MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy

N/AActive Not RecruitingNCT05471128

University of Oklahoma29 enrolled

Overview

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).

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

Conditions

Prostate Cancer

Interventions

Standard of Care BiopsyPROCEDURE

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

Sex: MALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Detection Rate

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

Time frame: 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.

Time frame: 2 years

Secondary Outcomes

Predictive Performance Measures

To evaluate the sensitivity of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer

Time frame: 2 years

Predictive Performance Measures

To evaluate the negative predictive value of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer

Time frame: 2 years

Data from ClinicalTrials.gov

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