A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme
NCT ID: NCT01752140
Last Updated: 2012-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
463 participants
INTERVENTIONAL
2009-01-31
2010-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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10-core prostate biopsy protocol group
Ultrasound guided prostate biopsy with extraction of 10 cores
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.
Vienna nomogram prostate biopsy protocol group
Ultrasound guided prostate biopsy performed according to the Vienna nomogram
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Abnormal digital rectal examination
* Abnormal findings on prostate imaging
Exclusion Criteria
* Documented previous pathological prostatitis
* History of urinary retention
* Recent lower urinary tract surgery
MALE
No
Sponsors
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Hospital de Santa Maria, Portugal
OTHER
Responsible Party
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Tito Palmela Leitão
Dr.
Principal Investigators
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Tito P Leitão, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital de Santa Maria
Locations
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Urology Department - Hospital de Santa Maria
Lisbon, Lisbon District, Portugal
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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BPTRVienna
Identifier Type: -
Identifier Source: org_study_id