Abiraterone Acetate Trial in African American Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone Acetate
Intervention description: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
Intervention MeSH terms: Abiraterone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: African American men; metastatic prostate cancer; castration resistant

Summary:

      This is a pilot study of abiraterone acetate in African American/Black patients with
      castration-resistant prostate cancer. The primary objective is to determine the correlation
      between germline polymorphisms and antitumor activity (as defined by a decline in PSA of ≥
      30%) in African American patients with castration-resistant prostate cancer treated with
      abiraterone acetate. Patients will receive abiraterone acetate until the time of disease
      progression, in the absence of prohibitive toxicities. Patients will be followed for disease
      progression and survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. 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

          -  African American or Black (by self identification)

          -  Male aged 18 years and above

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate

          -  Metastatic disease documented by standard imaging

          -  Progressive prostate cancer based on either rising PSA, new bone metastases, or
             progression of measurable disease according to PCWG2 12 guidelines.

          -  Patients in either of the following clinical states will be eligible for enrollment:

             i. No prior chemotherapy; ii. Patients previously treated with 1-2 prior chemotherapy
             regimens permitted, one of which must have been included docetaxel

          -  Surgically or medically castrated, with testosterone levels of < 50 ng/dl.

          -  Patients previously treated with an anti-androgen must demonstrate progression off of
             the anti-androgen.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

          -  Have a baseline serum potassium of ≥ 3.5 mEq/L

          -  Have aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin
             levels < 1.5 x ULN

          -  Have a serum albumin of ≥ 3.0 g/dL

          -  Total bilirubin ≤ 1.5 x ULN

          -  Have a platelet count of ≥ 100,000/μL

          -  Have an absolute neutrophil count of > 1500 cell/mm3

          -  Have a calculated creatinine clearance ≥ 60 mL/min

          -  Have a hemoglobin of ≥ 9.0 g/dL

          -  Able to swallow the study drug as a whole 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 during the study and for 1 week after last dose of
             abiraterone acetate

        Exclusion Criteria:

          -  Active infection or other medical condition that would make prednisone/prednisolone
             (corticosteroid) use contraindicated

          -  Known brain metastasis

          -  Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients
             with a history of hypertension are allowed provided blood pressure is controlled by
             anti-hypertensive treatment

          -  Active or symptomatic viral hepatitis or chronic liver disease

          -  History of pituitary or adrenal dysfunction

          -  Clinically significant heart disease as evidenced by myocardial infarction, or
             arterial thrombotic events in the past 6 months, severe or unstable angina, or New
             York Heart Association (NYHA) Class III-IV heart disease or cardiac ejection fraction
             measurement of < 50% at baseline

          -  Administration of an investigational therapeutic within 30 days of screening

          -  Have any condition that, in the opinion of the investigator, would compromise the
             well-being of the subject or the study or prevent the subject from meeting or
             performing study requirements

          -  Have poorly controlled diabetes

          -  Have a history of gastrointestinal disorders (medical disorders or extensive surgery)
             that may interfere with the absorption of the study agents

          -  Have a pre-existing condition that warrants long-term corticosteroid use in excess of
             study dose

          -  Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or
             prednisone or their excipients