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

Ferring

Status and phase: Terminated; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Leuprolide; Drug: Degarelix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02663908

000108

Details and patient eligibility

About

The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer and cardiovascular disease.

Enrollment: 545 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced prostate cancer
• Indication to initiate androgen deprivation therapy (ADT)
• Predefined cardiovascular disease

Exclusion criteria

• Previous or current hormonal management of prostate cancer (unless terminated at least 12 months prior to trial)
• Acute cardiovascular disease in the previous 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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545 participants in 2 patient groups

Degarelix

Experimental group

Treatment:

Drug: Degarelix

Leuprolide

Active Comparator group

Treatment:

Drug: Leuprolide