Trial comparing treatments for Recurrent Prostate Carcinoma
Official title REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
ClinicalTrials.gov ID: NCT06650579
What this study is testing
What is Abiraterone Acetate?
An investigational oral medicine being studied as a potential treatment for recurrent prostate carcinoma. It is designed to decrease the amount of certain hormones that can promote prostate cancer growth.
Also referred to as BR9004, BR9004-1, CB 7630, CB-7630, CB7630, JNJ-212082, Yonsa, Zytiga.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how each hormone‑therapy combination affects the heart and blood pressure, and whether one is safer than the other.
- Who it's for
- Men with advanced prostate cancer who have not yet received hormone therapy and are getting pelvic radiation.
- What's involved
- You will be assigned to take either relugolix plus abiraterone or leuprolide plus abiraterone, have blood tests and special heart CT scans, and attend regular clinic visits.
- Time commitment
- The trial lasts through the course of radiation and hormone treatment, requiring several clinic visits and cardiac CT scans over several months.
- Phase 3: a large, late-stage study
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.