Actively Recruiting
Investigation of Impact of AI on Prostate Cancer Workflow
Led by Case Comprehensive Cancer Center · Updated on 2025-11-26
150
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
Sponsors
C
Case Comprehensive Cancer Center
Lead Sponsor
S
Siemens Medical Solutions
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Investigation of Impact of AI on Prostate Cancer Workflow
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Pre-biopsy MRI is of low quality
- PI-QUAL score of 1 using PI-QUAL version 2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
A
Andrei Purysko, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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