Results from a PI-RADS-based MRI-directed diagnostic pathway for biopsy-naive patients in a non-university hospital

PURPOSE: To assess the safety and performance of a MRI-directed diagnostic pathway for patients with first-time suspicion of prostate cancer in a non-university hospital. METHODS: Between May 2017 and December 2018 all biopsy-naive patients examined in our hospital followed a MRI-directed diagnostic work-up algorithm based on PI-RADS score. In short, PI-RADS 1–2 was generally not biopsied and PI-RADS 3–5 was reviewed by a multidisciplinary team. Patients with PI-RADS 4-5 were all referred to biopsy, either transrectal ultrasound-guided biopsy or MRI in-bore biopsy for small tumors and for sites difficult to access. PI-RADS scores were compared to the histopathology from biopsies and surgical specimens for patients who had prostatectomy. Non-biopsied patients were referred to a safety net monitoring regimen. RESULTS: Two hundred and ninety-eight men were enrolled. 97 (33%) had PI-RADS 1–2, 44 (15%) had PI-RADS 3, and 157 (53%) had PI-RADS 4–5. 116 (39%) of the patients avoided biopsy. None of these were diagnosed with significant cancer within 2–3.5 years of safety net monitoring. Almost all high ISUP grade groups (≥ 3) were in the PI-RADS 4–5 category (98%). Prostatectomy specimens and systematic biopsies from MRI-negative areas indicated that very few clinically significant cancers were missed by the MRI-directed diagnostic pathway. CONCLUSION: Our findings add to evidence that a MRI-directed diagnostic pathway can be safely established in a non-university hospital. The pathway reduced the number of biopsies and reliably detected the site of the most aggressive cancers. GRAPHIC ABSTRACT: [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00261-021-03249-8.