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OpenTrials
Completed

NCT Number: NCT00421694

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

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 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

Treatment and study plan

bicalutamide

Drug

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Important dates

First posted
Jan 12, 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.

Published trials that share one or more normalized conditions with this study.