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Phase 3 N=1,195 Randomized Quadruple-blind Treatment

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

Prostatic Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00638690 ↗
Enrolled (actual)
1,195
Serious AEs
45.5%
Results posted
May 2013
Primary outcome: Primary: Overall Survival — 450.0; 332.0 Days — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Placebo (Drug); Abiraterone acetate (Drug); Prednisone/prednisolone (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
Cougar Biotechnology, Inc.
Primary completion
Aug 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Survival		 450.0; 332.0 <0.0001 sig
SECONDARY
Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria		 309.0; 200.0 <0.0001 sig
SECONDARY
Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%		 232; 22 <0.001 sig
SECONDARY
Radiographic Progression-free Survival		 171.0; 110.0 <0.0001 sig

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.

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 = 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00638690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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