
Overall Study COMPLETED	177	62
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Overall Study Adverse Event	3	0
Overall Study Protocol Violation	1	2
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer

Baseline characteristics by cohort

Measure	Degarelix 240 mg/80 mg n=180 Participants 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=64 Participants On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.	Total n=244 Participants Total of all reporting groups
Age Continuous	70.6 years STANDARD_DEVIATION 6.37 • n=5 Participants	70.8 years STANDARD_DEVIATION 5.96 • n=7 Participants	70.6 years STANDARD_DEVIATION 6.25 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	180 Participants n=5 Participants	64 Participants n=7 Participants	244 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	163 Participants n=5 Participants	61 Participants n=7 Participants	224 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	16 participants n=7 Participants	61 participants n=5 Participants
Region of Enrollment France	60 participants n=5 Participants	22 participants n=7 Participants	82 participants n=5 Participants
Region of Enrollment Greece	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Spain	9 participants n=5 Participants	3 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Netherlands	11 participants n=5 Participants	2 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Germany	9 participants n=5 Participants	4 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment United Kingdom	41 participants n=5 Participants	15 participants n=7 Participants	56 participants n=5 Participants
Body Weight	83.6 kilogram STANDARD_DEVIATION 14.2 • n=5 Participants	80.9 kilogram STANDARD_DEVIATION 12.4 • n=7 Participants	82.9 kilogram STANDARD_DEVIATION 13.8 • n=5 Participants
Body Mass Index	27.8 kilogram per square meter STANDARD_DEVIATION 3.99 • n=5 Participants	26.8 kilogram per square meter STANDARD_DEVIATION 3.69 • n=7 Participants	27.5 kilogram per square meter STANDARD_DEVIATION 3.93 • n=5 Participants
Gleason Score Gleason Score 2-6	41 participants n=5 Participants	12 participants n=7 Participants	53 participants n=5 Participants
Gleason Score Gleason Score 7	97 participants n=5 Participants	42 participants n=7 Participants	139 participants n=5 Participants
Gleason Score Gleason Score 8-10	42 participants n=5 Participants	10 participants n=7 Participants	52 participants n=5 Participants
Stage of Prostate Cancer Localized	111 participants n=5 Participants	41 participants n=7 Participants	152 participants n=5 Participants
Stage of Prostate Cancer Locally Advanced	63 participants n=5 Participants	20 participants n=7 Participants	83 participants n=5 Participants
Stage of Prostate Cancer Metastatic	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Stage of Prostate Cancer Not Classifiable	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Serum Testosterone Levels	3.92 nanograms per milliliter n=5 Participants	4.42 nanograms per milliliter n=7 Participants	4.06 nanograms per milliliter n=5 Participants
Serum Prostate-Specific Antigen (PSA) Levels	10 nanograms per millilter n=5 Participants	9.75 nanograms per millilter n=7 Participants	9.95 nanograms per millilter n=5 Participants
Serum Oestradiol Levels	1.9 nanograms per deciliter n=5 Participants	1.9 nanograms per deciliter n=7 Participants	1.9 nanograms per deciliter n=5 Participants
Prostate Volume	50.9 milliliter STANDARD_DEVIATION 20.3 • n=5 Participants	52.5 milliliter STANDARD_DEVIATION 18.8 • n=7 Participants	51.3 milliliter STANDARD_DEVIATION 19.9 • n=5 Participants
Total International Prostate Symptom Score (IPSS)	9.5 scores on a scale STANDARD_DEVIATION 6.71 • n=5 Participants	8.46 scores on a scale STANDARD_DEVIATION 6.3 • n=7 Participants	9.23 scores on a scale STANDARD_DEVIATION 6.61 • n=5 Participants
Quality of Life (QoL) Related to Urinary Symptoms	2.27 scores on a scale STANDARD_DEVIATION 1.63 • n=5 Participants	1.94 scores on a scale STANDARD_DEVIATION 1.56 • n=7 Participants	2.19 scores on a scale STANDARD_DEVIATION 1.62 • n=5 Participants

PRIMARY outcome

Timeframe: After treatment of 12 weeks compared to Baseline

Population: FAS, Observed Case (OC) i.e. only participants with a reported value were included in the analysis.

TRUS is a method of measuring the size of the prostate.

Outcome measures

Measure	Degarelix 240 mg/80 mg n=176 Participants 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=62 Participants On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)	-36.0 milliliter Standard Deviation 14.5	-35.3 milliliter Standard Deviation 16.7

PRIMARY outcome

Timeframe: After treatment of 12 weeks compared to Baseline

Population: FAS, OC.

TRUS is a method of measuring the size of the prostate.

Outcome measures

Measure	Degarelix 240 mg/80 mg n=154 Participants 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=54 Participants On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)	-36.2 milliliter Standard Deviation 14.5	-35.4 milliliter Standard Deviation 16.9

SECONDARY outcome

Timeframe: After treatment of 4, 8, and 12 weeks compared to Baseline

Population: FAS, OC.

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.

Outcome measures

Measure	Degarelix 240 mg/80 mg n=177 Participants 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=63 Participants On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 Week 4	-0.21 scores on a scale Standard Deviation 5.05	0.36 scores on a scale Standard Deviation 4.83
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 Week 8	-1.53 scores on a scale Standard Deviation 5.43	0.02 scores on a scale Standard Deviation 5.41
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 Week 12	-1.71 scores on a scale Standard Deviation 5.54	0.11 scores on a scale Standard Deviation 5.13

SECONDARY outcome

Timeframe: After treatment of 4, 8, and 12 weeks compared to Baseline

Population: FAS, OC.

Outcome measures

Measure	Degarelix 240 mg/80 mg n=170 Participants 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=63 Participants On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Change From Baseline in Serum Testosterone Levels During the Study Week 4	-3.8 nanograms per milliliter Interval -11.06 to -0.51	-4.22 nanograms per milliliter Interval -8.06 to 0.52
Change From Baseline in Serum Testosterone Levels During the Study Week 8	-3.77 nanograms per milliliter Interval -11.01 to -0.51	-4.26 nanograms per milliliter Interval -8.11 to -0.14
Change From Baseline in Serum Testosterone Levels During the Study Week 12	-3.81 nanograms per milliliter Interval -11.09 to -0.51	-4.3 nanograms per milliliter Interval -8.11 to -0.14

SECONDARY outcome

Timeframe: After treatment of 4, 8, and 12 weeks compared to Baseline

Population: FAS, OC.

Outcome measures

Measure	Degarelix 240 mg/80 mg n=172 Participants 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=62 Participants On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study Week 12	-8.35 nanograms per milliliter Interval -338.0 to -2.0	-9.05 nanograms per milliliter Interval -78.8 to -1.8
Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study Week 4	-6.3 nanograms per milliliter Interval -333.0 to 4.5	-5.9 nanograms per milliliter Interval -76.0 to 4.0
Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study Week 8	-7.95 nanograms per milliliter Interval -337.0 to -2.0	-8.8 nanograms per milliliter Interval -79.4 to -1.7

SECONDARY outcome

Timeframe: After treatment of 4, 8, and 12 weeks compared to Baseline

Population: FAS, OC.

Outcome measures

Measure	Degarelix 240 mg/80 mg n=124 Participants 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=36 Participants On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Change From Baseline in Serum Oestradiol Levels During the Study Week 4	-1.55 nanogram per deciliter Interval -4.35 to -0.63	-1.65 nanogram per deciliter Interval -3.5 to -0.9
Change From Baseline in Serum Oestradiol Levels During the Study Week 8	-1.6 nanogram per deciliter Interval -3.6 to -0.27	-1.65 nanogram per deciliter Interval -3.55 to -0.95
Change From Baseline in Serum Oestradiol Levels During the Study Week 12	-1.55 nanogram per deciliter Interval -4.35 to -0.48	-1.6 nanogram per deciliter Interval -3.55 to -0.8

SECONDARY outcome

Timeframe: After treatment of 4, 8, and 12 weeks compared to Baseline

Population: FAS, OC.

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').

Outcome measures

Measure	Degarelix 240 mg/80 mg n=179 Participants 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=63 Participants On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit Week 4	-0.07 scores on a scale Standard Deviation 1.31	0.16 scores on a scale Standard Deviation 0.92
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit Week 8	-0.24 scores on a scale Standard Deviation 1.34	0.05 scores on a scale Standard Deviation 1.11
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit Week 12	-0.33 scores on a scale Standard Deviation 1.46	0.16 scores on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline to 12 weeks of treatment

Population: Safety analysis set.

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.

Outcome measures

Measure	Degarelix 240 mg/80 mg n=181 Participants 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=64 Participants On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Body weight increase of >=7 percent	5 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Diastolic blood pressure <=50 and decrease >=15	0 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Diastolic blood pressure >=105 and increase >=15	3 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Systolic blood pressure <=90 and decrease >=20	0 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Systolic blood pressure >=180 and increase >=20	1 participants	1 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Heart rate <=50 and decrease >=15	1 participants	1 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Heart rate >=120 and increase >=15	0 participants	0 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Body weight decrease of >=7 percent	3 participants	2 participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks of treatment

Population: Safety analysis set.

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.

Outcome measures

Measure	Degarelix 240 mg/80 mg n=181 Participants 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=64 Participants On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Haematocrit (Ratio) <=0.37	31 participants	8 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Haemoglobin (g/L) <=115	4 participants	1 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Alanine aminotransferase (IU/L) >3 x ULN	1 participants	1 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Potassium (mmol/L) >=5.8	4 participants	1 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Urea nitrogen (mmol/L) >=10.7	10 participants	3 participants

Adverse Events

Degarelix 240 mg/80 mg

Serious events: 7 serious events

Other events: 158 other events

Deaths: 0 deaths

Goserelin (3.6 mg) + Bicalutamide (50 mg)

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	Degarelix 240 mg/80 mg n=181 participants at risk 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=64 participants at risk On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Cardiac disorders Atrial fibrillation	0.55% 1/181 • Number of events 1 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Eye disorders Retinal detachment	0.55% 1/181 • Number of events 1 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Investigations Alanine aminotransferase increased	0.55% 1/181 • Number of events 1 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Investigations Aspartate aminotransferase increased	0.55% 1/181 • Number of events 1 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Investigations Blood alkaline phosphatase increased	0.55% 1/181 • Number of events 1 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Investigations Gamma-glutamyltransferase increased	0.55% 1/181 • Number of events 1 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.55% 1/181 • Number of events 1 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.55% 1/181 • Number of events 1 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.55% 1/181 • Number of events 1 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Renal and urinary disorders Urinary retention	0.55% 1/181 • Number of events 1 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.

Other adverse events

Measure	Degarelix 240 mg/80 mg n=181 participants at risk 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.	Goserelin (3.6 mg) + Bicalutamide (50 mg) n=64 participants at risk On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
General disorders Injection site pain	33.1% 60/181 • Number of events 93 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	1.6% 1/64 • Number of events 1 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
General disorders Injection site erythema	24.9% 45/181 • Number of events 73 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
General disorders Asthenia	7.2% 13/181 • Number of events 15 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	9.4% 6/64 • Number of events 6 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
General disorders Injection site pruritus	7.2% 13/181 • Number of events 19 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
General disorders Fatigue	6.1% 11/181 • Number of events 13 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	9.4% 6/64 • Number of events 6 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
General disorders Injection site swelling	6.1% 11/181 • Number of events 17 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	0.00% 0/64 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Psychiatric disorders Libido decreased	6.6% 12/181 • Number of events 12 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	6.2% 4/64 • Number of events 4 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Renal and urinary disorders Pollakiuria	6.1% 11/181 • Number of events 13 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	6.2% 4/64 • Number of events 4 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Reproductive system and breast disorders Erectile dysfunction	7.7% 14/181 • Number of events 15 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	10.9% 7/64 • Number of events 7 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
Vascular disorders Hot flush	59.7% 108/181 • Number of events 132 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.	62.5% 40/64 • Number of events 46 • 12 weeks. Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.

Additional Information

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Restriction type: OTHER