Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer

Inclusion Criteria:

Histologically or cytologically confirmed prostate cancer with progressive disease defined as either:

2 or more new lesions on bone scan or
Progressive disease on computed tomography (CT)/magnetic resonance imaging (MRI) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria or
Rising prostate-specific antigen (PSA): PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 2 weeks apart
Evidence of castration resistance defined as disease progression despite a testosterone level < 50 ng/dL (or surgical castration)

Any prior therapy for castrate disease is acceptable except prior abiraterone, which is excluded; a minimum washout of 28 days for any other anticancer therapy prior to first dose of study drug is required

Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug
Denosumab or zoledronic acid are allowed
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Total bilirubin =< 1.5 x the upper limit of normal
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid (other than prednisone =< 10 mg/day) within 4 weeks prior to first dose of study drug

Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug is excluded with the following exceptions:

Conventional multivitamin supplements
Selenium
Lycopene
Soy supplements
Inability to swallow capsules or known gastrointestinal malabsorption
History of other malignancies, with the exception of adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for >= 5 years from enrollment
Blood pressure that is not controlled despite > 2 oral agents (systolic blood pressure [SBP] > 160 and diastolic blood pressure [DBP] > 90 documented during the screening period with no subsequent blood pressure readings < 160/100)
Serum potassium (K)+ < 3.5 mmoL/L on more than one reading within the screening period
Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled
Active psychiatric illness/social situations that would limit compliance with protocol requirements
New York Heart Association (NYHA) class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
Concurrent therapy with strong inhibitors or inducers of Cytochrome P450 (CYP)3A4 due to concerning possible drug-drug interactions with abiraterone