Investigation of Impact of AI on Prostate Cancer Workflow

Recruiting now · Not applicable

Conditions studied: Prostate Cancer, Prostatic Neoplasm, Cancer of the Prostate, Neoplasms, Prostate

In brief

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.

Key facts

Study ID

NCT07084779

Run by

Case Comprehensive Cancer Center

People needed

150

Starts

2025-09-09

Expected to finish

2026-11-30

Last updated by the study team

2026-05-15

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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