Using AI to help find prostate cancer on MRI
Official title: Investigation of Impact of AI on Prostate Cancer Workflow
Run by Case Comprehensive Cancer Center · NCT07084779 · Data updated 2026-11-12
This study tests whether an AI software can help doctors find suspicious lesions on prostate MRI in men aged 55–80 who are having a pre-biopsy MRI and planned prostate biopsy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years to 80 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | September 9, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07084779 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 55–80 with PSA 3–10 ng/mL who have not had prior prostate cancer and who are planning a prostate biopsy after a pre-biopsy MRI.
✕Probably not a fit
Patients with prior prostate cancer or treatment, those whose pre-biopsy MRI is low quality or has a PI-QUAL score of 1, or those outside the specified age and PSA ranges are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Men scheduled for a prostate biopsy after a pre-biopsy MRI will have their MRI images interpreted three ways: by a radiologist alone, by a radiologist using the AI tool, and by the AI tool alone. A systematic biopsy will be performed per standard of care, and the radiologist may choose to biopsy up to two additional AI-identified targets. The study compares lesion detection and PI-RADS scoring across the three interpretive approaches. Participation mainly involves consent review; MRI and biopsy follow routine clinical care.
Why it matters
Potential benefit: If successful, the AI could help detect more clinically significant prostate cancers on MRI and reduce missed lesions.
How similar studies have gone: Prior studies of AI for prostate MRI have shown promise in improving lesion detection and standardizing reads, but results vary and larger real-world comparisons remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Cleveland Clinic Foundation
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Andrei Purysko, MD — Case Comprehensive Cancer Center, Cleveland Clinic
- Study coordinator: Andrei Purysko, MD
- Email: puryska@ccf.org
- Phone: 216-445-9005
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.