Micro-Ultrasound/Magnetic Resonance Imaging 001

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

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.

Study Overview

• Status: Completed
• Conditions: Diagnoses Disease
• Intervention / Treatment: Diagnostic test: Micro-Ultrasound guided biopsy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients who are referred to confirm negative or positive for diagnosis of prostate cancer based on SOC biopsy, with superior resolution imaging devices. Referral may be indicated in the setting of increased PSA, abnormal DRE and/or abnormality of other serum or urinary tests specific for prostate cancer, for example PHI (Prostate Health Index) and PCA3. The current golden standard imaging for prostate cancer is mpMRI.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Potential Prostate Cancer; Biopsy naïve patients with rising Prostate Specific Antigen (PSA) results referred by their Urologist for a standard of care (SOC) biopsy.	Diagnostic test: Micro-Ultrasound guided biopsy; High-resolution imaging device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of csPCa detected for each modality.	Micro-ultrasound targeted biopsy will provide a non-inferior sensitivity to detect clinically significant prostate cancer compared to multiparametric MRI.	1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Micro-ultrasound will correctly predict extent of disease in the subset of biopsy subjects who proceed to radical prostatectomy.	1.5 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Sangeet Ghai, MD, University Health Network, Toronto

Publications and helpful links

General Publications

• Ghai S, Perlis N, Atallah C, Jokhu S, Corr K, Lajkosz K, Incze PF, Zlotta AR, Jain U, Fleming H, Finelli A, van der Kwast TH, Haider MA. Comparison of Micro-US and Multiparametric MRI for Prostate Cancer Detection in Biopsy-Naive Men. Radiology. 2022 Nov;305(2):390-398. doi: 10.1148/radiol.212163. Epub 2022 Jul 19.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 24, 2019
• Primary Completion (ACTUAL): September 14, 2020
• Study Completion (ACTUAL): February 1, 2021

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (ACTUAL): May 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Diagnostic Imaging; Prostatic Disease; Micro-Ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 19-5042.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No