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)

Last updated: January 31, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Urologic Cancer

Prostate Cancer

Prostate Cancer, Early, Recurrent

Treatment

Abiraterone acetate

Prednisone

Abiraterone acetate Placebo

Clinical Study ID

NCT01715285
CR100900
U1111-1135-7146
2012-002940-26
212082PCR3011
  • Ages > 18
  • Male

Study Summary

The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed metastatic prostate cancer within 3 months prior to randomizationwith histologically or cytologically confirmed adenocarcinoma of the prostatewithout neuroendocrine differentiation or small cell histology

  • Distant metastatic disease documented by positive bone scan or metastatic lesions oncomputed tomography (CT) or magnetic resonance imaging (MRI) scan

  • At least 2 of the following high-risk prognostic factors: Gleason score of greaterthan or equal to (>=8); presence of 3 or more lesions on bone scan; presence ofmeasurable visceral (excluding lymph node disease) metastasis on CT or MRI ResponseEvaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan

  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2

  • Adequate hematologic, hepatic, and renal function

  • Agrees to protocol-defined use of effective contraception

Exclusion

Exclusion Criteria:

  • Active infection or other medical condition that would make prednisone usecontraindicated

  • Any chronic medical condition requiring a higher systemic dose of corticosteroidthan 5 mg prednisone per day

  • Pathological finding consistent with small cell carcinoma of the prostate

  • Known brain metastasis

  • Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostatecancer (the following exception are permitted): up to 3 months of androgendeprivation therapy (ADT) with lutenizing hormone releasing hormone agonists orantagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1Day 1; participants may have one course of palliative radiation or surgical therapyto treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1)

Study Design

Total Participants: 1209
Treatment Group(s): 5
Primary Treatment: Abiraterone acetate
Phase: 3
Study Start date:
February 12, 2013
Estimated Completion Date:
February 13, 2022

Study Description

This is a randomized (the treatment group is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study designed to determine the efficacy of abiraterone acetate plus low-dose prednisone in participants with mHNPC. The study consists of 4 parts: Screening Phase (that is, 28 days before study commences on Day 1); Double-blind treatment Phase (consists of 4-week dosing cycles wherein abiraterone acetate will be administered as 1,000 milligram [mg] plus 5 mg prednisone or only placebo orally); Follow-up Phase (every 4 months up to 60 months or until death, lost to follow up, withdrawal of consent or study termination) Open-label Extension (OLE) Phase. Participants in the Double-blind Treatment Phase will have the opportunity to enroll into the OLE Phase. The OLE Phase will allow participants to receive active drug (abiraterone acetate plus prednisone) until Long-term Extension (LTE) Phase for an additional period of up to 3 years. Participants will discontinue study treatment at disease progression or unacceptable toxicity unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from study treatment. Participants will be randomized in a 1:1 ratio to the active treatment group (abiraterone acetate 1000 mg daily plus prednisone 5 mg daily plus ADT) or the control group (ADT plus placebos).Efficacy will be evaluated primarily by overall survival and radiographic progression-free survival. Participants' safety will be monitored throughout the study.

Connect with a study center

  • Buenos Aires,
    Argentina

    Site Not Available

  • Caba,
    Argentina

    Site Not Available

  • empty

    Capital Federal,
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires-Urologia

    Ciudad Autonoma Buenos Aires, C1181ACH
    Argentina

    Site Not Available

  • Instituto Medico Especializado Alexander Fleming

    Ciudad De Buenos Aires, C1426ANZ
    Argentina

    Site Not Available

  • Cordoba,
    Argentina

    Site Not Available

  • empty

    Córdoba,
    Argentina

    Site Not Available

  • Hospital San Roque

    Gonnet-La Plata,
    Argentina

    Site Not Available

  • La Rioja,
    Argentina

    Site Not Available

  • Hospital Bocalandro

    Loma Hermosa N/A, 00000
    Argentina

    Site Not Available

  • Rosario,
    Argentina

    Site Not Available

  • Fundacion Ars Medica

    San Salvador De Jujuy,
    Argentina

    Site Not Available

  • Adelaide,
    Australia

    Site Not Available

  • Peter MacCallum Cancer Institute

    East Melbourne, 3002
    Australia

    Site Not Available

  • Footscray,
    Australia

    Site Not Available

  • Liverpool,
    Australia

    Site Not Available

  • Malvern,
    Australia

    Site Not Available

  • Randwick,
    Australia

    Site Not Available

  • Wahroonga,
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, 4102
    Australia

    Site Not Available

  • Antwerpen,
    Belgium

    Site Not Available

  • Bonheiden,
    Belgium

    Site Not Available

  • Brasschaat,
    Belgium

    Site Not Available

  • Bruxelles,
    Belgium

    Site Not Available

  • Charleroi,
    Belgium

    Site Not Available

  • Liège,
    Belgium

    Site Not Available

  • Namur,
    Belgium

    Site Not Available

  • Ottignies,
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • Sint-Niklaas,
    Belgium

    Site Not Available

  • Yvoir,
    Belgium

    Site Not Available

  • Barretos,
    Brazil

    Site Not Available

  • Belo Horizonte,
    Brazil

    Site Not Available

  • Instituto de Cancer de Brasilia

    Brasilia, 72110-150
    Brazil

    Site Not Available

  • empty

    Campinas,
    Brazil

    Site Not Available

  • Caxias Do Sul,
    Brazil

    Site Not Available

  • Curitiba,
    Brazil

    Site Not Available

  • empty

    Fortaleza,
    Brazil

    Site Not Available

  • Ijui,
    Brazil

    Site Not Available

  • Hospital de Caridade de Ijui

    Ijuí, 98700-000
    Brazil

    Site Not Available

  • Jau,
    Brazil

    Site Not Available

  • Natal,
    Brazil

    Site Not Available

  • Novo Hamburgo,
    Brazil

    Site Not Available

  • Porto Alegre,
    Brazil

    Site Not Available

  • Ribeirao Preto,
    Brazil

    Site Not Available

  • Hospital das Clinicas da Faculdade de Medicina da USP de Ribeirao Preto

    Ribeirão Preto, 14048 900
    Brazil

    Site Not Available

  • empty

    Rio De Janeiro-Rj,
    Brazil

    Site Not Available

  • empty

    Rio Grande Do Sul,
    Brazil

    Site Not Available

  • Rio de Janeiro,
    Brazil

    Site Not Available

  • Salvador,
    Brazil

    Site Not Available

  • empty

    Santo André,
    Brazil

    Site Not Available

  • Sao Jose Do Rio Preto,
    Brazil

    Site Not Available

  • Sao Paulo,
    Brazil

    Site Not Available

  • empty

    São José do Rio Preto,
    Brazil

    Site Not Available

  • Gabrovo,
    Bulgaria

    Site Not Available

  • Sofia,
    Bulgaria

    Site Not Available

  • Edmonton, Alberta
    Canada

    Site Not Available

  • Vancouver, British Columbia
    Canada

    Site Not Available

  • Winnipeg, Manitoba
    Canada

    Site Not Available

  • Urology Consultants

    Halifax, Nova Scotia B3H 4R2
    Canada

    Site Not Available

  • Hamilton, Ontario
    Canada

    Site Not Available

  • Kingston, Ontario
    Canada

    Site Not Available

  • Oshawa, Ontario
    Canada

    Site Not Available

  • Ottawa, Ontario
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • Montreal, Quebec
    Canada

    Site Not Available

  • Quebec,
    Canada

    Site Not Available

  • Santiago,
    Chile

    Site Not Available

  • Beijing,
    China

    Site Not Available

  • Chengdu,
    China

    Site Not Available

  • Chongqing,
    China

    Site Not Available

  • Guangzhou,
    China

    Site Not Available

  • Hangzhou,
    China

    Site Not Available

  • Nanjing,
    China

    Site Not Available

  • Shanghai,
    China

    Site Not Available

  • Su Zhou,
    China

    Site Not Available

  • Tianjin,
    China

    Site Not Available

  • Wuhan,
    China

    Site Not Available

  • Bogota,
    Colombia

    Site Not Available

  • Floridablanca,
    Colombia

    Site Not Available

  • Medellin,
    Colombia

    Site Not Available

  • Hradec Kralove,
    Czechia

    Site Not Available

  • Olomouc,
    Czechia

    Site Not Available

  • Plzen,
    Czechia

    Site Not Available

  • Praha 10,
    Czechia

    Site Not Available

  • Praha 2,
    Czechia

    Site Not Available

  • Praha 4,
    Czechia

    Site Not Available

  • Aalborg sygehus Urologisk Afdelning

    Aalborg, 9000
    Denmark

    Site Not Available

  • empty

    Aarhus,
    Denmark

    Site Not Available

  • empty

    Aarhus N,
    Denmark

    Site Not Available

  • Aarhus N.,
    Denmark

    Site Not Available

  • Holsterbro,
    Denmark

    Site Not Available

  • empty

    Odense,
    Denmark

    Site Not Available

  • Odense N/a,
    Denmark

    Site Not Available

  • Roskilde,
    Denmark

    Site Not Available

  • Vejle,
    Denmark

    Site Not Available

  • empty

    Kuopio,
    Finland

    Site Not Available

  • empty

    Oulo,
    Finland

    Site Not Available

  • Oulu,
    Finland

    Site Not Available

  • Tampere,
    Finland

    Site Not Available

  • Centre Paul Papin

    Angers Cedex 01, 49033
    France

    Site Not Available

  • La Chaussee St Victor,
    France

    Site Not Available

  • Centre Jean Bernard - Clinique Victor Hugo

    Le Mans, 72000
    France

    Site Not Available

  • Lille,
    France

    Site Not Available

  • Montpellier,
    France

    Site Not Available

  • Paris Cedex 14,
    France

    Site Not Available

  • Hôpital Civil

    Strasbourg, 67000
    France

    Site Not Available

  • Suresnes,
    France

    Site Not Available

  • Toulouse,
    France

    Site Not Available

  • CHU BRETONNEAU - Oncology

    Tours, 37044
    France

    Site Not Available

  • Villejuif Cedex,
    France

    Site Not Available

  • Düsseldorf,
    Germany

    Site Not Available

  • Waldkrankenhaus St. Marien -Urologische Universitätsklinik-

    Erlangen, 91054
    Germany

    Site Not Available

  • Hamburg,
    Germany

    Site Not Available

  • Praxis Dr. Ralf Eckert - Germany

    Lutherstadt Eisleben, 06295
    Germany

    Site Not Available

  • Nürtingen,
    Germany

    Site Not Available

  • Budapest,
    Hungary

    Site Not Available

  • Budapest N/a,
    Hungary

    Site Not Available

  • Győr,
    Hungary

    Site Not Available

  • Miskolc,
    Hungary

    Site Not Available

  • Pecs,
    Hungary

    Site Not Available

  • Szentes,
    Hungary

    Site Not Available

  • Beer Yaakov,
    Israel

    Site Not Available

  • Beer-Sheva,
    Israel

    Site Not Available

  • Haifa,
    Israel

    Site Not Available

  • Jerusalem,
    Israel

    Site Not Available

  • Kfar Saba,
    Israel

    Site Not Available

  • Petah-Tikva,
    Israel

    Site Not Available

  • Ramat Gan,
    Israel

    Site Not Available

  • Sourasky Medical Center, Tel Aviv Sourasky Med Ctr

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • Chiba,
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • Gifu,
    Japan

    Site Not Available

  • Kashiwa,
    Japan

    Site Not Available

  • Matsuyama,
    Japan

    Site Not Available

  • Nankoku,
    Japan

    Site Not Available

  • Osaka-Sayama,
    Japan

    Site Not Available

  • Kitasato University Hospital

    Sagamihara, 252-0375
    Japan

    Site Not Available

  • Sakura,
    Japan

    Site Not Available

  • empty

    Shinjuku,
    Japan

    Site Not Available

  • Tokushima,
    Japan

    Site Not Available

  • Tokyo,
    Japan

    Site Not Available

  • Ube,
    Japan

    Site Not Available

  • Yokohama,
    Japan

    Site Not Available

  • Yufu,
    Japan

    Site Not Available

  • Bucheon-Si,
    Korea, Republic of

    Site Not Available

  • Busan,
    Korea, Republic of

    Site Not Available

  • Daegu,
    Korea, Republic of

    Site Not Available

  • Daejeon,
    Korea, Republic of

    Site Not Available

  • Gyeonggi-do,
    Korea, Republic of

    Site Not Available

  • Seoul,
    Korea, Republic of

    Site Not Available

  • Kuala Lumpur,
    Malaysia

    Site Not Available

  • Hospital Kuala Lumpur

    Kuala Lumpur N/A, 50586
    Malaysia

    Site Not Available

  • Kuching,
    Malaysia

    Site Not Available

  • Chihuahua,
    Mexico

    Site Not Available

  • empty

    Ciudad De Mexico,
    Mexico

    Site Not Available

  • Cuernavaca,
    Mexico

    Site Not Available

  • Durango,
    Mexico

    Site Not Available

  • Guadalajara,
    Mexico

    Site Not Available

  • empty

    Leon,
    Mexico

    Site Not Available

  • empty

    Mexico,
    Mexico

    Site Not Available

  • Monterrey,
    Mexico

    Site Not Available

  • Oaxaca,
    Mexico

    Site Not Available

  • empty

    Pachuca,
    Mexico

    Site Not Available

  • Pachuca de Soto,
    Mexico

    Site Not Available

  • empty

    Toluca,
    Mexico

    Site Not Available

  • empty

    Zamora,
    Mexico

    Site Not Available

  • Zapopan,
    Mexico

    Site Not Available

  • Alkmaar,
    Netherlands

    Site Not Available

  • Amsterdam,
    Netherlands

    Site Not Available

  • Amsterdam Zuidoost,
    Netherlands

    Site Not Available

  • HAGA Ziekenhuis, lokatie Leyenburg, afdeling Interne

    Den Haag, 2545 CH
    Netherlands

    Site Not Available

  • Atrium Med.Centrum Heerlen - Afd.Interne - INT

    Heerlen, 6419 PC
    Netherlands

    Site Not Available

  • Hilversum,
    Netherlands

    Site Not Available

  • Hoofddorp,
    Netherlands

    Site Not Available

  • Nieuwegein,
    Netherlands

    Site Not Available

  • Rotterdam,
    Netherlands

    Site Not Available

  • Auckland,
    New Zealand

    Site Not Available

  • Christchurch,
    New Zealand

    Site Not Available

  • Hamilton,
    New Zealand

    Site Not Available

  • Tauranga,
    New Zealand

    Site Not Available

  • empty

    Callao,
    Peru

    Site Not Available

  • empty

    Lima,
    Peru

    Site Not Available

  • Bydgoszcz,
    Poland

    Site Not Available

  • Gdansk,
    Poland

    Site Not Available

  • Lodz,
    Poland

    Site Not Available

  • Lublin,
    Poland

    Site Not Available

  • S.P.Z.O.Z.Ministerstwa Spraw Wewnetrznych

    Olsztyn, 10-228
    Poland

    Site Not Available

  • Warszawa,
    Poland

    Site Not Available

  • Braga,
    Portugal

    Site Not Available

  • Coimbra,
    Portugal

    Site Not Available

  • Lisboa,
    Portugal

    Site Not Available

  • Porto,
    Portugal

    Site Not Available

  • Hospital Da Arrábida

    Vila Nova De Gaia, 4400
    Portugal

    Site Not Available

  • Brasov,
    Romania

    Site Not Available

  • Bucharest,
    Romania

    Site Not Available

  • Bucuresti,
    Romania

    Site Not Available

  • Cluj Napoca,
    Romania

    Site Not Available

  • Iasi,
    Romania

    Site Not Available

  • Cabinet Oncologie Medicala "ONCOMED"

    Timisoara, 300239
    Romania

    Site Not Available

  • State Healthcare Institution "Arkhangelsk Regional Clinical Oncological Center"

    Arkhangelsk, 163045
    Russian Federation

    Site Not Available

  • Altai Regional Oncology Dispensary

    Barnaul, 656049
    Russian Federation

    Site Not Available

  • Chelyabinsk,
    Russian Federation

    Site Not Available

  • Ekaterinburg,
    Russian Federation

    Site Not Available

  • Saratov Regional Oncology Dispensary

    Engels Saratov Region, 413100
    Russian Federation

    Site Not Available

  • Ivanovo,
    Russian Federation

    Site Not Available

  • Izhevsk,
    Russian Federation

    Site Not Available

  • State Medical Institution "Republican Clinical Oncological Centre" at Republic of Tatarstan

    Kazan, 420029
    Russian Federation

    Site Not Available

  • Krasnoyarskaya state Medical Academy of Roszdrav

    Krasnoyarsk, 660022
    Russian Federation

    Site Not Available

  • empty

    Leningrad Region,
    Russian Federation

    Site Not Available

  • Moscow,
    Russian Federation

    Site Not Available

  • Nizhny Novgorod,
    Russian Federation

    Site Not Available

  • Obninsk,
    Russian Federation

    Site Not Available

  • Medical Radiological Research Center

    Obninsk, Kaluga Region, 249036
    Russian Federation

    Site Not Available

  • Obninsk, Kaluga Region,
    Russian Federation

    Site Not Available

  • Omsk,
    Russian Federation

    Site Not Available

  • Orenburg,
    Russian Federation

    Site Not Available

  • Perm Oncology Dispensary

    Perm, 614066
    Russian Federation

    Site Not Available

  • Pyatigorsk,
    Russian Federation

    Site Not Available

  • empty

    Rostov On Don,
    Russian Federation

    Site Not Available

  • Rostov-on-Don,
    Russian Federation

    Site Not Available

  • Ryazan,
    Russian Federation

    Site Not Available

  • Clinical Hospital #122 n.a. after L.G. Sokolov

    Saint Petersburg, 194291
    Russian Federation

    Site Not Available

  • Russian Scientific Center of Radiology and Surgical Technologies

    Saint-Petersburg, 197758
    Russian Federation

    Site Not Available

  • Sankt-Peterburg,
    Russian Federation

    Site Not Available

  • Saransk,
    Russian Federation

    Site Not Available

  • Saratov,
    Russian Federation

    Site Not Available

  • Sochi,
    Russian Federation

    Site Not Available

  • St. Petersburg GBUZ City Hospital # 26

    St Petersburg, 196247
    Russian Federation

    Site Not Available

  • St.-Petersburg,
    Russian Federation

    Site Not Available

  • Stavropol,
    Russian Federation

    Site Not Available

  • Tomsk Oncology Research Institute

    Tomsk, 634009
    Russian Federation

    Site Not Available

  • Tumen,
    Russian Federation

    Site Not Available

  • Ufa,
    Russian Federation

    Site Not Available

  • Vladimir Regional Clinical Oncology Dispensary

    Vladimir, 600020
    Russian Federation

    Site Not Available

  • Volgograd,
    Russian Federation

    Site Not Available

  • Yoshkar-Ola,
    Russian Federation

    Site Not Available

  • empty

    Singapore,
    Singapore

    Site Not Available

  • Košice-Šaca,
    Slovakia

    Site Not Available

  • Martin,
    Slovakia

    Site Not Available

  • Piestany,
    Slovakia

    Site Not Available

  • Prešov,
    Slovakia

    Site Not Available

  • Rimavska Sobota,
    Slovakia

    Site Not Available

  • Trnava,
    Slovakia

    Site Not Available

  • Rainbow Oncology

    Amanzimtoti, 4126
    South Africa

    Site Not Available

  • Cape Gate GVI Oncology

    Cape Town, 7570
    South Africa

    Site Not Available

  • Westridge Medical Centre

    Durban, 4069
    South Africa

    Site Not Available

  • George,
    South Africa

    Site Not Available

  • University of Witwatersrand

    Johannesburg, 2193
    South Africa

    Site Not Available

  • Port Elizabeth,
    South Africa

    Site Not Available

  • Pretoria,
    South Africa

    Site Not Available

  • Vosloorus,
    South Africa

    Site Not Available

  • empty

    A Coruña,
    Spain

    Site Not Available

  • Barcelona,
    Spain

    Site Not Available

  • Cordoba,
    Spain

    Site Not Available

  • Coruña,
    Spain

    Site Not Available

  • empty

    La Coruña,
    Spain

    Site Not Available

  • Madrid,
    Spain

    Site Not Available

  • Madrid N/a,
    Spain

    Site Not Available

  • Murcia N/a,
    Spain

    Site Not Available

  • empty

    Sanchinarro,
    Spain

    Site Not Available

  • Hospitalclinico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Göteborg,
    Sweden

    Site Not Available

  • Malmö,
    Sweden

    Site Not Available

  • Stockholm,
    Sweden

    Site Not Available

  • Umeå,
    Sweden

    Site Not Available

  • Uppsala,
    Sweden

    Site Not Available

  • Adana,
    Turkey

    Site Not Available

  • Ankara,
    Turkey

    Site Not Available

  • Istanbul,
    Turkey

    Site Not Available

  • Izmir,
    Turkey

    Site Not Available

  • Zonguldak,
    Turkey

    Site Not Available

  • Cherkassy,
    Ukraine

    Site Not Available

  • Bukovinian Regional Clinical Hospital

    Chernivtsi,
    Ukraine

    Site Not Available

  • Dnepropetrovsk,
    Ukraine

    Site Not Available

  • Dnipro,
    Ukraine

    Site Not Available

  • Municipal institution "Clinical oncological" of Dnipropetrovsk regional council, chemotherapy depar

    Dnipropetrovsk, 49055
    Ukraine

    Site Not Available

  • empty

    Ivano-Francovsk,
    Ukraine

    Site Not Available

  • Khakhiv,
    Ukraine

    Site Not Available

  • Kharkiv,
    Ukraine

    Site Not Available

  • empty

    Kharkov,
    Ukraine

    Site Not Available

  • State Institution "National Cancer Institute", Department of plastic and recontructive oncourology

    Kiev, 03022
    Ukraine

    Site Not Available

  • Kyiv,
    Ukraine

    Site Not Available

  • Lviv,
    Ukraine

    Site Not Available

  • Makiivka,
    Ukraine

    Site Not Available

  • Odessa,
    Ukraine

    Site Not Available

  • Uzhgorod,
    Ukraine

    Site Not Available

  • Zaporizhzhia,
    Ukraine

    Site Not Available

  • Cambridge,
    United Kingdom

    Site Not Available

  • Glasgow,
    United Kingdom

    Site Not Available

  • Manchester,
    United Kingdom

    Site Not Available

  • Nottingham,
    United Kingdom

    Site Not Available

  • Oxford,
    United Kingdom

    Site Not Available

  • Plymouth,
    United Kingdom

    Site Not Available

  • Rosemere Cancer Centre

    Preston, PR2 9HT
    United Kingdom

    Site Not Available

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