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 patients with prostate cancer and cardiovascular disease.

Condition

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

ArmDescriptionAssigned Intervention
Experimental
Degarelix
  • Drug: Degarelix
    Other names:
    • FIRMAGON
Active Comparator
Leuprolide
  • Drug: Leuprolide
    Other names:
    • LUPRON DEPOT

More Details

Status
Active, not recruiting
Sponsor
Ferring Pharmaceuticals

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.