Kinetics of the Finasteride Prostate Induced Apoptosis

Phase 4

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT00130767
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The aim of this study is to evaluate the mechanisms involved in the apoptosis induced by a treatment of finasteride on benign prostate hyperplasia (BPH). Five sets of patients who need a surgical procedure because of low tract urinary symptoms are randomly attributed to one of five sets of treatment: 0, 7, 14, 21 or 28 days of finasteride treatment before the day of the procedure. Prostate histological fragments are conditioned for molecular and histologic studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-16
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-26
• Last Update Posted: 2007-04-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 90

Inclusion Criteria

• Patients with low tract urinary symptoms needing a surgical procedure
• No previous treatment with finasteride
• No androgen deficiency; no prostate cancer suspected.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Date of the maximum apoptosis in the prostate tissues treated by finasteride

Secondary Outcome Measures

Name	Time	Method
Molecular mechanisms involved in BPH finasteride induced apoptosis
Decrease in the frequency of the hemorrhagic incidents after the surgical procedure in patients with a treatment using finasteride

Trial Locations

Locations (1)

Centre hospitalier Lyon Sud; 🇫🇷 Pierre Bénite, France