The BIOPRES Trial: Transrectal BIOpsies of the PRostate: End Versus Side-Firing - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 24, 2009

Last Updated Date

February 25, 2009

Start Date ^†

March 2009

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00851292 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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 April 1st 2009 - April 1st 2011, 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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Prostate Cancer

Intervention ^†

Device: TRUS probe

Study Arms / Comparison Groups

Active Comparator: prostate biopsies obtained with side-firing probe

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

1000

Estimated Completion Date

December 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

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

Gender

Male

Ages

Accepts Healthy Volunteers

Contacts ^††

Contact: Stijn Roemeling, MD, PhD

sroemeling@amphia.nl

Location Countries ^†

Netherlands

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00851292

Responsible Party

S. Roemeling, Amphia hospital

Secondary IDs ^††

Study Sponsor ^†

Amphia Hospital

Collaborators ^††

Investigators ^†

Principal Investigator:

Stijn Roemeling, MD, PhD

Amphia Hospital

Information Provided By

Amphia Hospital

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.