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

Hospital de Santa Maria, Portugal

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Vienna nomogram prostate biopsy protocol; Procedure: 10-core prostate biopsy protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01752140

BPTRVienna

Details and patient eligibility

About

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.

Full 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.

Enrollment: 463 patients

Sex: Male

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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463 participants in 2 patient groups

10-core prostate biopsy protocol group

Active Comparator group

Description:

Ultrasound guided prostate biopsy with extraction of 10 cores

Treatment:

Procedure: 10-core prostate biopsy protocol

Vienna nomogram prostate biopsy protocol group

Active Comparator group

Description:

Ultrasound guided prostate biopsy performed according to the Vienna nomogram

Treatment:

Procedure: Vienna nomogram prostate biopsy protocol