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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00638690
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : May 16, 2013
Last Update Posted : April 30, 2014
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Placebo Drug: Abiraterone acetate Drug: Prednisone/prednisolone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

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: Placebo
Four tablets once daily until disease progression

Drug: Prednisone/prednisolone
5 mg twice daily until disease progression

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00638690

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United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Beverly Hills, California, United States
Duarte, California, United States
Los Angeles, California, United States
Marina Del Rey, California, United States
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Sponsors and Collaborators
Cougar Biotechnology, Inc.
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Study Director: Cougar Biotechnology, Inc Clinical Trial Cougar Biotechnology, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Cougar Biotechnology, Inc. Identifier: NCT00638690     History of Changes
Other Study ID Numbers: CR016924
COU-AA-301 ( Other Identifier: Cougar Biotechnology, Inc )
First Posted: March 19, 2008    Key Record Dates
Results First Posted: May 16, 2013
Last Update Posted: April 30, 2014
Last Verified: April 2014

Keywords provided by Cougar Biotechnology, Inc.:
Metastatic Castration-Resistant Prostate Cancer
Abiraterone Acetate

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Methylprednisolone Hemisuccinate
Abiraterone Acetate
Methylprednisolone Acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Autonomic Agents