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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01752140

Enrollment

463

Registered

2012-12-19

Start date

2009-01-31

Completion date

2010-07-31

Last updated

2012-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, Prostate biopsy, Vienna nomogram

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.

Interventions

PROCEDURE10-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.

PROCEDUREVienna 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Prostate cancer detection rate	Up to four weeks after intervention

Secondary

Measure	Time frame
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

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026