NCT00421694

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P75+ for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed
Last Updated

October 8, 2007

Status Verified

October 1, 2007

First QC Date

January 10, 2007

Last Update Submit

October 5, 2007

Conditions

Prostate Cancer

Interventions

BicalutamideDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with cT2-T3a prostate cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of L'Aquila

L’Aquila, Abruzzo, 67100, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Giovanni Luca Gravina, M.D.

    University of L'Aquila

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 12, 2007

Last Updated

October 8, 2007

Record last verified: 2007-10

Locations

IT(1)