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

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ClinicalTrials.gov Identifier: NCT00638690
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : May 16, 2013
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.

Tracking Information
First Submitted Date  ICMJE March 13, 2008
First Posted Date  ICMJE March 19, 2008
Results First Submitted Date  ICMJE August 23, 2011
Results First Posted Date  ICMJE May 16, 2013
Last Update Posted Date April 30, 2014
Study Start Date  ICMJE May 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2013)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2008)		 Overall Survival [ Time Frame: During the Study ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2008)		 Proportion of patients achieving a PSA decline ≥ 50% according to Prostate Specific Antigen Working Group (PSAWG) criteria [ Time Frame: During Study Treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE
  • Drug: Placebo
    Four tablets once daily until disease progression
  • Drug: Abiraterone acetate
    Four 250-mg tablets once daily until disease progression
  • Drug: Prednisone/prednisolone
    5 mg twice daily until disease progression
Study Arms  ICMJE
  • Experimental: Abiraterone acetate plus prednisone/prednisolone
    Interventions:
    • Drug: Abiraterone acetate
    • Drug: Prednisone/prednisolone
  • Placebo Comparator: Placebo plus prednisone/prednisolone
    Interventions:
    • Drug: Placebo
    • Drug: Prednisone/prednisolone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2013)		 1195
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2008)		 1158
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Hungary,   Ireland,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries Italy,   Poland
 
Administrative Information
NCT Number  ICMJE NCT00638690
Other Study ID Numbers  ICMJE CR016924
COU-AA-301 ( Other Identifier: Cougar Biotechnology, Inc )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cougar Biotechnology, Inc.
Original Responsible Party Christopher M. Haqq MD PhD, Cougar Biotechnology, Inc.
Current Study Sponsor  ICMJE Cougar Biotechnology, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cougar Biotechnology, Inc Clinical Trial Cougar Biotechnology, Inc.
PRS Account Cougar Biotechnology, Inc.
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP