NCT07084779Recruiting
Investigation of Impact of AI on Prostate Cancer Workflow
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 17 Jul 2025
- Start date
- 9 Sept 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Case Comprehensive Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT07084779
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 9 Sept 2025 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Pre-biopsy MRI is of low quality
- PI-QUAL score of 1 using PI-QUAL version 2
Who the study is looking for
- 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
Age in the registry: 55 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.