NCT01752140

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: Hospital de Santa Maria, Portugal · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2012-12-19
• Last updated: 2012-12-19

Locations

1 site across 1 country: Portugal