NCT07084779 Investigation of Impact of AI on Prostate Cancer Workflow
| NCT ID | NCT07084779 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-09-09 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Andrei Purysko, MD
PRINCIPAL INVESTIGATOR
Case Comprehensive Cancer Center, Cleveland Clinic
Frequently Asked Questions
Who can join the NCT07084779 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 80 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07084779 currently recruiting?
Yes, NCT07084779 is actively recruiting participants. Contact the research team at puryska@ccf.org for enrollment information.
Where is the NCT07084779 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07084779 clinical trial?
NCT07084779 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Andrei Purysko, MD at Case Comprehensive Cancer Center, Cleveland Clinic. The trial plans to enroll 150 participants.
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