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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tito Palmela Leitão, Hospital de Santa Maria, Portugal
ClinicalTrials.gov Identifier:
NCT01752140
First received: December 13, 2012
Last updated: December 15, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Prostate Cancer
Procedure: 10-core prostate biopsy protocol
Procedure: Vienna nomogram prostate biopsy protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme

Resource links provided by NLM:


Further study details as provided by Hospital de Santa Maria, Portugal:

Primary Outcome Measures:
  • Prostate cancer detection rate [ Time Frame: Up to four weeks after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prostate cancer detection rate in prostate volume and age subclasses [ Time Frame: Up to four weeks after intervention ] [ Designated as safety issue: No ]
  • Gleason score concordance between biopsy and prostatectomy specimens [ Time Frame: Up to four weeks after prostatectomy ] [ Designated as safety issue: No ]

Enrollment: 463
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752140

Locations
Portugal
Urology Department - Hospital de Santa Maria
Lisboa, Lisbon, Portugal, 1649-035
Sponsors and Collaborators
Hospital de Santa Maria, Portugal
Investigators
Principal Investigator: Tito P Leitão, Dr. Hospital de Santa Maria
  More Information

Publications:
Responsible Party: Tito Palmela Leitão, Dr., Hospital de Santa Maria, Portugal
ClinicalTrials.gov Identifier: NCT01752140     History of Changes
Other Study ID Numbers: BPTRVienna
Study First Received: December 13, 2012
Last Updated: December 15, 2012
Health Authority: Portugal: Comissão de Ética para a Saúde do CHLN/FML

Keywords provided by Hospital de Santa Maria, Portugal:
Prostate cancer
Prostate biopsy
Vienna nomogram

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014