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Open (Enrolling)
Prostate Cancer (Adenocarcinoma)

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Trial Information

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

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

- 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

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

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:


Outcome Description:

PSA nadir samples will be assessed and compared to pre-Abiraterone treatment samples post completion of study

Outcome 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

Safety Issue:


Principal Investigator

Anthony Joshua, BSc(Med) MBBS PhD FRACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Cancer Centre


Canada: Ethics Review Committee

Study ID:

ABI Correlative Study



Start Date:

June 2012

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer (Adenocarcinoma)
  • Adenocarcinoma
  • Abiraterone
  • Abiraterone Acetate
  • Zytiga
  • Correlative study
  • Castrate Resistant Prostate Cancer
  • Abiraterone Correlative study
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms