Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

Not Recruiting

Trial ID: NCT01217697


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

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


Inclusion Criteria:

   - Confirmed prostate cancer

   - Prostate cancer progression after previous chemotherapy as assessed by the

   - 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

Exclusion Criteria:

   - 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

   - 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)


drug: abiraterone acetate

drug: Prednisone\Prednisolone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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