Status:
ACTIVE_NOT_RECRUITING
RElugolix VErsus LeUprolide Cardiac Trial
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Prostate Cancer Foundation
Conditions:
Biochemically Recurrent Prostate Carcinoma
Localized Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This clinical trial investigates the impact of prostate cancer treatment, specifically androgen deprivation therapy (ADT), on the heart and coronary vessels among men with localized, non-metastatic pr...
Detailed Description
PRIMARY OBJECTIVES: I. Identify and compare the association of gonadotrophin releasing hormone (GNRH)-agonist leuprolide versus GNRH-antagonist relugolix with coronary atherosclerosis and progression...
Eligibility Criteria
Inclusion
- Men \>= 18 years old
- Non-metastatic prostate cancer
- Non-metastatic, biochemically recurrent prostate cancer
- Plan to undergo curative-intent pelvic radiation therapy with or without ADT
Exclusion
- Metastatic prostate cancer requiring \> 24 months of ADT
- Prior exposure to androgen deprivation therapy
- Prior exposure to chemotherapy or immunotherapy
- History of cardiac bypass surgery or percutaneous coronary intervention
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT05320406
Start Date
June 6 2022
End Date
December 30 2025
Last Update
October 6 2025
Active Locations (4)
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1
Emory Proton Therapy Center
Atlanta, Georgia, United States, 30308
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
3
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
4
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342