NCT03141671 - Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509) | Biotech Hunter

Enrollment

345

Participants

Timeline

Start Date

November 24, 2017

Primary Completion Date

April 5, 2025

Study Completion Date

December 31, 2025

Conditions

Prostate Cancer

Interventions

DRUG

GnRH

-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

DRUG

Bicalutamide

-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

RADIATION

Salvage radiation

Radiation

DRUG

Abiraterone

-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

DRUG

Prednisone

Prednisone is a corticosteroid. It prevents the release of substances in the body that cause inflammation. It also suppresses the immune system.

DRUG

Apalutamide

-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread

Trial Locations (8)

Memorial Sloan Kettering Cancer Center, New York

University of Michigan, Ann Arbor

University of Chicago, Chicago

MD Anderson Cancer Center, Houston

University of California, San Diego, San Diego

University of California, San Francisco, San Francisco

Yale Cancer Center, New Haven

Dana-Farber Cancer Institute/Brigham and Women's Hospital, Boston