Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

Prostate Cancer Clinical Trial

Official title: Relugolix Versus Leuprolide in Patients With Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV)

Status Active, not recruiting

Clinical Trial Summary

This is a randomized study to evaluate the risk of major adverse cardiovascular events (MACE) for relugolix compared with leuprolide acetate. This study will collect clinical and cardiovascular risk factor data on patients ages 18 and older who are receiving relugolix or leuprolide acetate for their prostate cancer or as adjunct to radiation therapy with a treatment plan to be on androgen deprivation therapy (ADT) for at least one year.

Clinical Trial Description

Eligible patients will be randomized (1:1) to receive either relugolix or leuprolide acetate for prostate cancer or as an adjunct to primary or salvage radiation therapy. Patients who experience major adverse cardiovascular events (MACE) during the trial will be encouraged to stay on the study and continue to fill out questionnaires every 3 months. Each patient will also be asked to provide information regarding alternative contacts (eg, close relatives or friends, or primary care physician or cardiologist). In addition, patients will provide consent to obtain medical records (eg, hospitalizations, emergency room visits and clinic notes) for additional information, when appropriate. The primary endpoint in this study will be the time to first adjudicated MACE (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death). A surveillance approach will be used to collect clinical and cardiovascular risk data on patients receiving relugolix or leuprolide acetate for their prostate cancer. A rigorous, blinded adjudication of MACE by an independent clinical event adjudication committee (CEC) is included. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT05605964
• Study type: Interventional
• Source: Myovant Sciences GmbH
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 25, 2023
• Completion date: February 28, 2027