MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy

Prostate Cancer Clinical Trial

— OU-SCC-PROBX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471128
• Other study ID #: OU-SCC-PROBX
• Secondary ID: IRG-19-142-01
• Status: Recruiting
• Start date: January 27, 2023
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: Lead Nurse
• Phone: 405.271.8777
• Email: SCC-IIT-Office[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Standard of Care Biopsy
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

Locations

Country	Name	City	State
United States	Stephenson Cancer Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection Rate	To compare the detection rates of clinically significant prostate cancer lesions by ExactVu micro-ultrasound and by MRI-fusion	2 years
Primary	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	Predictive Performance Measures	To evaluate the sensitivity of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer	2 years
Secondary	Predictive Performance Measures	To evaluate the negative predictive value of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer	2 years