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Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer

StatusRecruiting
PhasePhase 2
Started2024-08-12
View on ClinicalTrials.gov ↗

Amendment history

2026-03-05
minor
Study Status, Sponsor/Collaborators v3
Collaborators3 to 2 entries
Myovant Sciences GmbH Sumitomo PharmaceuticalsPharma America, Inc.
2025-09-29
minor
Study Status v2
Re-verified, no change to tracked fields
2024-09-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-04-01→confirmed 2024-08-12
Study sitesdetails revised at 1 of 1 site
2024-03-19
minor
Original filing
This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes. Participants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following: 1. Comprehensive cardiac and exercise testing before and after starting ADT 2. Completion of quality-of-life questionnaires at specific intervals during the study period 3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers
Trial Details
NCT Number NCT06330805
Lead Sponsor Ohio State University Comprehensive Cancer Center
Collaborators: Pfizer, Sumitomo Pharma America, Inc.
Conditions Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8
Enrollment 70 participants
Start Date 2024-08-12
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-09