Abiraterone Acetate Trial in African American Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01735396
• Other study ID #: GCO 12-1727
• Status: Terminated
• Phase: Phase 2
• First received: November 24, 2012
• Last updated: January 9, 2017
• Start date: December 2012
• Est. completion date: March 2016

Study information

• Verified date: January 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Queens Cancer Center, Queens Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent change in PSA	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.	baseline and 12 weeks	No
Secondary	Time to progression	To determine the time to progression (as per PCWG2 guidelines); Post-treatment changes in measurable disease (as per PCWG2 guidelines)	up to 12 weeks	Yes
Secondary	RECIST	To determine post-treatment changes in measurable disease by RECIST	up to 12 weeks	Yes
Secondary	bone scan	To determine post-treatment changes in bone scans (as per PCWG2 guidelines) ("no new lesions" versus "new lesions.")	up to 12 weeks	Yes
Secondary	safety of abiraterone	To determine the safety of abiraterone Adverse events as defined by CTCAE v4	up to 12 weeks	Yes
Secondary	Testosterone	Post-treatment changes in testosterone	up to 12 weeks	Yes

External Links

•   Mt. Sinai Tisch Cancer Institute