MRI-Based Machine Learning Approach Versus Radiologist MRI Reading for the Detection of Prostate Cancer, The PRIMER Trial
NCT ID: NCT07162194
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2025-09-19
2028-10-15
Brief Summary
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Detailed Description
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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 determine the clinically significant prostate cancer (CSPCa) detection rate on Deep Learning (DL) AI-targeted biopsy.
II. To determine the patient-level diagnostic performance of GL AI, Deep Learning (DL) AI and PIRADS for clinically significant prostate cancer (CSPCa) detection.
III. To assess Targeted biopsy core characteristics. IV. To evaluate the predictors for patient-level CSPCa detection. V. To assess the spatial correlation of CSPCa distribution on radical prostatectomy (RP) specimens and region of interest (ROI) generated by GL AI and PIRADS.
OUTLINE: Patients undergoing prostate biopsy per standard of care (SOC) are assigned to Group 1. Patients who underwent a prostate biopsy followed by a radical prostatectomy within 6 months, as well as patients only undergoing a radical prostatectomy are assigned to Group 2.
GROUP 1: Patients are randomized to 1 of 6 arms.
ARM I: Patients undergo MRI/transrectal ultrasound (TRUS) followed by a targeted prostate biopsy using PIRADS on study. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy based on GL AI predictions. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy based on DL AI predictions. Finally, patients undergo up to 12 additional prostate biopsies per SOC.
ARM II: Patients undergo MRI/TRUS followed by a targeted prostate biopsy using PIRADS. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy based on DL AI predictions. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy based on GL AI predictions. Finally, patients undergo up to 12 additional prostate biopsies per SOC.
ARM III: Patients undergo MRI/TRUS followed by a targeted prostate biopsy using GL AI predictions. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy using PIRADS. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy based on DL AI predictions. Finally, patients undergo up to 12 additional prostate biopsies per SOC.
ARM IV: Patients undergo MRI/TRUS followed by a targeted prostate biopsy using GL AI predictions. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy based on DL AI predictions. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy using PIRADS. Finally, patients undergo up to 12 additional prostate biopsies per SOC.
ARM V: Patients undergo MRI/TRUS followed by a targeted prostate biopsy using DL AI predictions. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy based on GL AI predictions. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy using PIRADS. Finally, patients undergo up to 12 additional prostate biopsies per SOC.
ARM VI: Patients undergo MRI/TRUS followed by a targeted prostate biopsy using DL AI predictions. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy using PIRADS. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy based on GL AI predictions. Finally, patients undergo up to 12 additional prostate biopsies per SOC.
GROUP 2: Patients have their removed prostate evaluated using a special mold on study. Prostate tissue is mapped and compared with the prostate cancer prediction on MRI generated by radiologists and AI reports.
After completion of study intervention, patients are followed up at 10 days and at 3 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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Cohort 1 Arm I (MRI/TRUS, PIRADS, GL AI, DL AI)
Patients undergo MRI/TRUS followed by a targeted prostate biopsy using PIRADS on study. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy based on GL AI predictions. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy based on DL AI predictions. Finally, patients undergo up to 12 additional prostate biopsies per SOC.
Targeted Prostate Biopsy
Undergo targeted prostate biopsy
Prostate Imaging Reporting & Data System
PIRADS Assessment
Deep Learning Artificial Intelligence
Deep Learning (DL) AI predictions
Green Learning Artificial Intelligence
Green Learning (GL) AI predictions
Radical Prostatectomy
Undergo RP
Cohort 1 Arm II (MRI/TRUS, PIRADS, DL AI, GL AI)
Patients undergo MRI/TRUS followed by a targeted prostate biopsy using PIRADS. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy based on DL AI predictions. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy based on GL AI predictions. Patients undergo up to 12 additional prostate biopsies per SOC. Based on biopsy results, patients will either come off study or undergo radical prostatectomy without hormonal therapy within 180 days from baseline MRI.
Targeted Prostate Biopsy
Undergo targeted prostate biopsy
Prostate Imaging Reporting & Data System
PIRADS Assessment
Deep Learning Artificial Intelligence
Deep Learning (DL) AI predictions
Green Learning Artificial Intelligence
Green Learning (GL) AI predictions
Radical Prostatectomy
Undergo RP
Cohort 1 Arm III (MRI/TRUS, GL AI, PIRADS, DL AI)
Patients undergo MRI/TRUS followed by a targeted prostate biopsy using GL AI predictions. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy using PIRADS. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy based on DL AI predictions. Patients undergo up to 12 additional prostate biopsies per SOC. Based on biopsy results, patients will either come off study or undergo radical prostatectomy without hormonal therapy within 180 days from baseline MRI.
Targeted Prostate Biopsy
Undergo targeted prostate biopsy
Prostate Imaging Reporting & Data System
PIRADS Assessment
Deep Learning Artificial Intelligence
Deep Learning (DL) AI predictions
Green Learning Artificial Intelligence
Green Learning (GL) AI predictions
Radical Prostatectomy
Undergo RP
Cohort 1 Arm IV (MRI/TRUS, GL AI, DL AI, PIRADS)
Patients undergo MRI/TRUS followed by a targeted prostate biopsy using GL AI predictions. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy based on DL AI predictions. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy using PIRADS. Finally, patients undergo up to 12 additional prostate biopsies per SOC. Patients may also undergo DRE on study.
Targeted Prostate Biopsy
Undergo targeted prostate biopsy
Prostate Imaging Reporting & Data System
PIRADS Assessment
Deep Learning Artificial Intelligence
Deep Learning (DL) AI predictions
Green Learning Artificial Intelligence
Green Learning (GL) AI predictions
Radical Prostatectomy
Undergo RP
Cohort 1 Arm V (MRI/TRUS, DL AI, PIRADS, GL AI)
Patients undergo MRI/TRUS followed by a targeted prostate biopsy using DL AI predictions. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy using PIRADS. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy based on GL AI predictions. Patients undergo up to 12 additional prostate biopsies per SOC. Based on biopsy results, patients will either come off study or undergo radical prostatectomy without hormonal therapy within 180 days from baseline MRI.
Targeted Prostate Biopsy
Undergo targeted prostate biopsy
Prostate Imaging Reporting & Data System
PIRADS Assessment
Deep Learning Artificial Intelligence
Deep Learning (DL) AI predictions
Green Learning Artificial Intelligence
Green Learning (GL) AI predictions
Radical Prostatectomy
Undergo RP
Cohort 1 Arm VI (MRI/TRUS, DL AI, GL AI, PIRADS)
Patients undergo MRI/TRUS followed by a targeted prostate biopsy using DL AI predictions. Patients then undergo a 2nd MRI/TRUS followed by a targeted prostate biopsy based on GL AI predictions. Patients then undergo a 3rd MRI/TRUS followed by a targeted biopsy using PIRADS. Patients undergo up to 12 additional prostate biopsies per SOC. Based on biopsy results, patients will either come off study or undergo radical prostatectomy without hormonal therapy within 180 days from baseline MRI.
Targeted Prostate Biopsy
Undergo targeted prostate biopsy
Prostate Imaging Reporting & Data System
PIRADS Assessment
Deep Learning Artificial Intelligence
Deep Learning (DL) AI predictions
Green Learning Artificial Intelligence
Green Learning (GL) AI predictions
Radical Prostatectomy
Undergo RP
Cohort 2 (Radical Prostatectomy Cohort)
Patients undergo MRI/TRUS then a radical prostatectomy (RP), which are performed per standard of care at our institution. PIRADS, GL AI, and DL AI will be used to interpret the MRI/TRUS results prior to RP.
Prostate Imaging Reporting & Data System
PIRADS Assessment
Deep Learning Artificial Intelligence
Deep Learning (DL) AI predictions
Green Learning Artificial Intelligence
Green Learning (GL) AI predictions
Radical Prostatectomy
Undergo RP
Interventions
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Targeted Prostate Biopsy
Undergo targeted prostate biopsy
Prostate Imaging Reporting & Data System
PIRADS Assessment
Deep Learning Artificial Intelligence
Deep Learning (DL) AI predictions
Green Learning Artificial Intelligence
Green Learning (GL) AI predictions
Radical Prostatectomy
Undergo RP
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Andre Luis Abreu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2025-03027
Identifier Type: REGISTRY
Identifier Source: secondary_id
4P-25-1
Identifier Type: OTHER
Identifier Source: secondary_id
4P-25-1
Identifier Type: -
Identifier Source: org_study_id
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