A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer

Inclusion Criteria

• Have signed an informed consent document indicating that the subjects understands the purpose of and procedures required for the study and are willing to participate in the study
• Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
• Written Authorization for Use and Release of Health and Research Study Information has been obtained
• Male aged 18 years and above
• Able to swallow the study drug whole as a tablet
• Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken
• Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last study drug administration.
• Have a baseline serum potassium of ≥ 3.5 milliequivalents per litre (mEq/L)
• Have aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin levels 1500 cell/mm3
• Have a calculated creatinine clearance ≥ 60 mL/min
• Have a hemoglobin of ≥ 9.0 g/dL
• Have histologically confirmed adenocarcinoma of the prostate.
• No prior therapy with chemotherapy for metastatic prostate cancer.
• Have metastatic disease based on a positive bone scan or objective imaging on CT scan.
• Have ongoing gonadal androgen deprivation therapy with Luteinizing hormone-releasing hormone (LHRH) analogues or orchiectomy. Patients who have not had an orchiectomy must be maintained on effective LHRH analogue therapy for the duration of the trial.
• Testosterone 2 weeks for prostate cancer.
• Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug, except for any combination of the following:
• Conventional multivitamin supplements
• Selenium
• Lycopene
• Soy supplements
• Prior radiation therapy completed 1 year has passed since the administration of the last chemotherapy dose.
• Any "currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next year.
• Active psychiatric illnesses/social situations that would limit compliance with protocol requirements.
• Patients in whom urgent chemotherapy, in the opinion of the treating physician, is indicated should not be enrolled in this study.