124
Participants
Start Date
December 18, 2012
Primary Completion Date
September 28, 2020
Study Completion Date
September 28, 2020
Abiraterone acetate
Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.
Abiraterone acetate plus degarelix
Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter.
Degarelix
Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.
Memorial Sloan Kettering Cancer Center, New York
Memoral Sloan Kettering Cancer Center at Phelps, Sleepy Hollow
Memorial Sloan Kettering West Harrison, Harrison
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
University of North Carolina, Chapel Hill
Duke University Medical Center, Durham
Karmanos Cancer Institute, Wayne State University, Detroit
Northwestern University, Feinberg School of Medicine, Chicago
Urology Cancer Center and GU Research Network, Omaha
Oregon Health & Science University Knight Cancer Institute, Portland
Memoral Sloan Kettering Cancer Center, Basking Ridge
NorthShore University Health System, Long Island City
Weill Cornell Medical Center, New York
Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre
Cancer Institute of New Jersey, New Brunswick
Collaborators (3)
Janssen Scientific Affairs, LLC
INDUSTRY
OHSU Knight Cancer Institute
OTHER
Rutgers Cancer Institute of New Jersey
OTHER
Endeavor Health
OTHER
Duke University
OTHER
Northwestern University Feinberg School of Medicine
OTHER
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
University of North Carolina
OTHER
Wayne State University
OTHER
Perlmutter New York University Cancer Center
OTHER
Weill Medical College of Cornell University
OTHER
Ferring Pharmaceuticals
INDUSTRY
GU Research Network, LLC
OTHER
University of California, Los Angeles
OTHER
Memorial Sloan Kettering Cancer Center
OTHER