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Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

Sponsor
University of L'Aquila (Other)
Overall Status
Completed
CT.gov ID
NCT00418080
Collaborator
(none)
86
Enrollment
1
Location
56
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
The Role of HER Receptor Family as Indicator of Prognosis and Drug Responsiveness in Locally Advanced Prostate Cancer
Study Start Date :
Apr 1, 2002
Study Completion Date :
Dec 1, 2006

Outcome Measures

Primary Outcome Measures

  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. []

Secondary Outcome Measures

  1. Prostate cancer-specific mortality according to treatment modalities []

  2. Prostate cancer-specific mortality stratified according to EGFR and HER2/neu overexpression levels. []

  3. 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of L'Aquila L'Aquila Abruzzo Italy 67100

Sponsors and Collaborators

  • University of L'Aquila

Investigators

  • Principal Investigator: Giovanni Luca Gravina, M.D., University of L'Aquila

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00418080
Other Study ID Numbers:
  • BCLT-1236
First Posted:
Jan 4, 2007
Last Update Posted:
Oct 8, 2007
Last Verified:
Oct 1, 2007
Additional relevant MeSH terms:
Prostatic Neoplasms
Bicalutamide

Study Results

No Results Posted as of Oct 8, 2007