MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy

Active, not recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT05471128
• Lead Sponsor: University of Oklahoma

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).

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 Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Study Start: 2023-01-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-07
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 29

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection Rate	2 years	To compare the detection rates of clinically significant prostate cancer lesions by ExactVu micro-ultrasound and by MRI-fusion
Feasibility of ExactVu	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 Outcome Measures

Name	Time	Method
Predictive Performance Measures	2 years	To evaluate the negative predictive value of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center, Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States