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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752140
• Other study ID #: BPTRVienna
• Status: Completed
• Phase: N/A
• First received: December 13, 2012
• Last updated: December 15, 2012
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: December 2012
• Source: Hospital de Santa Maria, Portugal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Comissão de Ética para a Saúde do CHLN/FML
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Portugal	Urology Department - Hospital de Santa Maria	Lisboa	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Santa Maria, Portugal

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

Djavan B, Margreiter M. Biopsy standards for detection of prostate cancer. World J Urol. 2007 Mar;25(1):11-7. Epub 2007 Mar 7. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate cancer detection rate		Up to four weeks after intervention	No
Secondary	Prostate cancer detection rate in prostate volume and age subclasses		Up to four weeks after intervention	No
Secondary	Gleason score concordance between biopsy and prostatectomy specimens		Up to four weeks after prostatectomy	No