Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00418080
• Lead Sponsor: University of L'Aquila

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

Not available

Study Timeline

• Study Start: 2002-04
• Study Completion: 2006-12
• Study First Submitted: 2007-01-03
• Study First Submitted QC: 2007-01-03
• Study First Posted: 2007-01-04
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-05
• Last Update Posted: 2007-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

Inclusion Criteria

• Patients were eligible if they had histologically confirmed adenocarcinoma of the prostate and the following high-risk features: (1) clinical stage T3a disease with (2) Gleason sum of 7 with a predominant component of 4 (i.e., Gleason 4 + 3 = 7) or (4) Gleason sum of 8, 9 or 10.

Exclusion Criteria

• Prior hormonal therapy,
• Prior radiation,
• Prior investigational agents,
• Prior malignancy within the last five years or had any other serious medical or psychiatric condition or illness that would not permit the patient to be managed according to the protocol were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PSA recurrence rate stratified according to treatment modalities
EGFR and HER2/neu overexpression rate stratified according to treatment modalities
PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.

Secondary Outcome Measures

Name	Time	Method
Prostate cancer-specific mortality according to treatment modalities
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.

Trial Locations

Locations (1)

University of L'Aquila; 🇮🇹 L'Aquila, Abruzzo, Italy