Investigation of Impact of AI on Prostate Cancer Workflow

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07084779
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Not accepted

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

Study Details

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 Dates

Start date
Sep 9, 2025
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: AI-aided MRI & Prostate Biopsy

Primary Outcome Measure

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) [ Time Frame: One-time MRI, up to 30 days post-enrollment in study. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195
Andrei Purysko
[email protected]
216-445-9005

Find similar trials in Cleveland, OH

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Cleveland Clinic Foundation· Cleveland, OH

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