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NCT Number: NCT05471128

MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–99 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. 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. 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.

Secondary outcomes

  1. 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. 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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: OU-SCC-PROBX

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2022
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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