Investigation of Impact of AI on Prostate Cancer Workflow

ConditionsProstate Cancer Prostatic Neoplasm Cancer of the Prostate Neoplasms, Prostate

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age55-80

SponsorCase Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pre-biopsy MRI is of low quality

PI-QUAL score of 1 using PI-QUAL version 2

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: AI-aided MRI & Prostate BiopsyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame