A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,052

Participants

Timeline

Start Date

November 27, 2015

Primary Completion Date

September 7, 2020

Study Completion Date

December 31, 2027

Conditions
Prostate Cancer
Interventions
DRUG

Apalutamide

Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.

DRUG

Placebo

Participants will receive Placebo orally once daily in each 28 day treatment cycles.

DRUG

Androgen Deprivation Therapy (ADT)

All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.

Trial Locations (222)

Unknown

Homewood

Tucson

San Bernardino

San Diego

Denver

Norwalk

Fort Myers

Chicago

Fort Wayne

Jeffersonville

New Orleans

Baltimore

Rockville

Lansing

Troy

Omaha

Las Vegas

Brooklyn

Poughkeepsie

Syracuse

The Bronx

Raleigh

Salisbury

Cleveland

Middleburg Heights

Springfield

Bala-Cynwyd

Bryn Mawr

Lancaster

Charleston

Nashville

Dallas

Houston

San Antonio

Salt Lake City

Richmond

Virginia Beach

Burien

Spokane

Milwaukee

Berazategui

Buenos Aires

C.a.b.a.

Capital Federal

Ciudad Automoma Buenos Aires

Ciudad de Buenos Aires

Córdoba

La Plata

Pergamino

Rosario

San Miguel de Tucumán

San Salvador de Jujuy

Albury

Elizabeth Vale

Kogarah

Port Macquarie

South Brisbane

St Leonards

Barretos

Florianópolis

Goiânia

Ijuí

Natal

Ribeirão Preto

Rio de Janeiro

Salvador

Santo André

São Paulo

Sorocaba

Calgary

Vancouver

Hamilton

Kingston

Toronto

Québec

Beijing

Chengdu

Chongqing

Fuzhou

Guangzhou

Hangzhou

Nanjing

Shanghai

Suzhou

Wuhan

Wuxi

Xi'an

Hradec Králove

Liberec

Nový Jicin

Olomouc

Opava

Pardubice

Prague

Zlín

Clermont-Ferrand

Montpellier

Nancy

Paris

Pierre-Bénite

Strasbourg

Suresnes

Bonn

Braunschweig

Eisleben Lutherstadt

Hamburg

Hanover

Leipzig

Lübeck

Nürtingen

Sindelfingen

Straubing

Budapest

Győr

Pécs

Sopron

Beersheba

Haifa

Holon

Kfar Saba

Petah Tikva

Ramat Gan

Zrifin

Chūōku

Hakata-Ku

Koshigaya

Matsuyama

Minamiku

Miyazaki

Nagano

Nagasaki

Osaka

Osaka Sayama Shi

Sakura

Sapporo

Yokohama

Yufu

Durango

Guadalajara

León

Mexico City

México

Morelia

Zapopan

Bialystok

Bydgoszcz

Krakow

Kutno

Lodz

Lublin

Siedlce

Sochaczew

Warsaw

Wroclaw

Bucharest

Cluj-Napoca

Craiova

Târgu Mureş

Barnaul

Ivanovo

Moscow

Nizhny Novgorod

Obninsk

Omsk

Pyatigorsk

Rostov-on-Don

Ryazan

Saint Petersburg

Saransk

Sochi

Tambov

Tomsk

Tyumen

Ufa

Vologda

Daegu

Daejeon

Goyang-si

Jeollanam-do

Seongnam-si

Seoul

Barcelona

Córdoba

Jerez de la Frontera

Madrid

Pamplona

Gothenburg

Malmo

Örebro

Stockholm

Umeå

Uppsala

Vaxjo

Ankara

Edirne

Istanbul

Izmir

Mersin

Cherkasy

Dnipo

Dnipro

Ivano-Frankivsk

Khakhiv

Kharkiv

Khmelnytsky

Kyiv

Lviv

Odesa

Poltava

Uzhhorod

Vinnitsa

Zaporizhzhya

Carlisle

Dundee

Glasgow

London

Newcastle upon Tyne

Oxford

Plymouth

Scunthorpe

Stockton-on-Tees

Wolverhampton

Sponsors
All Listed Sponsors
lead

Aragon Pharmaceuticals, Inc.

INDUSTRY