Abiraterone Acetate Trial in African American Prostate Cancer Patients

NCT ID: NCT01735396

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-03-31

Brief 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abiraterone Acetate

Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.

Group Type: EXPERIMENTAL

Abiraterone Acetate

Intervention Type: DRUG

Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily

Interventions

Abiraterone Acetate

Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily

Intervention Type: DRUG

Other Intervention Names

Zytiga

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Matthew Galsky

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Galsky, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Queens Cancer Center, Queens Hospital

New York, New York, United States

Countries

United States

References

Tsao CK, Sfakianos J, Liaw B, Gimpel-Tetra K, Kemeny M, Bulone L, Shahin M, Oh WK, Galsky MD. Phase II Trial of Abiraterone Acetate Plus Prednisone in Black Men With Metastatic Prostate Cancer. Oncologist. 2016 Dec;21(12):1414-e9. doi: 10.1634/theoncologist.2016-0026. Epub 2016 Oct 14.

Reference Type: DERIVED

PMID: 27742908 (View on PubMed)

Other Identifiers

GCO 12-1727

Identifier Type: -

Identifier Source: org_study_id