NCT00636090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

2.9 years

First QC Date

March 9, 2008

Last Update Submit

December 3, 2013

Conditions

Metastatic Hormone Refractory Prostate Cancer

Outcome Measures

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.

    pre-treatment, day 29, and monthly blood samples

Secondary Outcomes (3)

  • 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

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

    pre-treatment, day 29, and monthly blood samples

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

This study involves the retention of tissue sample from tumor biopsies as well as blood samples.

Study Officials

  • Daniel J George, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2008

First Posted

March 14, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

US(1)