Status:
COMPLETED
Survival Outcomes and Tumor Molecular Profile Following Bicalutamide Neoadjuvant Therapy
Lead Sponsor:
University of L'Aquila
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief Summary
As clinical primary endpoints we assessed whether existed differences in: 1. PSA recurrence rate stratified according to treatment modalities 2. EGFR and HER2/neu overexpression rate stratified accor...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00418080
Start Date
April 1 2002
End Date
December 1 2006
Last Update
October 8 2007
Active Locations (1)
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1
University of L'Aquila
L’Aquila, Abruzzo, Italy, 67100