Trial Outcomes & Findings for A Study of Degarelix in Patients With Prostate Cancer (NCT NCT00928434)

NCT ID: NCT00928434

Last Updated: 2016-12-13

Results Overview

Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

409 participants

Primary outcome timeframe

At 14 month

Results posted on

2016-12-13

Participant Flow

Of the total 409 patients enrolled, six patients were not dosed either due to randomisation error, failing eligibility criteria or consent withdrawal after being randomised.

Participant milestones

Participant milestones
Measure	DI (Degarelix Intermittent) Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	DC (Degarelix Continuous) Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).	LC (Leuprolide Continuous) Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).
Overall Study STARTED	175	50	178
Overall Study Full Phase B Analysis Set	137	41	150
Overall Study COMPLETED	131	36	134
Overall Study NOT COMPLETED	44	14	44

Reasons for withdrawal

Reasons for withdrawal
Measure	DI (Degarelix Intermittent) Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	DC (Degarelix Continuous) Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).	LC (Leuprolide Continuous) Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).
Overall Study Adverse Event	14	5	18
Overall Study Protocol Violation	5	0	8
Overall Study Physician Decision	2	0	3
Overall Study Lost to Follow-up	1	0	3
Overall Study Withdrawal by Subject	5	3	2
Overall Study PSA failure (>2 ng/mL) at Visit 8	10	4	7
Overall Study PSA failure (>2 ng/mL) on other visit	2	1	1
Overall Study Other (not meeting above criteria)	5	1	2

Baseline Characteristics

A Study of Degarelix in Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DI (Degarelix Intermittent) n=175 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered. During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	DC (Degarelix Continuous) n=50 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).	LC (Leuprolide Continuous) n=178 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer's labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)	Total n=403 Participants Total of all reporting groups
Age, Continuous	71.9 Years STANDARD_DEVIATION 8.89 • n=5 Participants	71.7 Years STANDARD_DEVIATION 8.14 • n=7 Participants	71.0 Years STANDARD_DEVIATION 8.44 • n=5 Participants	71.5 Years STANDARD_DEVIATION 8.59 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	175 Participants n=5 Participants	50 Participants n=7 Participants	178 Participants n=5 Participants	403 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants	35 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=5 Participants	46 Participants n=7 Participants	164 Participants n=5 Participants	368 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	9 Participants n=7 Participants	38 Participants n=5 Participants	79 Participants n=4 Participants
Race (NIH/OMB) White	140 Participants n=5 Participants	39 Participants n=7 Participants	137 Participants n=5 Participants	316 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Height	1.77 Meter STANDARD_DEVIATION 0.089 • n=5 Participants	1.74 Meter STANDARD_DEVIATION 0.089 • n=7 Participants	1.76 Meter STANDARD_DEVIATION 0.080 • n=5 Participants	1.76 Meter STANDARD_DEVIATION 0.085 • n=4 Participants
Weight	90.3 Kg STANDARD_DEVIATION 19.4 • n=5 Participants	88.4 Kg STANDARD_DEVIATION 15.8 • n=7 Participants	91.9 Kg STANDARD_DEVIATION 16.9 • n=5 Participants	90.8 Kg STANDARD_DEVIATION 17.9 • n=4 Participants
Body Mass Index (BMI)	28.9 Kg/m^2 STANDARD_DEVIATION 5.45 • n=5 Participants	29.2 Kg/m^2 STANDARD_DEVIATION 4.89 • n=7 Participants	29.6 Kg/m^2 STANDARD_DEVIATION 4.94 • n=5 Participants	29.2 Kg/m^2 STANDARD_DEVIATION 5.16 • n=4 Participants
Prostate Specific Antigen (PSA)	16.4 ng/mL STANDARD_DEVIATION 66.3 • n=5 Participants	15.6 ng/mL STANDARD_DEVIATION 32.2 • n=7 Participants	10.7 ng/mL STANDARD_DEVIATION 24.4 • n=5 Participants	13.8 ng/mL STANDARD_DEVIATION 48 • n=4 Participants
Testosterone	3.65 ng/mL STANDARD_DEVIATION 1.43 • n=5 Participants	3.90 ng/mL STANDARD_DEVIATION 1.59 • n=7 Participants	3.76 ng/mL STANDARD_DEVIATION 1.58 • n=5 Participants	3.73 ng/mL STANDARD_DEVIATION 1.52 • n=4 Participants

PRIMARY outcome

Timeframe: At 14 month

Population: Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.

Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL	100 Percentage of patients Interval 97.3 to 100.0	98.4 Percentage of patients Interval 95.5 to 99.7	—	—

SECONDARY outcome

Timeframe: Phase A Visit 1-8 and Phase B Visit 9-15.

Absolute change from Baseline in serum PSA levels during the study period was measured.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Absolute Change From Baseline in Serum PSA Levels Phase B, Visit 15 (Month 14)	-6.74 ng/mL Standard Deviation 11	-14.8 ng/mL Standard Deviation 33.9	-8.6 ng/mL Standard Deviation 15.9	—
Absolute Change From Baseline in Serum PSA Levels Phase A, Visit 1 (Day 0)	NA ng/mL Standard Deviation NA This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.	-0.91 ng/mL Standard Deviation NA One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.	NA ng/mL Standard Deviation NA This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.	—
Absolute Change From Baseline in Serum PSA Levels Phase A, Visit 2 (Month 1)	-6.39 ng/mL Standard Deviation 10.2	-14.3 ng/mL Standard Deviation 34.8	-6.38 ng/mL Standard Deviation 13.2	—
Absolute Change From Baseline in Serum PSA Levels Phase A, Visit 3 (Month 2)	-6.94 ng/mL Standard Deviation 10.8	-14.8 ng/mL Standard Deviation 34.9	-8.12 ng/mL Standard Deviation 15.4	—
Absolute Change From Baseline in Serum PSA Levels Phase A, Visit 4 (Month 3)	-7.07 ng/mL Standard Deviation 10.9	-15 ng/mL Standard Deviation 35	-8.44 ng/mL Standard Deviation 15.7	—
Absolute Change From Baseline in Serum PSA Levels Phase A, Visit 5 (Month 4)	-7.16 ng/mL Standard Deviation 11	-15.1 ng/mL Standard Deviation 35.2	-8.51 ng/mL Standard Deviation 15.8	—
Absolute Change From Baseline in Serum PSA Levels Phase A, Visit 6 (Month 5)	-7.19 ng/mL Standard Deviation 11	-15.1 ng/mL Standard Deviation 35.2	-8.59 ng/mL Standard Deviation 15.9	—
Absolute Change From Baseline in Serum PSA Levels Phase A, Visit 7 (Month 6)	-7.21 ng/mL Standard Deviation 10.9	-15.1 ng/mL Standard Deviation 35.2	-8.64 ng/mL Standard Deviation 15.9	—
Absolute Change From Baseline in Serum PSA Levels Phase A, Visit 8 (Month 7)	-7.24 ng/mL Standard Deviation 11	-15.1 ng/mL Standard Deviation 35.2	-8.64 ng/mL Standard Deviation 15.9	—
Absolute Change From Baseline in Serum PSA Levels Phase B, Visit 9 (Month 8)	-7.25 ng/mL Standard Deviation 11	-15 ng/mL Standard Deviation 34.7	-8.64 ng/mL Standard Deviation 15.9	—
Absolute Change From Baseline in Serum PSA Levels Phase B, Visit 10 (Month 9)	-7.18 ng/mL Standard Deviation 11	-15 ng/mL Standard Deviation 34.7	-8.64 ng/mL Standard Deviation 15.9	—
Absolute Change From Baseline in Serum PSA Levels Phase B, Visit 11 (Month 10)	-7.07 ng/mL Standard Deviation 10.9	-14.9 ng/mL Standard Deviation 34.3	-8.63 ng/mL Standard Deviation 15.9	—
Absolute Change From Baseline in Serum PSA Levels Phase B, Visit 12 (Month 11)	-6.96 ng/mL Standard Deviation 10.9	-14.9 ng/mL Standard Deviation 33.9	-8.64 ng/mL Standard Deviation 15.9	—
Absolute Change From Baseline in Serum PSA Levels Phase B, Visit 13 (Month 12)	-6.81 ng/mL Standard Deviation 11	-14.8 ng/mL Standard Deviation 33.9	-8.64 ng/mL Standard Deviation 15.9	—
Absolute Change From Baseline in Serum PSA Levels Phase B, Visit 14 (Month 13)	-6.79 ng/mL Standard Deviation 11	-14.8 ng/mL Standard Deviation 33.9	-8.59 ng/mL Standard Deviation 16	—

SECONDARY outcome

Timeframe: Phase A Visit 1-8 and Phase B Visit 9-15.

Population: Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.

Percent change from Baseline in serum PSA levels during the study period was measured.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Percent Change From Baseline in Serum PSA Levels Phase A, Visit 2 (Month 1)	-80.8 Percent change Standard Deviation 24.4	-84.5 Percent change Standard Deviation 11.8	-62.8 Percent change Standard Deviation 31.2	—
Percent Change From Baseline in Serum PSA Levels Phase B, Visit 15 (Month 14)	-80.8 Percent change Standard Deviation 26.4	-94.4 Percent change Standard Deviation 12.9	-93.7 Percent change Standard Deviation 25.8	—
Percent Change From Baseline in Serum PSA Levels Phase A, Visit 1 (Day 0)	NA Percent change Standard Deviation NA This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.	-39.6 Percent change Standard Deviation NA One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.	NA Percent change Standard Deviation NA This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.	—
Percent Change From Baseline in Serum PSA Levels Phase A, Visit 3 (Month 2)	-90.4 Percent change Standard Deviation 12.2	-92.4 Percent change Standard Deviation 8.23	-87.3 Percent change Standard Deviation 12.3	—
Percent Change From Baseline in Serum PSA Levels Phase A, Visit 4 (Month 3)	-92.8 Percent change Standard Deviation 9.9	-94.5 Percent change Standard Deviation 7.37	-92.3 Percent change Standard Deviation 7.67	—
Percent Change From Baseline in Serum PSA Levels Phase A, Visit 5 (Month 4)	-94.1 Percent change Standard Deviation 8.45	-95.5 Percent change Standard Deviation 7.05	-93.4 Percent change Standard Deviation 9.39	—
Percent Change From Baseline in Serum PSA Levels Phase A, Visit 6 (Month 5)	-94.2 Percent change Standard Deviation 9.31	-95.7 Percent change Standard Deviation 7.8	-94.5 Percent change Standard Deviation 7.52	—
Percent Change From Baseline in Serum PSA Levels Phase A, Visit 7 (Month 6)	-94.8 Percent change Standard Deviation 8.34	-95.8 Percent change Standard Deviation 8.64	-95.3 Percent change Standard Deviation 7.23	—
Percent Change From Baseline in Serum PSA Levels Phase A, Visit 8 (Month 7)	-95.4 Percent change Standard Deviation 7.13	-95.4 Percent change Standard Deviation 10.8	-95.5 Percent change Standard Deviation 7.62	—
Percent Change From Baseline in Serum PSA Levels Phase B, Visit 9 (Month 8)	-95.7 Percent change Standard Deviation 6.97	-95.5 Percent change Standard Deviation 10.3	-95.2 Percent change Standard Deviation 12.3	—
Percent Change From Baseline in Serum PSA Levels Phase B, Visit 10 (Month 9)	-93.6 Percent change Standard Deviation 11.5	-95.6 Percent change Standard Deviation 10.6	-94.3 Percent change Standard Deviation 23.2	—
Percent Change From Baseline in Serum PSA Levels Phase B, Visit 11 (Month 10)	-91.9 Percent change Standard Deviation 13.4	-95.7 Percent change Standard Deviation 9.46	-93.1 Percent change Standard Deviation 24.9	—
Percent Change From Baseline in Serum PSA Levels Phase B, Visit 12 (Month 11)	-88 Percent change Standard Deviation 22.7	-95.1 Percent change Standard Deviation 11.9	-94.4 Percent change Standard Deviation 23.5	—
Percent Change From Baseline in Serum PSA Levels Phase B, Visit 13 (Month 12)	-84.2 Percent change Standard Deviation 24.9	-95.1 Percent change Standard Deviation 10.6	-94.5 Percent change Standard Deviation 23.5	—
Percent Change From Baseline in Serum PSA Levels Phase B, Visit 14 (Month 13)	-82.8 Percent change Standard Deviation 24.9	-95.1 Percent change Standard Deviation 10.4	-93.1 Percent change Standard Deviation 25.9	—

SECONDARY outcome

Timeframe: During 14 months

The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Physical well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the physical well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being Phase B, Month 12	-0.91 Scores on a scale Interval -1.44 to -0.38	-1.62 Scores on a scale Interval -2.59 to -0.66	-1.32 Scores on a scale Interval -1.83 to -0.82	-1.39 Scores on a scale Interval -1.83 to -0.94
Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being Phase A, Month 3	-1.47 Scores on a scale Interval -1.99 to -0.94	-1.63 Scores on a scale Interval -2.59 to -0.67	-1.41 Scores on a scale Interval -1.92 to -0.9	-1.46 Scores on a scale Interval -1.9 to -1.01
Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being Phase A, Month 7	-1.41 Scores on a scale Interval -1.93 to -0.88	-1.48 Scores on a scale Interval -2.43 to -0.52	-1.67 Scores on a scale Interval -2.17 to -1.17	-1.63 Scores on a scale Interval -2.07 to -1.18
Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being Phase B, Month 8	-0.96 Scores on a scale Interval -1.46 to -0.46	-1.92 Scores on a scale Interval -2.83 to -1.01	-1.74 Scores on a scale Interval -2.22 to -1.27	-1.78 Scores on a scale Interval -2.2 to -1.36
Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being Phase B, Month 9	-1.24 Scores on a scale Interval -1.8 to -0.68	-1.85 Scores on a scale Interval -2.87 to -0.82	-1.77 Scores on a scale Interval -2.31 to -1.24	-1.79 Scores on a scale Interval -2.26 to -1.32
Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being Phase B, Month 10	-1.05 Scores on a scale Interval -1.63 to -0.48	-2.08 Scores on a scale Interval -3.13 to -1.03	-1.68 Scores on a scale Interval -2.23 to -1.13	-1.76 Scores on a scale Interval -2.25 to -1.28
Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being Phase B, Month 11	-1.00 Scores on a scale Interval -1.56 to -0.44	-1.77 Scores on a scale Interval -2.79 to -0.75	-1.53 Scores on a scale Interval -2.07 to -1.0	-1.58 Scores on a scale Interval -2.05 to -1.11
Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being Phase B, Month 13	-1.00 Scores on a scale Interval -1.57 to -0.43	-2.10 Scores on a scale Interval -3.14 to -1.06	-1.40 Scores on a scale Interval -1.95 to -0.86	-1.55 Scores on a scale Interval -2.04 to -1.07
Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being Phase B, Month 14	-1.04 Scores on a scale Interval -1.62 to -0.47	-1.90 Scores on a scale Interval -2.95 to -0.85	-1.45 Scores on a scale Interval -2.0 to -0.91	-1.55 Scores on a scale Interval -2.03 to -1.06

SECONDARY outcome

Timeframe: During 14 months

The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Emotional well-being consist of 6 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the emotional well-being sub scale ranges from 0 to 24. Higher scores represent better QoL.Higher scores represent better QoL.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being Phase A, Month 3	0.69 Scores on a scale Interval 0.18 to 1.2	1.31 Scores on a scale Interval 0.37 to 2.24	0.76 Scores on a scale Interval 0.27 to 1.24	0.88 Scores on a scale Interval 0.45 to 1.3
Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being Phase A, Month 7	0.67 Scores on a scale Interval 0.16 to 1.18	0.57 Scores on a scale Interval -0.37 to 1.51	0.90 Scores on a scale Interval 0.42 to 1.39	0.83 Scores on a scale Interval 0.4 to 1.26
Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being Phase B, Month 8	0.65 Scores on a scale Interval 0.16 to 1.14	0.95 Scores on a scale Interval 0.05 to 1.86	1.11 Scores on a scale Interval 0.65 to 1.58	1.08 Scores on a scale Interval 0.67 to 1.49
Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being Phase B, Month 9	0.75 Scores on a scale Interval 0.27 to 1.24	1.11 Scores on a scale Interval 0.22 to 2.01	1.16 Scores on a scale Interval 0.7 to 1.62	1.15 Scores on a scale Interval 0.74 to 1.56
Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being Phase B, Month 10	1.09 Scores on a scale Interval 0.57 to 1.6	0.00 Scores on a scale Interval -0.94 to 0.95	0.98 Scores on a scale Interval 0.49 to 1.46	0.77 Scores on a scale Interval 0.34 to 1.2
Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being Phase B, Month 11	0.82 Scores on a scale Interval 0.34 to 1.3	0.94 Scores on a scale Interval 0.06 to 1.83	1.05 Scores on a scale Interval 0.59 to 1.5	1.03 Scores on a scale Interval 0.62 to 1.43
Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being Phase B, Month 12	0.99 Scores on a scale Interval 0.47 to 1.5	1.07 Scores on a scale Interval 0.12 to 2.02	1.23 Scores on a scale Interval 0.74 to 1.72	1.20 Scores on a scale Interval 0.76 to 1.63
Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being Phase B, Month 13	0.74 Scores on a scale Interval 0.22 to 1.26	0.52 Scores on a scale Interval -0.43 to 1.48	1.14 Scores on a scale Interval 0.64 to 1.63	1.01 Scores on a scale Interval 0.57 to 1.45
Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being Phase B, Month 14	0.40 Scores on a scale Interval -0.13 to 0.93	0.86 Scores on a scale Interval -0.11 to 1.83	1.12 Scores on a scale Interval 0.62 to 1.62	1.06 Scores on a scale Interval 0.62 to 1.51

SECONDARY outcome

Timeframe: During 14 months

The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Social well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the social well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being Phase A, Month 3	-0.18 Scores on a scale Interval -0.96 to 0.6	-0.06 Scores on a scale Interval -1.48 to 1.35	-0.36 Scores on a scale Interval -1.11 to 0.38	-0.30 Scores on a scale Interval -0.95 to 0.36
Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being Phase A, Month 7	0.00 Scores on a scale Interval -0.79 to 0.79	-0.30 Scores on a scale Interval -1.75 to 1.14	-0.46 Scores on a scale Interval -1.21 to 0.29	-0.43 Scores on a scale Interval -1.09 to 0.24
Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being Phase B, Month 8	-0.33 Scores on a scale Interval -1.06 to 0.39	-0.52 Scores on a scale Interval -1.84 to 0.8	-0.41 Scores on a scale Interval -1.1 to 0.28	-0.43 Scores on a scale Interval -1.04 to 0.18
Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being Phase B, Month 9	-0.02 Scores on a scale Interval -0.8 to 0.77	-0.95 Scores on a scale Interval -2.37 to 0.47	-1.10 Scores on a scale Interval -1.84 to -0.36	-1.07 Scores on a scale Interval -1.72 to -0.41
Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being Phase B, Month 10	0.36 Scores on a scale Interval -0.42 to 1.14	-1.00 Scores on a scale Interval -2.42 to 0.42	-1.15 Scores on a scale Interval -1.89 to -0.41	-1.12 Scores on a scale Interval -1.77 to -0.46
Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being Phase B, Month 11	0.20 Scores on a scale Interval -0.63 to 1.02	-1.09 Scores on a scale Interval -2.59 to 0.42	-0.83 Scores on a scale Interval -1.61 to -0.05	-0.88 Scores on a scale Interval -1.58 to -0.19
Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being Phase B, Month 12	-0.16 Scores on a scale Interval -0.94 to 0.63	-1.34 Scores on a scale Interval -2.78 to 0.09	-0.85 Scores on a scale Interval -1.59 to -0.1	-0.95 Scores on a scale Interval -1.61 to -0.29
Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being Phase B, Month 13	-0.02 Scores on a scale Interval -0.79 to 0.74	-1.35 Scores on a scale Interval -2.74 to 0.03	-0.72 Scores on a scale Interval -1.44 to 0.0	-0.85 Scores on a scale Interval -1.49 to -0.21
Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being Phase B, Month 14	0.28 Scores on a scale Interval -0.44 to 1.01	-0.68 Scores on a scale Interval -2.0 to 0.64	-0.55 Scores on a scale Interval -1.24 to 0.14	-0.58 Scores on a scale Interval -1.19 to 0.03

SECONDARY outcome

Timeframe: During 14 months

The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Functional well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the functional well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being Phase A, Month 3	-0.96 Scores on a scale Interval -1.7 to -0.23	-0.88 Scores on a scale Interval -2.23 to 0.47	-0.29 Scores on a scale Interval -0.99 to 0.41	-0.42 Scores on a scale Interval -1.04 to 0.21
Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being Phase A, Month 7	-1.41 Scores on a scale Interval -2.25 to -0.58	-0.78 Scores on a scale Interval -2.31 to 0.76	-1.24 Scores on a scale Interval -2.03 to -0.45	-1.15 Scores on a scale Interval -1.85 to -0.44
Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being Phase B, Month 8	-1.18 Scores on a scale Interval -1.9 to -0.45	-1.08 Scores on a scale Interval -2.41 to 0.26	-0.73 Scores on a scale Interval -1.42 to -0.04	-0.80 Scores on a scale Interval -1.41 to -0.19
Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being Phase B, Month 9	-1.14 Scores on a scale Interval -1.94 to -0.34	-1.07 Scores on a scale Interval -2.53 to 0.4	-1.23 Scores on a scale Interval -1.99 to -0.47	-1.20 Scores on a scale Interval -1.87 to -0.52
Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being Phase B, Month 10	-1.35 Scores on a scale Interval -2.15 to -0.54	-0.89 Scores on a scale Interval -2.36 to 0.58	-1.42 Scores on a scale Interval -2.18 to -0.66	-1.31 Scores on a scale Interval -1.98 to -0.63
Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being Phase B, Month 11	-1.25 Scores on a scale Interval -2.08 to -0.43	-0.80 Scores on a scale Interval -2.32 to 0.72	-1.24 Scores on a scale Interval -2.02 to -0.46	-1.15 Scores on a scale Interval -1.84 to -0.45
Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being Phase B, Month 12	-0.92 Scores on a scale Interval -1.7 to -0.15	-1.49 Scores on a scale Interval -2.91 to -0.07	-0.73 Scores on a scale Interval -1.46 to 0.0	-0.89 Scores on a scale Interval -1.54 to -0.24
Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being Phase B, Month 13	-1.49 Scores on a scale Interval -2.32 to -0.66	-2.22 Scores on a scale Interval -3.75 to -0.69	-0.96 Scores on a scale Interval -1.75 to -0.17	-1.22 Scores on a scale Interval -1.93 to -0.52
Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being Phase B, Month 14	-1.02 Scores on a scale Interval -1.78 to -0.26	-1.95 Scores on a scale Interval -3.35 to -0.55	-0.84 Scores on a scale Interval -1.56 to -0.12	-1.07 Scores on a scale Interval -1.71 to -0.43

SECONDARY outcome

Timeframe: During 14 months

The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Additional concerns consist of 12 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the additional concerns ranges from 0 to 48. Higher scores represent better QoL.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns Phase A, Month 3	-1.14 Scores on a scale Interval -1.96 to -0.32	-0.92 Scores on a scale Interval -2.42 to 0.57	-0.51 Scores on a scale Interval -1.3 to 0.27	-0.60 Scores on a scale Interval -1.29 to 0.09
Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns Phase A, Month 7	-0.89 Scores on a scale Interval -1.71 to -0.07	-1.34 Scores on a scale Interval -2.83 to 0.16	-1.03 Scores on a scale Interval -1.81 to -0.25	-1.10 Scores on a scale Interval -1.79 to -0.4
Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns Phase B, Month 8	-1.29 Scores on a scale Interval -2.1 to -0.48	-1.03 Scores on a scale Interval -2.5 to 0.45	-0.63 Scores on a scale Interval -1.4 to 0.14	-0.72 Scores on a scale Interval -1.4 to -0.03
Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns Phase B, Month 9	-0.97 Scores on a scale Interval -1.83 to -0.11	-1.64 Scores on a scale Interval -3.2 to -0.07	-0.90 Scores on a scale Interval -1.72 to -0.08	-1.06 Scores on a scale Interval -1.79 to -0.34
Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns Phase B, Month 10	-0.86 Scores on a scale Interval -1.73 to 0.01	-0.80 Scores on a scale Interval -2.39 to 0.78	-0.70 Scores on a scale Interval -1.52 to 0.13	-0.72 Scores on a scale Interval -1.45 to 0.01
Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns Phase B, Month 11	-0.80 Scores on a scale Interval -1.62 to 0.01	-0.56 Scores on a scale Interval -2.05 to 0.92	-0.58 Scores on a scale Interval -1.35 to 0.2	-0.57 Scores on a scale Interval -1.26 to 0.11
Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns Phase B, Month 12	-0.75 Scores on a scale Interval -1.6 to 0.1	-1.20 Scores on a scale Interval -2.75 to 0.35	-0.75 Scores on a scale Interval -1.56 to 0.06	-0.84 Scores on a scale Interval -1.56 to -0.13
Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns Phase B, Month 13	-0.91 Scores on a scale Interval -1.75 to -0.08	-0.96 Scores on a scale Interval -2.47 to 0.56	-0.86 Scores on a scale Interval -1.65 to -0.06	-0.88 Scores on a scale Interval -1.58 to -0.18
Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns Phase B, Month 14	-0.81 Scores on a scale Interval -1.69 to 0.06	-0.67 Scores on a scale Interval -2.26 to 0.92	-0.27 Scores on a scale Interval -1.1 to 0.57	-0.35 Scores on a scale Interval -1.09 to 0.38

SECONDARY outcome

Timeframe: During 14 months

The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Total FACT-P scores ranges from 0 to 156. Higher scores represent better QoL.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score Phase A, Month 3	-1.86 Scores on a scale Interval -3.62 to -0.1	-1.89 Scores on a scale Interval -5.13 to 1.34	-1.23 Scores on a scale Interval -2.92 to 0.45	-1.37 Scores on a scale Interval -2.87 to 0.12
Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score Phase A, Month 7	-2.03 Scores on a scale Interval -3.87 to -0.19	-2.64 Scores on a scale Interval -6.03 to 0.76	-2.38 Scores on a scale Interval -4.12 to -0.63	-2.43 Scores on a scale Interval -3.98 to -0.88
Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score Phase B, Month 8	-1.75 Scores on a scale Interval -3.45 to -0.04	-3.12 Scores on a scale Interval -6.26 to 0.03	-1.69 Scores on a scale Interval -3.31 to -0.07	-1.99 Scores on a scale Interval -3.42 to -0.55
Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score Phase B, Month 9	-1.61 Scores on a scale Interval -3.46 to 0.23	-3.49 Scores on a scale Interval -6.89 to -0.1	-2.84 Scores on a scale Interval -4.59 to -1.09	-2.98 Scores on a scale Interval -4.53 to -1.42
Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score Phase B, Month 10	-0.89 Scores on a scale Interval -2.84 to 1.05	-4.56 Scores on a scale Interval -8.15 to -0.98	-3.16 Scores on a scale Interval -5.01 to -1.31	-3.45 Scores on a scale Interval -5.09 to -1.81
Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score Phase B, Month 11	-1.18 Scores on a scale Interval -3.1 to 0.73	-3.27 Scores on a scale Interval -6.79 to 0.26	-2.48 Scores on a scale Interval -4.3 to -0.67	-2.65 Scores on a scale Interval -4.26 to -1.04
Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score Phase B, Month 12	-0.95 Scores on a scale Interval -2.88 to 0.98	-3.97 Scores on a scale Interval -7.52 to -0.42	-1.60 Scores on a scale Interval -3.43 to 0.23	-2.09 Scores on a scale Interval -3.72 to -0.47
Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score Phase B, Month 13	-1.74 Scores on a scale Interval -3.72 to 0.24	-5.62 Scores on a scale Interval -9.26 to -1.97	-1.85 Scores on a scale Interval -3.73 to 0.02	-2.64 Scores on a scale Interval -4.32 to -0.97
Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score Phase B, Month 14	-1.36 Scores on a scale Interval -3.24 to 0.52	-4.28 Scores on a scale Interval -7.75 to -0.81	-1.65 Scores on a scale Interval -3.44 to 0.13	-2.20 Scores on a scale Interval -3.79 to -0.61

SECONDARY outcome

Timeframe: During 14 months

The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Sexual drive domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the sexual drive domain ranges from 0 to 8. A higher scores represent better sexual function.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive Phase A, Month 3	-1.57 Scores on a scale Interval -1.83 to -1.32	-1.57 Scores on a scale Interval -2.04 to -1.1	-1.27 Scores on a scale Interval -1.51 to -1.03	-1.33 Scores on a scale Interval -1.55 to -1.12
Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive Phase A, Month 7	-1.71 Scores on a scale Interval -1.96 to -1.47	-1.39 Scores on a scale Interval -1.84 to -0.94	-1.67 Scores on a scale Interval -1.9 to -1.44	-1.61 Scores on a scale Interval -1.82 to -1.41
Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive Phase B, Month 9	-1.72 Scores on a scale Interval -1.98 to -1.46	-1.51 Scores on a scale Interval -1.99 to -1.02	-1.62 Scores on a scale Interval -1.87 to -1.37	-1.60 Scores on a scale Interval -1.82 to -1.38
Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive Phase B, Month 11	-1.59 Scores on a scale Interval -1.85 to -1.34	-1.52 Scores on a scale Interval -1.99 to -1.05	-1.65 Scores on a scale Interval -1.89 to -1.42	-1.63 Scores on a scale Interval -1.84 to -1.41
Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive Phase B, Month 13	-1.44 Scores on a scale Interval -1.69 to -1.19	-1.55 Scores on a scale Interval -2.02 to -1.08	-1.72 Scores on a scale Interval -1.96 to -1.48	-1.69 Scores on a scale Interval -1.9 to -1.47
Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive Phase B, Month 14	-1.30 Scores on a scale Interval -1.55 to -1.04	-1.65 Scores on a scale Interval -2.12 to -1.17	-1.72 Scores on a scale Interval -1.96 to -1.48	-1.71 Scores on a scale Interval -1.92 to -1.49

SECONDARY outcome

Timeframe: During 14 months

The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Erection domain consist of 3 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the erection domain ranges from 0 to 12. A higher scores represent better sexual function.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Sexual Function as Assessed by the SFI: Erection Phase A, Month 3	-1.32 Scores on a scale Interval -1.62 to -1.01	-0.91 Scores on a scale Interval -1.48 to -0.35	-1.21 Scores on a scale Interval -1.5 to -0.91	-1.14 Scores on a scale Interval -1.4 to -0.89
Change From Baseline in Sexual Function as Assessed by the SFI: Erection Phase A, Month 7	-1.43 Scores on a scale Interval -1.75 to -1.11	-1.06 Scores on a scale Interval -1.65 to -0.47	-1.34 Scores on a scale Interval -1.65 to -1.03	-1.28 Scores on a scale Interval -1.55 to -1.01
Change From Baseline in Sexual Function as Assessed by the SFI: Erection Phase B, Month 9	-1.52 Scores on a scale Interval -1.8 to -1.23	-1.07 Scores on a scale Interval -1.6 to -0.54	-1.46 Scores on a scale Interval -1.74 to -1.19	-1.38 Scores on a scale Interval -1.62 to -1.14
Change From Baseline in Sexual Function as Assessed by the SFI: Erection Phase B, Month 11	-1.15 Scores on a scale Interval -1.44 to -0.86	-1.34 Scores on a scale Interval -1.88 to -0.8	-1.28 Scores on a scale Interval -1.56 to -1.01	-1.30 Scores on a scale Interval -1.54 to -1.05
Change From Baseline in Sexual Function as Assessed by the SFI: Erection Phase B, Month 13	-0.97 Scores on a scale Interval -1.3 to -0.64	-1.36 Scores on a scale Interval -1.97 to -0.74	-1.33 Scores on a scale Interval -1.65 to -1.02	-1.34 Scores on a scale Interval -1.62 to -1.06
Change From Baseline in Sexual Function as Assessed by the SFI: Erection Phase B, Month 14	-0.90 Scores on a scale Interval -1.25 to -0.56	-1.43 Scores on a scale Interval -2.08 to -0.79	-1.26 Scores on a scale Interval -1.59 to -0.93	-1.29 Scores on a scale Interval -1.59 to -1.0

SECONDARY outcome

Timeframe: During 14 months

The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Ejaculation domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the ejaculation domain ranges from 0 to 8. A higher scores represent better sexual function.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation Phase A, Month 3	-1.04 Scores on a scale Interval -1.33 to -0.75	-0.90 Scores on a scale Interval -1.43 to -0.37	-0.87 Scores on a scale Interval -1.15 to -0.59	-0.88 Scores on a scale Interval -1.13 to -0.63
Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation Phase A, Month 7	-1.23 Scores on a scale Interval -1.48 to -0.97	-0.80 Scores on a scale Interval -1.27 to -0.34	-1.08 Scores on a scale Interval -1.32 to -0.84	-1.02 Scores on a scale Interval -1.23 to -0.8
Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation Phase B, Month 9	-1.24 Scores on a scale Interval -1.51 to -0.98	-1.06 Scores on a scale Interval -1.55 to -0.57	-0.94 Scores on a scale Interval -1.2 to -0.69	-0.97 Scores on a scale Interval -1.2 to -0.74
Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation Phase B, Month 11	-0.94 Scores on a scale Interval -1.22 to -0.67	-1.24 Scores on a scale Interval -1.74 to -0.74	-0.93 Scores on a scale Interval -1.19 to -0.67	-1.00 Scores on a scale Interval -1.23 to -0.76
Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation Phase B, Month 13	-0.89 Scores on a scale Interval -1.15 to -0.62	-1.07 Scores on a scale Interval -1.56 to -0.58	-1.12 Scores on a scale Interval -1.38 to -0.87	-1.11 Scores on a scale Interval -1.34 to -0.89
Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation Phase B, Month 14	-0.79 Scores on a scale Interval -1.1 to -0.48	-1.17 Scores on a scale Interval -1.73 to -0.61	-0.97 Scores on a scale Interval -1.27 to -0.68	-1.01 Scores on a scale Interval -1.27 to -0.75

SECONDARY outcome

Timeframe: During 14 months

The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Problem assessment domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the problem assessment domain ranges from 0 to 8. A higher scores represent better sexual function.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment Phase A, Month 3	-0.26 Scores on a scale Interval -0.93 to 0.41	-0.58 Scores on a scale Interval -1.82 to 0.66	-0.36 Scores on a scale Interval -1.0 to 0.28	-0.40 Scores on a scale Interval -0.97 to 0.16
Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment Phase A, Month 7	-0.90 Scores on a scale Interval -1.6 to -0.19	-0.88 Scores on a scale Interval -2.19 to 0.44	-0.57 Scores on a scale Interval -1.25 to 0.11	-0.63 Scores on a scale Interval -1.23 to -0.03
Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment Phase B, Month 9	-0.56 Scores on a scale Interval -1.3 to 0.17	-0.71 Scores on a scale Interval -2.07 to 0.65	-0.64 Scores on a scale Interval -1.34 to 0.06	-0.66 Scores on a scale Interval -1.28 to -0.03
Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment Phase B, Month 11	0.09 Scores on a scale Interval -0.65 to 0.83	-0.53 Scores on a scale Interval -1.9 to 0.84	-0.98 Scores on a scale Interval -1.68 to -0.27	-0.89 Scores on a scale Interval -1.51 to -0.26
Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment Phase B, Month 13	-0.15 Scores on a scale Interval -0.88 to 0.58	-1.63 Scores on a scale Interval -2.99 to -0.27	-1.07 Scores on a scale Interval -1.77 to -0.38	-1.19 Scores on a scale Interval -1.81 to -0.57
Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment Phase B, Month 14	-0.31 Scores on a scale Interval -1.04 to 0.41	-1.68 Scores on a scale Interval -3.03 to -0.33	-0.89 Scores on a scale Interval -1.58 to -0.19	-1.05 Scores on a scale Interval -1.67 to -0.44

SECONDARY outcome

Timeframe: During 14 months

The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Overall satisfaction domain consist of single question and is scored on a scale of 0-4 (0=minimum, 4=maximum). A higher score represent better sexual function.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life Phase A, Month 3	-0.32 Scores on a scale Interval -0.5 to -0.13	-0.18 Scores on a scale Interval -0.53 to 0.16	-0.27 Scores on a scale Interval -0.45 to -0.09	-0.25 Scores on a scale Interval -0.41 to -0.1
Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life Phase A, Month 7	-0.28 Scores on a scale Interval -0.48 to -0.07	-0.37 Scores on a scale Interval -0.74 to 0.01	-0.40 Scores on a scale Interval -0.59 to -0.21	-0.39 Scores on a scale Interval -0.56 to -0.22
Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life Phase B, Month 9	-0.33 Scores on a scale Interval -0.53 to -0.13	-0.34 Scores on a scale Interval -0.71 to 0.03	-0.41 Scores on a scale Interval -0.6 to -0.22	-0.39 Scores on a scale Interval -0.56 to -0.23
Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life Phase B, Month 11	-0.15 Scores on a scale Interval -0.35 to 0.05	-0.47 Scores on a scale Interval -0.85 to -0.09	-0.41 Scores on a scale Interval -0.6 to -0.21	-0.42 Scores on a scale Interval -0.59 to -0.25
Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life Phase B, Month 13	-0.11 Scores on a scale Interval -0.32 to 0.09	-0.57 Scores on a scale Interval -0.95 to -0.2	-0.42 Scores on a scale Interval -0.61 to -0.23	-0.45 Scores on a scale Interval -0.62 to -0.28
Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life Phase B, Month 14	-0.12 Scores on a scale Interval -0.32 to 0.08	-0.70 Scores on a scale Interval -1.08 to -0.33	-0.37 Scores on a scale Interval -0.57 to -0.18	-0.44 Scores on a scale Interval -0.61 to -0.27

SECONDARY outcome

Timeframe: During 14 months

The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Total SFI score ranges from 0 to 44. A higher scores represent better sexual function.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous n=191 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score Phase A, Month 3	-4.07 Scores on a scale Interval -5.1 to -3.05	-3.93 Scores on a scale Interval -5.84 to -2.02	-3.69 Scores on a scale Interval -4.67 to -2.71	-3.74 Scores on a scale Interval -4.61 to -2.87
Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score Phase A, Month 7	-5.20 Scores on a scale Interval -6.23 to -4.16	-4.28 Scores on a scale Interval -6.21 to -2.35	-4.57 Scores on a scale Interval -5.56 to -3.58	-4.51 Scores on a scale Interval -5.38 to -3.63
Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score Phase B, Month 9	-4.97 Scores on a scale Interval -6.04 to -3.91	-4.35 Scores on a scale Interval -6.33 to -2.37	-4.62 Scores on a scale Interval -5.63 to -3.61	-4.56 Scores on a scale Interval -5.46 to -3.66
Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score Phase B, Month 11	-3.56 Scores on a scale Interval -4.63 to -2.49	-4.62 Scores on a scale Interval -6.62 to -2.63	-4.74 Scores on a scale Interval -5.76 to -3.72	-4.71 Scores on a scale Interval -5.62 to -3.81
Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score Phase B, Month 13	-3.37 Scores on a scale Interval -4.48 to -2.26	-5.59 Scores on a scale Interval -7.66 to -3.52	-5.15 Scores on a scale Interval -6.21 to -4.09	-5.24 Scores on a scale Interval -6.18 to -4.3
Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score Phase B, Month 14	-3.27 Scores on a scale Interval -4.41 to -2.12	-5.93 Scores on a scale Interval -8.06 to -3.8	-4.68 Scores on a scale Interval -5.77 to -3.59	-4.94 Scores on a scale Interval -5.91 to -3.97

SECONDARY outcome

Timeframe: At 14 months

Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL	100 Percentage of patients Interval 97.3 to 100.0	97.6 Percentage of patients Interval 87.1 to 99.9	98.7 Percentage of patients Interval 95.3 to 99.8	—

SECONDARY outcome

Timeframe: During Phase B

The time to testosterone \>0.5 ng/mL level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix)

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group	112.0 Days Interval 112.0 to 140.0	—	—	—

SECONDARY outcome

Timeframe: During Phase B

The time to return to normal range (≥1.5 ng/mL) or Baseline testosterone level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix).

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level	168 Days Interval 140.0 to 168.0	—	—	—

SECONDARY outcome

Timeframe: Phase A Visit 1-8 and Phase B Visit 9-15.

Absolute Change From Baseline in Serum Testosterone Levels was measured.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Absolute Change From Baseline in Serum Testosterone Levels Phase A, Visit 1 (Day 0)	NA ng/mL Standard Deviation NA This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.	-2.97 ng/mL Standard Deviation NA One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.	NA ng/mL Standard Deviation NA This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.	—
Absolute Change From Baseline in Serum Testosterone Levels Phase A, Visit 2 (Month 1)	-3.64 ng/mL Standard Deviation 1.4	-3.77 ng/mL Standard Deviation 1.43	-3.7 ng/mL Standard Deviation 1.56	—
Absolute Change From Baseline in Serum Testosterone Levels Phase A, Visit 3 (Month 2)	-3.67 ng/mL Standard Deviation 1.4	-3.77 ng/mL Standard Deviation 1.44	-3.77 ng/mL Standard Deviation 1.56	—
Absolute Change From Baseline in Serum Testosterone Levels Phase A, Visit 4 (Month 3)	-3.68 ng/mL Standard Deviation 1.4	-3.78 ng/mL Standard Deviation 1.43	-3.77 ng/mL Standard Deviation 1.55	—
Absolute Change From Baseline in Serum Testosterone Levels Phase A, Visit 5 (Month 4)	-3.67 ng/mL Standard Deviation 1.41	-3.78 ng/mL Standard Deviation 1.44	-3.74 ng/mL Standard Deviation 1.61	—
Absolute Change From Baseline in Serum Testosterone Levels Phase A, Visit 6 (Month 5)	-3.67 ng/mL Standard Deviation 1.41	-3.78 ng/mL Standard Deviation 1.44	-3.78 ng/mL Standard Deviation 1.55	—
Absolute Change From Baseline in Serum Testosterone Levels Phase A, Visit 7 (Month 6)	-3.66 ng/mL Standard Deviation 1.41	-3.77 ng/mL Standard Deviation 1.44	-3.77 ng/mL Standard Deviation 1.56	—
Absolute Change From Baseline in Serum Testosterone Levels Phase A, Visit 8 (Month 7)	-3.66 ng/mL Standard Deviation 1.42	-3.78 ng/mL Standard Deviation 1.43	-3.78 ng/mL Standard Deviation 1.55	—
Absolute Change From Baseline in Serum Testosterone Levels Phase B, Visit 9 (Month 8)	-3.63 ng/mL Standard Deviation 1.44	-3.76 ng/mL Standard Deviation 1.44	-3.78 ng/mL Standard Deviation 1.56	—
Absolute Change From Baseline in Serum Testosterone Levels Phase B, Visit 10 (Month 9)	-3.41 ng/mL Standard Deviation 1.6	-3.76 ng/mL Standard Deviation 1.44	-3.78 ng/mL Standard Deviation 1.56	—
Absolute Change From Baseline in Serum Testosterone Levels Phase B, Visit 11 (Month 10)	-3.0 ng/mL Standard Deviation 1.76	-3.75 ng/mL Standard Deviation 1.44	-3.77 ng/mL Standard Deviation 1.57	—
Absolute Change From Baseline in Serum Testosterone Levels Phase B, Visit 12 (Month 11)	-2.57 ng/mL Standard Deviation 1.78	-3.74 ng/mL Standard Deviation 1.43	-3.78 ng/mL Standard Deviation 1.55	—
Absolute Change From Baseline in Serum Testosterone Levels Phase B, Visit 13 (Month 12)	-2.18 ng/mL Standard Deviation 1.8	-3.72 ng/mL Standard Deviation 1.43	-3.78 ng/mL Standard Deviation 1.56	—
Absolute Change From Baseline in Serum Testosterone Levels Phase B, Visit 14 (Month 13)	-2.1 ng/mL Standard Deviation 1.81	-3.73 ng/mL Standard Deviation 1.42	-3.77 ng/mL Standard Deviation 1.57	—
Absolute Change From Baseline in Serum Testosterone Levels Phase B, Visit 15 (Month 14)	-1.77 ng/mL Standard Deviation 2.27	-3.71 ng/mL Standard Deviation 1.42	-3.78 ng/mL Standard Deviation 1.56	—

SECONDARY outcome

Timeframe: Phase A Visit 1-8 and Phase B Visit 9-15.

Percent change from Baseline in serum testosterone levels was measured.

Outcome measures

Outcome measures
Measure	DI (Degarelix Intermittent) n=137 Participants Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.	Total Continuous n=41 Participants This is the combination of degarelix continuous and leuprolide continuous treatment arms.	LC (Leuprolide Continuous) n=150 Participants Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).	Total Continuous This is the combination of degarelix continuous and leuprolide continuous treatment arms.
Percent Change From Baseline in Serum Testosterone Levels Phase A, Visit 1 (Day 0)	NA Percent change Standard Deviation NA This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.	-95.8 Percent change Standard Deviation NA One patient erroneously received medication prior to this visit. Thus, the value obtained on this visit was considered as first post-baseline value for this patient and is reported. There was no SD.	NA Percent change Standard Deviation NA This visit was the first dosing visit. Serum samples were collected pre-dosing on this visit. Thus, the estimated value obtained on this visit were considered as Baseline value. Hence no change is reported.	—
Percent Change From Baseline in Serum Testosterone Levels Phase A, Visit 2 (Month 1)	-96.4 Percent change Standard Deviation 5.26	-97.4 Percent change Standard Deviation 2.31	-95.5 Percent change Standard Deviation 4.22	—
Percent Change From Baseline in Serum Testosterone Levels Phase A, Visit 3 (Month 2)	-97.3 Percent change Standard Deviation 2.46	-97.5 Percent change Standard Deviation 1.9	-97.7 Percent change Standard Deviation 1.44	—
Percent Change From Baseline in Serum Testosterone Levels Phase A, Visit 4 (Month 3)	-97.5 Percent change Standard Deviation 2.06	-97.8 Percent change Standard Deviation 1.41	-97.5 Percent change Standard Deviation 1.76	—
Percent Change From Baseline in Serum Testosterone Levels Phase A, Visit 5 (Month 4)	-97.2 Percent change Standard Deviation 4.26	-97.7 Percent change Standard Deviation 1.58	-96.2 Percent change Standard Deviation 14	—
Percent Change From Baseline in Serum Testosterone Levels Phase A, Visit 6 (Month 5)	-97.3 Percent change Standard Deviation 4.42	-97.6 Percent change Standard Deviation 2.49	-97.8 Percent change Standard Deviation 1.36	—
Percent Change From Baseline in Serum Testosterone Levels Phase A, Visit 7 (Month 6)	-96.8 Percent change Standard Deviation 7.01	-97.6 Percent change Standard Deviation 2.03	-97.9 Percent change Standard Deviation 1.46	—
Percent Change From Baseline in Serum Testosterone Levels Phase A, Visit 8 (Month 7)	-96.9 Percent change Standard Deviation 6.34	-97.5 Percent change Standard Deviation 2.54	-97.7 Percent change Standard Deviation 1.67	—
Percent Change From Baseline in Serum Testosterone Levels Phase B, Visit 9 (Month 8)	-95.6 Percent change Standard Deviation 9.69	-97.1 Percent change Standard Deviation 3.09	-97.8 Percent change Standard Deviation 1.43	—
Percent Change From Baseline in Serum Testosterone Levels Phase B, Visit 10 (Month 9)	-88.7 Percent change Standard Deviation 24.7	-97 Percent change Standard Deviation 3.14	-97.7 Percent change Standard Deviation 1.7	—
Percent Change From Baseline in Serum Testosterone Levels Phase B, Visit 11 (Month 10)	-77 Percent change Standard Deviation 34.8	-97 Percent change Standard Deviation 3.74	-97.5 Percent change Standard Deviation 3.49	—
Percent Change From Baseline in Serum Testosterone Levels Phase B, Visit 12 (Month 11)	-65.4 Percent change Standard Deviation 37.7	-96.7 Percent change Standard Deviation 3.43	-97.9 Percent change Standard Deviation 1.36	—
Percent Change From Baseline in Serum Testosterone Levels Phase B, Visit 13 (Month 12)	-54.7 Percent change Standard Deviation 41.5	-96 Percent change Standard Deviation 5.56	-97.8 Percent change Standard Deviation 1.45	—
Percent Change From Baseline in Serum Testosterone Levels Phase B, Visit 14 (Month 13)	-51.9 Percent change Standard Deviation 43.1	-96.5 Percent change Standard Deviation 3.7	-97.4 Percent change Standard Deviation 4.64	—
Percent Change From Baseline in Serum Testosterone Levels Phase B, Visit 15 (Month 14)	-44 Percent change Standard Deviation 66.1	-95.8 Percent change Standard Deviation 4.8	-97.7 Percent change Standard Deviation 1.56	—

Adverse Events

DI (Degarelix Intermittent)

Serious events: 26 serious events

Other events: 159 other events

Deaths: 0 deaths

DC (Degarelix Continuous)

Serious events: 6 serious events

Other events: 47 other events

Deaths: 0 deaths

LC (Leuprolide Continuous)

Serious events: 18 serious events

Other events: 158 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

Email: [email protected]

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.
Publication restrictions are in place

Restriction type: OTHER