RECRUITING

Investigation of Impact of AI on Prostate Cancer Workflow

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigation of Impact of AI on Prostate Cancer Workflow

Quick Facts

Study Start:2025-07-17
Study Completion:2026-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07084779

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Plan of care is to undergo a biopsy of the prostate after a pre-biopsy MRI
  2. * Age 55-80
  3. * Prostate-specific antigen (PSA) between 3-10 ng/mL
  4. * No prior diagnosis or treatment of prostate cancer
  1. * Pre-biopsy MRI is of low quality
  2. * PI-QUAL score of 1 using PI-QUAL version 2

Contacts and Locations

Study Contact

Andrei Purysko, MD
CONTACT
216-445-9005
puryska@ccf.org

Principal Investigator

Andrei Purysko, MD
PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center, Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Andrei Purysko, MD, PRINCIPAL_INVESTIGATOR, Case Comprehensive Cancer Center, Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-17
Study Completion Date2026-03-30

Study Record Updates

Study Start Date2025-07-17
Study Completion Date2026-03-30

Terms related to this study

Keywords Provided by Researchers

  • Artificial Intelligence
  • Magnetic Resonance Imaging
  • Biopsy

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Prostatic Neoplasm
  • Cancer of the Prostate
  • Neoplasms, Prostate