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Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

NCT05220501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 804

Last updated 2025-11-10

Study results available
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Summary

OPTIMUM is a study designed to compare the ability of ultra-high resolution transrectal micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion to guide prostate biopsy.

Conditions

Interventions

DIAGNOSTIC_TEST

Microultrasonography Targeted Biopsy

All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.

DIAGNOSTIC_TEST

MRI Targeted Biopsy

All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.

Sponsors & Collaborators

  • Exact Imaging

    collaborator INDUSTRY

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Laurence Klotz, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2024-09-06
Completion
2024-09-06
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05220501 on ClinicalTrials.gov