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

Paused · Not applicable

Conditions studied: Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT07162194

Run by

University of Southern California

People needed

130

Starts

2025-09-19

Expected to finish

2028-10-15

Last updated by the study team

2026-06-15

Who can join

Age: 20 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• PROSTATE BIOPSY COHORT: Patients undergoing transperineal MRI/TRUS fusion prostate biopsy (PBx) as per standard of care
• PROSTATE BIOPSY COHORT: Patients who underwent or are undergoing 3T multiparametric MRI (T2W, diffusion weighted imaging [DWI], apparent diffusion coefficient [ADC], and dynamic contrast-enhanced [DCE]) within 90 days prior to biopsy
• PROSTATE BIOPSY COHORT: Patients who consented to the study
• RADICAL PROSTATECTOMY COHORT: Patients undergoing radical prostatectomy for primary treatment of prostate cancer as per standard of care
• RADICAL PROSTATECTOMY COHORT: Patients who underwent or are undergoing 3T multiparametric MRI (T2W, DWI, ADC, and DCE) within 180 days prior to radical prostatectomy
• RADICAL PROSTATECTOMY COHORT: Patients who consented to the study

You may not qualify if…

• PROSTATE BIOPSY COHORT: Patients with a history of prostate cancer
• PROSTATE BIOPSY COHORT: Patients with a history of surgical treatment on benign prostate hyperplasia
• PROSTATE BIOPSY COHORT: Patients undergoing saturation prostate biopsy
• PROSTATE BIOPSY COHORT: Patients under 20 years old
• PROSTATE BIOPSY COHORT: Patients with previous PBx history
• PROSTATE BIOPSY COHORT: MRI which was not interpreted by PIRADS
• PROSTATE BIOPSY COHORT: MRI with significant artifact
• RADICAL PROSTATECTOMY COHORT: Patients who are undergoing neo-adjuvant hormonal therapy in conjunction with radical prostatectomy
• RADICAL PROSTATECTOMY COHORT: Patients with a history of surgical treatment on benign prostate hyperplasia
• RADICAL PROSTATECTOMY COHORT: Patients under 20 years old
• RADICAL PROSTATECTOMY COHORT: Patients without pre-treatment MRI
• RADICAL PROSTATECTOMY COHORT: MRI which was not interpreted by PIRADS
• RADICAL PROSTATECTOMY COHORT: MRI with significant artifact
• RADICAL PROSTATECTOMY COHORT: Patients who are included in the Biopsy cohort

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.