A new international clinical trial, the PARADIGM trial, will compare artificial intelligence (AI) against radiologists in detecting clinically significant prostate cancer on MRI scans. This initiative addresses a projected doubling of prostate cancer cases globally over the next two decades and an anticipated radiologist shortfall.
The trial will enroll 500 men across 45 centers in 14 countries, starting recruitment in early 2026. Participants will undergo standard MRI, with interpretations made independently by both a radiologist and an AI algorithm. The study aims to determine if AI can match radiologist performance in identifying cancer, defined as Gleason grade group ≥2. The findings will provide crucial level-1 evidence on AI's role in prostate MRI diagnosis.