trialsTrial

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

A phase 3 trial of Degarelix in Prostate cancer, run by Ferring Pharmaceuticals, recorded as terminated on the registry.

A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease is a phase 3 interventional study registered as NCT02663908 by Ferring Pharmaceuticals, with 545 participants recorded, started 2016-04-19 and due to reach its primary completion in 2021-03-29. Interventions recorded: Degarelix, Leuprolide. Conditions recorded: Prostate Cancer.

Linked to the drug Degarelix because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.

Setting

A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)

Phase

Phase 3

Sponsor

Ferring Pharmaceuticals

Registry

NCT02663908

Started

2016-04-19

Reported

2022

Enrolled

545 enrolled

Outcomes

2top

In plain words

What these results mean for people, not percentages

545 enrolled

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 Trialprimaryother endpoint

5.5 vs 4.1 out of 100 reached this endpoint with Degarelix 240 mg/80 mg compared with Leuprolide 22.5 mg; 1.4 more per 100.
On this measure the first group did worse, not better.
Put another way, the treated group had about 28 percent higher chance of the event at any given time (hazard ratio 1.283, likely range 0.589 to 2.794).

This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.

Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trialsurrogate endpoint

8.7 vs 10 out of 100 alive without the cancer growing with Degarelix 240 mg/80 mg compared with Leuprolide 22.5 mg; 1.3 fewer per 100.
On this measure the first group did worse, not better.
Put another way, the treated group had about 11 percent lower chance of the event at any given time (hazard ratio 0.887, likely range 0.512 to 1.539).

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Caveats

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
These results apply to the people the trial enrolled: A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist). People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

545 enrolled.

HR 1.283 (0.589 to 2.794) · p = 0.5294

Degarelix 240 mg/80 mg5.5 of 100

n = 275

Leuprolide 22.5 mg4.1 of 100

n = 269

Download

Figures from the ClinicalTrials.gov results section (first posted 2022-06-29), not from a publication

Source

Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial

HR 0.887 (0.512 to 1.539) · p = 0.6701

Degarelix 240 mg/80 mg8.7 of 100

n = 275

Leuprolide 22.5 mg10 of 100

n = 269

Download

Figures from the ClinicalTrials.gov results section (first posted 2022-06-29), not from a publication

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
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 Trialprimary	Degarelix 240 mg/80 mg	275	5.5%	1.283 (0.589 to 2.794)	0.5294	link
	Leuprolide 22.5 mg	269	4.1%	1.283 (0.589 to 2.794)	0.5294	link
Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial	Degarelix 240 mg/80 mg	275	8.7%	0.887 (0.512 to 1.539)	0.6701	link
	Leuprolide 22.5 mg	269	10%	0.887 (0.512 to 1.539)	0.6701	link

Connected

3top

Trial
Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Shares Ferring Pharmaceuticals, Degarelix, Prostate cancer and the tag pipeline.
Trial
Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
Shares Ferring Pharmaceuticals, Degarelix, Prostate cancer and the tag pipeline.
Trial
Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
Shares Ferring Pharmaceuticals and the tag pipeline.
Trial
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Shares Ferring Pharmaceuticals and the tag pipeline.
Trial
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
Shares Ferring Pharmaceuticals and the tag pipeline.
Trial
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
Shares Degarelix, Prostate cancer and the tag pipeline.
Trial
Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients
Shares Prostate cancer and the tag pipeline.
Trial
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
Shares Prostate cancer and the tag pipeline.

cancers

Prostate cancer

drugs

ApprovedGnRH antagonist depot

Degarelix · Firmagon

companies

Ferring Pharmaceuticals

Evidence strength57/100 · Solid

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
545 enrolled+14
Primary endpoint: surrogate (response, pCR, detection)+8
Result: not reported0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 5 drugs · diff · file

Sources & links

ClinicalTrials.gov NCT02663908

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

A phase 3 trial of Degarelix in Prostate cancer, run by Ferring Pharmaceuticals, recorded as terminated on the registry.

Linked to the drug Degarelix because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.

Setting

Phase

Phase 3

Sponsor

Ferring Pharmaceuticals

Registry

NCT02663908

Started

2016-04-19

Reported

2022

Enrolled

545 enrolled

Outcomes

2top

In plain words

What these results mean for people, not percentages

545 enrolled

5.5 vs 4.1 out of 100 reached this endpoint with Degarelix 240 mg/80 mg compared with Leuprolide 22.5 mg; 1.4 more per 100.
On this measure the first group did worse, not better.
Put another way, the treated group had about 28 percent higher chance of the event at any given time (hazard ratio 1.283, likely range 0.589 to 2.794).

This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.

Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trialsurrogate endpoint

8.7 vs 10 out of 100 alive without the cancer growing with Degarelix 240 mg/80 mg compared with Leuprolide 22.5 mg; 1.3 fewer per 100.
On this measure the first group did worse, not better.
Put another way, the treated group had about 11 percent lower chance of the event at any given time (hazard ratio 0.887, likely range 0.512 to 1.539).

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Caveats

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
These results apply to the people the trial enrolled: A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist). People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

545 enrolled.

HR 1.283 (0.589 to 2.794) · p = 0.5294

Degarelix 240 mg/80 mg5.5 of 100

n = 275

Leuprolide 22.5 mg4.1 of 100

n = 269

Download

Figures from the ClinicalTrials.gov results section (first posted 2022-06-29), not from a publication

Source

Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial

HR 0.887 (0.512 to 1.539) · p = 0.6701

Degarelix 240 mg/80 mg8.7 of 100

n = 275

Leuprolide 22.5 mg10 of 100

n = 269

Download

Figures from the ClinicalTrials.gov results section (first posted 2022-06-29), not from a publication

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
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 Trialprimary	Degarelix 240 mg/80 mg	275	5.5%	1.283 (0.589 to 2.794)	0.5294	link
	Leuprolide 22.5 mg	269	4.1%	1.283 (0.589 to 2.794)	0.5294	link
Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial	Degarelix 240 mg/80 mg	275	8.7%	0.887 (0.512 to 1.539)	0.6701	link
	Leuprolide 22.5 mg	269	10%	0.887 (0.512 to 1.539)	0.6701	link

Connected

3top

Trial
Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
Shares Ferring Pharmaceuticals, Degarelix, Prostate cancer and the tag pipeline.
Trial
Investigation of the Effect of Degarelix in Terms of Prostate Volume Reduction in Prostate Cancer Patients
Shares Ferring Pharmaceuticals, Degarelix, Prostate cancer and the tag pipeline.
Trial
Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
Shares Ferring Pharmaceuticals and the tag pipeline.
Trial
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Shares Ferring Pharmaceuticals and the tag pipeline.
Trial
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
Shares Ferring Pharmaceuticals and the tag pipeline.
Trial
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
Shares Degarelix, Prostate cancer and the tag pipeline.
Trial
Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients
Shares Prostate cancer and the tag pipeline.
Trial
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
Shares Prostate cancer and the tag pipeline.

cancers

Prostate cancer

drugs

ApprovedGnRH antagonist depot

Degarelix · Firmagon

companies

Ferring Pharmaceuticals

Evidence strength57/100 · Solid

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
545 enrolled+14
Primary endpoint: surrogate (response, pCR, detection)+8
Result: not reported0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 5 drugs · diff · file

Sources & links

ClinicalTrials.gov NCT02663908

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

Outcomes

Connected

Similar pages

cancers

drugs

companies

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

Outcomes

Connected

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cancers

drugs

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

Overview

Outcomes

Connected

Similar pages

cancers

drugs

companies

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

Overview

Outcomes

Connected

Similar pages

cancers

drugs

companies