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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00421694
First Posted: January 12, 2007
Last Update Posted: October 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of L'Aquila
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421694


Locations
Italy
University of L'Aquila
L'Aquila, Abruzzo, Italy, 67100
Sponsors and Collaborators
University of L'Aquila
Investigators
Principal Investigator: Giovanni Luca Gravina, M.D. University of L'Aquila
  More Information

ClinicalTrials.gov Identifier: NCT00421694     History of Changes
Other Study ID Numbers: SMBC142
First Submitted: January 10, 2007
First Posted: January 12, 2007
Last Update Posted: October 8, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents