A Study Comparing the Cardiovascular Safety of Degarelix versus Leuprolide in Men with Cardiovascular Disease Receiving Hormonal Therapy for Advanced Prostate Cancer

Full Title

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 (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)

Purpose

Testosterone drives the growth of prostate cancer. Hormonal therapy is commonly used to treat men with advanced prostate cancer by inhibiting the cancer-fueling effects of testosterone. However, these medications can cause cardiovascular (heart-related) side effects. Moreover, the risk of these cardiovascular complications is increased in men who already have heart disease.

In this study, researchers are comparing the cardiovascular safety of two different hormonal therapies in men with advanced prostate cancer who have cardiovascular disease: degarelix and leuprolide. Patients will be randomly assigned to receive either degarelix or leuprolide. Both medications are given by injection.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced or recurrent prostate cancer that has not yet been treated with hormonal therapy.
  • Patients must have pre-existing cardiovascular disease.

For more information about this study and to inquire about eligibility, please contact Dr. Susan F. Slovin at 646-422-4470.

Protocol

16-473

Phase

III/IV

Investigator

Co-Investigators