Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

NCT ID: NCT00887198

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1088 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-28
• Study Completion Date: 2017-05-25

Brief Summary

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).

Detailed Description

This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individuals and study personnel will not know the identity of study treatments), 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 in approximately 1,000 medically or surgically castrated male patients with metastatic CRPC who have shown tumor progression and are asymptomatic or mildly symptomatic. The study period will consist of screening, treatment, and follow-up phases. Patients will receive study treatment (abiraterone acetate or placebo) plus prednisone until radiographic progression of disease and/or unequivocal clinical progression. Efficacy evaluations will be performed throughout the treatment period and safety will be assessed until 30 days after the last dose of abiraterone acetate. throughout the study. Follow-up will continue for up to 60 months (5 years) or until the patient dies, is lost to follow-up, or withdraws informed consent. At the interim analysis of overall survival (OS; 43% of death events), the independent data monitoring committee (IDMC) reviewed the efficacy and safety data and concluded that all of the data pointed to a significant advantage for patients in one arm of the study compared with the other arm thereby unanimously recommending unblinding the study and allowing crossover from the placebo arm to active therapy. Patients currently receiving placebo will be offered crossover therapy to abiraterone acetate. Treatment for patients who were originally randomized to the abiraterone acetate treatment group will not change. Patients will be discontinued from long term follow-up at the time of the Clinical Cut-Off Date for Final Analysis (CCO-FA); however, patients still receiving treatment with abiraterone acetate at the CCO-FA will be offered to receive continued treatment for an additional period of up to 3 years or until disease progression or unacceptable toxicity. For these patients, safety assessment will be performed while continuing treatment, and for 30 days after the last dose of abiraterone acetate.

Conditions

Prostate Cancer

Study Design

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

Study Groups

Placebo + prednisone

Placebo plus prednisone

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

4 placebo tablets per day taken orally.

Prednisone

Intervention Type: DRUG

5 mg tablet orally twice daily.

Abiraterone + prednisone

Abiraterone acetate plus prednisone

Group Type: EXPERIMENTAL

Abiraterone acetate

Intervention Type: DRUG

1000 mg per day (4 x 250-mg tablets) taken orally.

Prednisone

Intervention Type: DRUG

5 mg tablet orally twice daily.

Interventions

Abiraterone acetate

1000 mg per day (4 x 250-mg tablets) taken orally.

Intervention Type: DRUG

Placebo

4 placebo tablets per day taken orally.

Intervention Type: DRUG

Prednisone

5 mg tablet orally twice daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Metastatic castration-resistant prostate cancer (CRPC)
• Previous anti-androgen therapy and progression after withdrawal
• ECOG performance status of either 0 or 1
• Medical or surgical castration with testosterone less than 50 ng/dL
• Life expectancy of at least 6 months

Exclusion Criteria

• Prior cytotoxic chemotherapy or biologic therapy for CRPC
• Prior ketoconazole for prostate cancer
• Known brain metastasis or visceral organ metastasis
• Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of 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

Birmingham, Alabama, United States

Tucson, Arizona, United States

Bellflower, 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

Stanford, California, United States

Aurora, Colorado, United States

New Haven, Connecticut, United States

Boca Raton, Florida, United States

Fort Myers, Florida, United States

Gainesville, Florida, United States

Atlanta, Georgia, United States

Honolulu, Hawaii, United States

Kansas City, Kansas, United States

Metairie, Louisiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Dearborn, Michigan, United States

Saint Louis Park, Minnesota, United States

St Louis, Missouri, United States

Billings, Montana, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

East Syracuse, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

Syracuse, New York, United States

Durham, North Carolina, United States

Raleigh, North Carolina, United States

Canton, Ohio, United States

Cleveland, Ohio, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Columbia, South Carolina, 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

Norfolk, Virginia, United States

Seattle, Washington, United States

Madison, Wisconsin, United States

Adelaide, , Australia

Camperdown, , Australia

Footscray, , Australia

Frankston, , Australia

Garran, , Australia

Geelong, , Australia

Heidelberg, , Australia

Herston, , Australia

Hornsby, , Australia

Kogarah, , Australia

Kurralta Park, , Australia

Lismore, , Australia

Liverpool, , Australia

Malvern, , Australia

Parkville, , Australia

Perth, , Australia

South Brisbane, , Australia

Southport, , Australia

Subiaco, , Australia

Aalst, , Belgium

Antwerp, , Belgium

Ghent, , Belgium

Hasselt, , Belgium

Leuven, , Belgium

Roeselare, , Belgium

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Kelowna, British Columbia, Canada

Vancouver, British Columbia, Canada

Victoria, British Columbia, Canada

Hamilton, Ontario, Canada

London, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Caen, , France

Clichy, , France

Dijon, , France

La Roche-sur-Yon, , France

Lyon, , France

Montpellier, , France

Paris, , France

Tours, , France

Villejuif, , France

Aachen, , Germany

Berlin, , Germany

Braunschweig, , Germany

Dresden, , Germany

Düsseldorf, , Germany

Hamburg, , Germany

Hanover, , Germany

Homburg, , Germany

Kempen, , Germany

Leipzig, , Germany

München, , Germany

Münster, , Germany

Wuppertal, , Germany

Athens, , Greece

Larissa, , Greece

Amsterdam, , Netherlands

Heerlen, , Netherlands

Nijmegen, , Netherlands

Rotterdam, , Netherlands

A Coruña, , Spain

Barcelona, , Spain

L'Hospitalet de Llobregat, , Spain

Madrid, , Spain

Oviedo, , Spain

Santander, , Spain

Santiago de Compostela, , Spain

Gothenburg, , Sweden

Malmo, , Sweden

Stockholm, , Sweden

Uppsala, , Sweden

Vaxjo, , Sweden

Birmingham, , United Kingdom

Cambridge, , United Kingdom

Glasgow, , United Kingdom

Leeds, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Metropolitan Borough of Wirral, , United Kingdom

Newcastle upon Tyne, , United Kingdom

Oxford, , United Kingdom

Sutton, , United Kingdom

Whitchurch, , United Kingdom

Countries

United States; Australia; Belgium; Canada; France; Germany; Greece; Netherlands; Spain; Sweden; United Kingdom

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Other Identifiers

COU-AA-302

Identifier Type: OTHER

Identifier Source: secondary_id

2008-008004-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR016927

Identifier Type: -

Identifier Source: org_study_id