RecruitingPhase 3NCT06650579

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

Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate (AA) Versus Relugolix Plus AA for Advanced Prostate Cancer: The REVELUTION-2 Trial


Sponsor

Emory University

Enrollment

72 participants

Start Date

Jan 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different hormonal therapy approaches in men with non-metastatic prostate cancer who are receiving radiation. It compares relugolix (a daily pill) plus abiraterone to leuprolide (a monthly injection) plus abiraterone — specifically looking at effects on heart health. **You may be eligible if...** - You are a man 18 or older - You have prostate cancer that has not spread to other parts of the body - Your PSA is rising after prior treatment (biochemically recurrent prostate cancer) - You are planning to receive pelvic radiation therapy with curative intent - You are planning to receive up to 24 months of combined hormonal therapy **You may NOT be eligible if...** - Your cancer has already spread (metastatic) - You have previously received hormonal therapy, chemotherapy, or radiation for prostate cancer - You have had heart bypass surgery or have a pacemaker/defibrillator Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbiraterone Acetate

Given abiraterone acetate

DRUGBicalutamide

Given PO

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography Angiography

Undergo CCTA

DRUGLeuprolide

Given IM or SC

DRUGPrednisone

Given prednisone

RADIATIONRadiation Therapy

Undergo standard of care radiation therapy

DRUGRelugolix

Given PO


Locations(4)

Emory Proton Therapy Center

Atlanta, Georgia, United States

Winship at Emory Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT06650579


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