Status:
RECRUITING
MRI-Based Machine Learning Approach Versus Radiologist MRI Reading for the Detection of Prostate Cancer, The PRIMER Trial
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Carcinoma
Eligibility:
MALE
20+ years
Phase:
NA
Brief 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 detectin...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the non-inferiority of targeted biopsy according to Green Learning (GL) AI over Prostate Imaging Reporting \& Data System (PIRADS). SECONDARY OBJECTIVES: I. To de...
Eligibility Criteria
Inclusion
- 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 provided with consent for the study
- RADICAL PROSTATECTOMY COHORT: Patients undergoing radical prostatectomy without neo-adjuvant hormonal therapy 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 provided with consent for the study
Exclusion
- 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 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
Key Trial Info
Start Date :
September 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT07162194
Start Date
September 19 2025
End Date
October 15 2028
Last Update
January 7 2026
Active Locations (1)
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1
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033