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

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ClinicalTrials.gov Identifier: NCT00851292
Recruitment Status : Unknown
Verified June 2011 by Amphia Hospital.
Recruitment status was:  Recruiting
First Posted : February 25, 2009
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:
Amphia Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: TRUS probe Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The BIOPRES Trial; Transrectal BIOpsies of the PRostate: End Versus Side-firing
Study Start Date : October 2009
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Side-firing
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

Active Comparator: End-firing Device: TRUS probe
end-firing and side-firing vary in the angle in which they sample the prostate




Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851292


Contacts
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Contact: Stijn Roemeling, MD, PhD sroemeling@amphia.nl

Locations
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Netherlands
Amphia hospital Recruiting
Breda, Noord-Brabant, Netherlands
Principal Investigator: Stijn Roemeling, MD, PhD         
Sponsors and Collaborators
Amphia Hospital
Investigators
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Principal Investigator: Stijn Roemeling, MD, PhD Amphia Hospital

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Responsible Party: S. Roemeling, Amphia hospital
ClinicalTrials.gov Identifier: NCT00851292    
Other Study ID Numbers: ROE-3
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011
Keywords provided by Amphia Hospital:
prostate cancer
biopsy
TRUS
diagnosis
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases