RElugolix VErsus LeUprolide Cardiac Trial

• Status: Not yet recruiting
• Trial end date: 2024-04-29
• Target enrollment: 0
• Participant gender: Male

Summary

This phase 4 trial investigates the impact of prostate cancer treatment, specifically androgen deprivation therapy (ADT, ie. leuprolide, relugolix), on the heart and coronary vessels among men with localized, non-metastatic prostate cancer undergoing definitive radiation therapy and concomitant ADT. Recently, the effect of hormone therapy that is routinely used for prostate cancer on the heart has emerged as a concern, yet studies to identify who is at risk and how damage to the heart may occur 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 hormone therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Leuprolide; Relugolix

Criteria

Inclusion Criteria:

• Men >= 18 years old

• Non-metastatic prostate cancer

• Non-metastatic, biochemically recurrent prostate cancer

• Plan to undergo curative-intent pelvic radiation therapy with or without ADT

Exclusion Criteria:

• Metastatic prostate cancer requiring > 24 months of ADT

• Prior exposure to androgen deprivation therapy

• Prior exposure to chemotherapy or immunotherapy