NCT06650579 REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
| NCT ID | NCT06650579 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Emory University |
| Condition | Recurrent Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-01-31 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 72 participants in total. It began in 2025-01-31 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase III/IV trial compares the impact of leuprolide and abiraterone acetate (AA) versus relugolix and AA on the heart in hormone-naive patients with advanced prostate cancer receiving pelvic radiation therapy. Leuprolide is in a class of medications called gonadotropin-releasing hormone agonists (GNRHa). It prevents the body from making luteinizing hormone-releasing hormone (LHRH) and luteinizing hormone (LH). This causes the testicles to stop making testosterone (a male hormone) in men and may stop the growth of prostate tumor cells that need testosterone to grow. Abiraterone acetate, an androgen biosynthesis inhibitor, works by decreasing the amount of certain hormones in the body. Relugolix, a GNRH antagonist, works by decreasing the amount of testosterone produced by the body. This may slow or stop the spread of prostate tumor cells that need testosterone to grow. The use of hormone therapy with radiation therapy has been shown to improve survival, however, studies have suggested that the addition of hormone therapy may worsen heart (cardiac) disease and high blood pressure. In fact, studies have shown that the most common cause of death in prostate cancer patients is due to heart disease or heart attacks. Computed tomography (CT) scans create a series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine. In this study, sophisticated cardiac CT images are used to take pictures of patients' heart and coronary arteries to help assess damage to the heart. Using cardiac CT and blood tests, this trial may help doctors determine which patients are at risk of cardiac disease when treated with combination hormone therapy, as well as the differential risk of leuprolide versus relugolix in combination with abiraterone acetate.
Eligibility 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
Contact & Investigator
Sagar A Patel, MD
PRINCIPAL INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Frequently Asked Questions
Who can join the NCT06650579 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Recurrent Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06650579 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 72 participants.
Is NCT06650579 currently recruiting?
Yes, NCT06650579 is actively recruiting participants. Contact the research team at bill.zheng@emory.edu for enrollment information.
Where is the NCT06650579 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States, Atlanta, United States, Atlanta, United States.
Who is sponsoring the NCT06650579 clinical trial?
NCT06650579 is sponsored by Emory University. The principal investigator is Sagar A Patel, MD at Emory University Hospital/Winship Cancer Institute. The trial plans to enroll 72 participants.