Princess Margaret Cancer Centre
Toronto, Ontario, Canada
NCT Number: NCT03938376
Micro-ultrasound is a novel real-time imaging modality which maintains the clinical workflow of conventional ultrasound-guided prostate biopsy, while potentially maintaining a similar ability to detect clinically significant prostate cancer (csPCa) to MRI. This prospective trial aims to compare micro-ultrasound to mpMRI in detection of csPCa in the biopsy naïve.
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Observational
Toronto, Ontario, Canada
Evidence from a large randomized clinical trial (clinical trials.gov ID NCT02079025), suggests that micro-ultrasound system is more sensitive than conventional transrectal-ultrasound (TRUS) to detect prostate cancer (PCa). the PRI-MUS (prostate risk identification using micro-ultrasound) scoring system was developed and validated to assess the risk of prostate cancer for targeted biopsy with the micro-ultrasound platform, similar to the PIRADS scoring system for suspicious areas on mpMRI. This project will compare micro-ultrasound imaging modality to the current gold-standard imaging for prostate cancer, mpMRI. By applying both modalities to the same patients, the investigators will provide a direct comparison of their screening abilities in terms of sensitivity, specificity, negative predictive value and positive predictive value. It will build evidence to demonstrate that micro-ultrasound may replace MRI/Fusion biopsy in these patients.This project aims to demonstrate that the micro-ultrasound 1) provides more sensitive initial biopsy, reducing the need for repeated procedures, thus lowering the rate of severe sepsis and the number of cancers found after local or regional progression, and 2) reduces the need for mpMRI following initial biopsy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High-resolution imaging device
Time frame: 1.5 years
Micro-ultrasound targeted biopsy will provide a non-inferior sensitivity to detect clinically significant prostate cancer compared to multiparametric MRI.
Time frame: 1.5 years
Micro-ultrasound will correctly predict extent of disease in the subset of biopsy subjects who proceed to radical prostatectomy.
University Health Network, Toronto
Other
Comparison of Micro-ultrasound Targeted Biopsy to mpMRI of Prostate for Detection of Clinically Significant Prostate Cancer
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