Open Label Pharmacodynamic Study of Abiraterone in the Treatment of Metastatic, Castration Resistant Prostate Cancer
From the protocol:
The primary objectives of this study are:
- To determine the ability of abiraterone in patients with metastatic CRPC resistant to LHRH
agonist ± antiandrogen to suppress tumor testosterone at one month compared to baseline
tissue testosterone, to confirm proposed mechanism of action. Tumor levels of
testosterone, DHT, DHEA and androstenedione will also be analyzed at baseline, one month,
three months and progression with each time point being addressed in different cohorts.
The exploratory objectives of this study are:
- To determine response to dose escalation of abiraterone and associate response to tumor
androgen levels prior to dose escalation
- To determine potential mechanisms of resistance to abiraterone by analyzing tissue
microarray, tissue androgen levels at progression and evaluating wild type and splice
variant AR levels at baseline and at time of progression.
- To determine whether circulating tumor cells acquired from peripheral blood reflect
molecular changes in tumor metastases and are a potential biomarker for mechanisms of
sensitivity and resistance.
- To determine if microRNA acquired from peripheral blood reflect molecular changes in
tumor metastases and are a potential biomarker for mechanisms of sensitivity and
resistance.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tissue androgen levels
Tissue testosterone and DHT levels will be measured in metastatic prostate cancer tissue before and at 30 days after treatment with abiraterone
One month
No
R. Bruce Montgomery, MD
Principal Investigator
University of Washington, Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center
United States: Institutional Review Board
212082PCR2012
NCT01508234
January 2012
Name | Location |
---|---|
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |