MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy (OU-SCC-PROBX)

February 5, 2026 updated by: University of Oklahoma

MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy for the Detection of Clinically Significant Prostate Cancer

The purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (ExactVu) and by multiparametric magnetic-resonance imaging (mpMRI).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a pilot clinical trial with 30 patients with either: 1) suspected prostate cancer (based on elevated PSA or abnormal digital rectal exam (DRE), or 2) known low-risk prostate cancer being managed with active surveillance.

Enrolled patients will undergo MRI fusion biopsy and standard-template 12 core TRUS biopsy as the standard-of-care. Patients will also undergo micro-ultrasound evaluation and targeted biopsy if lesions are identified. Detection rates of clinically significant lesions by ExactVu and by MRI will be compared.

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population will cover all races, including socioeconomically disadvantaged minorities, that have been diagnosed with prostate cancer.

Description

Inclusion Criteria:

  1. Patients scheduled to undergo biopsy and with one of the following:

    • Men with suspicion of prostate cancer
    • Men on active surveillance
  2. Age ≥18 [30]
  3. Have available multiparametric prostate MRI
  4. Able to provide written, informed consent
  5. No significant medical illness which in the opinion of the Investigator would preclude entry to study procedures
  6. Be willing and able to comply with scheduled visits

Exclusion Criteria:

  1. Previously confirmed prostate cancer diagnosis with Grade Group >= 2
  2. Unable to undergo prostate biopsy
  3. Prostate MRI unable to be evaluated using the PI-RADS v2 criteria
  4. Men with contraindication for MRI or a prostate biopsy
  5. Prostate biopsy within 8 weeks prior to mpMRI.
  6. Any history of prostate treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection Rate
Time Frame: 2 years
To compare the detection rates of clinically significant prostate cancer lesions by ExactVu micro-ultrasound and by MRI-fusion
2 years
Feasibility of ExactVu
Time Frame: 2 years
To determine the feasibility of using ExactVu micro-ultrasounds to screen for prostate cancer in socioeconomically disadvantaged populations with limited access to care. Feasibility is measured by the percentage of patients that successfully undergo the study procedures.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive Performance Measures
Time Frame: 2 years
To evaluate the sensitivity of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer
2 years
Predictive Performance Measures
Time Frame: 2 years
To evaluate the negative predictive value of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Andrew McIntosh, MD, University of Oklahoma Stephenson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2023

Primary Completion (Actual)

May 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 13, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OU-SCC-PROBX
  • IRG-19-142-01 (Other Grant/Funding Number: American Cancer Society)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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