Spots Global Cancer Trial Database for Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

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Trial Identification

Brief Title: Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

Official Title: The Role of HER Receptor Family as Indicator of Prognosis and Drug Responsiveness in Locally Advanced Prostate Cancer

Study ID: NCT00418080

Conditions

Prostate Cancer

Interventions

bicalutamide

Study Description

Brief 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.

Detailed Description: