Investigation of Impact of AI on Prostate Cancer Workflow

NCT07084779 | Recruiting DMC

• 1 other identifier: CASE3825
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll participants who are undergoing an MRI before a prostate biopsy due to suspected prostate cancer. The purpose of this study is to see if the use of Artificial Intelligence (AI) helps detect lesions on an MRI better than a radiologist not using AI. The AI Rad Companion (AIRC) Prostate MRI application is a software that uses measurements of the prostate and will be utilized in this study to help detect potential cancerous lesions. The AI software will assign the lesions a PI-RADS score, which is a way to measure the chance of the lesion being cancer. There are two parts to this study. The first part involves comparing the interpretation of prostate MRI images by a radiologist alone, a radiologist aided by AI, and AI alone. A systematic biopsy will be completed per standard of care. The radiologist may opt to include up to 2 additional AI-identified targets to biopsy in addition to those biopsied for standard of care. The second part of the study involves utilizing the MRI images from the first part of the study in addition to retrospective prostate MRI images. These de-identified images, along with Prostate Image Quality (PI-QUAL) scores, clinical data, and biopsy results will be sent to Siemens in order to aid in the development of methods to identify good or bad image quality in prostate MRI images.

Conditions

Prostate Cancer; Prostatic Neoplasm; Cancer of the Prostate; Neoplasms, Prostate

Keywords

Artificial Intelligence; Magnetic Resonance Imaging; Biopsy

Outcome Measures

Primary Outcomes (1)

• Readers' (radiologists') mean quadrant-level area under the receiver operating characteristic curve (AUC) in predicting the presence or absence of clinically significant prostate cancer (csPCa)

  csPCa is defined as Gleason grade group ≥ 2.

  One-time MRI, up to 30 days post-enrollment in study.

Secondary Outcomes (8)

• Inter-reader agreement on the presence/absence of csPCa at the participant-level

  One-time MRI, up to 30 days post-enrollment in study.

• Inter-reader agreement on the presence/absence of csPCa at the quadrant-level

  One-time MRI, up to 30 days post-enrollment in study.

• Participant-level sensitivity for detection of clinically significant prostate cancer

  One-time MRI, up to 30 days post-enrollment in study.

• Participant-level specificity for detection of clinically significant prostate cancer

  One-time MRI, up to 30 days post-enrollment in study.

• Quadrant-level sensitivity for detection of clinically significant prostate cancer

  One-time MRI, up to 30 days post-enrollment in study.

Study Arms (1)

AI-aided MRI & Prostate Biopsy

EXPERIMENTAL

Device: AI

Interventions

AI DEVICE

Following the completion of a pre-biopsy prostate MRI, the radiologist will interpret the MRI. Once interpreted by the radiologist alone, the radiologist will interpret the scan while aided by AI. A systematic biopsy in conjunction with radiologist-identified targets will be completed per standard of care, with the optional inclusion of up to 2 AI-detected targets. When completing a biopsy per SOC, the prostate is divided into quadrants. In addition to noted targets, samples are taken systematically from each quadrant. If targets are detected by AI that were not identified by the physician when reviewing the MRI, these targets will be sampled. Sampling of these targets will not be in addition to the systematic sampling in each quadrant, but in place of up to two of the samples biopsied systematically

AI-aided MRI & Prostate Biopsy

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Plan of care is to undergo a biopsy of the prostate after a pre-biopsy MRI
• Age 55-80
• Prostate-specific antigen (PSA) between 3-10 ng/mL
• No prior diagnosis or treatment of prostate cancer

You may not qualify if:

• Pre-biopsy MRI is of low quality
• PI-QUAL score of 1 using PI-QUAL version 2

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• Siemens Medical Solutions: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andrei Purysko, MD

  Case Comprehensive Cancer Center, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrei Purysko, MD

CONTACT

216-445-9005; puryska@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: September 9, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)