OncoMatch/Clinical Trials/NCT06330805
Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer
Is NCT06330805 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Leuprolide and Relugolix for prostate adenocarcinoma.
Treatment: Leuprolide · Relugolix — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IIB, IIC (AJCC v8)
Excluded: Stage III, IV
Grade: Gleason 7 (3+4 or 4+3, ISUP grade group 2-3) (Gleason / ISUP)
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 [ISUP grade group 2-3]); High risk features (Gleason 8-10 [ISUP grade group 4-5], PSA>20, cT3-4) excluded
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radical surgery
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.
Cannot have received: radiation therapy
Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields.
Cannot have received: bilateral orchiectomy
Previous bilateral orchiectomy.
Cannot have received: hormonal therapy (luteinizing hormone-releasing hormone (LHRH) agonists, leuprolide, goserelin, buserelin, triptorelin, LHRH antagonist, degarelix, anti-androgens, flutamide, bicalutamide, cyproterone acetate)
Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed.
Lab requirements
Blood counts
Absolute neutrophil ≥ 1,000 cells/mm^3; Hemoglobin ≥ 10 g/dL; Platelet count ≥ 100,000 cells/mm^3
Kidney function
Creatinine clearance (CrCl) ≥ 30 mL/min estimated by Cockcroft-Gault Equation
Liver function
Total bilirubin: 1.5 ≤ institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × institutional ULN
Absolute neutrophil ≥ 1,000 cells/mm^3; Hemoglobin ≥ 10 g/dL; Platelet count ≥ 100,000 cells/mm^3; Creatinine clearance (CrCl) ≥ 30 mL/min; Total bilirubin: 1.5 ≤ institutional ULN; AST and ALT ≤ 2.5 × institutional ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
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