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REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial

RecruitingPhase 3Ages 18 Years - anyMaleEmory University
NCT06650579 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ho

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📋 Eligibility rules (as published)
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
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What it tests

  • Abiraterone Acetate
  • Bicalutamide
  • Biospecimen Collection
  • Computed Tomography Angiography
  • Leuprolide
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Where

4 sites
Emory Proton Therapy Center
Atlanta, United States
Winship at Emory Midtown
Atlanta, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
Emory Saint Joseph's Hospital
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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