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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

982

Participants

Timeline

Start Date

November 26, 2014

Primary Completion Date

March 19, 2018

Study Completion Date

December 31, 2027

Conditions
Prostatic Neoplasms
Interventions
DRUG

Apalutamide

Participants will receive 240 mg (4\*60 mg tablets) of apalutamide once daily orally.

DRUG

Abiraterone acetate

Participants will receive 1000 mg (4\*250 mg tablets) of abiraterone acetate (AA) once daily orally.

DRUG

Prednisone

Participants will receive 5 mg tablet of prednisone twice daily orally.

DRUG

Placebo

Participants will receive matching placebo to apalutamide once daily orally.

Trial Locations (173)

Unknown

Phoenix

La Mesa

Los Angeles

Modesto

San Diego

San Francisco

Santa Barbara

Aurora

Denver

Jensen Beach

Lakeland

New Port Richey

Ocala

Atlanta

Melrose

Niles

Marrero

New Orleans

Shreveport

Auburn

Baltimore

St Louis

Omaha

Las Vegas

Albany

Johnson City

New York

Poughkeepsie

Syracuse

The Bronx

Columbus

Tualatin

Lancaster

Pittsburgh

Charleston

Myrtle Beach

Nashville

Austin

Houston

Norfolk

Richmond

Auburn

Seattle

Spokane

Wenatchee

Madison

Ciudad Automoma Buenos Aires

Ciudad de Buenos Aires

Córdoba

La Rioja

Mendoza

Rosario

Adelaide

Ashford

Camperdown

Herston

Liverpool

Malvern

Melbourne

Southport

Wahroonga

West Heidelberg

Woolloongabba

Antwerp

Brussels

Ghent

Gosselies

Leuven

Liège

Namur

Ottignies

Roeselare

Sint-Niklaas

Barretos

Ijuí

Natal

Porto Alegre

São José do Rio Preto

São Paulo

Abbotsford

Kelowna

Vancouver

Halifax

Barrie

London

Oakville

Toronto

Weston

Montreal

Québec

Sherbrooke

Angers

Caen

Dijon

Le Mans

Lyon

Montpellier

Paris

Saint-Herblain

Toulouse

Berlin

Dresden

Freiburg im Breisgau

Hamburg

Heidelberg

Münster

Nürtingen

Wuppertal

Fukuoka

Kanazawa

Kashiwa

Kita-Gun

Kumamoto

Kurume

Matsuyama

Miyazaki

Nagasaki

Osaka

Ōsaka-sayama

Sakura

Sapporo

Ube

Yokohama

Chihuahua City

Cuernavaca

Culiacán

México

Oaxaca City

Zapopan

Amsterdam

Amsterdam-Zuidoost

Blaricum

Dordrecht

Groningen

Heerlen

Nieuwegein

Nijmegen

Rotterdam

The Hague

Kursk

Moscow

Omsk

Pyatigorsk

Rostov-on-Don

Saint Petersburg

Ufa

Bloemfontein

Cape Town

Johannesburg

Pretoria

Goyang-si

Seongnam

Seoul

Alcorcón

Barcelona

Cadiz

Córdoba

Madrid

San Sebastián de los Reyes

Valencia

Ayr

Belfast

Birmingham

Edinburgh

Glasgow

London

Manchester

Metropolitan Borough of Wirral

Plymouth

Preston

Stevenage

Sutton

Westcliff-on-Sea

Sponsors
All Listed Sponsors
lead

Aragon Pharmaceuticals, Inc.

INDUSTRY