Randomized trial: PSMA PET/CT-guided robot-assisted prostate biopsy detected cancer in 97.1% versus 81.0% for cognitive MRI-fusion biopsy

In a single-centre randomized trial (NCT05137561), biopsy-naive men with PSA at least 4 ng/mL, abnormal digital rectal examination and PI-RADS 4-5 lesions were assigned to [68Ga]Ga-PSMA-11 PET/CT-guided robot-assisted biopsy or to cognitive MRI-ultrasound fusion biopsy. Prostate cancer was detected in 101 of 104 men (97.1%) versus 85 of 105 (81.0%), with major complications occurring only in the fusion-biopsy arm (n=5) and any complications in 10.8% versus 51.4%. The very high detection rates reflect a highly selected population: all participants had both an abnormal examination and a PI-RADS 4-5 lesion before randomization. This is a single-centre trial, so the comparison needs confirmation in multicentre settings before it can inform practice.