A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme
|Prostate Cancer||Procedure: 10-core prostate biopsy protocol Procedure: Vienna nomogram prostate biopsy protocol|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme|
- Prostate cancer detection rate [ Time Frame: Up to four weeks after intervention ]
- Prostate cancer detection rate in prostate volume and age subclasses [ Time Frame: Up to four weeks after intervention ]
- Gleason score concordance between biopsy and prostatectomy specimens [ Time Frame: Up to four weeks after prostatectomy ]
|Study Start Date:||January 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 10-core prostate biopsy protocol group
Ultrasound guided prostate biopsy with extraction of 10 cores
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.
Active Comparator: Vienna nomogram prostate biopsy protocol group
Ultrasound guided prostate biopsy performed according to the Vienna nomogram
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752140
|Urology Department - Hospital de Santa Maria|
|Lisboa, Lisbon, Portugal, 1649-035|
|Principal Investigator:||Tito P Leitão, Dr.||Hospital de Santa Maria|