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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: 10-core prostate biopsy protocol
* Procedure: Vienna nomogram prostate biopsy protocol


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10-core prostate biopsy protocol group<br>Ultrasound guided prostate biopsy with extraction of 10 cores | Procedure: 10-core prostate biopsy protocol<br>* 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.<br>|
| Active Comparator: Vienna nomogram prostate biopsy protocol group<br>Ultrasound guided prostate biopsy performed according to the Vienna nomogram | Procedure: Vienna nomogram prostate biopsy protocol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate cancer detection rate |  | Up to four weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Prostate biopsy, Vienna nomogram