Comparing heart effects of two hormone therapies in advanced prostate cancer
Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: The REVELUTION-2 Trial
This study is testing whether two different hormone treatments for advanced prostate cancer affect heart health differently in men receiving radiation therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, prednisone |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Trial ID | NCT06650579 on ClinicalTrials.gov |
What this trial studies
This phase III trial evaluates the cardiovascular outcomes of leuprolide combined with abiraterone acetate versus relugolix combined with abiraterone acetate in hormone-naive men with advanced prostate cancer undergoing pelvic radiation therapy. The study aims to measure the impact of these hormone therapies on heart health and identify any genomic factors that may increase cardiovascular toxicity. Patients will be randomized into two groups, receiving either leuprolide or relugolix alongside standard treatment, with assessments including coronary computed tomography angiography and blood sample collection. The trial seeks to improve understanding of hormone therapy's effects on cardiovascular health in this patient population.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with non-metastatic, biochemically recurrent prostate cancer planning to undergo curative pelvic radiation therapy.
Not a fit: Patients with metastatic prostate cancer or those who have previously received androgen deprivation therapy or chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer hormone therapy options for patients with advanced prostate cancer, minimizing cardiovascular risks.
How similar studies have performed: Other studies have shown varying success with hormone therapies in prostate cancer, but this specific comparison of cardiovascular outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 (photons or protons) with or without brachytherapy * Plan to undergo up to 24 months of combination androgen deprivation therapy (ADT) plus AA and prednisone Exclusion Criteria: * Metastatic prostate cancer requiring indefinitive ADT or chemotherapy * Prior exposure to androgen deprivation therapy * Prior exposure to chemotherapy, immunotherapy, or radiation therapy * History of cardiac bypass surgery or percutaneous coronary intervention * History of cardiac pacemaker or defibrillator
Where this trial is running
Atlanta, Georgia and 3 other locations
- Emory Proton Therapy Center — Atlanta, Georgia, United States (Recruiting)
- Winship at Emory Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Sagar A Patel, MD — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Bill Zheng, BS
- Email: bill.zheng@emory.edu
- Phone: 404-686-6856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.