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

Amphia Hospital

Status and phase: Unknown; Phase 3

Conditions: Prostate Cancer

Treatments: Device: TRUS probe

Study type: Interventional

Funder types: Other

Identifiers

NCT00851292

ROE-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 2 patient groups

Side-firing

Active Comparator group

Description:

prostate biopsies obtained with side-firing probe

Treatment:

Device: TRUS probe

End-firing

Active Comparator group

Treatment:

Device: TRUS probe