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Clinical Trial

Testing Treatment for Prostate Cancer

Study Description

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

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 (a?$ 50 ng/dL [1.7 nmol/L] in participants with androgen-sensitive advanced prostate cancer.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Relugolix

Relugolix 120 mg tablet administered orally once daily following an oral loading dose of 360 mg on Day 1

Drug - Leuprolide Acetate

Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in some Asian countries), every 3-months by subcutaneous or intramuscular injection

Additional Information

Official Study 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

Clinical Trial ID

NCT03085095

ParticipAid ID

PdyvPe