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Completed

NCT Number: NCT00418080

Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of L'Aquila

L’Aquila, Abruzzo, 67100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bicalutamide

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2006
First posted
Jan 4, 2007
Registry last updated
Oct 8, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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