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

This study has been completed.
Sponsor:
Information provided by:
University of L'Aquila
ClinicalTrials.gov Identifier:
NCT00421694
First received: January 10, 2007
Last updated: October 5, 2007
Last verified: October 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind

Resource links provided by NLM:


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

Estimated Enrollment: 119
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00421694     History of Changes
Other Study ID Numbers: SMBC142
Study First Received: January 10, 2007
Last Updated: October 5, 2007
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on October 20, 2014