NCT00418080

Brief Summary

As clinical primary endpoints we assessed whether existed differences in:

  1. 1.PSA recurrence rate stratified according to treatment modalities
  2. 2.EGFR and HER2/neu overexpression rate stratified according to treatment modalities
  3. 3.PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.
  4. 4.prostate cancer-specific mortality according to treatment modalities
  5. 5.prostate cancer-specific mortality stratified according to EGFR and HER2/neu overexpression levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Apr 2002

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
Last Updated

October 8, 2007

Status Verified

October 1, 2007

First QC Date

January 3, 2007

Last Update Submit

October 5, 2007

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

  • PSA recurrence rate stratified according to treatment modalities

  • EGFR and HER2/neu overexpression rate stratified according to treatment modalities

  • PSA recurrence rate stratified according to EGFR and HER2/neu overexpression levels.

Secondary Outcomes (3)

  • Prostate cancer-specific mortality according to treatment modalities

  • Prostate cancer-specific mortality stratified according to EGFR and HER2/neu overexpression levels.

  • For this purpose a post treatment PSA-doubling time of less than 3 months found following PSA recurrence was considered as a surrogate endpoint for prostate cancer-specific mortality.

Interventions

bicalutamideDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients were eligible if they had histologically confirmed adenocarcinoma of the prostate and the following high-risk features: (1) clinical stage T3a disease with (2) Gleason sum of 7 with a predominant component of 4 (i.e., Gleason 4 + 3 = 7) or (4) Gleason sum of 8, 9 or 10.

You may not qualify if:

  • Prior hormonal therapy,
  • Prior radiation,
  • Prior investigational agents,
  • Prior malignancy within the last five years or had any other serious medical or psychiatric condition or illness that would not permit the patient to be managed according to the protocol were excluded.

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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 4, 2007

Study Start

April 1, 2002

Study Completion

December 1, 2006

Last Updated

October 8, 2007

Record last verified: 2007-10

Locations

IT(1)