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Comparison of 20-core Versus 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
prostate biopsy
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Male

Inclusion Criteria:

  • Patients older than 18
  • Patients with a PSA value between 3 et 20 ng/ml
  • Obtained informed consent
  • Patients able to comply with the study protocol
  • Patients covered by a social insurance

Exclusion Criteria:

  • None

Sites / Locations

  • service d'Urologie - CHU de Poitiers - 2 rue de la Milétrie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 20 cores

arm 12 cores

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 8, 2009
Last Updated
August 28, 2012
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00992615
Brief Title
Comparison of 20-core Versus 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer
Official Title
Comparison of 20-core vs 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Poitiers University Hospital

4. Oversight

5. Study Description

Brief Summary
The optimal number of prostate cores extracted during a prostate biopsy performed because of a suspected prostate cancer is still debated. The present consensus is to sample 12 cores. However, recent data published in the literature brought arguments in favour of a higher number, probably 20. This would have the advantages of decreasing the false negatives and the re-biopsy rate.

6. Conditions and Keywords

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

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
Arm 20 cores
Arm Type
Experimental
Arm Title
arm 12 cores
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
prostate biopsy
Intervention Description
prostate cores - 12 or 20

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Patients older than 18 Patients with a PSA value between 3 et 20 ng/ml Obtained informed consent Patients able to comply with the study protocol Patients covered by a social insurance Exclusion Criteria: None
Facility Information:
Facility Name
service d'Urologie - CHU de Poitiers - 2 rue de la Milétrie
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23313205
Citation
Irani J, Blanchet P, Salomon L, Coloby P, Hubert J, Malavaud B, Mottet N. Is an extended 20-core prostate biopsy protocol more efficient than the standard 12-core? A randomized multicenter trial. J Urol. 2013 Jul;190(1):77-83. doi: 10.1016/j.juro.2012.12.109. Epub 2013 Jan 9.
Results Reference
derived

Learn more about this trial

Comparison of 20-core Versus 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer

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