NCT00851292

The BIOPRES Trial: Transrectal BIOpsies of the PRostate: End Versus Side-firing

The BIOPRES Trial; Transrectal BIOpsies of the PRostate: End Versus Side-firing

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Amphia Hospital · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to study the difference in prostate cancer between two prostate biopsy techniques, namely end-firing and side-firing. These differ in the angle at which the prostate is biopsied.

Detailed description

Rationale: Research towards the efficacy of transrectal prostate biopsies has predominantly focused on the amount of biopsy cores. However, variation in the angle of entrance of the biopsy gun has been less studied. It is believed that obtaining biopsy cores by end firing will improve the efficacy, because of an improved sampling of the apical region. Objectives: To investigate the difference between side and end-firing in transrectal prostate needle biopsies in terms of qualitative and quantitative prostate cancer detection. Methods: From September 1st 2009 - September 1st 2012, all men with an initial prostate biopsy in a representative, Dutch, general hospital with six participating urologists and two residents will be subjected to a randomized controlled, single blind, single center, diagnostics trial. Men will be randomized for a biopsy using an end-firing or a side-firing probe. The primary endpoint is the prostate cancer detection rate; secondary endpoints are the number of cores invaded with prostate cancer, nomogram for indolent cancer-score, Gleason score, complications and biopsy length. Expected outcomes: We hypothesize that no differences between the biopsy techniques exist.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	TRUS probe	end-firing and side-firing vary in the angle in which they sample the prostate

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2009-02-25
• Last updated: 2011-06-22

Locations

1 site across 1 country: Netherlands