REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
Launched by EMORY UNIVERSITY · Oct 18, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
The REVELUTION-2 trial is a study looking at how two different hormone treatments affect the heart in men with advanced prostate cancer who are receiving radiation therapy. The trial compares leuprolide, a medication that reduces testosterone production, with relugolix, which works in a similar way, alongside abiraterone acetate, another hormone therapy. The goal is to understand if one treatment has a greater risk of causing heart problems than the other, especially since heart disease is a leading cause of death for men with prostate cancer.
To be eligible for this trial, participants need to be men aged 18 or older with non-metastatic prostate cancer who plan to undergo radiation therapy. They should also be ready to receive up to 24 months of combined hormone therapy. Throughout the trial, participants will have detailed heart scans and blood tests to help doctors identify any potential heart risks associated with these treatments. This research hopes to provide valuable insights into how hormone therapies impact heart health in patients with prostate cancer.
Gender
MALE
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
About Emory University
Emory University, a leading research institution located in Atlanta, Georgia, is dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Emory harnesses the expertise of its renowned faculty and state-of-the-art facilities to conduct cutting-edge research across various fields, including oncology, neurology, and infectious diseases. The university's commitment to ethical research practices and patient safety ensures that all clinical trials are designed to generate valuable data that can lead to significant therapeutic advancements. By fostering partnerships with local hospitals and community organizations, Emory strives to translate research findings into real-world applications, ultimately enhancing health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Patients applied
Trial Officials
Sagar A Patel, MD
Principal Investigator
Emory University Hospital/Winship Cancer Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported