The BIOPRES Trial: Transrectal BIOpsies of the PRostate: End Versus Side-firing (BIOPRES)
The BIOPRES Trial; Transrectal BIOpsies of the PRostate: End Versus Side-firing
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Noord-Brabant
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Breda, Noord-Brabant, Netherlands
- Recruiting
- Amphia Hospital
-
Principal Investigator:
- Stijn Roemeling, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Side-firing
prostate biopsies obtained with side-firing probe
|
end-firing and side-firing vary in the angle in which they sample the prostate
|
|
ACTIVE_COMPARATOR: End-firing
|
end-firing and side-firing vary in the angle in which they sample the prostate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The presence of prostate cancer in the tissue obtained by prostate needle biopsy
Time Frame: This outcome parameter will be available 5 days after the biopsy has been done. E.g. there will be virtually no 'follow-up' period.
|
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
Outcome Measure |
Time Frame |
|---|---|
|
Number of cores invaded with prostate cancer
Time Frame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
|
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
Time Frame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
|
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
Time Frame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
|
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
Time Frame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
|
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
Time Frame: All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
|
All secondary outcome measures, except for the complications will be available when the pathology report emerges. Initial complications will be registered after 2 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stijn Roemeling, MD, PhD, Amphia Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROE-3
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