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

This study has been completed.
Information provided by:
University of L'Aquila Identifier:
First received: January 10, 2007
Last updated: October 5, 2007
Last verified: October 2007
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

Condition Intervention Phase
Prostate Cancer Drug: Bicalutamide Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single

Resource links provided by NLM:

Further study details as provided by University of L'Aquila:

Estimated Enrollment: 119

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00421694

University of L'Aquila
L'Aquila, Abruzzo, Italy, 67100
Sponsors and Collaborators
University of L'Aquila
Principal Investigator: Giovanni Luca Gravina, M.D. University of L'Aquila
  More Information Identifier: NCT00421694     History of Changes
Other Study ID Numbers: SMBC142
Study First Received: January 10, 2007
Last Updated: October 5, 2007

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents processed this record on September 18, 2017