Food Effect Study of Abiraterone Acetate for Treatment of Patients With Castration-Resistant Prostate Cancer
Condition: Castration-resistant Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: abiraterone acetate
Intervention description: Given PO
Intervention MeSH terms: Abiraterone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Male
Healthy volunteers: No

Summary:

      This randomized phase II trial studies the best way to give abiraterone acetate in treating
      patients with castration-resistant prostate cancer. Abiraterone acetate is effective in
      treating castrate resistant prostate cancer and is taken in the fasting state. However, the
      body's absorption of abiraterone is increased with food intake. This study will test the
      whether a lower dose of abiraterone taken with food has a similar effect on prostate specific
      antigen (PSA) compared to full dose taken fasting.
    

Eligibility criteria:

        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