Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
As clinical primary endpoints we assessed whether existed differences in:
1. PSA recurrence rate stratified according to treatment modalities
2. EGFR and HER2/neu overexpression rate stratified according to treatment modalities
3. PSA recurrence rate stratified according to EGFR and HER2/neu 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 HER2/neu
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 HER2/Neu 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 HER2/Neu levels.