Prostate multiparametric MRI is now standard for suspected cancer, but global resource limits prevent widespread use. The PARADIGM trial aims to determine if Artificial Intelligence (AI) can match or exceed radiologist accuracy in identifying clinically significant prostate cancer. This is crucial as prostate cancer incidence is predicted to double globally in the next two decades, while a significant radiologist shortfall is projected.
PARADIGM is a prospective, multicenter study recruiting 500 men over 18 months. Participants will undergo standard MRI scans. An AI algorithm and a radiologist will independently analyze the images, both blinded to each other's findings. The radiologist can then override AI results for safety. Biopsies will be performed on suspicious lesions identified by either method.
Eighty-one centers across 25 countries have shown interest in participating. The trial will open for recruitment in October 2026, providing the first Level 1 evidence on AI's diagnostic performance for prostate cancer detection via MRI.