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Molecular, Genetic, and Genomic Assessments of MTOR Inhibition in Metastatic Hormone-Refractory Prostate Cancer Tissue From Patients Treated With RAD001


N/A
18 Years
N/A
Not Enrolling
Male
Metastatic Hormone Refractory Prostate Cancer

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Trial Information

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.


Inclusion Criteria:



- Patients must be enrolled in the clinical study entitled: A Single Arm, Phase II
Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer at
the time of enrollment onto this study.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Functional extent of mTOR inhibition in the phosphorylation status of S6K and CA IX protein in prostate tumors from patients treated with RAD001.

Outcome Time Frame:

pre-treatment, day 29, and monthly blood samples

Safety Issue:

No

Principal Investigator

Daniel J George, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00000346

NCT ID:

NCT00636090

Start Date:

January 2007

Completion Date:

January 2010

Related Keywords:

  • Metastatic Hormone Refractory Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Duke University Medical CenterDurham, North Carolina  27710