Recruiting
Phase 3

Relugolix & Leuprolide

Sponsor:

Emory University

Code:

NCT06650579

Conditions

Recurrent Prostate Carcinoma

Stage III Prostate Cancer AJCC v8

Stage IVA Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Abiraterone Acetate

Bicalutamide

Biospecimen Collection

Computed Tomography Angiography

Leuprolide

Study Details

Brief 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

Recurrent Prostate Carcinoma

Stage III Prostate Cancer AJCC v8

Stage IVA Prostate Cancer AJCC v8

Study ID

NCT06650579

Start date

Jan 31, 2025

Status verified date

Feb, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Abiraterone Acetate

Given abiraterone acetate

Bicalutamide

Given PO

Biospecimen Collection

Undergo blood sample collection

Computed Tomography Angiography

Undergo CCTA

Leuprolide

Given IM or SC

Prednisone

Given prednisone

Radiation Therapy

Undergo standard of care radiation therapy

Relugolix

Given PO

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 ]
  • Need for new or escalated anti-hypertensive medication [ Time Frame: At baseline and up to 12 months ]
  • Incidence of moderate-to-severe atherosclerosis of major coronary vessels [ Time Frame: From month 0 to month 12 ]

Central Contacts and Locations

Central contacts

Bill Zheng, BS

404-686-6856bill.zheng@emory.edu

Locations

Emory Proton Therapy Center

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Bill Zheng

404-686-6856bill.zheng@emory.edu

Winship at Emory Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Bill Zheng

404-686-6856bill.zheng@emory.edu

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Sagar A. Patel, MD

404-686-4835Sagar.patel@emory.edu

Principal Investigator:

Sagar A. Patel

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Bill Zheng

404-686-6856bill.zheng@emory.edu

More Information

Sponsor

Emory University

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Keywords

  • node-positive prostate cancer
  • advanced prostate cancer
  • very-high-risk prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-02-24.