RecruitingNot ApplicableNCT07162194

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

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


Sponsor

University of Southern California

Enrollment

130 participants

Start Date

Sep 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study compares how well a computer (AI/machine learning) reads prostate MRI scans versus how well a radiologist does — to see whether the AI can match or improve on human accuracy in detecting prostate cancer. **You may be eligible if...** - You are a man scheduled for a prostate biopsy or prostate removal surgery as part of standard care - You have had a high-quality prostate MRI (3T multiparametric MRI) within 90 days of biopsy or 180 days of surgery - You have consented to participate **You may NOT be eligible if...** - You have not had the required type of MRI - You have not consented to the study Note: This is an observational study — no new treatments are given. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETargeted Prostate Biopsy

Undergo targeted prostate biopsy

DIAGNOSTIC_TESTProstate Imaging Reporting & Data System

PIRADS Assessment

DIAGNOSTIC_TESTDeep Learning Artificial Intelligence

Deep Learning (DL) AI predictions

DIAGNOSTIC_TESTGreen Learning Artificial Intelligence

Green Learning (GL) AI predictions

PROCEDURERadical Prostatectomy

Undergo RP


Locations(1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

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NCT07162194


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