NCT01752140

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

1.5 years

First QC Date

December 13, 2012

Last Update Submit

December 15, 2012

Conditions

Prostate Cancer

Keywords

Prostate cancerProstate biopsyVienna nomogram

Outcome Measures

Primary Outcomes (1)

  • Prostate cancer detection rate

    Up to four weeks after intervention

Secondary Outcomes (2)

  • Prostate cancer detection rate in prostate volume and age subclasses

    Up to four weeks after intervention

  • Gleason score concordance between biopsy and prostatectomy specimens

    Up to four weeks after prostatectomy

Study Arms (2)

10-core prostate biopsy protocol group

ACTIVE COMPARATOR

Ultrasound guided prostate biopsy with extraction of 10 cores

Procedure: 10-core prostate biopsy protocol

Vienna nomogram prostate biopsy protocol group

ACTIVE COMPARATOR

Ultrasound guided prostate biopsy performed according to the Vienna nomogram

Procedure: Vienna nomogram prostate biopsy protocol

Interventions

10-core prostate biopsy protocolPROCEDURE

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.

10-core prostate biopsy protocol group
Vienna nomogram prostate biopsy protocolPROCEDURE

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.

Vienna nomogram prostate biopsy protocol group

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Department - Hospital de Santa Maria

Lisbon, Lisbon District, 1649-035, Portugal

Location

Related Publications (4)

  • Uzzo RG, Wei JT, Waldbaum RS, Perlmutter AP, Byrne JC, Vaughan ED Jr. The influence of prostate size on cancer detection. Urology. 1995 Dec;46(6):831-6. doi: 10.1016/s0090-4295(99)80353-7.

    PMID: 7502425BACKGROUND

  • Djavan B, Margreiter M. Biopsy standards for detection of prostate cancer. World J Urol. 2007 Mar;25(1):11-7. doi: 10.1007/s00345-007-0151-1. Epub 2007 Mar 7.

    PMID: 17342490BACKGROUND

  • Lecuona A, Heyns CF. A prospective, randomized trial comparing the Vienna nomogram to an eight-core prostate biopsy protocol. BJU Int. 2011 Jul;108(2):204-8. doi: 10.1111/j.1464-410X.2010.09887.x. Epub 2010 Nov 19.

    PMID: 21087452BACKGROUND

  • Remzi M, Fong YK, Dobrovits M, Anagnostou T, Seitz C, Waldert M, Harik M, Marihart S, Marberger M, Djavan B. The Vienna nomogram: validation of a novel biopsy strategy defining the optimal number of cores based on patient age and total prostate volume. J Urol. 2005 Oct;174(4 Pt 1):1256-60; discussion 1260-1; author reply 1261. doi: 10.1097/01.ju.0000173924.83392.cc.

    PMID: 16145388BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Tito P Leitão, Dr.

    Hospital de Santa Maria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 19, 2012

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations

PT(1)