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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)

Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Neoplasms

Intervention: Abiraterone acetate (Drug); Prednisone (Drug); Androgen deprivation therapy (ADT) (Other); Abiraterone acetate Placebo (Drug); Prednisone Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

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 and low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

Clinical Details

Official title: A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Overall Survival (OS)

Radiographic progression-free survival (PFS)

Secondary outcome:

Time to next skeletal-related event

Time to prostate specific antigen (PSA) progression

Time to next subsequent therapy for prostate cancer

Time to initiation of chemotherapy

Time to Pain Progression

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 and 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] along with 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) and Open-label Extension Phase (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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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)

Locations and Contacts

Buenos Aires, Argentina

Cordoba, Argentina

Córdoba, Argentina

La Rioja, Argentina

Rosario, Argentina

Adelaide, Australia

Footscray, Australia

Liverpool, Australia

Malvern, Australia

Randwick, Australia

Wahroonga, Australia

Antwerpen, Belgium

Bonheiden, Belgium

Brasschaat, Belgium

Bruxelles, 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

Jau, Brazil

Natal, Brazil

Novo Hamburgo, Brazil

Porto Alegre, Brazil

Ribeirão Preto, Brazil

Rio De Janeiro, Brazil

Salvador, Brazil

Sao Jose Do Rio Preto, Brazil

Sao Paulo, Brazil

Gabrovo, Bulgaria

Sofia, Bulgaria

Quebec, Canada

Santiago, Chile

Beijing, China

Chengdu, China

Chongqing, China

Guangzhou, China

Hangzhou, China

Nanjing, China

Shanghai, China

Su Zhou, China

Tianjin, China

Wuhan, China

Bogota, Colombia

Floridablanca, Colombia

Medellin, Colombia

Hradec Kralove, Czech Republic

Olomouc, Czech Republic

Plzen, Czech Republic

Praha 10, Czech Republic

Praha 2, Czech Republic

Praha 4, Czech Republic

Aarhus, Denmark

Holsterbro, Denmark

Odense N/A, Denmark

Roskilde, Denmark

Vejle, Denmark

Oulo, Finland

Tampere, Finland

La Chaussee St Victor, France

Lille, France

Montpellier, France

Paris Cedex 14, France

Suresnes, France

Toulouse, France

Villejuif Cedex, France

Düsseldorf, Germany

Hamburg, Germany

Nürtingen, Germany

Budapest N/A, Hungary

Budapest, Hungary

Győr, Hungary

Miskolc, Hungary

Pecs, Hungary

Szentes, Hungary

Beer Yaakov, Israel

Beer-Sheva, Israel

Haifa, Israel

Jerusalem, Israel

Kfar Saba, Israel

Petah-Tikva, Israel

Ramat Gan, Israel

Chiba, Japan

Gifu, Japan

Kashiwa, Japan

Matsuyama, Japan

Nankoku, Japan

Osaka-Sayama, Japan

Sakura, Japan

Tokushima, Japan

Tokyo, Japan

Ube, Japan

Yokohama, Japan

Yufu, Japan

Busan, Korea, Republic of

Daegu, Korea, Republic of

Daejeon, Korea, Republic of

Gyeonggi-Do, Korea, Republic of

Seoul, Korea, Republic of

Kuala Lumpur N/A, Malaysia

Kuala Lumpur, Malaysia

Kuching, Malaysia

Chihuahua, Mexico

Cuernavaca, Mexico

Durango, Mexico

Guadalajara, Mexico

Monterrey, Mexico

Oaxaca, Mexico

Pachuca De Soto, Mexico

Zapopan, Mexico

Alkmaar, Netherlands

Amsterdam Zuidoost, Netherlands

Amsterdam, 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

Warszawa, Poland

Braga, Portugal

Coimbra, Portugal

Lisboa, Portugal

Porto, Portugal

Brasov, Romania

Bucharest, Romania

Bucuresti, Romania

Cluj Napoca, Romania

Iasi, Romania

Chelyabinsk, Russian Federation

Ekaterinburg, Russian Federation

Ivanovo, Russian Federation

Izhevsk, Russian Federation

Moscow, Russian Federation

Nizhny Novgorod, Russian Federation

Obninsk, Kaluga Region, Russian Federation

Omsk, Russian Federation

Orenburg, Russian Federation

Pyatigorsk, Russian Federation

Rostov-On-Don, Russian Federation

Ryazan, Russian Federation

Saint-Petersburg, Russian Federation

Saransk, Russian Federation

Saratov, Russian Federation

Sochi, Russian Federation

St.-Petersburg, Russian Federation

Stavropol, Russian Federation

Tumen, Russian Federation

Ufa, Russian Federation

Volgograd, Russian Federation

Yoshkar-Ola, Russian Federation

Košice-Šaca, Slovakia

Martin, Slovakia

Piestany, Slovakia

Prešov, Slovakia

Rimavska Sobota, Slovakia

Trnava, Slovakia

George, South Africa

Port Elizabeth, South Africa

Pretoria, South Africa

Vosloorus, South Africa

Barcelona, Spain

Cordoba, Spain

Coruña, Spain

Madrid N/A, Spain

Madrid, Spain

Murcia N/A, Spain

Göteborg, Sweden

Malmö, Sweden

Stockholm, Sweden

Umeå, Sweden

Uppsala, Sweden

Adana, Turkey

Ankara, Turkey

Istanbul, Turkey

Izmir, Turkey

Zonguldak, Turkey

Cherkassy, Ukraine

Dnepropetrovsk, Ukraine

Dnipropetrovsk, Ukraine

Kharkiv, Ukraine

Kharkov, Ukraine

Kyiv, Ukraine

Lviv, Ukraine

Makiivka, Ukraine

Odessa, Ukraine

Uzhgorod, Ukraine

Zaporizhzhia, Ukraine

Cambridge, United Kingdom

Glasgow, United Kingdom

Manchester, United Kingdom

Nottingham, United Kingdom

Oxford, United Kingdom

Plymouth, United Kingdom

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

Additional Information

Starting date: February 2013
Last updated: August 18, 2015

Page last updated: August 23, 2015

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