RElugolix VErsus LeUprolide Cardiac Trial

Summary

This clinical trial investigates the impact of prostate cancer treatment, specifically androgen deprivation therapy (ADT), on the heart and coronary vessels among men with localized, non-metastatic prostate cancer undergoing definitive radiation therapy and concomitant ADT. Recently, cardiovascular toxicity from hormone therapy that is routinely used for prostate cancer (e.g. leuprolide) has emerged as a concern, yet studies identifying who is at risk and the mechanism of cardiac damage are lacking. Additionally, a new hormone therapy drug, relugolix, has recently been Food and Drug Administration (FDA)-approved and may reduce toxicity to the heart. This trial intends to investigate the mechanism of cardiovascular toxicity from ADT, investigate the mechanism by which relugolix reduces cardiovascular toxicity, and identify predictive biomarkers to improve individualized risk-assessment for cardiovascular toxicity from ADT.

Timeline

Start

2022-06-06

Primary completion

2025-01-30

Completion

2026-10-30

Publications

• Patel SA, Yadalam AK, van Assen M, Cantu SM, Onnis C, Zheng B, Koo A, Goyal S, Liu Y, Liu C, Sebastian NT, Dhere VR, Hershatter BW, Patel PR, Chaudagar K, Stillman AE, De Cecco CN, Sanda MG, Jani AB, Mandawat A. Coronary Plaque Progression After Androgen Deprivation Therapy in Men With Prostate Cancer: A Randomized Clinical Trial. JAMA Cardiol. 2026 May 1;11(5):459-463. doi: 10.1001/jamacardio.2025.5586.

Drugs

Indications