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CompletedNCT00421694Updated Oct 8, 2007

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

A Phase 2/3 interventional study of Bicalutamide in Prostate Cancer, sponsored by University of L'Aquila. Completed at 1 site in Italy. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-10-08.

Sponsored by University of L'Aquila · Phase 2/3 and Interventional

Phase
Phase 2/3
Study type
Interventional
Enrollment
119
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 119 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of L'Aquila is the lead sponsor of 45 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with cT2-T3a prostate cancer

Exclusion criteria

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
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Study design

Phase
Phase 2 / Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
119 participants

Interventions

  • DrugBicalutamide
06

Study locations

1 site
  • University of L'Aquila
    L'Aquila, Abruzzo 67100, Italy
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00421694
Lead sponsor
University of L'Aquila
First posted
Jan 12, 2007
Last update
Oct 8, 2007

Study contacts

Giovanni Luca Gravina, M.D.
principal investigator · University of L'Aquila
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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