Status:
COMPLETED
Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer.
Lead Sponsor:
Ente Ospedaliero Ospedali Galliera
Collaborating Sponsors:
Universita degli Studi di Genova
Cliniche Humanitas Gavazzeni
Conditions:
Prostate Cancer
Prostatic Intraepithelial Neoplasia
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Pre-surgical, window-of-opportunity trials provide a suitable model to assess the activity of preventive interventions in a cost-effective manner using tissue biomarkers as surrogate endpoints. Finast...
Detailed Description
In this randomized, phase IIB, double blind, placebo controlled, multicenter, pre-surgical, window-of-opportunity trial we compared the effects of finasteride (5 mg/day) versus low-dose flutamide (250...
Eligibility Criteria
Inclusion
- Patients aged \> 18 years
- Patients with a biopsy proven, clinically intracapsular PCa who are candidates to radical retropubic prostatectomy
- ECOG performance status ≤ 2
- Satisfactory hematological and biochemical functions:
- Platelets ≥100 x 10\^9/L
- AST and ALT in the normal range
- Able to understand and sign an informed consent
Exclusion
- Previous hormone treatment during the 8 weeks before enrollment
- Neurologic and psychiatric diseases precluding patient participation in the study
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing or participating in the study and/or comply with the study procedures.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2017
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06601205
Start Date
January 1 2004
End Date
June 16 2017
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical Oncology Ente Ospedaliero Ospedali Galliera
Genova, Italy, Italy, 16128