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

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ClinicalTrials.gov Identifier: NCT00421694
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : October 8, 2007
Sponsor:
Information provided by:
University of L'Aquila

January 10, 2007
January 12, 2007
October 8, 2007
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Complete list of historical versions of study NCT00421694 on ClinicalTrials.gov Archive Site
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Positive Surgical Margins Rate and EGFR Family Members Expression in Prostate Cancer Treated With Bicalutamide
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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
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Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Prostate Cancer
Drug: Bicalutamide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
Same as current
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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
Sexes Eligible for Study: Male
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00421694
SMBC142
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University of L'Aquila
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Principal Investigator: Giovanni Luca Gravina, M.D. University of L'Aquila
University of L'Aquila
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP