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NCT06650579 · ClinicalTrials.gov registry record · Phase 3
REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
A Phase 3 study of Recurrent Prostate Carcinoma and Stage III Prostate Cancer AJCC v8, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
- 4
- Study locations
NCT06650579 is a Phase 3 study of Recurrent Prostate Carcinoma and Stage III Prostate Cancer AJCC v8 that is actively recruiting participants, run by Emory University. The registered enrollment target is 72 participants, below the 163-participant average among 29 other Recurrent Prostate Carcinoma trials with a reported enrollment target (56% lower). The trial reports 4 study locations across 1 state.
The verdict
NCT06650579, a Phase 3 study of Recurrent Prostate Carcinoma and Stage III Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
- 4
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Abiraterone Acetate
- DRUG Bicalutamide
- PROCEDURE Computed Tomography Angiography
- DRUG Leuprolide
Study Locations (4)
Georgia
- Emory Proton Therapy Center - Atlanta
- Winship at Emory Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2025-01-31 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06650579
The ClinicalTrials.gov registry entry for NCT06650579 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 163-participant average among 29 other Recurrent Prostate Carcinoma trials with a reported enrollment target (56% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Recurrent Prostate Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06650579 reports 4 study locations spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT06650579 about?
NCT06650579 is a clinical study titled "REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial". 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 agonis...
What is the current status of trial NCT06650579?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2025-01-31. Estimated completion is 2029-07-01.
What conditions does trial NCT06650579 study?
This clinical trial studies the following conditions: Recurrent Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT06650579?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Abiraterone Acetate (DRUG), Bicalutamide (DRUG), Computed Tomography Angiography (PROCEDURE), Leuprolide (DRUG).
Who is sponsoring clinical trial NCT06650579?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06650579 being conducted?
This trial has 4 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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