A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease (PRONOUNCE)

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ClinicalTrials.gov Identifier: NCT02663908

Recruitment Status : Terminated (Recruitment rate; a lower than anticipated observed cardiovascular event rate. The Sponsor decision to stop the trial was not based on any safety concerns or any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.)

First Posted : January 26, 2016

Results First Posted : June 29, 2022

Last Update Posted : June 29, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Memorial Sloan Kettering Cancer Center

Duke Clinical Research Institute

Information provided by (Responsible Party):

Ferring Pharmaceuticals

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition	Prostate Cancer
Interventions	Drug: Degarelix Drug: Leuprolide
Enrollment	545

Participant Flow

Recruitment Details	The trial was performed at 113 investigational sites in 12 countries between Apr 2016 to Mar 2021.
Pre-assignment Details	In total, 702 subjects were screened of which 545 subjects were randomized. Of the randomized subjects, 544 subjects were exposed to the investigational medicinal product (IMP): 275 to Degarelix and 269 to Leuprolide. One subject was randomized in error and not exposed to IMP.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two subcutaneous (SC) depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Period Title: Overall Study
Started	276	269
Full Analysis Set (FAS)	275	269
Completed	244	245
Not Completed	32	24
Reason Not Completed
Withdrawal by Subject	8	5
Lost to Follow-up	1	5
Adverse Event	13	11
Protocol Violation	1	2
Lack of therapeutic response	2	0
COVID-19	1	0
Site closed	1	0
Subject to begin treatment with an exclusionary medication	1	0
Subject ended trial due to being prescribed prohibited medication	1	0
Intolerance to FIRMAGON therapy	1	0
Death	1	0
Subject randomized in error and did not receive the IMP	1	0
Subject discontinued treatment as he was in hospice and could not make it for end-of-trial visit	0	1

Baseline Characteristics

Arm/Group Title		Degarelix 240 mg/80 mg	Leuprolide 22.5 mg	Total
Arm/Group Description		Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...	Total of all reporting groups
Arm/Group Description		Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.	Total of all reporting groups
Overall Number of Baseline Participants		275	269	544
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	275 participants	269 participants	544 participants
		73.3 (7.28)	73.1 (7.16)	73.2 (7.22)
Age, Customized Measure Type: Count of Participants Unit of measure: Participants
< 75 years	Number Analyzed	275 participants	269 participants	544 participants
< 75 years		153	151	304
>= 75 years	Number Analyzed	275 participants	269 participants	544 participants
>= 75 years		122	118	240
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	275 participants	269 participants	544 participants
	Female	0	0	0
	Male	275	269	544
Ethnicity (NIH/OMB) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	275 participants	269 participants	544 participants
	Hispanic or Latino	16	14	30
	Not Hispanic or Latino	256	254	510
	Unknown or Not Reported	3	1	4
		[1] Measure Analysis Population Description: Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.
Race (NIH/OMB) ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	275 participants	269 participants	544 participants
	American Indian or Alaska Native	2	0	2
	Asian	3	5	8
	Native Hawaiian or Other Pacific Islander	0	0	0
	Black or African American	16	12	28
	White	252	251	503
	More than one race	0	0	0
	Unknown or Not Reported	2	1	3
		[1] Measure Analysis Population Description: Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.
Region of Enrollment Measure Type: Number Unit of measure: Participants
Greece	Number Analyzed	275 participants	269 participants	544 participants
Greece		15	15	30
Canada	Number Analyzed	275 participants	269 participants	544 participants
Canada		25	25	50
United States	Number Analyzed	275 participants	269 participants	544 participants
United States		111	102	213
Czechia	Number Analyzed	275 participants	269 participants	544 participants
Czechia		22	25	47
Finland	Number Analyzed	275 participants	269 participants	544 participants
Finland		0	1	1
Poland	Number Analyzed	275 participants	269 participants	544 participants
Poland		3	5	8
South Africa	Number Analyzed	275 participants	269 participants	544 participants
South Africa		2	0	2
United Kingdom	Number Analyzed	275 participants	269 participants	544 participants
United Kingdom		8	7	15
Slovakia	Number Analyzed	275 participants	269 participants	544 participants
Slovakia		37	45	82
France	Number Analyzed	275 participants	269 participants	544 participants
France		16	14	30
Germany	Number Analyzed	275 participants	269 participants	544 participants
Germany		10	9	19
Russia	Number Analyzed	275 participants	269 participants	544 participants
Russia		26	21	47
Baseline body mass index (BMI) ^[1] Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	273 participants	268 participants	541 participants
		28.38 (5.057)	28.58 (4.589)	28.48 (4.828)
		[1] Measure Analysis Population Description: Number analyzed differs from the overall population as baseline BMI was not reported for some of the subjects.
Stage of prostate cancer Measure Type: Count of Participants Unit of measure: Participants
Localized	Number Analyzed	275 participants	269 participants	544 participants
Localized		138	133	271
Locally Advanced	Number Analyzed	275 participants	269 participants	544 participants
Locally Advanced		63	80	143
Metastatic	Number Analyzed	275 participants	269 participants	544 participants
Metastatic		63	48	111
Not classifiable	Number Analyzed	275 participants	269 participants	544 participants
Not classifiable		11	8	19
Eastern Cooperative Oncology Group (ECOG) performance score ^[1] Measure Type: Count of Participants Unit of measure: Participants
0 score	Number Analyzed	275 participants	269 participants	544 participants
0 score		178	167	345
1 score	Number Analyzed	275 participants	269 participants	544 participants
1 score		75	80	155
2 score	Number Analyzed	275 participants	269 participants	544 participants
2 score		8	11	19
		[1] Measure Description: The ECOG performance status was assessed according to a scale from 0 to 4, where 0 is fully active, able to carry on all pre-disease performance without restriction and where 4 is completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
Testosterone levels ^[1] Mean (Standard Deviation) Unit of measure: ng/dL
	Number Analyzed	274 participants	269 participants	543 participants
		353.6 (150.49)	351.6 (140.32)	352.6 (145.41)
		[1] Measure Analysis Population Description: Number analyzed differs from the overall population as baseline testosterone was not reported for some of the subjects.
Prostate Specific Antigen (PSA) ^[1] Mean (Standard Deviation) Unit of measure: ng/mL
	Number Analyzed	275 participants	268 participants	543 participants
		119.7 (472.10)	59.9 (236.68)	90.2 (375.72)
		[1] Measure Analysis Population Description: Number analyzed differs from the overall population as baseline PSA was not reported for some of the subjects.

Outcome Measures

1.Primary Outcome


Title	Time From Randomization to the First Confirmed (Adjudicated) Occurrence of the Composite Major Adverse Cardiovascular Event (MACE) Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Description	Composite MACE endpoint was defined as: death due to any cause, non-fa...
Description	Composite MACE endpoint was defined as: death due to any cause, non-fatal myocardial infarction or non-fatal stroke. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) occurrence of composite MACE over time. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.
Time Frame	Randomization to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: percentage of subjects
	5.5	4.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.5294
	Comments	[Not Specified]
	Method	Log Rank
	Comments	The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.283
	Confidence Interval	(2-Sided) 95% 0.589 to 2.794
	Estimation Comments	Baseline hazards for the Cox regression were stratified over variables: age group and region.

2.Secondary Outcome


Title	Time From Randomization to the First Confirmed (Adjudicated) Occurrence of Cardiovascular (CV)-Related Death, Non-fatal Myocardial Infarction or Non-fatal Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Description	Kaplan Meier plots of the cumulative incidence rate by treatment group...
Description	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) occurrence of CV-related death, non-fatal myocardial infarction or non-fatal stroke. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.
Time Frame	Randomization to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: percentage of subjects
	3.3	2.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7126
	Comments	[Not Specified]
	Method	Log Rank
	Comments	The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.204
	Confidence Interval	(2-Sided) 95% 0.448 to 3.234
	Estimation Comments	Baseline hazards for the Cox regression were stratified over variables: age group and region.

3.Secondary Outcome


Title	Time From Randomization to Confirmed (Adjudicated) CV-related Death; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Description	Kaplan Meier plots of the cumulative incidence rate by treatment group...
Description	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) CV-related death. Percentage of observed subjects with outcome measure events during the trial are reported. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.
Time Frame	Randomization to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: percentage of subjects
	0.4	1.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0853
	Comments	[Not Specified]
	Method	Log Rank
	Comments	The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.186
	Confidence Interval	(2-Sided) 95% 0.022 to 1.595
	Estimation Comments	Baseline hazards for the Cox regression were stratified over variables: age group and region.

4.Secondary Outcome


Title	Time From Randomization to the First Confirmed (Adjudicated) Myocardial Infarction; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Description	Kaplan Meier plots of the cumulative incidence rate by treatment group...
Description	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) myocardial infarction. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.
Time Frame	Randomization to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: percentage of subjects
	1.8	1.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.5196
	Comments	[Not Specified]
	Method	Log Rank
	Comments	The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.594
	Confidence Interval	(2-Sided) 95% 0.381 to 6.673
	Estimation Comments	Baseline hazards for the Cox regression were stratified over variables: age group and region.

5.Secondary Outcome


Title	Time From Randomization to the First Confirmed (Adjudicated) Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Description	Kaplan Meier plots of the cumulative incidence rate by treatment group...
Description	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) stroke. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.
Time Frame	Randomization to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: percentage of subjects
	1.1	1.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8966
	Comments	[Not Specified]
	Method	Log Rank
	Comments	The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.899
	Confidence Interval	(2-Sided) 95% 0.181 to 4.457
	Estimation Comments	Baseline hazards for the Cox regression were stratified over variables: age group and region.

6.Secondary Outcome


Title	Time From Randomization to the First Confirmed (Adjudicated) Unstable Angina Requiring Hospitalization; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Description	Kaplan Meier plots of the cumulative incidence rate by treatment group...
Description	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) unstable angina requiring hospitalization. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.
Time Frame	Randomization to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: percentage of subjects
	0.7	1.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.3857
	Comments	[Not Specified]
	Method	Log Rank
	Comments	The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.480
	Confidence Interval	(2-Sided) 95% 0.088 to 2.620
	Estimation Comments	Baseline hazards for the Cox regression were stratified over variables: age group and region.

7.Secondary Outcome


Title	Time From Randomization to Death Due to Any Cause; Percentage of Observed Subjects With Outcome Measure Events During the Trial
Description	Kaplan Meier plots of the cumulative incidence rate by treatment group...
Description	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict death due to any cause. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first.
Time Frame	Randomization to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: percentage of subjects
	2.9	3.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7180
	Comments	[Not Specified]
	Method	Log Rank
	Comments	The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.839
	Confidence Interval	(2-Sided) 95% 0.324 to 2.176
	Estimation Comments	Baseline hazards for the Cox regression were stratified over variables: age group and region.

8.Secondary Outcome


Title	Testosterone Levels at Days 28, 168 and 336 in the Degarelix and Leuprolide Treatment Groups
Description	Median levels and interquartile ranges for serum testosterone at Days ...
Description	Median levels and interquartile ranges for serum testosterone at Days 28, 168, and 336 are presented.
Time Frame	Days 28, 168 and 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.


Arm/Group Title		Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:		Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:		Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed		264	257
Median (Inter-Quartile Range) Unit of Measure: ng/dL
Day 28	Number Analyzed	264 participants	257 participants
Day 28		8.650 (6.810 to 13.960)	14.410 (10.910 to 20.170)
Day 168	Number Analyzed	247 participants	248 participants
Day 168		8.650 (5.760 to 12.750)	8.475 (5.760 to 11.530)
Day 336	Number Analyzed	234 participants	228 participants
Day 336		9.855 (5.760 to 14.410)	8.650 (5.760 to 11.530)

9.Secondary Outcome


Title	Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial
Description	Time to failure in PFS was defined as the time, measured in days, from...
Description	Time to failure in PFS was defined as the time, measured in days, from randomization to the first occurrence of either death, radiographic disease progression, introduction of additional prostate cancer therapies for progression, or PSA failure. Subjects who discontinued treatment with IMP or withdrew from the trial were censored at the time of discontinuation/withdrawal. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict failure in PFS. Percentage of observed subjects with outcome measure events during the trial are reported.
Time Frame	From randomization to end-of-trial for each subject (subjects not censored at Day 336)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: percentage of subjects
	8.7	10.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6701
	Comments	[Not Specified]
	Method	Log Rank
	Comments	The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.887
	Confidence Interval	(2-Sided) 95% 0.512 to 1.539
	Estimation Comments	Baseline hazards for the Cox regression were stratified over variables: age group and region.

10.Secondary Outcome


Title	Changes From Baseline in International Prostate Symptom Score (IPSS) Total and Quality of Life (QoL) Scores
Description	Lower urinary tract symptoms were measured with the IPSS Version 1 (IP...
Description	Lower urinary tract symptoms were measured with the IPSS Version 1 (IPSS-1). The IPSS is a subject-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question was assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total IPSS-1 score was then calculated as summation over the responses for all 7 questions. The total IPSS-1 score was transformed to a scale from 0 (lowest score) to 100 (highest score). Higher scores reflect higher severity of symptoms. The IPSS-1 included an additional single question to assess a subject's QoL in relation to his urinary symptoms; response to this question was analyzed separately and was not included in the total IPSS score. The score was similarly scaled from 0 to 100. Change from baseline in IPSS Total and QoL scores are presented.
Time Frame	Baseline to Days 168 and 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:		Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:		Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed		234	232
Least Squares Mean (95% Confidence Interval) Unit of Measure: score on a scale
IPSS Total at Day 168	Number Analyzed	234 participants	232 participants
IPSS Total at Day 168		-0.000 (-0.804 to 0.804)	0.907 (0.098 to 1.715)
IPSS, QoL at Day 168	Number Analyzed	234 participants	232 participants
IPSS, QoL at Day 168		-0.115 (-0.298 to 0.068)	0.098 (-0.086 to 0.282)
IPSS Total at Day 336	Number Analyzed	195 participants	191 participants
IPSS Total at Day 336		-0.795 (-1.619 to 0.029)	0.121 (-0.712 to 0.953)
IPSS, QoL at Day 336	Number Analyzed	195 participants	191 participants
IPSS, QoL at Day 336		-0.281 (-0.467 to -0.095)	-0.234 (-0.422 to -0.046)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	IPSS Total at Day 168
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1193
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	-0.907
	Confidence Interval	(2-Sided) 95% -2.048 to 0.235
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	IPSS, QoL at Day 168
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1080
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	-0.213
	Confidence Interval	(2-Sided) 95% -0.473 to 0.047
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	IPSS Total at Day 336
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1256
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	-0.916
	Confidence Interval	(2-Sided) 95% -2.089 to 0.257
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	IPSS, QoL at Day 336
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.7261
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	-0.047
	Confidence Interval	(2-Sided) 95% -0.312 to 0.218
	Estimation Comments	[Not Specified]

11.Secondary Outcome


Title	Total Number of CV-related Hospitalization Events Over the Duration of the Trial
Description	The total number of CV-related hospitalizations over the duration of t...
Description	The total number of CV-related hospitalizations over the duration of the trial was defined as the number of hospitalizations due to CV-related adverse events, observed from the first exposure to IMP up until Day 336 for each subject.
Time Frame	First dose of IMP to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: Events
	15	17

12.Secondary Outcome


Title	Total Number of Coronary Artery By-pass Grafting (CABG) or Percutaneous Coronary Intervention (PCI) Procedures Over the Duration of the Trial
Description	The total number of CABG or PCI procedures observed for each subject o...
Description	The total number of CABG or PCI procedures observed for each subject over the duration of the trial
Time Frame	First dose of IMP to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: Events
	3	6

13.Secondary Outcome


Title	Total Number of CV-related Emergency Room (ER) Visit Events Over the Duration of the Trial
Description	CV-related ER visit events (that did not lead to hospitalization) was ...
Description	CV-related ER visit events (that did not lead to hospitalization) was observed from the first exposure to IMP up until Day 336 for each subject.
Time Frame	First dose of IMP to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: Events
	8	2

14.Secondary Outcome


Title	Change in Utility, Based on EuroQol Group 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)
Description	The EQ-5D-5L essentially consists of 2 systems - the EQ-5D-5L descript...
Description	The EQ-5D-5L essentially consists of 2 systems - the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS is an overall estimation of the present health status. The results from the EQ-5D-5L questionnaire were converted into quality adjusted life year (QALY) units. The QALY is estimated by combining the value of life (utility value) and length of life. Quality adjusted life years are based on a principle assuming that a year of life lived in perfect health is worth 1 QALY and that a year of life lived in a state of less than perfect health is worth less than 1.
Time Frame	Baseline to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	243	239
Least Squares Mean (95% Confidence Interval) Unit of Measure: QALY
	0.794 (0.770 to 0.818)	0.796 (0.772 to 0.820)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9110
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	Compared using an ANCOVA model, where the QALY is the dependent variable and adjusted for treatment group, age group and region, respectively.

Method of Estimation	Estimation Parameter	Treatment difference
	Estimated Value	-0.002
	Confidence Interval	(2-Sided) 95% -0.036 to 0.032
	Estimation Comments	[Not Specified]

15.Secondary Outcome


Title	Changes From Baseline in Duke Activity Status Index (DASI) Global Score
Description	The DASI is a self-administered instrument developed to measure functi...
Description	The DASI is a self-administered instrument developed to measure functional capacity in subjects with cardiovascular disease (CVD). It contains 12 items referring to the present time, assessing the ability to perform physical tasks in five domains: personal care (1 item), ambulation (4 items), household tasks (4 items), sexual function (1 item) and recreation (2 items). Each question was answered by one of four options: 'yes with no difficulty' / 'yes, but with some difficulty' / 'no, I can't do this' / 'don't do this for other reasons'. A global score was calculated with a higher score indicating a higher functional capacity. The minimum score is 0 and the maximum score is 58.2 points. Change from baseline in DASI Global score is presented.
Time Frame	Baseline to Days 168 and 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:		Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:		Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed		234	232
Least Squares Mean (95% Confidence Interval) Unit of Measure: score on a scale
Change in DASI to Day 168	Number Analyzed	234 participants	232 participants
Change in DASI to Day 168		-2.65 (-3.95 to -1.35)	-1.08 (-2.38 to 0.23)
Change in DASI to Day 336	Number Analyzed	195 participants	191 participants
Change in DASI to Day 336		-2.18 (-3.54 to -0.81)	-3.01 (-4.39 to -1.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	DASI at Day 168
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0936
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	-1.57
	Confidence Interval	(2-Sided) 95% -3.41 to 0.27
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	DASI at Day 336
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.4000
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95% -1.11 to 2.78
	Estimation Comments	[Not Specified]

16.Secondary Outcome


Title	Changes From Baseline in Cardiac Anxiety Questionnaire (CAQ) Global Score and Score Per Domain
Description	The CAQ is a self-administered questionnaire developed to measure hear...
Description	The CAQ is a self-administered questionnaire developed to measure heart-focused anxiety in persons with or without heart disease. It contains 18 items referring to the present time assessing cardiac anxiety in three domains: fear (8 items, each item could be scored between 0 "never" to 4 "always", maximum total score 32), avoidance (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20) and attention (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20). A higher score indicated greater cardiac anxiety and the total score range was between 0 and 72. Change from baseline in CAQ Global score and score per domain are presented.
Time Frame	Baseline to Days 168 and 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:		Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:		Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed		234	232
Least Squares Mean (95% Confidence Interval) Unit of Measure: score on a scale
CAQ global score (Day 168)	Number Analyzed	234 participants	232 participants
CAQ global score (Day 168)		0.034 (-0.021 to 0.088)	-0.011 (-0.066 to 0.044)
CAQ domain score for Attention (Day 168)	Number Analyzed	234 participants	232 participants
CAQ domain score for Attention (Day 168)		0.030 (-0.034 to 0.094)	-0.006 (-0.070 to 0.059)
CAQ domain score for Avoidance (Day 168)	Number Analyzed	234 participants	232 participants
CAQ domain score for Avoidance (Day 168)		0.155 (0.062 to 0.248)	0.039 (-0.054 to 0.133)
CAQ domain score for Fear (Day 168)	Number Analyzed	234 participants	232 participants
CAQ domain score for Fear (Day 168)		-0.036 (-0.106 to 0.034)	-0.048 (-0.119 to 0.022)
CAQ global score (Day 336)	Number Analyzed	195 participants	191 participants
CAQ global score (Day 336)		0.102 (0.043 to 0.161)	0.051 (-0.009 to 0.110)
CAQ domain score for Attention (Day 336)	Number Analyzed	195 participants	191 participants
CAQ domain score for Attention (Day 336)		0.023 (-0.046 to 0.092)	-0.015 (-0.085 to 0.054)
CAQ domain score for Avoidance (Day 336)	Number Analyzed	195 participants	191 participants
CAQ domain score for Avoidance (Day 336)		0.228 (0.130 to 0.325)	0.220 (0.122 to 0.319)
CAQ domain score for Fear (Day 336)	Number Analyzed	195 participants	191 participants
CAQ domain score for Fear (Day 336)		0.075 (-0.003 to 0.153)	-0.018 (-0.097 to 0.061)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	CAQ Global Score at Day 168
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2535
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.045
	Confidence Interval	(2-Sided) 95% -0.032 to 0.122
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	CAQ domain score for Attention at Day 168
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.4370
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.036
	Confidence Interval	(2-Sided) 95% -0.055 to 0.127
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	CAQ domain score for Avoidance at Day 168
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0852
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.116
	Confidence Interval	(2-Sided) 95% -0.016 to 0.248
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	CAQ domain score for Fear at Day 168
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8156
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.012
	Confidence Interval	(2-Sided) 95% -0.087 to 0.111
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	CAQ Global Score at Day 336
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2299
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.051
	Confidence Interval	(2-Sided) 95% -0.033 to 0.135
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	CAQ domain score for Attention at Day 336
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.4440
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.038
	Confidence Interval	(2-Sided) 95% -0.060 to 0.136
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	CAQ domain score for Avoidance at Day 336
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9172
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.007
	Confidence Interval	(2-Sided) 95% -0.131 to 0.146
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Degarelix 240 mg/80 mg, Leuprolide 22.5 mg
	Comments	CAQ domain score for Fear at Day 336
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1028
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.

Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	0.093
	Confidence Interval	(2-Sided) 95% -0.019 to 0.204
	Estimation Comments	[Not Specified]

17.Secondary Outcome


Title	Number of Subjects With Adverse Events (AEs)
Description	Adverse events were recorded from signed informed consent until end-of...
Description	Adverse events were recorded from signed informed consent until end-of-trial. Adverse events with onset after start of IMP treatment, and within 3 months after (1 month=28 days) last dosing of IMP, were considered 'treatment-emergent' and are presented for the safety analysis set.
Time Frame	Start of IMP treatment until 3 months after last dosing of IMP

Outcome Measure Data

Analysis Population Description

The safety analysis set consisted of all treated subjects (who received at least one dose of IMP) and was analyzed based on the actual treatment received.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: subjects
AEs	250	228
SAEs	47	44
AE leading to death	11	9

18.Secondary Outcome


Title	Intensity of AEs
Description	The intensity of AE was graded using the National Cancer Institute (NC...
Description	The intensity of AE was graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.02) 5-point scale. AE were categorized as grade 1 Mild (minor; no specific medical intervention; asymptomatic laboratory findings only; marginal clinical relevance), Grade 2 Moderate (minimal intervention: local intervention; non-invasive intervention), Grade 3 Severe (significant symptoms, requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation), Grade 4 Life-threatening or disabling (complicated by acute, life-threatening metabolic or CV complications such as circulatory failure, hemorrhage, sepsis. Life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation) and Grade 5 Death. Events with grades 3, 4 and 5 were categorized as severe.
Time Frame	Start of IMP treatment until 3 months after last dosing of IMP

Outcome Measure Data

Analysis Population Description

The safety analysis set consisted of all treated subjects (who received at least one dose of IMP) and was analyzed based on the actual treatment received.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	275	269
Measure Type: Number Unit of Measure: subjects
Mild AE	224	200
Moderate AE	160	135
Severe AE	59	55

19.Secondary Outcome


Title	Changes in Vital Signs
Description	Number of subjects shifting from normal value(s) in vital signs (pulse...
Description	Number of subjects shifting from normal value(s) in vital signs (pulse and blood pressure) at baseline to clinically significant abnormal value(s) at end-of-trial are presented. Note: Only subjects with appropriate baseline and post-baseline data are included in the evaluation.
Time Frame	Baseline to Day 336 (end-of-trial)

Outcome Measure Data

Analysis Population Description

The safety analysis set consisted of all treated subjects (who received at least one dose of IMP) and was analyzed based on the actual treatment received. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.


Arm/Group Title	Degarelix 240 mg/80 mg	Leuprolide 22.5 mg
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix a...	Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description:	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.	Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
Overall Number of Participants Analyzed	196	193
Measure Type: Count of Participants Unit of Measure: Participants
	0	1

Adverse Events

Time Frame	Start of IMP treatment until 3 months after last dosing of IMP
Adverse Event Reporting Description	Adverse events were recorded from signing of the informed consent until end-of-trial. Events with onset after start of IMP treatment, and within 3 months after (1 month=28 days) last dosing of IMP, were considered 'treatment-emergent' and are presented for the safety analysis set (defined above). Non-fatal serious adverse events (SAEs) of myocardial infarction, stroke, and unstable angina constituted exceptions to the SAE reporting (6 events in the degarelix group, 10 in the leuprolide group).

Arm/Group Title	Degarelix 240 mg/80 mg		Leuprolide 22.5 mg
Arm/Group Description	Degarelix 240 mg/80 mg: Degarelix a...		Leuprolide 22.5 mg: Leuprolide at d...
Arm/Group Description	Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals.		Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial.
All-Cause Mortality
	Degarelix 240 mg/80 mg		Leuprolide 22.5 mg
	Affected / at Risk (%)		Affected / at Risk (%)
Total	11/275 (4.00%)		9/269 (3.35%)
Serious Adverse Events Serious Adverse Events
	Degarelix 240 mg/80 mg		Leuprolide 22.5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	47/275 (17.09%)		44/269 (16.36%)
Cardiac disorders
Cardiac failure chronic ^† 1	3/275 (1.09%)	4	1/269 (0.37%)	1
Cardiac failure ^† 1	1/275 (0.36%)	1	2/269 (0.74%)	2
Atrial flutter ^† 1	2/275 (0.73%)	2	0/269 (0.00%)	0
Atrioventricular block complete ^† 1	2/275 (0.73%)	2	0/269 (0.00%)	0
Bradycardia ^† 1	2/275 (0.73%)	2	0/269 (0.00%)	0
Acute myocardial infarction ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Angina pectoris ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Arrhythmia ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Ischaemic cardiomyopathy ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Sinus node dysfunction ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Supraventricular tachycardia ^† 1	1/275 (0.36%)	2	0/269 (0.00%)	0
Tachyarrhythmia ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Ventricular fibrillation ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Gastrointestinal disorders
Diarrhoea ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Gastric ulcer haemorrhage ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Haematochezia ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Ileus ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Inguinal hernia ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Intestinal obstruction ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Rectal haemorrhage ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Umbilical hernia ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
General disorders
Death ^† 1	3/275 (1.09%)	3	1/269 (0.37%)	1
Malaise ^† 1	1/275 (0.36%)	1	1/269 (0.37%)	1
Injection site swelling ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Non-cardiac chest pain ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Oedema peripheral ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Pyrexia ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Hepatobiliary disorders
Cholecystitis ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Hepatic failure ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Infections and infestations
Pneumonia ^† 1	5/275 (1.82%)	5	3/269 (1.12%)	4
Sepsis ^† 1	2/275 (0.73%)	2	3/269 (1.12%)	3
COVID-19 pneumonia ^† 1	2/275 (0.73%)	2	0/269 (0.00%)	0
Urinary tract infection ^† 1	1/275 (0.36%)	1	1/269 (0.37%)	1
Bacteraemia ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Cellulitis ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Cystitis ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Diverticulitis intestinal haemorrhagic ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Enterococcal sepsis ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Intervertebral discitis ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Osteomyelitis ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Pyelonephritis ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Respiratory tract infection ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Hepatic echinococciasis ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Injury, poisoning and procedural complications
Fall ^† 1	2/275 (0.73%)	2	0/269 (0.00%)	0
Anastomotic ulcer haemorrhage ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Cervical vertebral fracture ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Femoral neck fracture ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Femur fracture ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Hip fracture ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Lumbar vertebral fracture ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Rib fracture ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Skin laceration ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Spinal compression fracture ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Subdural haematoma ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Upper limb fracture ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Investigations
Heart rate irregular ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Metabolism and nutrition disorders
Hyperkalaemia ^† 1	0/275 (0.00%)	0	2/269 (0.74%)	2
Failure to thrive ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Hypocalcaemia ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Hypokalaemia ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Musculoskeletal and connective tissue disorders
Back pain ^† 1	1/275 (0.36%)	1	2/269 (0.74%)	2
Bone pain ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Rhabdomyolysis ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Hodgkin's disease ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Pancreatic carcinoma ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Nervous system disorders
Syncope ^† 1	0/275 (0.00%)	0	4/269 (1.49%)	4
Cerebrovascular accident ^† 1	1/275 (0.36%)	1	1/269 (0.37%)	1
Cerebral haemorrhage ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Cognitive disorder ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Sciatica ^† 1	1/275 (0.36%)	2	0/269 (0.00%)	0
Toxic encephalopathy ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Tremor ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Psychiatric disorders
Suicidal ideation ^† 1	1/275 (0.36%)	1	1/269 (0.37%)	1
Completed suicide ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Renal and urinary disorders
Acute kidney injury ^† 1	0/275 (0.00%)	0	3/269 (1.12%)	3
Urinary retention ^† 1	2/275 (0.73%)	2	1/269 (0.37%)	1
Nephrolithiasis ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Renal failure ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Urinary tract obstruction ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Reproductive system and breast disorders
Prostatitis ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism ^† 1	2/275 (0.73%)	2	1/269 (0.37%)	1
Acute respiratory failure ^† 1	1/275 (0.36%)	1	1/269 (0.37%)	1
Pneumothorax ^† 1	0/275 (0.00%)	0	2/269 (0.74%)	2
Respiratory failure ^† 1	2/275 (0.73%)	2	0/269 (0.00%)	0
Acute respiratory distress syndrome ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Chronic obstructive pulmonary disease ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Pulmonary oedema ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Vascular disorders
Hypotension ^† 1	2/275 (0.73%)	2	1/269 (0.37%)	1
Deep vein thrombosis ^† 1	0/275 (0.00%)	0	2/269 (0.74%)	2
Hypertension ^† 1	0/275 (0.00%)	0	1/269 (0.37%)	1
Hypovolaemic shock ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Peripheral artery thrombosis ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Peripheral ischaemia ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
Thrombosis ^† 1	1/275 (0.36%)	1	0/269 (0.00%)	0
1 Term from vocabulary, MedDRA (24.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Degarelix 240 mg/80 mg		Leuprolide 22.5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	250/275 (90.91%)		228/269 (84.76%)
Gastrointestinal disorders
Diarrhoea ^† 1	23/275 (8.36%)	26	26/269 (9.67%)	28
Constipation ^† 1	18/275 (6.55%)	21	20/269 (7.43%)	20
Nausea ^† 1	19/275 (6.91%)	21	11/269 (4.09%)	12
General disorders
Fatigue ^† 1	50/275 (18.18%)	57	34/269 (12.64%)	35
Injection site pain ^† 1	73/275 (26.55%)	232	6/269 (2.23%)	7
Injection site erythema ^† 1	58/275 (21.09%)	163	1/269 (0.37%)	1
Injection site swelling ^† 1	27/275 (9.82%)	62	3/269 (1.12%)	3
Asthenia ^† 1	15/275 (5.45%)	18	8/269 (2.97%)	9
Oedema peripheral ^† 1	8/275 (2.91%)	8	15/269 (5.58%)	17
Injection site induration ^† 1	19/275 (6.91%)	79	2/269 (0.74%)	3
Pyrexia ^† 1	16/275 (5.82%)	20	5/269 (1.86%)	6
Infections and infestations
Urinary tract infection ^† 1	20/275 (7.27%)	26	13/269 (4.83%)	14
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	24/275 (8.73%)	29	16/269 (5.95%)	17
Back pain ^† 1	22/275 (8.00%)	25	19/269 (7.06%)	22
Pain in extremity ^† 1	15/275 (5.45%)	19	11/269 (4.09%)	13
Nervous system disorders
Dizziness ^† 1	20/275 (7.27%)	20	14/269 (5.20%)	16
Psychiatric disorders
Insomnia ^† 1	12/275 (4.36%)	12	14/269 (5.20%)	14
Renal and urinary disorders
Pollakiuria ^† 1	24/275 (8.73%)	25	28/269 (10.41%)	31
Dysuria ^† 1	25/275 (9.09%)	27	21/269 (7.81%)	24
Haematuria ^† 1	8/275 (2.91%)	17	15/269 (5.58%)	17
Nocturia ^† 1	8/275 (2.91%)	8	14/269 (5.20%)	14
Vascular disorders
Hot flush ^† 1	107/275 (38.91%)	112	120/269 (44.61%)	127
Hypertension ^† 1	17/275 (6.18%)	27	23/269 (8.55%)	31
1 Term from vocabulary, MedDRA (24.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

The trial was terminated prematurely due to a slower than anticipated recruitment rate and a lower than anticipated observed CV event rate. Approximately 900 patients were planned to be included, however, at the time of stopping screening and recruitment 216 patients had completed the trial, 292 were ongoing, and 37 were withdrawn. The Sponsor decision to stop the trial was not based on any safety concerns, any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

A Publications Committee, including the signatory investigators, other Steering Committee members, and Sponsor representatives was established to function as an independent body of scientific and medical experts acting to facilitate, encourage, and coordinate the complete and accurate presentation and publication of the trial results. Members of the Publication Committee are responsible for review and approval of all abstracts and manuscripts based on the trial results.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Global Clinical Compliance
Organization:	Ferring Pharmaceuticals
EMail:	DK0-Disclosure@ferring.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lopes RD, Higano CS, Slovin SF, Nelson AJ, Bigelow R, Sorensen PS, Melloni C, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Clarke NW, Olesen TK, Doyle-Olsen BT, Kristensen H, Arney L, Roe MT, Alexander JH; PRONOUNCE Study Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial. Circulation. 2021 Oct 19;144(16):1295-1307. doi: 10.1161/CIRCULATIONAHA.121.056810. Epub 2021 Aug 30. Erratum In: Circulation. 2021 Oct 19;144(16):e273.

Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

Melloni C, Slovin SF, Blemings A, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Zubovskiy K, Olesen TK, Dugi K, Clarke NW, Higano CS, Roe MT; PRONOUNCE Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer: The PRONOUNCE Trial Study Design. JACC CardioOncol. 2020 Mar 17;2(1):70-81. doi: 10.1016/j.jaccao.2020.01.004. eCollection 2020 Mar.

Layout table for additonal information

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02663908
Other Study ID Numbers:	000108
First Submitted:	January 22, 2016
First Posted:	January 26, 2016
Results First Submitted:	March 21, 2022
Results First Posted:	June 29, 2022
Last Update Posted:	June 29, 2022

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