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

Sponsored by:	Amphia Hospital
Information provided by:	Amphia Hospital
ClinicalTrials.gov Identifier:	NCT00851292

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Device: TRUS probe	Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	The BIOPRES Trial; Transrectal BIOpsies of the PRostate: End Versus Side-firing

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Amphia Hospital:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Side-firing: Active Comparator prostate biopsies obtained with side-firing probe	Device: TRUS probe end-firing and side-firing vary in the angle in which they sample the prostate
End-firing: Active Comparator	Device: TRUS probe end-firing and side-firing vary in the angle in which they sample the prostate

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

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851292

Contacts

Contact: Stijn Roemeling, MD, PhD

sroemeling@amphia.nl

Locations

Netherlands, Noord-Brabant
Amphia hospital
Breda, Noord-Brabant, Netherlands

Sponsors and Collaborators

Amphia Hospital

Investigators

Principal Investigator:

Stijn Roemeling, MD, PhD

Amphia Hospital

More Information

No publications provided

Responsible Party:	Amphia hospital ( S. Roemeling )
Study ID Numbers:	ROE-3
Study First Received:	February 24, 2009
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00851292 History of Changes
Health Authority:	Netherlands: Dutch Health Care Inspectorate; Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Amphia Hospital:

prostate cancer
biopsy
TRUS
diagnosis

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009