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)
• Patients must have received prior docetaxel based chemotherapy for metastatic castrate resistant prostate cancer (CRPC)

• 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