NCT00992615

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
Last Updated

August 29, 2012

Status Verified

November 1, 2009

First QC Date

October 8, 2009

Last Update Submit

August 28, 2012

Conditions

Prostate Cancer

Study Arms (2)

Arm 20 cores

EXPERIMENTAL
Procedure: prostate biopsy

arm 12 cores

ACTIVE COMPARATOR
Procedure: prostate biopsy

Interventions

prostate biopsyPROCEDURE

prostate cores - 12 or 20

Arm 20 coresarm 12 cores

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Poitiers, 86021, France

Location

Related Publications (1)

  • 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.

    PMID: 23313205DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 9, 2009

Last Updated

August 29, 2012

Record last verified: 2009-11

Locations

FR(1)