This study is currently recruiting participants.

Thanks to a heads up from Jan Manarite of PCRI, I have just learned about a trial of Abiraterone Acetate that is currently recruiting participants. In this trial everyone will get abiraterone, nobody will receive a placebo.

NO PLACEBO

This is a study to collect information on adverse events (side effects) that occur during treatment with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (CRPC). To participate in this study patients must have failed 1 or 2 chemotherapy regimens (1 of which contained a taxane such as docetaxel), reside in an area where abiraterone acetate is not yet available through local health care providers, and not be eligible for enrollment in any other ongoing clinical research study of abiraterone acetate.

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)

Currently the open sites are in New York and California with additional sites to open in the future.

For more information go to: http://www.clinicaltrials.gov/ct2/show/NCT01217697?term=abiraterone&recr=Open&rank=6

Joel T Nowak, M.A., M.S.W.