Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418080
Status:
COMPLETED
Last Update Posted:
2007-10-08
First Post:
2007-01-03
Brief Title:
Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy
Sponsor:
University of LAquila
Organization:
University of LAquila
Study Overview
Official Title:
The Role of HER Receptor Family as Indicator of Prognosis and Drug Responsiveness in Locally Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
As clinical primary endpoints we assessed whether existed differences in
1 PSA recurrence rate stratified according to treatment modalities
2 EGFR and HER2neu overexpression rate stratified according to treatment modalities
3 PSA recurrence rate stratified according to EGFR and HER2neu overexpression levels
As secondary clinical endpoints we assessed whether existed differences in
1 prostate cancer-specific mortality according to treatment modalities
2 prostate cancer-specific mortality stratified according to EGFR and HER2neu overexpression levels
For this purpose a post treatment PSA-doubling time of less than 3 months found following PSA recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality Pre-clinical endpoints As pre-clinical endpoint we assessed whether exist differences in efficacy rate of Bicalutamide and Gefitinib treatment in primary tumor cultures stratified for high and low EGFR and HER2Neu expression levels The evaluation of efficacy rate of these treatments was documented by comparing the differences of drugs IC50 values among the groups stratified for EGFR and HER2Neu levels
1 PSA recurrence rate stratified according to treatment modalities
2 EGFR and HER2neu overexpression rate stratified according to treatment modalities
3 PSA recurrence rate stratified according to EGFR and HER2neu overexpression levels
As secondary clinical endpoints we assessed whether existed differences in
1 prostate cancer-specific mortality according to treatment modalities
2 prostate cancer-specific mortality stratified according to EGFR and HER2neu overexpression levels
For this purpose a post treatment PSA-doubling time of less than 3 months found following PSA recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality Pre-clinical endpoints As pre-clinical endpoint we assessed whether exist differences in efficacy rate of Bicalutamide and Gefitinib treatment in primary tumor cultures stratified for high and low EGFR and HER2Neu expression levels The evaluation of efficacy rate of these treatments was documented by comparing the differences of drugs IC50 values among the groups stratified for EGFR and HER2Neu levels
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None