6/29/23, 11:45 PM STHLM3MR-2 Pathway Feedback Search Clinical Topics Home Studies STHLM3MR 2 STHLM3MR 2 Disease Prostate cancer Trial question Is MRI with targeted biopsy noninferior to standard biopsy in prostate cancer screening? Study design Multi-center Open label RCT Population 1532 male patients Inclusion criteria: men aged 50 to 74 years with PSA levels 3 ng/mL Key exclusion criteria: previous diagnosis of prostate cancer; a prostate biopsy within 60 days of invitation; contraindication to MRI; severe illness Interventions N=929 MRI-targeted biopsy (MRI with targeted and standard biopsy if the MRI results suggested prostate cancer) N=603 standard biopsy (systematic biopsy of the prostate if PSA 3 ng/mL) Primary outcome Detection of a clinically significant cancer 21.0 % 21 18 15.8 % 10.5 % Difference not exceeding nonferiority margin 5.3 % 0.0 % https://web.pathway.md/studies/recVpm2i7SCqs2DnF 1/2 6/29/23, 11:45 PM STHLM3MR-2 Pathway MRI-targeted biopsy Standard biopsy Difference not exceeding nonferiority margin in the detection of a clinically significant cancer (21% vs. 18%; AD 3%, 95% CI -1 to 7) Secondary outcomes Significant decrease in the detection of a clinically insignificant cancer (4% vs. 12%; ARD -8, 95% CI -11 to -5) Significant decrease in benign biopsy findings (11% vs. 43%; ARD -32, 95% CI -36 to -27) Safety outcomes No significant difference in post-biopsy infections and hospitalization. Conclusion In men aged 50 to 74 years with PSA levels 3 ng/mL, MRI-targeted biopsy was noninferior to standard biopsy with respect to the detection of a clinically significant cancer. Reference Martin Eklund, Fredrik J derling, Andrea Discacciati et al. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021 Sep 2;385(10):908-920. Open reference URL https://web.pathway.md/studies/recVpm2i7SCqs2DnF 2/2