Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

NCT ID: NCT00638690

Last Updated: 2014-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-10-31

Brief Summary

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.

Detailed Description

Abiraterone acetate is a steroidal irreversible inhibitor of CYP17 (17α hydroxylase/C17, 20-lyase), blocking 2 important enzymatic activities in the synthesis of testosterone. The goal of this study is to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens, one of which contains docetaxel. All patients involved in the study will be randomized (assigned by chance) into one of two arms and will not know what study drug is being given to them. Study drug randomization allocation will be 2:1 (abiraterone acetate: placebo). The study will be conducted in the United States, Canada, Australia, and the EU. The study will consist of screening, treatment, and follow-up. In this study, patients will receive study treatment (abiraterone acetate or placebo) plus prednisone until progression of clinical disease. Follow-up will continue until patient dies, is lost to follow-up, or withdraws informed consent. After providing written informed consent, patients will have screening procedures completed to determine eligibility. Safety evaluations at the screening procedure will include a physical examination, vital signs, and clinical blood laboratory tests, ECG, radiographs, urine tests, and recording of any adverse events including details of current prostate cancer symptoms. Patients will be asked to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.

Study medication, abiraterone acetate,is an oral (by mouth) medication to be administered as four (4) 250mg abiraterone acetate tablets or 4 placebo tablets to be taken at least one hour before or two hours after a meal anytime up to 10PM everyday. Prednisone will be administered as 5mg orally twice a day for both groups. Each cycle will be 28 days. Study treatment will continue until disease progression as determined by investigator or when the patient meets criteria for withdrawal from study.

Conditions

Prostatic Neoplasms

Study Design

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

Study Groups

Abiraterone acetate plus prednisone/prednisolone

Group Type: EXPERIMENTAL

Abiraterone acetate

Intervention Type: DRUG

Four 250-mg tablets once daily until disease progression

Prednisone/prednisolone

Intervention Type: DRUG

5 mg twice daily until disease progression

Placebo plus prednisone/prednisolone

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Four tablets once daily until disease progression

Prednisone/prednisolone

Intervention Type: DRUG

5 mg twice daily until disease progression

Interventions

Placebo

Four tablets once daily until disease progression

Intervention Type: DRUG

Abiraterone acetate

Four 250-mg tablets once daily until disease progression

Intervention Type: DRUG

Prednisone/prednisolone

5 mg twice daily until disease progression

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior cytotoxic chemotherapies
• At least one chemotherapy must have contained docetaxel
• Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2
• Medical or surgical castration with testosterone < 50 ng/dL
• Adequate bone marrow, hepatic and renal function
• Potassium >= 3.5 mmol/L
• Able to swallow the study drug whole as a tablet
• Informed Consent

Exclusion Criteria

• More than two prior cytotoxic chemotherapy regimens
• Prior Ketoconazole for prostate cancer
• Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
• Uncontrolled hypertension
• Active or symptomatic viral hepatitis or chronic liver disease
• History of pituitary or adrenal dysfunction
• Clinically significant heart disease
• Other malignancy
• Known brain metastasis
• GI disorder affecting absorption
• Not willing to use contraception

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

Sponsors

Cougar Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cougar Biotechnology, Inc Clinical Trial

Role: STUDY_DIRECTOR

Cougar Biotechnology, Inc.

Locations

Birmingham, Alabama, United States

Tucson, Arizona, United States

Beverly Hills, California, United States

Duarte, California, United States

Los Angeles, California, United States

Marina del Rey, California, United States

Sacramento, California, United States

San Diego, California, United States

San Francisco, California, United States

Aurora, Colorado, United States

Bristol, Connecticut, United States

New Haven, Connecticut, United States

Stamford, Connecticut, United States

Boca Raton, Florida, United States

Fort Lauderdale, Florida, United States

Fort Myers, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Galesburg, Illinois, United States

Indianapolis, Indiana, United States

Westwood, Kansas, United States

Wichita, Kansas, United States

Marrero, Louisiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Robbinsdale, Minnesota, United States

St Louis, Missouri, United States

Billings, Montana, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Box 302, New York, United States

East Setauket, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

Stony Brook, New York, United States

Durham, North Carolina, United States

Raleigh, North Carolina, United States

Canton, Ohio, United States

Cincinnati, Ohio, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Myrtle Beach, South Carolina, United States

Chattanooga, Tennessee, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Virgiania Beach, Virginia, United States

Seattle, Washington, United States

Adelaide, , Australia

Camperdown, , Australia

Footscray, , Australia

Geelong, , Australia

Heidelberg, , Australia

Herston, , Australia

Hobart, , Australia

Hornsby, , Australia

Kogarah, , Australia

Kurralta Park, , Australia

Liverpool, , Australia

Milton, , Australia

Parkville, , Australia

Perth, , Australia

Subiaco, , Australia

Wodonga, , Australia

Wollongong, , Australia

Linz, , Austria

Salzburg, , Austria

Vienna, , Austria

Antwerp, , Belgium

Bonheiden, , Belgium

Brussels, , Belgium

Ghent, , Belgium

Hasselt, , Belgium

Kortrijk, , Belgium

Leuven, , Belgium

Liège, , Belgium

Roeselare, , Belgium

Edmonton, Alberta, Canada

Kelowna, British Columbia, Canada

Vancouver, British Columbia, Canada

Victoria, British Columbia, Canada

Halifax, Nova Scotia, Canada

Hamilton, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Regina, Saskatchewan, Canada

Calgary Ab, , Canada

London, , Canada

Angers, , France

Caen, , France

Cannes, , France

Dijon, , France

Lyon, , France

Paris, , France

Saint-Herblain, , France

Vandœuvre-lès-Nancy, , France

Villejuif, , France

Aachen, , Germany

Berlin, , Germany

Dresden, , Germany

Hamburg, , Germany

Homburg/Saar, , Germany

Pécs, , Hungary

Szombathely, , Hungary

Cork, , Ireland

Dublin, , Ireland

Nijmegen, , Netherlands

Badalona, , Spain

Barcelona, , Spain

Madrid, , Spain

Belfast, , United Kingdom

Birmingham, , United Kingdom

Cambridge, , United Kingdom

Glasgow, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Newcastle upon Tyne, , United Kingdom

Northwood, , United Kingdom

Oxford, , United Kingdom

Sutton, , United Kingdom

Whitchurch, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; France; Germany; Hungary; Ireland; Netherlands; Spain; United Kingdom

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Other Identifiers

COU-AA-301

Identifier Type: OTHER

Identifier Source: secondary_id

CR016924

Identifier Type: -

Identifier Source: org_study_id