Proscar Long-Term Efficacy and Safety Study (PLESS)

Introduction

4 year industry-sonsored study, with 2 year extension

3040 men with symptomatic benign prostatic hypertrophy (BPH)

Finasteride treatment vs placebo

Combined endpoint:

• acute urinary retention
• BPH-related surgery

End point reached less frequently in the finasteride group than the placebo group

• 7% vs 13% (after 4 years)
• 8% vs 15% (after 6 years)

14 men need to be treated to prevent 1 from reaching the endpoint within 6 years

More general terms

• clinical trial

Additional terms

• benign prostatic hyperplasia (BPH)
• finasteride (Proscar, Propecia)