A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy — Prostress  

Enlarged Prostate Clinical Trial

Official title: A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of PROSCAR in Men With Initial Negative Prostate Biopsies

Status Completed

Clinical Trial Summary

The purpose of this study is to assess whether six months of daily finasteride (PROSCAR), following an initial negative prostate biopsy, will improve the detection of prostate cancer on repeat biopsy.

144 subjects with an initial negative prostate biopsy will be randomized to receive either finasteride or placebo for 6 months. The subjects will undergo a second prostate biopsy following drug intervention. PSA (prostate specific antigen) measurements, testosterone levels, and quality of life questionnaires will also be assessed during the study. The two groups will then be compared.

Clinical Trial Description

5.0. Study Design and Treatment 5.1. Study Design This is a randomized, two-arm, double blind, placebo controlled study of daily PROSCAR® or placebo for 6 months in men with an initial negative prostate biopsy.

5.1.1. Biopsy The TRUS guided biopsy, to be carried out at Visit 4, will be performed by one physician. The biopsy will be performed as per the standard protocol at UHN, including 13-15 cores. The physician performing the biopsy will be blinded to the initial biopsy results and the PSA change over time. Before biopsy, a DRE will be performed. Aside from the standard biopsy scheme, suspicious areas on TRUS can be further biopsied. (e.g. a hypoechoic nodule).

5.2. Methods for Accrual and Randomization: Patients with an initial negative prostate biopsy that was performed at UHN and seen at the Prostate Center of the Princess Margaret Hospital will be considered for enrolment. Randomization by a random numbers table will be performed in blocks of 4 patients. After patients are deemed eligible for the study, the central office at Merck will be contacted and patient assignment given. The code will match the study drug label and the drug shipment will contain a blinded allocation envelope. The investigators, study participants and research coordinators will be blinded to the intervention. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Enlarged Prostate

• NCT number: NCT00542243
• Study type: Interventional
• Source: University Health Network, Toronto
• Status: Completed
• Phase: Phase 3
• Start date: February 2008
• Completion date: December 2012