Actively Recruiting
Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-03-09
70
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
Sponsors
O
Ohio State University Comprehensive Cancer Center
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed adenocarcinoma of the prostate within 270 days prior to registration
- Diagnosed with unfavorable intermediate risk prostate cancer defined by specific PSA levels, clinical stage T2b-c, and Gleason score 7
- Presence of one or more unfavorable intermediate-risk features such as more than one intermediate risk factor, Gleason 4+3=7, or 50% or more biopsy cores positive
- No high-risk prostate cancer features
- Appropriate staging with negative bone scan and clinically negative lymph nodes within 120 days prior to registration
- Age 18 years or older
- ECOG performance status of 0-1 within 120 days prior to registration
- Non-castrate testosterone level above 50 ng/dL within 120 days prior to registration
- Adequate blood counts and kidney and liver function within 120 days prior to registration
- HIV-infected patients on effective therapy with undetectable viral load are eligible
- Patients with controlled hepatitis B or cured hepatitis C infection under specified conditions are eligible
- Provide informed consent and authorization for release of personal health information for U.S. patients
You will not qualify if you...
- Previous prostate surgery or curative ablation treatments for prostate cancer
- Evidence of metastatic disease
- Prior invasive or hematologic malignancy unless disease free for at least 3 years
- Prior radiotherapy to the prostate or pelvis overlapping planned radiation fields
- Previous bilateral orchiectomy
- Prior hormonal therapy including LHRH agonists/antagonists or anti-androgens started before study registration
- Use of 5-alpha-reductase inhibitors stopped less than 30 days before pre-registration PSA measurement
- Testosterone replacement therapy within 1 year prior to registration
- Severe uncontrolled cardiac conditions such as angina, arrhythmias, or NYHA class II-IV heart failure
- Significant obstructive urinary symptoms suspected due to prostate cancer or benign prostatic hypertrophy
- Disabilities preventing moderate intensity exercise testing
- Inability to tolerate or contraindications to MRI or gadolinium contrast
- Significant uncontrolled gastrointestinal or metabolic diseases
- Active inflammatory or immune-related diseases treated with steroids or immunosuppressants
- Inability to swallow oral medication
- Presence of high-risk prostate cancer features such as Gleason 8-10, PSA over 20, or clinical stage T3-4 with extra-prostatic extension
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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