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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Prostate Cancer (Adenocarcinoma)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Abiraterone acetate

All patients will be receiving abiraterone acetate as per standard of care

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

MALE

Accepts Healthy Volunteers

No