Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

February 18, 2021

Primary Completion Date

May 28, 2024

Study Completion Date

May 28, 2024

Conditions
Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Sensitive Prostate CancerNon-Metastatic Castration-Resistant Prostate Cancer
Interventions
DRUG

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."

DRUG

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.

DRUG

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."

DRUG

Methylprednisolone

For participants with mCRPC taking fine-particle abiraterone acetate, methylprednisolone 4 mg will be administered orally twice daily.

DRUG

Apalutamide

Apalutamide 240 mg (4 x 60-mg tablets) will be administered orally once daily.

DRUG

Docetaxel

Docetaxel 75 mg/m2 dose will be administered every 3 weeks as a 1-hour intravenous infusion.

Trial Locations (16)

11590

Clinical Research Alliance, Inc., Westbury

17604

Keystone Urology Specialists, Lancaster

19004

Center for Advanced Urology, LLP d/b/a: MidLantic Urology, Bala-Cynwyd

21204

Chesapeake Urology Research Associates, Baltimore

27157

Wake Forest Baptist Health, Winston-Salem

27403

Alliance Urology, Greensboro

29572

Carolina Urologic Research Center, Myrtle Beach

37209

Urology Associates, P.C., Nashville

44130

Helios Clinical Research, LLC., Middleburg Heights

72211

Arkansas Urology, Little Rock

75390

UT Southwestern Medical Center, Dallas

78229

Urology San Antonio, San Antonio

80228

Colorodo Clinical Research, Lakewood

85741

Urological Associates of Southern Arizona, P.C., Tucson

01655

University of Massachusetts Medical School, Worcester

07663

New Jersey Urology, Saddle Brook

All Listed Sponsors
lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT04666129 - Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer | Biotech Hunter | Biotech Hunter