NCT07231627 – A Prospective Randomized Phase I/II Study of Artificial Intelligence Algorithm-Informed Biopsy for Detection of Prostate Cancer in Patients with Indeterminate and Low-risk prostate MRI lesions
July 14, 2026
This is a UAMS investigator-initiated trial studying whether an artificial intelligence algorithm can improve detection of prostate cancer in patients whose prostate MRI shows indeterminate or low risk lesions, a group where the decision to biopsy is often unclear under current imaging based risk categories (PI-RADS). The study randomizes patients to biopsy guided by the AI algorithm’s assessment of the lesion versus the standard approach, to see whether AI-informed targeting improves the detection of clinically significant prostate cancer in this ambiguous risk group. The trial is not yet recruiting, with an estimated start in mid-2026 and primary completion expected in January 2028.