Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy - Full Text View

Sponsored by:	University of L'Aquila
Information provided by:	University of L'Aquila
ClinicalTrials.gov Identifier:	NCT00418080

Purpose

As clinical primary endpoints we assessed whether existed differences in:

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.

As secondary clinical endpoints we assessed whether existed differences in:

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 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 II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Bicalutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	The Role of HER Receptor Family as Indicator of Prognosis and Drug Responsiveness in Locally Advanced Prostate Cancer

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, Abruzzo
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

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

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Bicalutamide

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Androgen Antagonists
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009