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Completed

NCT Number: NCT00636090

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

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.

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Key information

Conditions

Metastatic Hormone Refractory Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: pre-treatment, day 29, and monthly blood samples

Secondary outcomes

  1. 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.

    Time frame: pre-treatment, day 19, and monthly blood samples

  2. To identify expression profiles associated with AKT activation and RAD001 treatment effect.

    Time frame: pre-treatment, day 29, and monthly blood samples

  3. To identify candidate plasma markers of glycolysis that reflect tumor AKT activity.

    Time frame: pre-treatment, day 29, and monthly blood samples

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Mar 14, 2008
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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