Clinical trial NCT00636090: Molecular, Genetic, and Genomic Assessments From Patients Treated With RAD001
Official title: Molecular, Genetic, and Genomic Assessments of MTOR Inhibition in Metastatic Hormone-Refractory Prostate Cancer Tissue From Patients Treated With RAD001
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Hormone Refractory Prostate Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2008-03-14
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men enrolled in the study entitled: A Single Arm, Phase II Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional extent of mTOR inhibition in the phosphorylation status of S6K and CA IX protein in prostate tumors from patients treated with RAD001.
timeFrame: pre-treatment, day 29, and monthly blood samples
Secondary outcomes:
measure: 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.
timeFrame: pre-treatment, day 19, and monthly blood samples
measure: To identify expression profiles associated with AKT activation and RAD001 treatment effect.
timeFrame: pre-treatment, day 29, and monthly blood samples
measure: To identify candidate plasma markers of glycolysis that reflect tumor AKT activity.
timeFrame: pre-treatment, day 29, and monthly blood samples
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Daniel J George, MD
role: PRINCIPAL_INVESTIGATOR
References: