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

December 15, 2012 updated by: Tito Palmela Leitão, Hospital de Santa Maria, Portugal
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Trans rectal ultrasound (TRUS) guided prostate biopsy remains the standard for prostate cancer diagnosis. However, the standard protocols miss 15 to 30% of cancers, leading to a variable number of repeat biopsies.

In 2005 the Vienna nomogram was introduced, defining the number of cores to be obtained in a prostate biopsy in relation to age and prostate volume in patients with a serum PSA level of 2-10 ng/mL.

The objective of the study is to determine if the Vienna nomogram increases the detection rate of trans rectal ultrasound guided prostate biopsies, compared to a 10-core biopsy.

This prospective randomized study enrolled men eligible for a prostate biopsy were randomized to a Vienna nomogram protocol or a 10-core protocol. They were further stratified according to age (≤65; >65 and ≤70; >70 years) and prostate volume (≤30; >30 and ≤50; >50 and ≤70; >70 cc).

A subgroup analysis for patients with serum PSA values between 2 and 10 ng/mL was performed.

Study Type

Interventional

Enrollment (Actual)

463

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Lisbon
      • Lisboa, Lisbon, Portugal, 1649-035
        • Urology Department - Hospital de Santa Maria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • PSA elevation
  • Abnormal digital rectal examination
  • Abnormal findings on prostate imaging

Exclusion Criteria:

  • Active urinary tract infection
  • Documented previous pathological prostatitis
  • History of urinary retention
  • Recent lower urinary tract surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10-core prostate biopsy protocol group
Ultrasound guided prostate biopsy with extraction of 10 cores
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.
Active Comparator: Vienna nomogram prostate biopsy protocol group
Ultrasound guided prostate biopsy performed according to the Vienna nomogram
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prostate cancer detection rate
Time Frame: Up to four weeks after intervention
Up to four weeks after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Prostate cancer detection rate in prostate volume and age subclasses
Time Frame: Up to four weeks after intervention
Up to four weeks after intervention
Gleason score concordance between biopsy and prostatectomy specimens
Time Frame: Up to four weeks after prostatectomy
Up to four weeks after prostatectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Santa Maria, Portugal

Investigators

  • Principal Investigator: Tito P Leitão, Dr., Hospital de Santa Maria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

December 13, 2012

First Submitted That Met QC Criteria

December 15, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 15, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPTRVienna

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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