The BIOPRES Trial; Transrectal BIOpsies of the PRostate: End Versus Side-firing
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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.
Stijn Roemeling, MD, PhD
Netherlands: Dutch Health Care Inspectorate