Kinetics of the Finasteride Prostate Induced Apoptosis

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: finasteride (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Hospices Civils de Lyon

Official(s) and/or principal investigator(s):
Alain RUFFION, MD, Principal Investigator, Affiliation: Hospices Civils de Lyon

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.

Official title: Kinetics of the Finasteride Prostate Induced Apoptosis

Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment

Primary outcome: Date of the maximum apoptosis in the prostate tissues treated by finasteride

Secondary outcome:

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

Minimum age: 40 Years. Maximum age: 90 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Patients with low tract urinary symptoms needing a surgical procedure

- No previous treatment with finasteride

- No androgen deficiency; no prostate cancer suspected.

Centre hospitalier Lyon Sud, Pierre Bénite 69495, France

Starting date: December 2004
Last updated: April 26, 2007