Comparison of 20-core Versus 12-core Prostate Biopsy Diag... | NCT00992615

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

NCT00992615

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Aug 29, 2012Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

prostate biopsy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 8, 2009

First Submission Date that Met QC Criteria

Oct 8, 2009

First Posted Date

Oct 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2012

Last Update Posted Date

Aug 29, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 20 cores	Experimental		Procedure: prostate biopsy
arm 12 cores	Active Comparator		Procedure: prostate biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
prostate biopsy	Procedure	prostate cores - 12 or 20	Arm 20 cores arm 12 cores

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
service d'Urologie - CHU de Poitiers - 2 rue de la Milétrie		Poitiers		86021	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23313205	Derived	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.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms