A Pilot Study of Abiraterone Acetate in African American/Black Patients With Castration Resistant Prostate Cancer
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