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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014