A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme
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
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Prostate cancer detection rate
Up to four weeks after intervention
Tito P Leitão, Dr.
Hospital de Santa Maria
Portugal: Comissão de Ética para a Saúde do CHLN/FML