Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

University of L'Aquila86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

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.