Actively Recruiting

Phase Not Applicable
Age: 55Years - 80Years
All Genders
NCT07084779

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

Age: 55Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

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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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