About this trial
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 criteria
Qualifiers
Pathologically proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration.
Prostate-specific antigen (PSA) 10-20 ng/mL
Clinical stage tumor (T)2b-c (digital rectal exam [DRE] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition
Gleason Score 7 (Gleason 3+4 or 4+3 [International Society of Urological Pathology [ISUP] grade group 2-3])
Disqualifiers
Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, High-intensity focused ultrasound (HIFU), laser thermal ablation, etc.) for prostate cancer.
Definitive clinical or radiologic evidence of metastatic disease (M1).
Prior invasive malignancy (except non-melanomatous skin cancer) or hematologic malignancy unless disease free for a minimum of 3 years.
Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields.
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Contrast Agent
- Leuprolide
- Magnetic Resonance Imaging
- Physical Performance Testing
- Relugolix
Treatment groups
Sponsors and collaborators
Ohio State University Comprehensive Cancer Center
Lead sponsor
Pfizer
Collaborator
Sumitomo Pharma America, Inc.
Collaborator