MRI-Based Machine Learning Approach Versus Radiologist MRI Reading for the Detection of Prostate Cancer, The PRIMER Trial

Conditions

• Prostate Carcinoma

Eligibility Criteria

Sex

MALE

Age

20 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Targeted Prostate Biopsy — PROCEDURE
  Undergo targeted prostate biopsy
• Prostate Imaging Reporting & Data System — DIAGNOSTIC_TEST
  PIRADS Assessment
• Deep Learning Artificial Intelligence — DIAGNOSTIC_TEST
  Deep Learning (DL) AI predictions
• Green Learning Artificial Intelligence — DIAGNOSTIC_TEST
  Green Learning (GL) AI predictions
• Radical Prostatectomy — PROCEDURE
  Undergo RP

Study Details

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.

Key Dates

Start date

Sep 19, 2025

Status verified

Jan 2026

Primary completion

Oct 15, 2027

Completion

Oct 15, 2028

Study Design

Enrollment

130 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.

Primary Outcome Measure

Clinically-significant prostate cancer (CSPCa) detection rate on Green Learning (GL) artificial intelligence (AI)-targeted and Prostate Imaging-Reporting and Data System (PIRADS)-targeted biopsies [ Time Frame: Up to 3 months ]

Central Contacts

• Ileana Aldana
  323-865-0702
  [email protected]

Locations (1)

Find similar trials in Los Angeles, CA

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