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Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

This study has been completed.
Sponsor:
Information provided by:
University of L'Aquila
ClinicalTrials.gov Identifier:
NCT00418080
First received: January 3, 2007
Last updated: October 5, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer
 Drug: bicalutamide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Role of HER Receptor Family as Indicator of Prognosis and Drug Responsiveness in Locally Advanced Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of L'Aquila:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 86
Study Start Date: April 2002
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00418080

Locations
Italy
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00418080     History of Changes
Other Study ID Numbers: BCLT-1236
Study First Received: January 3, 2007
Last Updated: October 5, 2007
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
 Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013