Molecular, Genetic, and Genomic Assessments of MTOR Inhibition in Metastatic Hormone-Refractory Prostate Cancer Tissue From Patients Treated With RAD001
This correlative science study will be a minimum risk assessment of tumor and plasma samples
collected as part of a Phase II clinical trial of RAD001 in patients with HRPC. Prior to
enrollment or at the time of signing consent in the Phase II trial, patients will be
approached to participate in the correlative science study. Patients who agree to
participate will be assigned a separate study number which will be used to identify their
molecular, genetic, genomic and biomarker assessments using the tumor and plasma samples.
Clinical outcome results from the accompanying Phase II trial will be used for correlative
assessments in this study, however, results from this correlative science study will be kept
separate from the assessments and reporting of the clinical trial.
Observational Model: Cohort, Time Perspective: Prospective
Functional extent of mTOR inhibition in the phosphorylation status of S6K and CA IX protein in prostate tumors from patients treated with RAD001.
pre-treatment, day 29, and monthly blood samples
Daniel J George, MD
United States: Institutional Review Board
|Duke University Medical Center||Durham, North Carolina 27710|