Abiraterone Acetate Trial in African American Prostate Cancer Patients

NCT01735396 | Terminated Phase 2 Results DMC

• 1 other identifier: GCO 12-1727
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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

Keywords

African American men; metastatic prostate cancer; castration resistant

Outcome Measures

Primary Outcomes (1)

• Number of Participants With ≥ 30% 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

Secondary Outcomes (5)

• Response Assessment

  up to 12 weeks

• Time to Progression

  up to 12 weeks

• Bone Scan

  up to 12 weeks

• Safety of Abiraterone

  up to 12 weeks

• Testosterone

  up to 12 weeks

Study Arms (1)

Abiraterone Acetate

EXPERIMENTAL

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

Drug: Abiraterone Acetate

Interventions

Abiraterone Acetate DRUG

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

Also known as: Zytiga

Abiraterone Acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Queens Cancer Center, Queens Hospital

New York, New York, 11432, United States

Location

Related Publications (1)

• 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.

  PMID: 27742908 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Matthew David Galsky
• Organization: Tisch Cancer Center, Icahn School of Medicine at Mount Sinai

matthew.galsky@mssm.edu

212-689-5412

Study Officials

• Matthew Galsky, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 24, 2012
• First Posted: November 28, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 12, 2017
• Results First Posted: May 12, 2017

Record last verified: 2017-04

Locations

US (2)