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]; 1.7 nanomoles/liter [nmol/L]) 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. 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 castration resistance free survival and 138 Chinese participants (enrolled in China and Taiwan) to support registration in China. There are 2 analyses for this study, a primary analysis and a final analysis. The primary analysis of efficacy and safety will occur after approximately 915 participants have been randomized to the study and evaluated for 48 weeks and completed the 30-day safety follow-up visit or discontinued early with 30-day safety follow-up. The final analysis will occur after approximately 390 participants with metastatic disease (or approximately 1100 participants with or without metastatic prostate cancer) have been randomized from any sites to the study. 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 138 participants. 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society