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

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

TRUS probe

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, biopsy, TRUS, diagnosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Amphia hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Side-firing

End-firing

Arm Description

prostate biopsies obtained with side-firing probe

Outcomes

Primary Outcome Measures

The presence of prostate cancer in the tissue obtained by prostate needle biopsy

Secondary Outcome Measures

Number of cores invaded with prostate cancer

Gleason score

Complications

Biopsy length

Nomogram score for indolent prostate cancer

Full Information

NCT ID

NCT00851292

First Posted

February 24, 2009

Last Updated

June 21, 2011

Sponsor

Amphia Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00851292

Brief Title

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

Acronym

BIOPRES

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Unknown status

Study Start Date

October 2009 (undefined)

Primary Completion Date

September 2012 (Anticipated)

Study Completion Date

September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Amphia Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate cancer, biopsy, TRUS, diagnosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Side-firing

Arm Type

Active Comparator

Arm Description

prostate biopsies obtained with side-firing probe

Arm Title

End-firing

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

TRUS probe

Intervention Description

end-firing and side-firing vary in the angle in which they sample the prostate

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

Number of cores invaded with prostate cancer

Time Frame