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)

NCT ID: NCT01715285

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-12
• Study Completion Date: 2022-02-13

Brief 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).

Detailed 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.

Conditions

Prostate Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Abiraterone acetate + Prednisone + ADT

Participants will receive abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) will be administered.

Group Type: EXPERIMENTAL

Abiraterone acetate

Intervention Type: DRUG

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.

Prednisone

Intervention Type: DRUG

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

Androgen deprivation therapy (ADT)

Intervention Type: OTHER

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.

Placebo + Androgen Deprivation Therapy (ADT)

Participants will receive placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT will be administered.

Group Type: PLACEBO_COMPARATOR

Androgen deprivation therapy (ADT)

Intervention Type: OTHER

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.

Abiraterone acetate Placebo

Intervention Type: DRUG

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

Prednisone Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Prednisone

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

Abiraterone acetate Placebo

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

Intervention Type: DRUG

Prednisone Placebo

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

Intervention Type: DRUG

Other Intervention Names

Zytiga

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
• Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan
• At least 2 of the following high-risk prognostic factors: Gleason score of greater than or equal to (>=8); presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response Evaluation 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 Criteria

• Active infection or other medical condition that would make prednisone use contraindicated
• Any chronic medical condition requiring a higher systemic dose of corticosteroid than 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 prostate cancer (the following exception are permitted): up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Buenos Aires, , Argentina

Caba, , Argentina

Córdoba, , Argentina

La Rioja, , Argentina

Rosario, , Argentina

Adelaide, , Australia

Footscray, , Australia

Liverpool, , Australia

Malvern, , Australia

Randwick, , Australia

Wahroonga, , Australia

Antwerp, , Belgium

Bonheiden, , Belgium

Brasschaat, , Belgium

Brussels, , Belgium

Charleroi, , Belgium

Liège, , Belgium

Namur, , Belgium

Ottignies, , Belgium

Sint-Niklaas, , Belgium

Yvoir, , Belgium

Barretos, , Brazil

Belo Horizonte, , Brazil

Caxias do Sul, , Brazil

Curitiba, , Brazil

Ijuí, , Brazil

Jaú, , Brazil

Natal, , Brazil

Novo Hamburgo, , Brazil

Porto Alegre, , Brazil

Ribeirão Preto, , Brazil

Rio de Janeiro, , Brazil

Salvador, , Brazil

São José do Rio Preto, , Brazil

São Paulo, , Brazil

Gabrovo, , Bulgaria

Sofia, , Bulgaria

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

Hamilton, Ontario, Canada

Kingston, Ontario, Canada

Oshawa, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Santiago, , Chile

Beijing, , China

Chengdu, , China

Chongqing, , China

Guangzhou, , China

Hangzhou, , China

Nanjing, , China

Shanghai, , China

Suzhou, , China

Tianjin, , China

Wuhan, , China

Bogotá, , Colombia

Floridablanca, , Colombia

Medellín, , Colombia

Hradec Králové, , Czechia

Olomouc, , Czechia

Pilsen, , Czechia

Prague, , Czechia

Aarhus N, , Denmark

Holsterbro, , Denmark

Odense, , Denmark

Roskilde, , Denmark

Vejle, , Denmark

Oulu, , Finland

Tampere, , Finland

La Chaussée-Saint-Victor, , France

Lille, , France

Montpellier, , France

Paris, , France

Suresnes, , France

Toulouse, , France

Villejuif, , France

Düsseldorf, , Germany

Hamburg, , Germany

Nürtingen, , Germany

Budapest, , Hungary

Győr, , Hungary

Miskolc, , Hungary

Pécs, , Hungary

Szentes, , Hungary

Beer Yaakov, , Israel

Beersheba, , Israel

Haifa, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Chiba, , Japan

Gifu, , Japan

Kashiwa, , Japan

Matsuyama, , Japan

Nankoku, , Japan

Ōsaka-sayama, , Japan

Sakura, , Japan

Tokushima, , Japan

Tokyo, , Japan

Ube, , Japan

Yokohama, , Japan

Yufu, , Japan

Kuala Lumpur, , Malaysia

Kuching, , Malaysia

Chihuahua City, , Mexico

Cuernavaca, , Mexico

Durango, , Mexico

Guadalajara, , Mexico

Monterrey, , Mexico

Oaxaca City, , Mexico

Pachuca, , Mexico

Zapopan, , Mexico

Alkmaar, , Netherlands

Amsterdam, , Netherlands

Amsterdam-Zuidoost, , Netherlands

Hilversum, , Netherlands

Hoofddorp, , Netherlands

Nieuwegein, , Netherlands

Rotterdam, , Netherlands

Auckland, , New Zealand

Christchurch, , New Zealand

Hamilton, , New Zealand

Tauranga, , New Zealand

Bydgoszcz, , Poland

Gdansk, , Poland

Lodz, , Poland

Lublin, , Poland

Warsaw, , Poland

Braga, , Portugal

Coimbra, , Portugal

Lisbon, , Portugal

Porto, , Portugal

Brasov, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Iași, , Romania

Chelyabinsk, , Russia

Ivanovo, , Russia

Izhevsk, , Russia

Moscow, , Russia

Nizhny Novgorod, , Russia

Obninsk, , Russia

Omsk, , Russia

Orenburg, , Russia

Pyatigorsk, , Russia

Rostov-on-Don, , Russia

Ryazan, , Russia

Saint Petersburg, , Russia

Saransk, , Russia

Saratov, , Russia

Sochi, , Russia

Stavropol, , Russia

Tyumen, , Russia

Ufa, , Russia

Volgograd, , Russia

Yekaterinburg, , Russia

Yoshkar-Ola, , Russia

Košice-Šaca, , Slovakia

Martin, , Slovakia

Piešťany, , Slovakia

Prešov, , Slovakia

Rimavská Sobota, , Slovakia

Trnava, , Slovakia

George, , South Africa

Port Elizabeth, , South Africa

Pretoria, , South Africa

Vosloorus, , South Africa

Bucheon-si, , South Korea

Busan, , South Korea

Daegu, , South Korea

Daejeon, , South Korea

Gyeonggi-do, , South Korea

Seoul, , South Korea

A Coruña, , Spain

Barcelona, , Spain

Córdoba, , Spain

Madrid, , Spain

Murcia, , Spain

Gothenburg, , Sweden

Malmo, , Sweden

Stockholm, , Sweden

Umeå, , Sweden

Uppsala, , Sweden

Adana, , Turkey (Türkiye)

Ankara, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Zonguldak, , Turkey (Türkiye)

Cherkassy, , Ukraine

Dnipro, , Ukraine

Khakhiv, , Ukraine

Kharkiv, , Ukraine

Kyiv, , Ukraine

Lviv, , Ukraine

Makiivka, , Ukraine

Odesa, , Ukraine

Uzhhorod, , Ukraine

Zaporizhzhia, , Ukraine

Cambridge, , United Kingdom

Glasgow, , United Kingdom

Manchester, , United Kingdom

Nottingham, , United Kingdom

Oxford, , United Kingdom

Plymouth, , United Kingdom

Countries

Argentina; Australia; Belgium; Brazil; Bulgaria; Canada; Chile; China; Colombia; Czechia; Denmark; Finland; France; Germany; Hungary; Israel; Japan; Malaysia; Mexico; Netherlands; New Zealand; Poland; Portugal; Romania; Russia; Slovakia; South Africa; South Korea; Spain; Sweden; Turkey (Türkiye); Ukraine; United Kingdom

References

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Other Identifiers

CR100900

Identifier Type: -

Identifier Source: org_study_id

212082PCR3011

Identifier Type: OTHER

Identifier Source: secondary_id

2012-002940-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1135-7146

Identifier Type: OTHER

Identifier Source: secondary_id