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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Targeted Prostate Biopsy (Procedure)
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.
Intervention: Radical Prostatectomy (Procedure)
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.
Intervention: Prostate Imaging Reporting & Data System (Diagnostic Test)
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.
Intervention: Deep Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Green Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Radical Prostatectomy (Procedure)
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.
Intervention: Targeted Prostate Biopsy (Procedure)
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.
Intervention: Prostate Imaging Reporting & Data System (Diagnostic Test)
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.
Intervention: Deep Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Green Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Radical Prostatectomy (Procedure)
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.
Intervention: Targeted Prostate Biopsy (Procedure)
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.
Intervention: Prostate Imaging Reporting & Data System (Diagnostic Test)
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.
Intervention: Deep Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Green Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Radical Prostatectomy (Procedure)
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.
Intervention: Targeted Prostate Biopsy (Procedure)
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.
Intervention: Prostate Imaging Reporting & Data System (Diagnostic Test)
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.
Intervention: Deep Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Green Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Radical Prostatectomy (Procedure)
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.
Intervention: Targeted Prostate Biopsy (Procedure)
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.
Intervention: Prostate Imaging Reporting & Data System (Diagnostic Test)
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.
Intervention: Deep Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Green Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Radical Prostatectomy (Procedure)
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.
Intervention: Targeted Prostate Biopsy (Procedure)
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.
Intervention: Prostate Imaging Reporting & Data System (Diagnostic Test)
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.
Intervention: Deep Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Green Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Radical Prostatectomy (Procedure)
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.
Intervention: Prostate Imaging Reporting & Data System (Diagnostic Test)
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.
Intervention: Deep Learning Artificial Intelligence (Diagnostic Test)
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.
Intervention: Green Learning Artificial Intelligence (Diagnostic Test)
Outcomes
Primary Outcomes
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
Detection rates of PIRADS and GL AI-targeted biopsy will be evaluated per index region of interest (ROI), respectively.
CSPCa detection rate on GL AI-targeted and Deep Learning (DL) AI-targeted biopsies
Time Frame: Up to 3 months
Detection rates of GL AI and DL AI targeted biopsy will be evaluated per index ROI, respectively.
Secondary Outcomes
- Patient-level diagnostic performance of GL AI and PIRADS for CSPCa detection(Up to 3 months)
- Targeted biopsy core characteristics(Up to 3 months)
- Predictors for patient-level CSPCa detection(Up to 3 months)
- Dice score and linear correlation coefficient of CSPCa distribution on radical prostatectomy (RP) specimens and ROI generated by GL AI, DL AI and PIRADS(Up to 3 months)