A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,209

Participants

Timeline

Start Date

February 12, 2013

Primary Completion Date

October 31, 2016

Study Completion Date

February 13, 2022

Conditions
Prostate Neoplasms
Interventions
DRUG

Abiraterone acetate

Abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day until disease progression, withdrawal of consent or unacceptable toxicity.

DRUG

Prednisone

Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

OTHER

Androgen deprivation therapy (ADT)

All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.

DRUG

Abiraterone acetate Placebo

Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

DRUG

Prednisone Placebo

Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

Trial Locations (208)

Unknown

Buenos Aires

Caba

Córdoba

La Rioja

Rosario

Adelaide

Footscray

Liverpool

Malvern

Randwick

Wahroonga

Antwerp

Bonheiden

Brasschaat

Brussels

Charleroi

Liège

Namur

Ottignies

Sint-Niklaas

Yvoir

Barretos

Belo Horizonte

Caxias do Sul

Curitiba

Ijuí

Jaú

Natal

Novo Hamburgo

Porto Alegre

Ribeirão Preto

Rio de Janeiro

Salvador

São José do Rio Preto

São Paulo

Gabrovo

Sofia

Edmonton

Vancouver

Winnipeg

Hamilton

Kingston

Oshawa

Ottawa

Toronto

Montreal

Québec

Santiago

Beijing

Chengdu

Chongqing

Guangzhou

Hangzhou

Nanjing

Shanghai

Suzhou

Tianjin

Wuhan

Bogotá

Floridablanca

Medellín

Hradec Králové

Olomouc

Pilsen

Prague

Aarhus N

Holsterbro

Odense

Roskilde

Vejle

Oulu

Tampere

La Chaussée-Saint-Victor

Lille

Montpellier

Paris

Suresnes

Toulouse

Villejuif

Düsseldorf

Hamburg

Nürtingen

Budapest

Győr

Miskolc

Pécs

Szentes

Beer Yaakov

Beersheba

Haifa

Jerusalem

Kfar Saba

Petah Tikva

Ramat Gan

Chiba

Gifu

Kashiwa

Matsuyama

Nankoku

Ōsaka-sayama

Sakura

Tokushima

Tokyo

Ube

Yokohama

Yufu

Kuala Lumpur

Kuching

Chihuahua City

Cuernavaca

Durango

Guadalajara

Monterrey

Oaxaca City

Pachuca

Zapopan

Alkmaar

Amsterdam

Amsterdam-Zuidoost

Hilversum

Hoofddorp

Nieuwegein

Rotterdam

Auckland

Christchurch

Hamilton

Tauranga

Bydgoszcz

Gdansk

Lodz

Lublin

Warsaw

Braga

Coimbra

Lisbon

Porto

Brasov

Bucharest

Cluj-Napoca

Iași

Chelyabinsk

Ivanovo

Izhevsk

Moscow

Nizhny Novgorod

Obninsk

Omsk

Orenburg

Pyatigorsk

Rostov-on-Don

Ryazan

Saint Petersburg

Saransk

Saratov

Sochi

Stavropol

Tyumen

Ufa

Volgograd

Yekaterinburg

Yoshkar-Ola

Košice-Šaca

Martin

Piešťany

Prešov

Rimavská Sobota

Trnava

George

Port Elizabeth

Pretoria

Vosloorus

Bucheon-si

Busan

Daegu

Daejeon

Gyeonggi-do

Seoul

A Coruña

Barcelona

Córdoba

Madrid

Murcia

Gothenburg

Malmo

Stockholm

Umeå

Uppsala

Adana

Ankara

Istanbul

Izmir

Zonguldak

Cherkassy

Dnipro

Khakhiv

Kharkiv

Kyiv

Lviv

Makiivka

Odesa

Uzhhorod

Zaporizhzhia

Cambridge

Glasgow

Manchester

Nottingham

Oxford

Plymouth

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01715285 - A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC) | Biotech Hunter | Biotech Hunter