NCT01857908

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Last Updated

June 22, 2015

Status Verified

June 1, 2015

Enrollment Period

2.4 years

First QC Date

March 19, 2013

Last Update Submit

June 19, 2015

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

AdenocarcinomaAbirateroneAbiraterone AcetateZytigaCorrelative studyCastrate Resistant Prostate CancerAbiraterone Correlative study

Outcome Measures

Primary Outcomes (1)

  • PSA

    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

Study Arms (1)

Abiraterone acetate

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

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving Abiraterone Acetate for Castrate Resistant Prostate Cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Prostatic NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Anthony Joshua, BSc(Med) MBBS PhD FRACP

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

  • Bernie Eigl, MD

    British Columbia Cancer Agency

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

May 20, 2013

Study Start

June 1, 2012

Primary Completion

November 1, 2014

Last Updated

June 22, 2015

Record last verified: 2015-06

Locations

CA(2)