Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

Trial ID or NCT#



not recruiting iconNOT RECRUITING


The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).

Official Title

An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy

Eligibility Criteria

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Confirmed prostate cancer* Prostate cancer progression after previous chemotherapy as assessed by the investigator* Received at least 1 but not more than 2 chemotherapy regimens for metastatic CRPC (at least one regimen must have contained a taxane such as docetaxel)* Serum testosterone of less than 50ng/dL (less than 2.0 nM)* Eastern Cooperative Oncology Group (ECOG) performance status of \<=2 (ie, patients who do not have symptoms of prostate cancer and who are fully active, patients who have symptoms but are able to perform light work, or patients who are able to get around and are capable of taking care of themselves but are unable to carry out any work activities)
Exclusion Criteria:
  1. * Serious or uncontrolled co-existent non-malignant disease (including active and uncontrolled infection)* Active or symptomatic viral hepatitis or chronic liver disease or any abnormal liver function assessed by liver function tests* Clinically significant heart disease as assessed by the Investigator or uncontrolled hypertension (systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=95 mmHg)* History of gastrointestinal disorders that may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction* Known brain metastasis (ie, spread of cancer to the brain)


Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

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Cancer Clinical Trials Office