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Abiraterone Acetate Trial in African American Prostate Cancer Patients

This study has been terminated.
(poor accrual)
Sponsor:
Information provided by (Responsible Party):
Matthew Galsky, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01735396
First received: November 24, 2012
Last updated: April 4, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Drug: Abiraterone Acetate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Pilot Study of Abiraterone Acetate in African American/Black Patients With Castration Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Matthew Galsky, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Number of Participants With ≥ 30% Change in PSA [ Time Frame: 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:
  • Response Assessment [ Time Frame: 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

  • Time to Progression [ Time Frame: up to 12 weeks ]
    post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)

  • Bone Scan [ Time Frame: up to 12 weeks ]
    post-treatment changes in bone scans (as per PCWG2 guidelines) ("no new lesions" versus "new lesions.")

  • Safety of Abiraterone [ Time Frame: 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 [ Time Frame: up to 12 weeks ]
    Post-treatment changes in testosterone


Enrollment: 11
Study Start Date: December 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abiraterone Acetate
Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.
Drug: Abiraterone Acetate
Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
Other Name: Zytiga

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735396

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Queens Cancer Center, Queens Hospital
New York, New York, United States, 11432
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Matthew Galsky, MD Icahn School of Medicine at Mount Sinai
  More Information

Additional Information:
Responsible Party: Matthew Galsky, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01735396     History of Changes
Other Study ID Numbers: GCO 12-1727
Study First Received: November 24, 2012
Results First Received: April 4, 2017
Last Updated: April 4, 2017

Keywords provided by Matthew Galsky, Icahn School of Medicine at Mount Sinai:
African American men
metastatic prostate cancer
castration resistant

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 28, 2017