504
Participants
Start Date
March 6, 2017
Primary Completion Date
July 1, 2025
Study Completion Date
January 1, 2026
Apalutamide
Take apalutamide 240 mg (four 60 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.
LHRH Analogue
"Patients will receive a LHRH analogue therapy of either Degarelix OR Leuprolide with bicalutamide.~Degarelix:~Patients will receive subcutaneous injections every 28 days (+/- 3 days). Patients will receive a loading dose of 240 mg (two 120 mg injections) on C1D1, followed by maintenance dose of 80 mg on Day 1 of subsequent cycles.~Leuprolide:~Patients treated with leuprolide will receive a 7.5 mg IM injection on C1D1. Patients in arm A ONLY will take this in combination with bicalutamide 50 mg orally once daily starting on C1D1 and continuing for 28 days through completion of cycle 1. Starting on C2D1, patients will continue on one of the following two treatments at investigator discretion:~1. Leuprolide 7.5 mg IM injection on Day 1 of subsequent cycles without concurrent bicalutamide.~ OR:~2. Leuprolide 22.5 mg IM injection at the following visits without concurrent bicalutamide: C2D1, C5D1, C8D1, and C11D1."
Abiraterone Acetate
Take abiraterone acetate 1000 mg (four 250 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.
Prednisone
Take two prednisone 5 mg tablets daily, starting on C1D1 and continuing throughout the 52-week treatment period. Following completion of treatment period, patients will taper off prednisone per institutional guidelines. Suggested tapering plan: prednisone 5 mg daily for 7 days, then 2.5 mg daily for 7 days before discontinuing.
Memorial Sloan Kettering Cancer Center, New York
Weill Cornell Medical Ctr - New York Presbyterian Hospital, New York
Montefiore Medical Center, New York
Memorial Sloan Kettering Cancer Center, Harrison
Memorial Sloan Kettering Cancer Center, Commack
SUNY Upstate Medical University, Syracuse
VA Western New York, Buffalo
Roswell Park Cancer Institute, Buffalo
University of Pittsburgh Medical Center, Pittsburgh
Georgetown University Medical Center, Washington D.C.
MedStar Washington Hospital Center, Washington D.C.
Wake Forest University Health Sciences, Winston-Salem
University of North Carolina Hospital, Chapel Hill
VA Salisbury, Salisbury
Novant Health Presbyterian Medical Center, Charlotte
Spartanburg Medical Center/Gibbs Cancer Center, Spartanburg
The Ohio State University Comprehensive Cancer Center, Columbus
The Toledo Clinic, Toledo
Dayton Physicians Miami Valley South, Centerville
Froedtert Hospital/Medical College of Wisconsin, Milwaukee
Marshfield Clinic Cancer Center, Marshfield
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park
University of Minnesota, Minneapolis
Loyola University, Maywood
Northshore University Health System, Evanston
University of Chicago Comprehensive Cancer Center, Chicago
Carle Cancer Center, Urbana
Quincy Medical Group, Quincy
Washington University School of Medicine, St Louis
Cancer Center of Kansas, Wichita
Nebraska Methodist Hospital, Omaha
Oklahoma Cancer Specialists and Research Institute, Tulsa
University of Texas MD Anderson Cancer Center, Houston
The Mayo Clinic - Phoenix, Phoenix
New Mexico Oncology Hematology Consultants, Albuquerque
University of New Mexico Comprehensive Cancer Center, Albuquerque
Christus St. Vincent's Regional Cancer Center, Santa Fe
Memorial Medical Center- Cancer Center, Las Cruces
Nevada Cancer Research Foundation, Las Vegas
City of Hope National Medical Center, Duarte
Sharp Memorial Hospital, Chula Vista
Sharp Memorial Hospital, La Mesa
University of California San Diego - Moores Cancer Center, San Diego
Sharp Memorial Hospital, San Diego
VA Central California Health Care System, Fresno
Palo Alto Medical Foundation, Mountain View
Palo Alto Medical Foundation, Sunnyvale
University of California San Francisco, San Francisco
Palo Alto Medical Foundation, Palo Alto
Palo Alto Medical Foundation, Fremont
Adventist Health St. Helena/St. Helena Hospital/Martin O'Neil Cancer Center, St. Helena
Palo Alto Medical Foundation, Santa Cruz
Pali Momi Medical Center, ‘Aiea
University of Hawaii Cancer Center, Honolulu
Providence Portland Medical Center, Portland
Oregon Health & Science University, Portland
Rush University Medical Center, Chicago
Eastern Maine Medical Center, Brewer
New England Cancer Specialists, Kennebunk
New England Cancer Specialists, Scarborough
New England Cancer Specialists, Topsham
Dana Farber Cancer Institute, Boston
Dana Farber Cancer Institute, Milford
Dana Farber Cancer Institute, South Weymouth
New Hampshire Oncology & Hematology, Concord
New Hampshire Oncology & Hematology, Hooksett
Memorial Sloan Kettering Basking Ridge, Basking Ridge
Memorial Sloan Kettering Cancer Center, Middletown
Atlantic Health System/Morristown Medical Center, Morristown
Janssen Research & Development, LLC
INDUSTRY
Alliance Foundation Trials, LLC.
OTHER