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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01857908
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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 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.

Condition or disease
Prostate Cancer (Adenocarcinoma)

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

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : June 2012
Actual Primary Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving Abiraterone Acetate for Castrate Resistant Prostate Cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857908


Locations
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Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Anthony Joshua, BSc(Med) MBBS PhD FRACP Princess Margaret Cancer Centre
Principal Investigator: Bernie Eigl, MD British Columbia Cancer Agency
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01857908    
Other Study ID Numbers: ABI Correlative Study
12-5042-CE ( Other Identifier: Janssen Inc. )
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015
Keywords provided by University Health Network, Toronto:
Adenocarcinoma
Abiraterone
Abiraterone Acetate
Zytiga
Correlative study
Castrate Resistant Prostate Cancer
Abiraterone Correlative study
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type