NCT05320406Active, not recruitingPhase 2
RElugolix VErsus LeUprolide Cardiac Trial
Mechanism and Predictors of Cardiotoxicity After Prostate Cancer Treatment: A Parallel Cohort and Randomized Trial Comparing Radiation Alone, Radiation Plus Leuprolide, and Radiation Plus Relugolix
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 94 (actual)
- First submitted
- 18 Mar 2022
- Start date
- Jun 2022
- Primary completion date
- Jan 2025
- Lead sponsor
- Emory University
- Diseases
- Prostate cancer
- NCT number
- NCT05320406
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 94
- From Jun 2022 to the primary completion date, Jan 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to androgen deprivation therapy
- Prior exposure to chemotherapy or immunotherapy
Other illness
- Metastatic prostate cancer requiring \> 24 months of ADT
- History of cardiac bypass surgery or percutaneous coronary intervention
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory Saint Joseph's Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory University/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory Proton Therapy Center Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
Related publications
- Coronary Plaque Progression After Androgen Deprivation Therapy in Men With Prostate Cancer: A Randomized Clinical Trial.JAMA Cardiol · 2026 · PMID 41706486
This page is information, not medical advice. Discuss any trial with your doctor.