NCT07162194

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
29mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Sep 2025Oct 2028

First Submitted

Initial submission to the registry

August 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

September 19, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2028

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

August 29, 2025

Last Update Submit

January 8, 2026

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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

    Detection rates of PIRADS and GL AI-targeted biopsy will be evaluated per index region of interest (ROI), respectively.

    Up to 3 months

  • CSPCa detection rate on GL AI-targeted and Deep Learning (DL) AI-targeted biopsies

    Detection rates of GL AI and DL AI targeted biopsy will be evaluated per index ROI, respectively.

    Up to 3 months

Secondary Outcomes (4)

  • 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

Study Arms (7)

Cohort 1 Arm I (MRI/TRUS, PIRADS, GL AI, DL AI)

EXPERIMENTAL

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.

Procedure: Targeted Prostate BiopsyDiagnostic Test: Prostate Imaging Reporting & Data SystemDiagnostic Test: Deep Learning Artificial IntelligenceDiagnostic Test: Green Learning Artificial IntelligenceProcedure: Radical Prostatectomy

Cohort 1 Arm II (MRI/TRUS, PIRADS, DL AI, GL AI)

EXPERIMENTAL

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.

Procedure: Targeted Prostate BiopsyDiagnostic Test: Prostate Imaging Reporting & Data SystemDiagnostic Test: Deep Learning Artificial IntelligenceDiagnostic Test: Green Learning Artificial IntelligenceProcedure: Radical Prostatectomy

Cohort 1 Arm III (MRI/TRUS, GL AI, PIRADS, DL AI)

EXPERIMENTAL

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.

Procedure: Targeted Prostate BiopsyDiagnostic Test: Prostate Imaging Reporting & Data SystemDiagnostic Test: Deep Learning Artificial IntelligenceDiagnostic Test: Green Learning Artificial IntelligenceProcedure: Radical Prostatectomy

Cohort 1 Arm IV (MRI/TRUS, GL AI, DL AI, PIRADS)

EXPERIMENTAL

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.

Procedure: Targeted Prostate BiopsyDiagnostic Test: Prostate Imaging Reporting & Data SystemDiagnostic Test: Deep Learning Artificial IntelligenceDiagnostic Test: Green Learning Artificial IntelligenceProcedure: Radical Prostatectomy

Cohort 1 Arm V (MRI/TRUS, DL AI, PIRADS, GL AI)

EXPERIMENTAL

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.

Procedure: Targeted Prostate BiopsyDiagnostic Test: Prostate Imaging Reporting & Data SystemDiagnostic Test: Deep Learning Artificial IntelligenceDiagnostic Test: Green Learning Artificial IntelligenceProcedure: Radical Prostatectomy

Cohort 1 Arm VI (MRI/TRUS, DL AI, GL AI, PIRADS)

EXPERIMENTAL

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.

Procedure: Targeted Prostate BiopsyDiagnostic Test: Prostate Imaging Reporting & Data SystemDiagnostic Test: Deep Learning Artificial IntelligenceDiagnostic Test: Green Learning Artificial IntelligenceProcedure: Radical Prostatectomy

Cohort 2 (Radical Prostatectomy Cohort)

EXPERIMENTAL

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.

Diagnostic Test: Prostate Imaging Reporting & Data SystemDiagnostic Test: Deep Learning Artificial IntelligenceDiagnostic Test: Green Learning Artificial IntelligenceProcedure: Radical Prostatectomy

Interventions

Targeted Prostate BiopsyPROCEDURE

Undergo targeted prostate biopsy

Also known as: TB, Prostate Biopsy, PBx
Cohort 1 Arm I (MRI/TRUS, PIRADS, GL AI, DL AI)Cohort 1 Arm II (MRI/TRUS, PIRADS, DL AI, GL AI)Cohort 1 Arm III (MRI/TRUS, GL AI, PIRADS, DL AI)Cohort 1 Arm IV (MRI/TRUS, GL AI, DL AI, PIRADS)Cohort 1 Arm V (MRI/TRUS, DL AI, PIRADS, GL AI)Cohort 1 Arm VI (MRI/TRUS, DL AI, GL AI, PIRADS)
Prostate Imaging Reporting & Data SystemDIAGNOSTIC_TEST

PIRADS Assessment

Also known as: PIRADS
Cohort 1 Arm I (MRI/TRUS, PIRADS, GL AI, DL AI)Cohort 1 Arm II (MRI/TRUS, PIRADS, DL AI, GL AI)Cohort 1 Arm III (MRI/TRUS, GL AI, PIRADS, DL AI)Cohort 1 Arm IV (MRI/TRUS, GL AI, DL AI, PIRADS)Cohort 1 Arm V (MRI/TRUS, DL AI, PIRADS, GL AI)Cohort 1 Arm VI (MRI/TRUS, DL AI, GL AI, PIRADS)Cohort 2 (Radical Prostatectomy Cohort)
Deep Learning Artificial IntelligenceDIAGNOSTIC_TEST

Deep Learning (DL) AI predictions

Also known as: DL AI
Cohort 1 Arm I (MRI/TRUS, PIRADS, GL AI, DL AI)Cohort 1 Arm II (MRI/TRUS, PIRADS, DL AI, GL AI)Cohort 1 Arm III (MRI/TRUS, GL AI, PIRADS, DL AI)Cohort 1 Arm IV (MRI/TRUS, GL AI, DL AI, PIRADS)Cohort 1 Arm V (MRI/TRUS, DL AI, PIRADS, GL AI)Cohort 1 Arm VI (MRI/TRUS, DL AI, GL AI, PIRADS)Cohort 2 (Radical Prostatectomy Cohort)
Green Learning Artificial IntelligenceDIAGNOSTIC_TEST

Green Learning (GL) AI predictions

Also known as: GL AI
Cohort 1 Arm I (MRI/TRUS, PIRADS, GL AI, DL AI)Cohort 1 Arm II (MRI/TRUS, PIRADS, DL AI, GL AI)Cohort 1 Arm III (MRI/TRUS, GL AI, PIRADS, DL AI)Cohort 1 Arm IV (MRI/TRUS, GL AI, DL AI, PIRADS)Cohort 1 Arm V (MRI/TRUS, DL AI, PIRADS, GL AI)Cohort 1 Arm VI (MRI/TRUS, DL AI, GL AI, PIRADS)Cohort 2 (Radical Prostatectomy Cohort)
Radical ProstatectomyPROCEDURE

Undergo RP

Also known as: RP
Cohort 1 Arm I (MRI/TRUS, PIRADS, GL AI, DL AI)Cohort 1 Arm II (MRI/TRUS, PIRADS, DL AI, GL AI)Cohort 1 Arm III (MRI/TRUS, GL AI, PIRADS, DL AI)Cohort 1 Arm IV (MRI/TRUS, GL AI, DL AI, PIRADS)Cohort 1 Arm V (MRI/TRUS, DL AI, PIRADS, GL AI)Cohort 1 Arm VI (MRI/TRUS, DL AI, GL AI, PIRADS)Cohort 2 (Radical Prostatectomy Cohort)

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Andre Luis Abreu, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ileana Aldana

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 9, 2025

Study Start

September 19, 2025

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2028

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

US(1)