Clinical trial · Interventional
A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme
NCT01752140CI-TRIAL-00008708completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 10-core prostate biopsy protocol | Procedure | — | UNRESOLVED |
| Vienna nomogram prostate biopsy protocol | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 10-core prostate biopsy protocol group
- description
- Ultrasound guided prostate biopsy with extraction of 10 cores
- interventionNames
- Procedure: 10-core prostate biopsy protocol
- type
- ACTIVE_COMPARATOR
- label
- Vienna nomogram prostate biopsy protocol group
- description
- Ultrasound guided prostate biopsy performed according to the Vienna nomogram
- interventionNames
- Procedure: Vienna nomogram prostate biopsy protocol
Primary outcomes (1)
- measure
- Prostate cancer detection rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDUzzo RG, Wei JT, Waldbaum RS, Perlmutter AP, Byrne JC, Vaughan ED Jr. The influence of prostate size on cancer detection. Urology. 1995 Dec;46(6):831-6. doi: 10.1016/s0090-4295(99)80353-7. PMID 7502425
- BACKGROUNDDjavan B, Margreiter M. Biopsy standards for detection of prostate cancer. World J Urol. 2007 Mar;25(1):11-7. doi: 10.1007/s00345-007-0151-1. Epub 2007 Mar 7. PMID 17342490
- BACKGROUNDLecuona A, Heyns CF. A prospective, randomized trial comparing the Vienna nomogram to an eight-core prostate biopsy protocol. BJU Int. 2011 Jul;108(2):204-8. doi: 10.1111/j.1464-410X.2010.09887.x. Epub 2010 Nov 19. PMID 21087452
- BACKGROUNDRemzi M, Fong YK, Dobrovits M, Anagnostou T, Seitz C, Waldert M, Harik M, Marihart S, Marberger M, Djavan B. The Vienna nomogram: validation of a novel biopsy strategy defining the optimal number of cores based on patient age and total prostate volume. J Urol. 2005 Oct;174(4 Pt 1):1256-60; discussion 1260-1; author reply 1261. doi: 10.1097/01.ju.0000173924.83392.cc. PMID 16145388