Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deep Learning Artificial Intelligence | Diagnostic Test | — | UNRESOLVED |
| Green Learning Artificial Intelligence | Diagnostic Test | — | UNRESOLVED |
| Prostate Imaging Reporting & Data System | Diagnostic Test | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
| Targeted Prostate Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Cohort 1 Arm I (MRI/TRUS, PIRADS, GL AI, DL AI)
- description
- 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.
- interventionNames
- Procedure: Targeted Prostate Biopsy
- Diagnostic Test: Prostate Imaging Reporting & Data System
- Diagnostic Test: Deep Learning Artificial Intelligence
- Diagnostic Test: Green Learning Artificial Intelligence
- Procedure: Radical Prostatectomy
- type
- EXPERIMENTAL
- label
- Cohort 1 Arm II (MRI/TRUS, PIRADS, DL AI, GL AI)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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 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 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
References
Publications (0)
Data not yet available