NCT07162194 · University of Southern California
MRI-Based Machine Learning Approach Versus Radiologist MRI Reading for the Detection of Prostate Cancer, The PRIMER Trial
What this study 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.
View original scientific description
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.
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
Primary outcome measures
Clinically-significant prostate cancer (CSPCa) detection rate on Green Learning (GL) artificial intelligence (AI)-targeted and Prostate Imaging-Reporting and Data System (PIRADS)-targeted biopsies
Time frame: Up to 3 months
Detection rates of PIRADS and GL AI-targeted biopsy will be evaluated per index region of interest (ROI), respectively.
CSPCa detection rate on GL AI-targeted and Deep Learning (DL) AI-targeted biopsies
Time frame: Up to 3 months
Detection rates of GL AI and DL AI targeted biopsy will be evaluated per index ROI, respectively.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 365 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 365 days prior to radical prostatectomy
- RADICAL PROSTATECTOMY COHORT: Patients who consented to the study
Exclusion criteria
- 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
- Los Angeles, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 1, 2026 · Source of record for eligibility and locations