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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06650579
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Prostate Carcinoma
  • Stage III Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abiraterone Acetate — DRUG
    Given abiraterone acetate
  • Bicalutamide — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography Angiography — PROCEDURE
    Undergo CCTA
  • Leuprolide — DRUG
    Given IM or SC
  • Prednisone — DRUG
    Given prednisone
  • Radiation Therapy — RADIATION
    Undergo standard of care radiation therapy
  • Relugolix — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jan 31, 2025
Status verified
Feb 2026
Primary completion
Jul 1, 2029
Completion
Jul 1, 2029

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (leuprolide plus abiraterone acetate/prednisone)
    Patients receive leuprolide IM or SC injections every 3 to 6 months plus oral abiraterone acetate (AA) with prednisone daily for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy.
  • Experimental: Arm II (relugolix + abiraterone acetate/prednisone)
    Patients receive oral relugolix daily plus oral abiraterone acetate (AA) with prednisone daily for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy.

Primary Outcome Measure

Incidence of ambulatory systolic blood pressure (BP) > 140 or diastolic > 90 (measurement on 2 separate days) [ Time Frame: At baseline and up to 12 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Emory Proton Therapy CenterAtlantaGeorgia30308
Bill Zheng
[email protected]
404-686-6856
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Bill Zheng
[email protected]
404-686-6856
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Sagar A. Patel, MD
[email protected]
404-686-4835
Sagar A. Patel (PRINCIPAL_INVESTIGATOR)
Winship at Emory MidtownAtlantaGeorgia30308
Bill Zheng
[email protected]
404-686-6856

Find similar trials in Atlanta, GA

By research site
Emory Proton Therapy Center· Atlanta, GAEmory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GAWinship at Emory Midtown· Atlanta, GA

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