247
Participants
Start Date
December 16, 2013
Primary Completion Date
September 23, 2016
Study Completion Date
August 23, 2024
Enzalutamide
160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food.
exemestane
25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet after unblinding) by mouth once daily after food.
Placebo (for enzalutamide)
Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.
exemestane
50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) by mouth once daily after food.
Pharmacy Department, Dublin
Radiology Department, Dublin
St Vincent's University Hospital, Dublin
Institute for Cancer Research, Dublin
Mater Private Hospital, Dublin
Pharmacy Department, Dublin
Radiology Department, Dublin
Institut Jules Bordet, Brussels
GZA, Wilrijk
UZA, Edegem
Memorial Sloan Kettering Cancer Center, New York
IRCCS Ospedale San Raffaele, Milan
Divisione di Senologia Medica; Istituto Europeo di Oncologia, Milan
Virginia Cancer Institute, Mechanicsville
Virginia Cancer Institute, Richmond
Virginia Cancer Institute, Richmond
Hospital Universitario Ramon Y Cajal, Madrid
Hospital Universitario 12 Octubre, Madrid
Centro Integral Oncologico Clara Campal, Madrid
Hospital de Madrid Norte Sanchinarro, Madrid
Hospital Universitario HM Monteprincipe, Boadilla del Monte
Greenville Health System, Spartanburg
Greenville Health System, Greenville
Greenville Health System, Seneca
Florida Cancer Specialists, Gainesville
Florida Cancer Specialists, Altamonte Springs
Florida Cancer Specialists, Orange City
Florida Cancer Specialists, Tavares
Florida Cancer Specialists, Orlando
Florida Cancer Specialists, Brandon
Florida Cancer Specialists, Tampa
Florida Cancer Specialists, St. Petersburg
Florida Cancer Specialists, Clearwater
Florida Cancer Specialists, Largo
Florida Cancer Specialists, Fort Myers
Florida Cancer Specialists, Fort Myers
Florida Cancer Specialists, Fort Myers
Florida Cancer Specialists, Cape Coral
Florida Cancer Specialists, Port Charlotte
Florida Cancer Specialists, Naples
Florida Cancer Specialists, Bonita Springs
Florida Cancer Specialists, Bradenton
Florida Cancer Specialists, Englewood
Florida Cancer Specialists, Sarasota
Florida Cancer Specialists, Sarasota
Florida Cancer Specialists, Venice
Florida Cancer Specialists, Venice
Florida Cancer Specialists, Spring Hill
Florida Cancer Specialists, New Port Richey
Florida Cancer Specialists, Hudson
Tennessee Oncology, PLLC, Gallatin
Tennessee Oncology, PLLC, Franklin
Tennessee Oncology, PLLC, Hermitage
Tennessee Oncology, PLLC, Lebanon
Tennessee Oncology, PLLC, Murfreesboro
Tennessee Oncology, PLLC, Shelbyville
Tennessee Oncology, PLLC, Smyrna
Tennessee Oncology, PLLC, Nashville
The Sarah Cannon Research Institute, Nashville
Vanderbilt Breast Center at One Hundred Oaks, Nashville
Vanderbilt Health Pharmacy One Hundred Oaks, Nashville
Tennessee Oncology, PLLC, Nashville
Tennessee Oncology, PLLC, Nashville
Henry-Joyce Cancer Clinic, Nashville
The West Clinic, P.C. d/b/a West Cancer Center, Memphis
The West Clinic, P.C. d/b/a West Cancer Center, Germantown
The West Clinic, P.C. d/b/a West Cancer Center, Southaven
The West Clinic, P.C., Corinth
Azienda Ospedaliera S.Orsola Malpighi, Bologna
Oncology Hematology Care, Inc., Fairfield
Oncology Hematology Care, Inc., Cincinnati
Oncology Hematology Care, Inc., Cincinnati
Oncology Hematology Care, Inc., Cincinnati
Oncology Hematology Care, Inc., Cincinnati
Oncology Hematology Care, Inc., Cincinnati
Indiana University Health Hospital, Indianapolis
Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis
Investigational Drug Services, Indianapolis
Sidney and Lois Eskenazi Hospital, Indianapolis
Springmill Medical Clinic, Indianapolis
Minnesota Oncology Hematology, P.A, Minneapolis
Abbott Northwestern Hospital, Minneapolis
Allina Health System DBA Virginia Piper Cancer Institute, Minneapolis
Dr.Michaela Tsai, Minneapolis
U.O. Farmaceutica, Nuovo Ospedale di Prato, Prato
U.O. Oncologia Medica, Nuovo Ospedale di Prato, Prato
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital, New Lenox
Northwestern Medical Faculty Foundation, Chicago
Northwestern Memorial Hospital, Chicago
The University of Chicago Medical Center,, Chicago
The University of Chicago, Chicago
Barnes-Jewish Hospital, St Louis
Washington University Infusion Center Pharmacy, St Louis
Washington University School of Medicine, St Louis
Siteman Cancer Center-South County, St Louis
Siteman Cancer Center- West County, St Louis
Siteman Cancer Center, City of Saint Peters
Texas Oncology-Longview Cancer Center, Longview
Texas Oncology - Tyler, Tyler
Texas Oncology - Memorial City, Houston
ATTN-Research Pharmacist, Aurora
University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora
University of Colorado Hospital, Anschutz Outpatient Pavilion, Aurora
Rocky Mountain Cancer Centers, Lone Tree
Rocky Mountain Cancer Centers, Lakewood
Rocky Mountain Cancer Centers, Colorado Springs
Brigham and Women's Hospital, Boston
Dana-Farber Cancer Institute, Boston
Hematology Oncology Associates of Northern NJ, Morristown
Sunnybrook Research Institute, Toronto
McGill University Health Center- Cedars Cancer Center, Montreal
McGill University Health Centre - Cedars Cancer Centre, Montreal
Cancer Clinical Trials Unit, Dublin
Pharmacy Department, Dublin
Radiology Department, Dublin
Institute for Cancer Research, Dublin
Mater Private Hospital, Dublin
Pharmacy Department, Dublin
Radiology Department, Dublin
A.O.di Perugia S. Maria Della Misericoridia, Perugia
Dipartimento di Oncologia Medica, Istituto Nazionale Tumori Regina Elena, Roma
Grupo Hospitalario Quiron - Hospital Universitari Quiron Dexeus, Barcelona
Hospital Universitari Vall d'Hebron, Barcelona
Brighton and Sussex University Hospital NHS Trust, Brighton
Pharmacy Department, Brighton
Radiation Safety Service, Medical Physics Department, Brighton
Clinical Investigation & Research Unit, Brighton
Histopathology Department, Nottingham
Nottingham University Hospital, Nottingham
Pharmacy Department, Nottingham
Radiology Department, Nottingham
Radiology Department, Nottingham
Department of Radiology, Truro
Pharmacy Department, Truro
Royal Cornwall Hospitals NHS trust, Truro
Lead Sponsor
Collaborators (2)
Astellas Pharma Inc
INDUSTRY
Medivation, Inc.
INDUSTRY
Pfizer
INDUSTRY