Clinical trial NCT00851292: The BIOPRES Trial: Transrectal BIOpsies of the PRostate: End Versus Side-firing
Official title: The BIOPRES Trial; Transrectal BIOpsies of the PRostate: End Versus Side-firing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
biopsy
TRUS
diagnosis
Lead sponsor: Amphia Hospital
Sponsor class: OTHER
First posted: 2009-02-25
Enrollment: 800
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: The presence of prostate cancer in the tissue obtained by prostate needle biopsy
timeFrame: 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 outcomes:
measure: Number of cores invaded with prostate cancer
timeFrame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
measure: Gleason score
timeFrame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
measure: Complications
timeFrame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
measure: Biopsy length
timeFrame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
measure: Nomogram score for indolent prostate cancer
timeFrame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia hospital
state: Noord-Brabant
Study officials:
affiliation: Amphia Hospital
name: Stijn Roemeling, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: