Biomarkers of Response to Taxotere in Hormone-Refractory Prostate Cancer
OBJECTIVES:
Primary
- To determine if mRNA present in circulating tumor cells will help predict response in
patients with hormone-refractory prostate cancer treated with docetaxel.
- In parallel with this, based on discoveries made since our protocol was initially
submitted to ICORG, here we also propose to analyse serum specimens from these
consenting patients for the presence of EC miRNA, mRNA and protein predictive of
response to Taxotere.
Secondary
- To develop a predictive model based on the most accurate and sensitive combination of
these biomarkers.
OUTLINE: This is a multicenter study.
Treatment Plan:
All patients will be treated with Docetaxel on a weekly, biweekly or three weekly schedule,
dose and schedule at the discretion of the treating physician.
Blood samples are collected for biomarker laboratory studies at baseline, every 3-4 weeks
during study, and at disease progression or every 12 weeks after completion of study.
Samples are analyzed for mRNA via RT-PCR.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Presence of mRNA in circulating tumor cells as a predictor of response
ongoing
No
Ray McDermott, MD
Principal Investigator
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Ireland: Health Information and Quality Authority
CDR0000680613
NCT01160705
November 2008
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