Micro-Ultrasound/Magnetic Resonance Imaging 001

NCT ID: NCT03938376

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-24
• Study Completion Date: 2021-02-01

Brief Summary

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.

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.

Conditions

Diagnoses Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Potential Prostate Cancer

Biopsy naïve patients with rising Prostate Specific Antigen (PSA) results referred by their Urologist for a standard of care (SOC) biopsy.

Micro-Ultrasound guided biopsy

Intervention Type: DIAGNOSTIC_TEST

High-resolution imaging device

Interventions

Micro-Ultrasound guided biopsy

High-resolution imaging device

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sangeet Ghai, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35852425 (View on PubMed)

Other Identifiers

19-5042.0

Identifier Type: -

Identifier Source: org_study_id