RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer
The purpose of this study is to determine the biochemical response rate (PSA) to single agent RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Arm, Two Center, Phase II Study of RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer|
- Biochemical Response Rate [ Time Frame: Patients were followed for a median of 315 days ] [ Designated as safety issue: No ]Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.
- Pathologic Response [ Time Frame: Patients were followed for a median of 315 days ] [ Designated as safety issue: No ]Number of participants with either a 50% or greater decrease in proliferation index or a 50% or greater increase in apoptotic index
- Progression Free Survival [ Time Frame: Patients were followed for a median of 315 days, with the last patient censored at 1309 days. ] [ Designated as safety issue: No ]Time in months from the start of study treatment to the date of first progression according to RECIST 1.0, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
- Molecular Response [ Time Frame: Patients were followed for a median of 315 days ] [ Designated as safety issue: No ]Functional extent of mTOR inhibition by changes in the phosphorylation status of pS6 in prostate tumors.
- Clinical Response [ Time Frame: Patients were followed for a median of 315 days ] [ Designated as safety issue: No ]
The percentage of participants with a complete or partial response as defined by RECIST 1.0. Response Criteria are defined below:
Complete Response: Disappearance of all target lesions Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD
|Study Start Date:||August 2005|
|Study Completion Date:||January 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
RAD001 at a dose of 10 mg PO daily
RAD001 at a dose of 10 mg PO daily
Other Name: Everolimus
This is a single center, Phase II study of RAD001 in men with HRPC. The study design is a straight forward, two-stage design with tumor biopsies scheduled at screening and again at 4 weeks. FLT-PET scans are performed at screening and again at day 28, following initiation of treatment in the first 10 patients. Patients are assessed for adverse events every two weeks for the first month and monthly thereafter. Patients are assessed for response by PSA every 4 weeks and when applicable, for objective response every 2 months. If 4 or more responses are seen in the first 39 patients then the study will expand to 60 patients.
|United States, North Carolina|
|Duke University MEdical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Daniel J George, MD||Duke University Health System|