A Correlative Study of Biomarkers of Resistance in Patients With Castrate Resistant Prostate Cancer Treated With Abiraterone

June 19, 2015 updated by: University Health Network, Toronto
Adrenal androgens are serum biomarkers of interest that may help guide abiraterone acetate treatment, particularly at the time of progression. Biomarkers may also help identify pathways to resistance of abiraterone acetate treatment. The most practical way of approaching this question is to explore surrogate biomarkers of prostate cancer including quantification of pharmacodynamic endocrine biomarkers.

Study Overview

Status

Completed

Conditions

Detailed Description

Goals of this study include:

  • Explore which circulating endocrine markers or endocrine related markers have the best potential to predict clinical response to abiraterone acetate in CRPC patients
  • Explore the utility of microRNA, circulating DNA and exosome analyses in complementing the previous objective

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency
    • Ontario
      • Toronto, Ontario, Canada, M5G2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients receiving Abiraterone Acetate for Castrate Resistant Prostate Cancer

Description

Inclusion Criteria:

  • Signed written informed consent. Before any study procedures are performed, subjects (or their legally acceptable representatives) will have the details of the study described to them, and they will be given a written informed consent document to read. If subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel
  • Be suitable for receiving treatment with abiraterone acetate and prednisone
  • Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Patients may not receive any other investigational agent or dose escalation of abiraterone acetate during study participation
  • Patient consents to comply to treatment with abiraterone acetate as directed by their physician

Exclusion Criteria:

  • Taking a dose of abiraterone acetate other than 1g daily or lack of compliance to daily dosing of abiraterone acetate and prednisone
  • Patients receiving spironolactone or any other steroidogenic compounds in excess of the associated prednisone 5mg bid are excluded due to the potential for androgen receptor agonism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Abiraterone acetate
All patients will be receiving abiraterone acetate as per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA
Time Frame: Patients will be followed from Day 1 (date of initiation of Abiraterone treatment) until the date of first documented progression (estimated to be 1 year). PSA will be assessed every 30 days (approximately) until the time of PSA/clinical progression
PSA nadir samples will be assessed and compared to pre-Abiraterone treatment samples post completion of study
Patients will be followed from Day 1 (date of initiation of Abiraterone treatment) until the date of first documented progression (estimated to be 1 year). PSA will be assessed every 30 days (approximately) until the time of PSA/clinical progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Anthony Joshua, BSc(Med) MBBS PhD FRACP, Princess Margaret Cancer Centre
  • Principal Investigator: Bernie Eigl, MD, British Columbia Cancer Agency

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

May 15, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

June 22, 2015

Last Update Submitted That Met QC Criteria

June 19, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABI Correlative Study
  • 12-5042-CE (Other Identifier: Janssen Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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