CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,134 enrolled
Drug / intervention
Relugolix +1 moredrug
Likely dose
Relugolix 360 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03085095
NCT03085095Phase 3Completed
CompareCT.gov

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

Myovant Sciences GmbH·interventional·Posted Mar 21, 2017·Updated Jan 18, 2022

In Brief

A Phase 3 clinical trial evaluating Relugolix and Leuprolide Acetate for Prostate Cancer. Completed, enrolled 1,134 participants across 162 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesAustralia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, New Zealand, Poland, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 21, 2017
Enrollment StartApr 18, 2017
Primary CompletionOct 25, 2019
Study CompletionNov 26, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.3 years ago

Interventions

Relugolixdrug

Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1

Leuprolide Acetatedrug

Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, Taiwan, and China), every 3 months by subcutaneous injection