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

NCT07162194 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

  • Prostate Carcinoma

Interventions

PROCEDURE

Radical Prostatectomy

Undergo RP

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Andre Luis Abreu, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-19
Primary Completion
2027-10-15
Completion
2028-10-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07162194 on ClinicalTrials.gov