NCT07162194Recruiting
MRI-Based Machine Learning Approach Versus Radiologist MRI Reading for the Detection of Prostate Cancer, The PRIMER Trial
PRIMER (Prostate MRI With Machine LEarning vs. Radiologist) A Novel MRI-Based Machine Learning Approach vs Radiologist MRI Reading for Targeted Prostate Biopsy: A Non-Inferiority, Within-Person Randomized Controlled Trial for Prostate Cancer Detection
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 29 Aug 2025
- Start date
- Sept 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- University of Southern California
- Diseases
- Prostate cancer
- NCT number
- NCT07162194
What you commit to
- Study type: Interventional
- Planned participants: 130
- From Sept 2025 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- PROSTATE BIOPSY COHORT: Patients with previous PBx history
- RADICAL PROSTATECTOMY COHORT: Patients who are undergoing neo-adjuvant hormonal therapy in conjunction with radical prostatectomy
Other illness
- PROSTATE BIOPSY COHORT: Patients with a history of prostate cancer
- PROSTATE BIOPSY COHORT: Patients with a history of surgical treatment on benign prostate hyperplasia
- RADICAL PROSTATECTOMY COHORT: Patients with a history of surgical treatment on benign prostate hyperplasia
Age
- PROSTATE BIOPSY COHORT: Patients under 20 years old
- RADICAL PROSTATECTOMY COHORT: Patients under 20 years old
Other
- PROSTATE BIOPSY COHORT: Patients undergoing saturation prostate biopsy
- PROSTATE BIOPSY COHORT: MRI which was not interpreted by PIRADS
- PROSTATE BIOPSY COHORT: MRI with significant artifact
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.