MRI-based machine learning versus radiologist reads to detect prostate cancer
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
This trial tests whether MRI-based AI methods can find clinically significant prostate cancer as well as experienced radiologists in men getting a prostate biopsy or prostate removal surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 20 Years and up |
| Sex | Male |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07162194 on ClinicalTrials.gov |
What this trial studies
This prospective interventional study enrolls men undergoing transperineal MRI/TRUS fusion prostate biopsy (Group 1) and men undergoing radical prostatectomy or prostatectomy after biopsy (Group 2). In the biopsy cohort, patients are randomized to arms in which targeted biopsies are obtained sequentially based on standard PIRADS reads, a Green Learning (GL) AI prediction, and a Deep Learning (DL) AI prediction, alongside standard-of-care systematic cores. The primary objective is to show non-inferiority of GL AI-targeted biopsy versus PIRADS, with secondary goals including DL AI detection rates, patient-level diagnostic performance comparisons, biopsy core characteristics, predictors of clinically significant cancer, and spatial correlation with prostatectomy specimens. All participants require a 3T multiparametric prostate MRI performed within the study windows and are enrolled at the USC/Norris Comprehensive Cancer Center.
Who should consider this trial
Good fit: Men undergoing transperineal MRI/TRUS fusion prostate biopsy with a 3T multiparametric MRI within 90 days, or men undergoing radical prostatectomy with a 3T mpMRI within 180 days, who are willing to consent and attend the USC site.
Not a fit: Men with a prior history of prostate cancer, prior prostate surgery, no qualifying 3T mpMRI, or those unable to attend the USC/Norris site are not eligible and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the AI approaches could match radiologist accuracy for clinically significant prostate cancer and help standardize readings and expand access to high-quality MRI interpretation.
How similar studies have performed: Previous retrospective and some prospective reports have shown AI can approach or match experienced radiologist performance for detecting clinically significant prostate cancer on MRI, but randomized non-inferiority comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 this trial is running
Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Andre Luis Abreu, MD — University of Southern California
- Study coordinator: Ileana Aldana
- Email: Ileana.aldana@med.usc.edu
- Phone: 323-865-0702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.