MRI-Based Machine Learning Approach Versus Radiologist MRI Reading for the Detection of Prostate … (NCT07162194) | Clinical Trial Compass
SuspendedNot Applicable
MRI-Based Machine Learning Approach Versus Radiologist MRI Reading for the Detection of Prostate Cancer, The PRIMER Trial
Stopped: Pending IRB approval and implementation of protocol amendment
United States130 participantsStarted 2025-09-19
Plain-language 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.
Who can participate
Age range
20 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
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 w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Up to 3 months
2
CSPCa detection rate on GL AI-targeted and Deep Learning (DL) AI-targeted biopsies