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

NCT ID: NCT00421694

Last Updated: 2007-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

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Bicalutamide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of L'Aquila

OTHER

Sponsor Role lead

Principal Investigators

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Giovanni Luca Gravina, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of L'Aquila

Locations

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University of L'Aquila

L’Aquila, Abruzzo, Italy

Site Status

Countries

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Italy

Other Identifiers

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SMBC142

Identifier Type: -

Identifier Source: org_study_id