Clinical trial NCT01752140: A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme
Official title: A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Prostate biopsy
Vienna nomogram
Lead sponsor: Hospital de Santa Maria, Portugal
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 463
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Prostate cancer detection rate
timeFrame: Up to four weeks after intervention
Secondary outcomes:
measure: Prostate cancer detection rate in prostate volume and age subclasses
timeFrame: Up to four weeks after intervention
measure: Gleason score concordance between biopsy and prostatectomy specimens
timeFrame: Up to four weeks after prostatectomy
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Urology Department - Hospital de Santa Maria
state: Lisbon
Study officials:
affiliation: Hospital de Santa Maria
name: Tito P Leitão, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.