48
Participants
Start Date
February 18, 2021
Primary Completion Date
May 28, 2024
Study Completion Date
May 28, 2024
Relugolix
"(Part 1 and Part 3) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 120-mg dose (1 x 120-mg tablets), taken once daily at approximately the same time each day.~(Part 2) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 240-mg dose (2 x 120-mg tablets), taken once daily at approximately the same time each day."
Abiraterone
Abiraterone acetate (1000 mg \[2 x 500-mg tablets\]) or fine-particle abiraterone acetate (500 mg \[4 x 125-mg tablets\]) will be administered orally once daily.
Prednisone
"(Part 1 only) For participants with mCSPC, a 5-mg dose of prednisone will be administered orally once daily, and for participants with mCRPC, a 5-mg dose of prednisone will be administered orally twice daily.~(Part 3 only) Prednisone 5 mg can be administered orally twice daily but is not required."
Methylprednisolone
For participants with mCRPC taking fine-particle abiraterone acetate, methylprednisolone 4 mg will be administered orally twice daily.
Apalutamide
Apalutamide 240 mg (4 x 60-mg tablets) will be administered orally once daily.
Docetaxel
Docetaxel 75 mg/m2 dose will be administered every 3 weeks as a 1-hour intravenous infusion.
Clinical Research Alliance, Inc., Westbury
Keystone Urology Specialists, Lancaster
Center for Advanced Urology, LLP d/b/a: MidLantic Urology, Bala-Cynwyd
Chesapeake Urology Research Associates, Baltimore
Wake Forest Baptist Health, Winston-Salem
Alliance Urology, Greensboro
Carolina Urologic Research Center, Myrtle Beach
Urology Associates, P.C., Nashville
Helios Clinical Research, LLC., Middleburg Heights
Arkansas Urology, Little Rock
UT Southwestern Medical Center, Dallas
Urology San Antonio, San Antonio
Colorodo Clinical Research, Lakewood
Urological Associates of Southern Arizona, P.C., Tucson
University of Massachusetts Medical School, Worcester
New Jersey Urology, Saddle Brook
Sumitomo Pharma America, Inc.
INDUSTRY