Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

October 5, 2007 updated by: University of L'Aquila

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Abruzzo
      • L'Aquila, Abruzzo, Italy, 67100
        • University of L'Aquila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Estimate)

October 8, 2007

Last Update Submitted That Met QC Criteria

October 5, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCLT-1236

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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