Actively Recruiting

Phase Not Applicable
Age: 20Years +
MALE
NCT07162194

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

Led by University of Southern California · Updated on 2026-01-12

130

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

Sponsors

U

University of Southern California

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 20Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing transperineal MRI/TRUS fusion prostate biopsy as standard care
  • Patients who had or are having 3T multiparametric MRI within 90 days before biopsy
  • Patients who consented to participate in the study
  • Patients undergoing radical prostatectomy for primary prostate cancer treatment
  • Patients who had or are having 3T multiparametric MRI within 180 days before radical prostatectomy
  • Patients who consented to participate in the study
Not Eligible

You will not qualify if you...

  • History of prostate cancer (biopsy cohort)
  • History of surgical treatment for benign prostate hyperplasia (both cohorts)
  • Undergoing saturation prostate biopsy (biopsy cohort)
  • Under 20 years old (both cohorts)
  • Previous prostate biopsy history (biopsy cohort)
  • MRI not interpreted by PIRADS (both cohorts)
  • MRI with significant artifacts (both cohorts)
  • Undergoing neo-adjuvant hormonal therapy with radical prostatectomy (prostatectomy cohort)
  • Patients included in the biopsy cohort (prostatectomy cohort)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Actively Recruiting

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Research Team

I

Ileana Aldana

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

7

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