IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

Exclusion Criteria

• •Have prior or current evidence of local disease progression or metastatic disease as defined by modified response evaluation criteria in solid tumors (RECIST) criteria
• •Have received chemotherapy for treatment of castrate-resistant prostate cancer; however, if a patient received chemotherapy in an adjuvant setting, prior to having CRPC, for castrate-sensitive prostate cancer, the patient is still eligible
• •Are currently receiving any antiandrogen therapy (eg, bicalutamide, flutamide, or nilutamide).
• •If previously treated with antiandrogen therapy, there must be documentation of at least 2 consecutive rising PSA values at least 2 weeks apart obtained prior to screening
• •If previously treated with flutamide, at least 1 of the PSA values must be obtained 4 weeks or more after flutamide discontinuation.
• •If previously treated with bicalutamide or nilutamide, at least 1 of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation
• •Have previously received agents having any CYP17 inhibitory activity for the treatment of prostate cancer, such as ketoconazole
• •Have previously received aminoglutethimide
• •Have an active infection or other medical condition that would contraindicate prednisone use
• •Have uncontrolled hypertension
• •Have active hepatitis or chronic liver disease
• •Have clinically significant heart disease
• •Have poorly controlled diabetes
• •Have received an investigational therapeutic within 30 days of screening
• •Have partners of childbearing potential and are not 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 dose of abiraterone acetate.