Micro-Ultrasound/Magnetic Resonance Imaging 001

Diagnoses Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03938376
• Other study ID #: 19-5042.0
• Status: Completed
• Start date: May 24, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2021
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Diagnoses Disease

Intervention

Diagnostic Test:
• Micro-Ultrasound guided biopsy
High-resolution imaging device

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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