Clinical Research Directory
Browse clinical research sites, groups, and studies.
An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Sponsor: Aragon Pharmaceuticals, Inc.
Summary
The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy \[treatment of cancer using drugs\]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland \[gland that makes fluid that aids movement of sperm\]).
Official title: A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
982
Start Date
2014-11-26
Completion Date
2027-12-31
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Apalutamide
Participants will receive 240 mg (4\*60 mg tablets) of apalutamide once daily orally.
Abiraterone acetate
Participants will receive 1000 mg (4\*250 mg tablets) of abiraterone acetate (AA) once daily orally.
Prednisone
Participants will receive 5 mg tablet of prednisone twice daily orally.
Placebo
Participants will receive matching placebo to apalutamide once daily orally.
Locations (173)
Phoenix, Arizona, United States
La Mesa, California, United States
Los Angeles, California, United States
Modesto, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Jensen Beach, Florida, United States
Lakeland, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Atlanta, Georgia, United States
Melrose, Illinois, United States
Niles, Illinois, United States
Marrero, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Auburn, Maine, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Albany, New York, United States
Johnson City, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Columbus, Ohio, United States
Tualatin, Oregon, United States
Lancaster, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Myrtle Beach, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Auburn, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Wenatchee, Washington, United States
Madison, Wisconsin, United States
Ciudad Automoma Buenos Aires, Argentina
Ciudad de Buenos Aires, Argentina
Córdoba, Argentina
La Rioja, Argentina
Mendoza, Argentina
Rosario, Argentina
Adelaide, Australia
Ashford, Australia
Camperdown, Australia
Herston, Australia
Liverpool, Australia
Malvern, Australia
Melbourne, Australia
Southport, Australia
Wahroonga, Australia
West Heidelberg, Australia
Woolloongabba, Australia
Antwerp, Belgium
Brussels, Belgium
Ghent, Belgium
Gosselies, Belgium
Leuven, Belgium
Liège, Belgium
Namur, Belgium
Ottignies, Belgium
Roeselare, Belgium
Sint-Niklaas, Belgium
Barretos, Brazil
Ijuí, Brazil
Natal, Brazil
Porto Alegre, Brazil
São José do Rio Preto, Brazil
São Paulo, Brazil
Abbotsford British Columbia, British Columbia, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Barrie, Ontario, Canada
London, Ontario, Canada
Oakville, Ontario, Canada
Toronto, Ontario, Canada
Weston, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Angers, France
Caen, France
Dijon, France
Le Mans, France
Lyon, France
Montpellier, France
Paris, France
Saint-Herblain, France
Toulouse, France
Berlin, Germany
Dresden, Germany
Freiburg im Breisgau, Germany
Hamburg, Germany
Heidelberg, Germany
Münster, Germany
Nürtingen, Germany
Wuppertal, Germany
Fukuoka, Japan
Kanazawa, Japan
Kashiwa, Japan
Kita-Gun, Japan
Kumamoto, Japan
Kurume, Japan
Matsuyama, Japan
Miyazaki, Japan
Nagasaki, Japan
Osaka, Japan
Ōsaka-sayama, Japan
Sakura, Japan
Sapporo, Japan
Ube, Japan
Yokohama, Japan
Chihuahua City, Mexico
Cuernavaca, Mexico
Culiacán, Mexico
México, Mexico
Oaxaca City, Mexico
Zapopan, Mexico
Amsterdam, Netherlands
Amsterdam-Zuidoost, Netherlands
Blaricum, Netherlands
Dordrecht, Netherlands
Groningen, Netherlands
Heerlen, Netherlands
Nieuwegein, Netherlands
Nijmegen, Netherlands
Rotterdam, Netherlands
The Hague, Netherlands
Kursk, Russia
Moscow, Russia
Omsk, Russia
Pyatigorsk, Russia
Rostov-on-Don, Russia
Saint Petersburg, Russia
Ufa, Russia
Bloemfontein, South Africa
Cape Town, South Africa
Johannesburg, South Africa
Pretoria, South Africa
Goyang-si, South Korea
Seongnam, South Korea
Seoul, South Korea
Alcorcón, Spain
Barcelona, Spain
Cadiz, Spain
Córdoba, Spain
Madrid, Spain
San Sebastián de los Reyes, Spain
Valencia, Spain
Ayr, United Kingdom
Belfast, United Kingdom
Birmingham, United Kingdom
Edinburgh, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Metropolitan Borough of Wirral, United Kingdom
Plymouth, United Kingdom
Preston, United Kingdom
Stevenage, United Kingdom
Sutton, United Kingdom
Westcliff-on-Sea, United Kingdom