Recruiting

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

Sponsor:

University of Southern California

Code:

NCT07162194

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 20+

Healthy Volunteers: Not accepted

Interventions

Targeted Prostate Biopsy

Prostate Imaging Reporting & Data System

Deep Learning Artificial Intelligence

Green Learning Artificial Intelligence

Radical Prostatectomy

Study Details

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 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

Prostate Carcinoma

Study ID

NCT07162194

Start date

Sep 19, 2025

Status verified date

Aug, 2026

Completion date

Oct 15, 2028

Anticipated

Primary completion date

Oct 15, 2027

Anticipated

Eligibility Criteria

Sex: Male

Age: 20+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

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

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 ]
CSPCa detection rate on GL AI-targeted and Deep Learning (DL) AI-targeted biopsies [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Ileana Aldana

323-865-0702 Ileana.aldana@med.usc.edu

Locations

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Andre Luis Abreu

323-865-3000 andre.abreu@med.usc.edu

Principal Investigator:

Andre Luis Abreu

More Information

Sponsor

University of Southern California

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-09-01.