Status:
COMPLETED
A Correlative Study of Biomarkers of Resistance in Patients With Castrate Resistant Prostate Cancer Treated With Abiraterone
Lead Sponsor:
University Health Network, Toronto
Conditions:
Prostate Cancer (Adenocarcinoma)
Eligibility:
MALE
Brief Summary
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 ...
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 * ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01857908
Start Date
June 1 2012
Last Update
June 22 2015
Active Locations (2)
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1
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
2
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G2M9