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

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The percent change in PSA

Outcome Description:

The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone.The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.

Outcome Time Frame:

baseline and 12 weeks

Safety Issue:


Principal Investigator

Matthew Galsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Institutional Review Board

Study ID:

GCO 12-1727



Start Date:

December 2012

Completion Date:

December 2016

Related Keywords:

  • Prostate Cancer
  • African American men
  • metastatic prostate cancer
  • castration resistant
  • Prostatic Neoplasms



Mount Sinai Medical CenterNew York, New York  10029
Queens Cancer Center, Queens HospitalNew York, New York  11432