Abiraterone Acetate Trial in African American Prostate Cancer Patients

Phase 2

Terminated

Conditions: Prostate Cancer

Interventions: Drug: Abiraterone Acetate

Registration Number: NCT01735396

Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 11

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With ≥ 30% Change in PSA	baseline and 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Time to Progression	up to 12 weeks	post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)
Response Assessment	up to 12 weeks	Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Bone Scan	up to 12 weeks	post-treatment changes in bone scans (as per PCWG2 guidelines) ("no new lesions" versus "new lesions.")
Safety of Abiraterone	up to 12 weeks	To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5
Testosterone	up to 12 weeks	Post-treatment changes in testosterone

Trial Locations

Locations (2): Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
Queens Cancer Center, Queens Hospital
🇺🇸
New York, New York, United States