A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

Official Title

HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

Summary:

The purpose of this study is to determine the benefit and safety of relugolix 120 mg orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (≤ 50 ng/dL [1.7 nmol/L] in participants with androgen-sensitive advanced prostate cancer.

Trial Description

Primary Outcome:

• Sustained Castration Rate

Secondary Outcome:

• Castration Rate by Visit
• Profound Castration Rate
• Prostate-specific Antigen (PSA) Response Rate by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria
• PSA Response Rate
• Time to PSA Progression
• Quality of Life (QoL) Total Score and Each Subdomain Score
• QoL Total Score and Each Subdomain Score
• Castration Resistance Free Survival
• Composite of Safety as Measure of Safety and Tolerability
• Pharmacokinetics of Relugolix
• Serum Concentrations of Luteinizing Hormone, Follicle-Stimulating Hormone, Dihydrotestosterone, Sex Hormone-Binding Globulin
• Testosterone Recovery
• Sustained Profound Castration Rate

This study is an international phase 3 randomized, open-label, parallel group efficacy and safety study to evaluate oral daily relugolix 120 mg in participants with androgen-sensitive advanced prostate cancer who require at least 1 year (48 weeks) of continuous androgen deprivation therapy. Relugolix 120 mg orally once daily or leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in some Asian countries), every 3-months by subcutaneous or intramuscular injection will be administered to participants with prostate cancer who require androgen deprivation therapy. Approximately 1100 participants will be enrolled in this study, including approximately 390 participants with metastatic advanced prostate cancer to support the analysis of the secondary endpoint of time to castration-resistance and 138 Chinese participants (enrolled in China and Taiwan) to support registration in China. The study includes a Screening Period, a Treatment Period of 48 weeks, and a Follow-up Period. Additionally, unscheduled follow-up visit(s) may be arranged for participants with study-related safety concerns as needed. Eligible participants include those with evidence of biochemical relapse (rising prostate-specific antigen) following local primary intervention with curative intent, newly diagnosed metastatic disease (excluding metastases to the brain), and/or advanced localized disease. Following successful completion of the Screening period study participants will be randomized 2:1 to oral relugolix 120 mg once daily or leuprolide acetate 22.5 mg (or 11.25 mg in some Asian countries) 3-month depot subcutaneous or intramuscular injection and will attend visits monthly (every 4 weeks) where serum testosterone and prostate-specific antigen will be assessed. Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, and 12-lead electrocardiograms.

View this trial on ClinicalTrials.gov