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NCT00992615 Clinical Trial

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

Prostate Cancer Clinical Trial

Official title:
Comparison of 20-core vs 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00992615
Other study ID # BP20-12
Secondary ID
Status Completed
Phase N/A
First received October 8, 2009
Last updated August 28, 2012

Study information
Verified date November 2009
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility 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:

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Procedure:
• prostate biopsy
prostate cores - 12 or 20

Locations
Country Name City State
France service d'Urologie - CHU de Poitiers - 2 rue de la Milétrie Poitiers

Sponsors (1)
Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

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