This phase III/IV trial compares the impact of leuprolide and abiraterone acetate (AA) to relugolix and AA on the heart in patients with prostate cancer that has not spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (non-metastatic) and that may have come back after a period of improvement (recurrent). 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 taking leuprolide and AA or relugolix and AA for non-metastatic recurrent prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06650579.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory Saint Joseph's HospitalStatus: Active
Contact: Sagar Anil Patel
Emory Proton Therapy CenterStatus: Active
Contact: Sagar Anil Patel
Emory University Hospital MidtownStatus: Active
Contact: Sagar Anil Patel
Emory University Hospital/Winship Cancer InstituteStatus: Active
Contact: Sagar Anil Patel
Phone: 205-370-8119
Decatur
Emory Decatur HospitalStatus: Active
Contact: Sagar Anil Patel
Phone: 205-370-8119
PRIMARY OBJECTIVE:
I. Measure cardiovascular outcomes between combination gonadotropin releasing hormone agonist (GNRHa, i.e. leuprolide) plus abiraterone acetate (AA) versus gonadotropin releasing hormone antagonist (GNRH-antagonist, i.e. relugolix) plus AA in men with advanced prostate cancer receiving definitive radiation therapy.
SECONDARY OBJECTIVES:
I. Identify genomic alterations that predispose an individual to enhanced cardiovascular (CV) toxicity following hormone therapy with leuprolide or relugolix in combination with abiraterone acetate.
II. Evaluate serum testosterone kinetics during and after treatment with combination leuprolide+AA versus relugolix+AA.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive leuprolide intramuscularly (IM) or subcutaneously (SC) once monthly, every 3 months or every 6 months and AA with prednisone for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy. Patients may also receive bicalutamide orally (PO) once daily (QD) prior to and after the time of first leuprolide injection at the discretion of the treating provider. Additionally, patients undergo coronary computed tomography angiography (CCTA) and blood sample collection throughout the study.
ARM II: Patients receive relugolix PO QD and AA with prednisone for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy. Additionally, patients undergo CCTA and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 and 60 days.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorSagar Anil Patel
