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

Phase 3

• Conditions: Prostate Cancer
• Interventions: Device: TRUS probe

• Registration Number: NCT00851292
• Lead Sponsor: Amphia Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Study Start: 2009-10
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 800

Inclusion Criteria

• PSA and DRE performed in advance of the biopsy
• Informed consent
• Number of biopsy cores according to the volume dependent biopsy protocol (8 cores in prostates with a volume less than 40 mL., 10 in 40-60 mL. and 12 in >60 mL.)

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Side-firing	TRUS probe	prostate biopsies obtained with side-firing probe
End-firing	TRUS probe	-

Primary Outcome Measures

Name	Time	Method
The presence of prostate cancer in the tissue obtained by prostate needle biopsy	This outcome parameter will be available 5 days after the biopsy has been done. E.g. there will be virtually no 'follow-up' period.

Secondary Outcome Measures

Name	Time	Method
Number of cores invaded with prostate cancer	All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Gleason score	All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Complications	All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Biopsy length	All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Nomogram score for indolent prostate cancer	All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.

Trial Locations

Locations (1)

Amphia hospital; 🇳🇱 Breda, Noord-Brabant, Netherlands