Molecular, Genetic, and Genomic Assessments From Patients Treated With RAD001

Completed

• Conditions: Metastatic Hormone Refractory Prostate Cancer

• Registration Number: NCT00636090
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to look at the genetic changes that RAD001 causes in prostate cancer cells and how those changes relate to patients' response to RAD001 treatment.

Detailed Description

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-03-09
• Study First Submitted QC: 2008-03-13
• Study First Posted: 2008-03-14
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To identify candidate plasma markers of glycolysis that reflect tumor AKT activity.	pre-treatment, day 29, and monthly blood samples
To determine by comparative genomic hybridation (CGH) loss of heterozygosity (LOH) patterns of the 10q23 locus (to assess PTEN status) and other sites of chromosomal alterations associated with pathologic response to mTOR inhibition.	pre-treatment, day 19, and monthly blood samples
To identify expression profiles associated with AKT activation and RAD001 treatment effect.	pre-treatment, day 29, and monthly blood samples

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States