“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.
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
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