Positive Surgical Margins Rate and EGFR Family Members Expression in Prostate Cancer Treated With Bicalutamide

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421694
• Other study ID #: SMBC142
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 10, 2007
• Last updated: October 5, 2007

Study information

• Verified date: October 2007
• Source: University of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Following radical prostatectomy (RP), about 20% to 40% of the patients with prostate cancer (PCa) exhibit pathological parameters which are associated with a high risk of disease recurrence. The rationale for NHT is based on the theory that androgen ablation induces PCa apoptosis which induces a regression of the primary tumor bulk before RP. However the use of NHT prior RP is highly controversial. In spite of these unenthusiastic results, the relative short time of treatment and the use of different drugs from those utilized in other trials might still to make this regimen attractive in terms of drug related side effects and effectiveness. In this regard, Bicalutamide presents unique characteristics since it work differently respect to other anti-hormonal agents by interfering on both genotropic and non-genotropic mechanisms of androgen receptor

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with cT2-T3a prostate cancer

Exclusion Criteria:

• Men>75 years

• Men<18 years

• Prior hormonal therapy

• Prior radiation or chemotherapy

• Prior investigational agents

• Life expectancy > 10 years

• Prior malignancy within the last five years

• Any other serious medical or psychiatric condition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Bicalutamide

Locations

Country	Name	City	State
Italy	University of L'Aquila	L'Aquila	Abruzzo

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy,