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 efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer.

Trial Description

Primary Outcome:

• Sustained Castration Rate

Secondary Outcome:

• Castration Rate
• Confirmed Prostate-specific Antigen (PSA) Response Rate
• Profound Castration Rate
• Follicle-Stimulating Hormone (FSH) Level
• Castration Resistance Free Survival In Participants With Metastatic Prostate Cancer
• Castration Resistance Free Survival In Participants With Or Without Metastatic Prostate Cancer
• Testosterone Recovery To 280 ng/dL
• Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1 And Week 25 Day 1 Through Week 49 Day 1
• Undetectable PSA Rate
• PSA Response Rate
• Time To PSA Progression
• Testosterone Recovery
• Absolute Value And Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organisation Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30
• Absolute Value And Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-C30
• Absolute Value And Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Hormonal-Treatment-Related Symptom Subdomains
• Absolute Value And Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-PR25
• Absolute Value And Change From Baseline In QoL Total Score As Assessed By The European Quality Of Life 5-Dimension 5-Level Questionnaire
• Incidence Of Treatment-emergent Adverse Events
• Serum Concentrations Of Luteinizing Hormone
• Serum Concentrations Of FSH
• Serum Concentrations Of Dihydrotestosterone
• Serum Concentrations Of Sex Hormone-Binding Globulin
• Maximum Observed Plasma Concentration (Cmax) Of Relugolix
• Area Under The Concentration-Time Curve (AUC0-τ) Of Relugolix
• Time To Maximum Observed Plasma Concentration (Tmax) Of Relugolix

This is a phase 3, multinational, randomized, open-label, parallel group study to evaluate the efficacy and safety of oral daily relugolix 120 mg in participants with androgen-sensitive advanced prostate cancer who require at least 1 year of continuous androgen-deprivation therapy. Relugolix 120 mg orally once daily or leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan based on local labels), every 3 months by subcutaneous injection will be administered to participants. There are 2 analyses for this study, a primary analysis and a final analysis. Primary Analysis: The primary analysis of efficacy and safety has been completed (N=934). Participants were randomized 2:1 to receive relugolix or leuprolide for 48 weeks, followed by a 30-day safety follow-up visit or early termination 30-day safety follow-up. Final Analysis: The final analysis will occur after additional participants with metastatic disease (approximately 130) have been enrolled and randomized from any sites to the study, and have completed the 48-week treatment period. A cohort of participants being enrolled in China and Taiwan will be analyzed separately once they have completed treatment to support registration in China. Eligible participants will be randomized 2:1 to relugolix or leuprolide arm 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. Castration resistance-free survival will be assessed up to Week 49, Day 1 of the study and reported as part of the final analysis. Approximately 1100 participants will be enrolled in this study, including approximately 130 participants with metastatic advanced prostate cancer to support the analysis of the secondary endpoint of castration resistance-free survival and approximately 130 Chinese participants (enrolled in China and Taiwan) to support registration in China. Note: To support registration in China, the study will continue to enroll additional nonmetastatic or metastatic participants from China after the final analysis to reach the target enrollment of approximately 130 participants.

View this trial on ClinicalTrials.gov