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A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme

NCT01752140 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2012-12-19

No results posted yet for this study

Summary

In this study, the investigators aim to determine if the Vienna nomogram increases the detection rate of TRUS-guided prostate biopsies by conducting a prospective randomized study comparing the Vienna nomogram with a 10-core biopsy protocol.

Conditions

Interventions

PROCEDURE

10-core prostate biopsy protocol

Local vascular bundle anesthesia with 2% lidocaine was performed using a 22G Chiba needle. Ultrasound guided prostate biopsy using a standard biopsy device to obtain 10 biopsy cores.

PROCEDURE

Vienna nomogram prostate biopsy protocol

Local vascular bundle anesthesia with 2% lidocaine was performed using a 22G Chiba needle. Ultrasound guided prostate biopsy using a standard biopsy device to obtain a number of cores as defined by the Vienna nomogram.

Sponsors & Collaborators

  • Hospital de Santa Maria, Portugal

    lead OTHER

Principal Investigators

  • Tito P Leitão, Dr. · Hospital de Santa Maria

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01752140 on ClinicalTrials.gov