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RECRUITING
NCT07162194
NA

MRI-Based Machine Learning Approach Versus Radiologist MRI Reading for the Detection of Prostate Cancer, The PRIMER Trial

Sponsor: University of Southern California

View on ClinicalTrials.gov

Summary

This clinical trial studies how well a magnetic resonance imaging (MRI)-based machine learning approach (i.e., artificial intelligence \[AI\]) works as compared to radiologist MRI readings in detecting prostate cancer. One of the current methods used to help diagnose possible prostate cancer is performing a prostate MRI. An MRI uses a magnetic field to take pictures of the body. The MRI images are examined by a radiologist. If a suspicious area is seen in the MRI, the radiologist assigns it a PIRADS score. This stands for Prostate Imaging Reporting and Data System. The PIRADS score is used to report how likely it is that a suspicious area in the prostate is cancer. The AI system has been developed also to be able to analyze prostate MRI images and detect suspicious areas in the prostate that may be cancer. The AI system's ability to diagnose aggressive prostate cancer may be similar to detection performed by experienced radiologists using the standard PIRADS system of analyzing prostate MRI.

Official title: PRIMER (Prostate MRI With Machine LEarning vs. Radiologist) A Novel MRI-Based Machine Learning Approach vs Radiologist MRI Reading for Targeted Prostate Biopsy: A Non-Inferiority, Within-Person Randomized Controlled Trial for Prostate Cancer Detection

Key Details

Gender

MALE

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2025-09-19

Completion Date

2028-10-15

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

PROCEDURE

Targeted Prostate Biopsy

Undergo targeted prostate biopsy

DIAGNOSTIC_TEST

Prostate Imaging Reporting & Data System

PIRADS Assessment

DIAGNOSTIC_TEST

Deep Learning Artificial Intelligence

Deep Learning (DL) AI predictions

DIAGNOSTIC_TEST

Green Learning Artificial Intelligence

Green Learning (GL) AI predictions

PROCEDURE

Radical Prostatectomy

Undergo RP

Locations (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States