NCT00418080

Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (planned)
• Sponsor: University of L'Aquila · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	bicalutamide

Timeline

• Start date: 2002-04-01
• Completion: 2006-12-01
• First posted: 2007-01-04
• Last updated: 2007-10-08

Locations

1 site across 1 country: Italy