Trial Outcomes & Findings for Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients (NCT NCT00884273)

NCT ID: NCT00884273

Last Updated: 2013-11-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 182 participants
• Primary outcome timeframe: After treatment of 12 weeks compared to Baseline
• Results posted on: 2013-11-13

Participant Flow

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.

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.

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) 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.
Overall Study STARTED	84	98
Overall Study Full Analysis Set (FAS)	82	97
Overall Study Per Protocol (PP) Analysis Set	81	92
Overall Study Safety Analysis Set	84	98
Overall Study COMPLETED	82	93
Overall Study NOT COMPLETED	2	5

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) 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.
Overall Study Adverse Event	0	2
Overall Study Protocol Violation	1	3
Overall Study Practical reasons	1	0

Baseline Characteristics

Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients

Baseline characteristics by cohort

Measure	Degarelix 240 mg/80 mg n=82 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=97 Participants 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.	Total n=179 Participants Total of all reporting groups
Age Continuous	71.9 years STANDARD_DEVIATION 7.71 • n=93 Participants	73.0 years STANDARD_DEVIATION 7.10 • n=4 Participants	72.5 years STANDARD_DEVIATION 7.39 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	82 Participants n=93 Participants	97 Participants n=4 Participants	179 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	82 Participants n=93 Participants	97 Participants n=4 Participants	179 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Portugal	4 participants n=93 Participants	7 participants n=4 Participants	11 participants n=27 Participants
Region of Enrollment Finland	14 participants n=93 Participants	17 participants n=4 Participants	31 participants n=27 Participants
Region of Enrollment Belgium	2 participants n=93 Participants	2 participants n=4 Participants	4 participants n=27 Participants
Region of Enrollment Turkey	14 participants n=93 Participants	14 participants n=4 Participants	28 participants n=27 Participants
Region of Enrollment Denmark	13 participants n=93 Participants	15 participants n=4 Participants	28 participants n=27 Participants
Region of Enrollment Norway	4 participants n=93 Participants	8 participants n=4 Participants	12 participants n=27 Participants
Region of Enrollment Italy	20 participants n=93 Participants	22 participants n=4 Participants	42 participants n=27 Participants
Region of Enrollment Sweden	11 participants n=93 Participants	12 participants n=4 Participants	23 participants n=27 Participants
Body Weight	79.7 kilogram STANDARD_DEVIATION 12.4 • n=93 Participants	79.7 kilogram STANDARD_DEVIATION 12.2 • n=4 Participants	79.7 kilogram STANDARD_DEVIATION 12.2 • n=27 Participants
Body Mass Index	26.8 kilogram per square meter STANDARD_DEVIATION 4.07 • n=93 Participants	26.5 kilogram per square meter STANDARD_DEVIATION 3.72 • n=4 Participants	26.6 kilogram per square meter STANDARD_DEVIATION 3.88 • n=27 Participants
Gleason Score Gleason Score 2-4	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants
Gleason Score Gleason Score 5-6	16 participants n=93 Participants	15 participants n=4 Participants	31 participants n=27 Participants
Gleason Score Gleason Score 7-10	65 participants n=93 Participants	81 participants n=4 Participants	146 participants n=27 Participants
Stage of Prostate Cancer Localized	24 participants n=93 Participants	32 participants n=4 Participants	56 participants n=27 Participants
Stage of Prostate Cancer Locally Advanced	30 participants n=93 Participants	23 participants n=4 Participants	53 participants n=27 Participants
Stage of Prostate Cancer Metastatic	22 participants n=93 Participants	31 participants n=4 Participants	53 participants n=27 Participants
Stage of Prostate Cancer Not Classifiable	6 participants n=93 Participants	11 participants n=4 Participants	17 participants n=27 Participants
Serum Testosterone Levels	4.08 nanograms per milliliter n=93 Participants	4.33 nanograms per milliliter n=4 Participants	4.23 nanograms per milliliter n=27 Participants
Serum Protsate-Specific Antigen (PSA) Levels	27.8 nanograms per milliliter n=93 Participants	15.6 nanograms per milliliter n=4 Participants	20.2 nanograms per milliliter n=27 Participants
Prostate Volume	54.8 milliliter STANDARD_DEVIATION 26.0 • n=93 Participants	49.9 milliliter STANDARD_DEVIATION 15.5 • n=4 Participants	52.1 milliliter STANDARD_DEVIATION 21.1 • n=27 Participants
Total International Prostate Symptom Score (IPSS)	14.3 scores on a scale STANDARD_DEVIATION 6.91 • n=93 Participants	13.4 scores on a scale STANDARD_DEVIATION 7.36 • n=4 Participants	13.8 scores on a scale STANDARD_DEVIATION 7.15 • n=27 Participants
Quality of Life (QoL) Related to Urinary Symptoms	2.85 scores on a scale STANDARD_DEVIATION 1.62 • n=93 Participants	2.73 scores on a scale STANDARD_DEVIATION 1.66 • n=4 Participants	2.79 scores on a scale STANDARD_DEVIATION 1.64 • n=27 Participants
Benign Prostatic Hyperplasia Impact Index (BPHII)	5.06 scores on a scale STANDARD_DEVIATION 3.39 • n=93 Participants	4.58 scores on a scale STANDARD_DEVIATION 3.58 • n=4 Participants	4.80 scores on a scale STANDARD_DEVIATION 3.49 • n=27 Participants

PRIMARY outcome

Timeframe: After treatment of 12 weeks compared to Baseline

Population: Full Analysis Set (FAS), Last Observation Carried Forward (LOCF).

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

Outcome measures

Measure	Degarelix 240 mg/80 mg n=82 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=97 Participants 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.
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	-39.0 milliliter Standard Deviation 17.7

PRIMARY outcome

Timeframe: After treatment of 12 weeks compared to Baseline

Population: Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).

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

Outcome measures

Measure	Degarelix 240 mg/80 mg n=81 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=92 Participants 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.
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	-39.0 milliliter Standard Deviation 18.4

SECONDARY outcome

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

Population: FAS, Last Observation Carried Forward (LOCF).

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

Outcome measures

Measure	Degarelix 240 mg/80 mg n=82 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=97 Participants 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.
Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8 Week 4	-19.2 milliliter Standard Deviation 15.2	-21.2 milliliter Standard Deviation 17.7
Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8 Week 8	-33.1 milliliter Standard Deviation 14.8	-33.2 milliliter Standard Deviation 20.6

SECONDARY outcome

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

Population: FAS, Last Observation Carried Forward (LOCF).

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=82 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=97 Participants 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.
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	-1.36 scores on a scale Standard Deviation 5.86
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	-3.13 scores on a scale Standard Deviation 6.06
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	-2.74 scores on a scale Standard Deviation 6.37

SECONDARY outcome

Timeframe: At 4, 8, and 12 weeks compared to baseline.

Population: FAS.

Outcome measures

Measure	Degarelix 240 mg/80 mg n=82 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=97 Participants 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.
Change in Serum Testosterone Levels During the Study Week 4	-3.91 nanograms per milliliter Interval -10.62 to -0.2	-4.17 nanograms per milliliter Interval -9.3 to 0.03
Change in Serum Testosterone Levels During the Study Week 8	-3.97 nanograms per milliliter Interval -10.61 to -0.12	-4.24 nanograms per milliliter Interval -9.44 to -0.08
Change in Serum Testosterone Levels During the Study Week 12	-4.09 nanograms per milliliter Interval -10.58 to 0.0	-4.23 nanograms per milliliter Interval -9.31 to -0.03

SECONDARY outcome

Timeframe: At 4, 8, and 12 weeks compared to baseline.

Population: FAS.

Outcome measures

Measure	Degarelix 240 mg/80 mg n=82 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=97 Participants 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.
Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study Week 4	-20.25 nanograms per milliliter Interval -4205.0 to 4.5	-12.10 nanograms per milliliter Interval -2823.0 to 3.3
Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study Week 8	-22.5 nanograms per milliliter Interval -6192.0 to 4.3	-14.6 nanograms per milliliter Interval -2828.0 to -2.0
Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study Week 12	-25.15 nanograms per milliliter Interval -6195.0 to 4.7	-13.1 nanograms per milliliter Interval -2815.0 to -1.2

SECONDARY outcome

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

Population: FAS.

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=82 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=97 Participants 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.
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	-0.56 scores on a scale Standard Deviation 1.30
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	-0.79 scores on a scale Standard Deviation 1.37
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	-1.01 scores on a scale Standard Deviation 1.38

SECONDARY outcome

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

Population: FAS.

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.

Outcome measures

Measure	Degarelix 240 mg/80 mg n=82 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=97 Participants 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.
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	-0.70 scores on a scale Standard Deviation 2.34
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	-1.09 scores on a scale Standard Deviation 2.48
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	-1.16 scores on a scale Standard Deviation 2.67

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=84 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=98 Participants 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.
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	0 participants	1 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	2 participants	4 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Heart rate <=50 and decrease >=15	1 participants	0 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	0 participants	5 participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Body weight increase of >=7 percent	2 participants	3 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=84 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=98 Participants 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.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Haematocrit (Ratio) <=0.37	13 participants	16 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Haemoglobin (g/L) <=115	2 participants	1 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-Red blood cell count (10^12/L) <=3.5	1 participants	0 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables B-White blood cell count (10^9/L) <=2.8	3 participants	1 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Alanine aminotransferase (IU/L) >3xULN	1 participants	2 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Alkaline phosphatase (IU/L) >3xULN+25% increase	0 participants	1 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Aspartate aminotransferase (IU/L) >3xULN	0 participants	2 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Cholesterol (mmol/L) >=8.0	2 participants	0 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Glutamyltransferase (IU/L) >3xULN	1 participants	0 participants
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables S-Potassium (mmol/L) >=5.8	3 participants	3 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: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Goserelin (3.6 mg) + Bicalutamide (50 mg)

Serious events: 7 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	Degarelix 240 mg/80 mg n=84 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=98 participants at risk 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.
Cardiac disorders Cardiac failure	0.00% 0/84 • 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.	2.0% 2/98 • Number of events 2 • 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.
Gastrointestinal disorders Gastric ulcer	0.00% 0/84 • 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.	1.0% 1/98 • 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 Catheter related complication	1.2% 1/84 • 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% 0/98 • 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.
Infections and infestations Pneumonia	0.00% 0/84 • 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.	2.0% 2/98 • Number of events 2 • 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.
Infections and infestations Staphylococcal sepsis	0.00% 0/84 • 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.	1.0% 1/98 • 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.
Investigations Haemoglobin decreased	0.00% 0/84 • 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.	1.0% 1/98 • 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.
Metabolism and nutrition disorders Gout	0.00% 0/84 • 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.	1.0% 1/98 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/84 • 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.	1.0% 1/98 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.00% 0/84 • 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.	1.0% 1/98 • 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.
Nervous system disorders Transient ischaemic attack	0.00% 0/84 • 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.	1.0% 1/98 • 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.
Renal and urinary disorders Ureteric obstruction	1.2% 1/84 • 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% 0/98 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/84 • 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.	1.0% 1/98 • 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.

Other adverse events

Measure	Degarelix 240 mg/80 mg n=84 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=98 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.00% 0/84 • 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.	2.0% 2/98 • Number of events 2 • 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.
Cardiac disorders Cardiac failure	0.00% 0/84 • 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.	2.0% 2/98 • Number of events 2 • 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.
Cardiac disorders Atrial fibrillation	0.00% 0/84 • 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.	2.0% 2/98 • Number of events 2 • 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.
Gastrointestinal disorders Gastric ulcer	0.00% 0/84 • 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.	2.0% 2/98 • Number of events 2 • 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 pain	14.3% 12/84 • Number of events 20 • 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% 0/98 • 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	3.6% 3/84 • 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.	0.00% 0/98 • 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	3.6% 3/84 • 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.	0.00% 0/98 • 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	2.4% 2/84 • Number of events 2 • 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.	1.0% 1/98 • 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 induration	2.4% 2/84 • 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.	0.00% 0/98 • 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 inflammation	2.4% 2/84 • Number of events 2 • 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% 0/98 • 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	2.4% 2/84 • Number of events 2 • 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% 0/98 • 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.
Infections and infestations Pneumonia	0.00% 0/84 • 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.	3.1% 3/98 • Number of events 3 • 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.
Infections and infestations Urinary tract infection	0.00% 0/84 • 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.	2.0% 2/98 • Number of events 2 • 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 Weight decreased	1.2% 1/84 • 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.	3.1% 3/98 • Number of events 3 • 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	0.00% 0/84 • 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.	2.0% 2/98 • Number of events 2 • 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 Weight increased	0.00% 0/84 • 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.	2.0% 2/98 • Number of events 2 • 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 Back pain	2.4% 2/84 • Number of events 2 • 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.	2.0% 2/98 • Number of events 2 • 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 Myalgia	1.2% 1/84 • 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.	2.0% 2/98 • Number of events 2 • 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.
Nervous system disorders Headache	3.6% 3/84 • Number of events 3 • 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% 0/98 • 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	0.00% 0/84 • 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.	2.0% 2/98 • Number of events 2 • 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	4.8% 4/84 • Number of events 5 • 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.	4.1% 4/98 • 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.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.8% 4/84 • 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.	5.1% 5/98 • Number of events 5 • 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	9.5% 8/84 • Number of events 8 • 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.	17.3% 17/98 • 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.
Vascular disorders Flushing	1.2% 1/84 • 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.	2.0% 2/98 • Number of events 2 • 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 Hypertension	2.4% 2/84 • Number of events 2 • 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.	1.0% 1/98 • 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.

Additional Information

Ferring Pharmaceuticals

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Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
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Restriction type: OTHER