Clinical trial · Interventional
Comparison of a Novel Transperineal Targeted Fusion Biopsy System to Conventional Transrectal Targeted Fusion Biopsy
Comparison of a Novel Transperineal Targeted Fusion Biopsy System to Conventional Transrectal Targeted Fusion Biopsy for Diagnosis of Clinically Significant Prostate Cancers and to Eliminate Post-procedure Related Infections: A Randomized Control Trial
- 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)
This study is designed as a randomized control trial which intends to determine if transperineal (TP) targeted biopsy is not inferior to transrectal (TR) targeted biopsy for diagnosis of clinically significant prostate cancer while comparing post-procedural infection rates between the two techniques. The study will also look to compare patient reported pain scores related to the procedure, rates of other minor complications (e.g. bleeding, urinary retention) and procedure time. The expected sample size at The Ottawa Hospital is 360 men.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound (US) Targeted Fusion Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transperineal (TP) Ultrasound (US) Targeted Fusion Biopsy
- description
- Transperineal (TP) ultrasound (US) targeted fusion biopsy (which is performed using a validated Health Canada approved elastic software fusion platform).
- interventionNames
- Procedure: Ultrasound (US) Targeted Fusion Biopsy
- type
- ACTIVE_COMPARATOR
- label
- Transrectal (TR) Ultrasound (US) Targeted Fusion Biopsies
- description
- Transrectal (TR) ultrasound (US) targeted fusion biopsy (which is performed using a validated Health Canada approved elastic software fusion platform).
- interventionNames
- Procedure: Ultrasound (US) Targeted Fusion Biopsy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * MRI positive - abnormal area detected * Patient re-evaluated in the TOH Prostate CAC (Cancer Assessment Centre) for planning of targeted biopsy * Signed Consent Exclusion Criteria: * MRI negative - no abnormal area detected * Patient with a prior diagnosis of prostate cancer enrolled in active surveillance
References
Publications (13)
- BACKGROUNDAhmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20. PMID 28110982
- BACKGROUNDKasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18. PMID 29552975
- BACKGROUNDNam RK, Saskin R, Lee Y, Liu Y, Law C, Klotz LH, Loblaw DA, Trachtenberg J, Stanimirovic A, Simor AE, Seth A, Urbach DR, Narod SA. Increasing hospital admission rates for urological complications after transrectal ultrasound guided prostate biopsy. J Urol. 2013 Jan;189(1 Suppl):S12-7; discussion S17-8. doi: 10.1016/j.juro.2012.11.015. PMID 23234616
- BACKGROUNDRudzinski JK, Kawakami J. Incidence of infectious complications following transrectal ultrasound-guided prostate biopsy in Calgary, Alberta, Canada: A retrospective population-based analysis. Can Urol Assoc J. 2014 May;8(5-6):E301-5. doi: 10.5489/cuaj.1751. PMID 24940454
- BACKGROUNDGuo LH, Wu R, Xu HX, Xu JM, Wu J, Wang S, Bo XW, Liu BJ. Comparison between Ultrasound Guided Transperineal and Transrectal Prostate Biopsy: A Prospective, Randomized, and Controlled Trial. Sci Rep. 2015 Nov 3;5:16089. doi: 10.1038/srep16089. PMID 26526558