Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418080
• Other study ID #: BCLT-1236
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2007
• Last updated: October 5, 2007
• Start date: April 2002
• Est. completion date: December 2006

Study information

• Verified date: October 2007
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• bicalutamide

Locations

Country	Name	City	State
Italy	University of L'Aquila	L'Aquila	Abruzzo

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA recurrence rate stratified according to treatment modalities
Primary	EGFR and HER2/neu overexpression rate stratified according to treatment modalities
Primary	PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.
Secondary	Prostate cancer-specific mortality according to treatment modalities
Secondary	Prostate cancer-specific mortality stratified according to EGFR and HER2/neu overexpression levels.
Secondary	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.