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Completed

NCT Number: NCT03938376

Micro-Ultrasound/Magnetic Resonance Imaging 001

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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Key information

Sex eligibility

Male

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men with indication for a prostate biopsy will be offered inclusion in the study. Indications for biopsy include clinical suspicion of prostate cancer due to elevated PSA or abnormal digital rectal exam (DRE)

Exclusion criteria

  • Patients with history of prostate cancer
  • Patients with prior prostate biopsies
  • Patients who are unwilling or unable to give informed consent
  • Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)

Treatment and study plan

Micro-Ultrasound guided biopsy

Diagnostic Test

High-resolution imaging device

Primary outcomes

  1. The proportion of csPCa detected for each modality.

    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.

Secondary outcomes

  1. The proportion of zones of PCa correctly predicted by each modality in the whole-mount pathology specimen for the subset of men selecting radical prostatectomy for treatment.

    Time frame: 1.5 years

    Micro-ultrasound will correctly predict extent of disease in the subset of biopsy subjects who proceed to radical prostatectomy.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Comparison of Micro-ultrasound Targeted Biopsy to mpMRI of Prostate for Detection of Clinically Significant Prostate Cancer

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 6, 2019
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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