A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease
Purpose
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.
Condition
- Prostate Cancer
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Degarelix |
|
|
Active Comparator Leuprolide |
|
More Details
- Status
- Terminated
- Sponsor
- Ferring Pharmaceuticals