Recruiting

AI Prostate MRI

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07084779

Conditions

Prostate Cancer

Prostatic Neoplasm

Cancer of the Prostate

Neoplasms, Prostate

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

AI

Study Details

Brief summary:

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

Prostate Cancer

Prostatic Neoplasm

Cancer of the Prostate

Neoplasms, Prostate

Study ID

NCT07084779

Start date

Sep 9, 2025

Status verified date

May, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pre-biopsy MRI is of low quality
  • PI-QUAL score of 1 using PI-QUAL version 2

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: AI-aided MRI & Prostate Biopsy

Interventions

AI

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

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 and Locations

Central contacts

Andrei Purysko, MD

216-445-9005puryska@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Andrei Purysko

216-445-9005puryska@ccf.org

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • Artificial Intelligence
  • Magnetic Resonance Imaging
  • Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-05-15.