Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

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.

Timeline

Start

2002-04

Primary completion

—

Completion

2006-12

Drugs

Indications