AI Algorithm-Informed Biopsy for Prostate Cancer Detection With Indeterminate and Low-Risk Prostate MRI Lesions
NCT07231627 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-05-19
Summary
Use of AI algorithm for PCa detection is feasible, and AI-informed biopsies (AI-targeted and perilesional biopsy) improves csPCa detection in patients with indeterminate MRI lesions and in patients with low-risk MRI lesions and high-risk clinical features.
Conditions
Interventions
- DEVICE
-
Bi-parametric MRI-based cascaded deep-learning AI algorithm
Artificial intelligence system used in medical imaging, primarily for the automated detection and classification of lesions (such as prostate cancer) using only specific types of magnetic resonance imaging (MRI) data.
Sponsors & Collaborators
-
University of Arkansas
lead OTHER
Principal Investigators
-
Ahmet M Aydin, MD · University of Arkansas
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2028-01-31
- Completion
- 2029-01-31
Countries
- United States
Study Locations
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