RecruitingPhase 2NCT06330805

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

A Comparison of Orgovyx (Relugolix) vs Eligard (Leuprolide) on Cardiovascular Function and Biomarkers During Standard of Care Combined ADT (Androgen Deprivation Therapy)-Radiation for Prostate Cancer


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

70 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two hormone therapy drugs — relugolix and leuprolide — in men with prostate cancer who need hormone therapy (called androgen deprivation therapy, or ADT) as part of their treatment. Both drugs lower testosterone to fight prostate cancer, but they work differently. Researchers want to know if relugolix has better effects on heart function, since heart health is a major concern for men on long-term hormone therapy. **You may be eligible if:** - You have been diagnosed with prostate cancer within the past 9 months, confirmed by pathology - Your cancer is classified as "unfavorable intermediate risk" — meaning it has certain features that increase risk of progression, but has not yet spread to lymph nodes or distant organs - You are not yet on hormone therapy or radiation **You may NOT be eligible if:** - Your cancer has spread to lymph nodes or distant sites - You have already had radiation or hormone therapy for prostate cancer - You do not meet the specific risk criteria defined for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood and urine sample collection

OTHERContrast Agent

Given IV

DRUGLeuprolide

Given injection

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERPhysical Performance Testing

Undergo functional fitness tests

DRUGRelugolix

Given PO


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT06330805


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