©2022 Stanford Medicine
Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer
Not Recruiting
Trial ID: NCT01217697
Purpose
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
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
Inclusion Criteria:
- 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:
- 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)
Intervention(s):
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
650-498-7061