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

April 10, 2014 updated by: Cougar Biotechnology, Inc.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1195

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • 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
  • Austria
      • Linz, Austria
      • Salzburg, Austria
      • Wien, Austria
  • Belgium
      • Antwerpen, Belgium
      • Bonheiden, Belgium
      • Bruxelles, Belgium
      • Gent, Belgium
      • Hasselt, Belgium
      • Kortrijk, Belgium
      • Leuven, Belgium
      • Liege, Belgium
      • Roeselare, Belgium
  • Canada
      • Calgary Ab, Canada
      • London, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada
  • France
      • Angers Cedex 01, France
      • Caen, France
      • Cannes, France
      • Dijon, France
      • Lyon, France
      • Paris, France
      • Saint Herblain, France
      • Vandoeuvre Les Nancy Cedex, France
      • Villejuif N/A, France
  • Germany
      • Aachen, Germany
      • Berlin, Germany
      • Dresden, Germany
      • Hamburg, Germany
      • Homburg/Saar, Germany
  • Hungary
      • Pecs, Hungary
      • Szombathely, Hungary
  • Ireland
      • Cork, Ireland
      • Dublin, Ireland
      • Dublin 7, Ireland
  • Netherlands
      • Nijmegen, Netherlands
  • Spain
      • Badalona, Spain
      • Barcelona, Spain
      • Madrid, Spain
  • United Kingdom
      • 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
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • 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
    • Colorado
      • Aurora, Colorado, United States
    • Connecticut
      • Bristol, Connecticut, United States
      • New Haven, Connecticut, United States
      • Stamford, Connecticut, United States
    • Florida
      • Boca Raton, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Fort Myers, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Chicago, Illinois, United States
      • Galesburg, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Westwood, Kansas, United States
      • Wichita, Kansas, United States
    • Louisiana
      • Marrero, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • Minnesota
      • Robbinsdale, Minnesota, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • 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
    • North Carolina
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Canton, Ohio, United States
      • Cincinnati, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Myrtle Beach, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Virgiania Beach, Virginia, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abiraterone acetate plus prednisone/prednisolone
Drug: Abiraterone acetate
Four 250-mg tablets once daily until disease progression
Drug: Prednisone/prednisolone
5 mg twice daily until disease progression
Placebo Comparator: Placebo plus prednisone/prednisolone
Drug: Prednisone/prednisolone
5 mg twice daily until disease progression
Drug: Placebo
Four tablets once daily until disease progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to 60 months
Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.
Up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
Time Frame: Up to 12 months
The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.
Up to 12 months
Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%
Time Frame: Up to 12 months
A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.
Up to 12 months
Radiographic Progression-free Survival
Time Frame: Up to 11 months
Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion.
Up to 11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cougar Biotechnology, Inc.

Investigators

  • Study Director: Cougar Biotechnology, Inc Clinical Trial, Cougar Biotechnology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 13, 2008

First Submitted That Met QC Criteria

March 13, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Estimate)

April 30, 2014

Last Update Submitted That Met QC Criteria

April 10, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016924
  • COU-AA-301 (Other Identifier: Cougar Biotechnology, Inc)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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