MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy

NCT05471128 | Active Not Recruiting

• 2 other identifiers: OU-SCC-PROBXIRG-19-142-01
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Detection Rate

  To compare the detection rates of clinically significant prostate cancer lesions by ExactVu micro-ultrasound and by MRI-fusion

  2 years

• Feasibility of ExactVu

  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 Outcomes (2)

• Predictive Performance Measures

  2 years

• Predictive Performance Measures

  2 years

Interventions

Standard of Care Biopsy PROCEDURE

Patients will be evaluated with multiparametric MRI prostate followed by ExactVu micro-ultrasound to identify target lesions all of which will be biopsied by the examiner

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients scheduled to undergo biopsy and with one of the following:
• Men with suspicion of prostate cancer
• Men on active surveillance
• Age ≥18 \[30\]
• Have available multiparametric prostate MRI
• Able to provide written, informed consent
• No significant medical illness which in the opinion of the Investigator would preclude entry to study procedures
• Be willing and able to comply with scheduled visits

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andrew McIntosh, MD

  University of Oklahoma Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 22, 2022
• Study Start: January 27, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)