A Head-to-head Comparison of Prostate Cancer Diagnostic Strategies Using the Stockholm3 Test, Magnetic Resonance Imaging, and Swedish National Guidelines: Results from a Prospective Population-based Screening Study.

Background: Strategies for early detection of prostate cancer aim to detect clinically significant prostate cancer (csPCa) and avoid detection of insignificant cancers and unnecessary biopsies. Swedish national guidelines (SNGs), years 2019 and 2020, involve prostate-specific antigen (PSA) testing, clinical variables, and magnetic resonance imaging (MRI). The Stockholm3 test and MRI have been suggested to improve selection of men for prostate biopsy. Performance of SNGs compared with the Stockholm3 test or MRI in a screening setting is unclear.

Objective: To compare strategies based on previous and current national guidelines, Stockholm3, and MRI to select patients for biopsy in a screening-by-invitation setting.

Design Setting And Participants: All participants underwent PSA test, and men with PSA ≥3 ng/ml underwent Stockholm3 testing and MRI. Men with Stockholm3 ≥11%, Prostate Imaging Reporting and Data System score ≥3 on MRI, or indication according to SNG-2019 or SNG-2020 were referred to biopsy.

Outcome Measurements And Statistical Analysis: The primary outcome was the detection of csPCa at prostate biopsy, defined as an International Society of Urological Pathology (ISUP) grade of ≥2.

Results And Limitations: We invited 8764 men from the general population, 272 of whom had PSA ≥3 ng/ml. The median PSA was 4.1 (interquartile range: 3.4-5.8), and 136 of 270 (50%) who underwent MRI lacked any pathological lesions. In total, 37 csPCa cases were diagnosed. Using SNG-2019, 36 csPCa cases with a high biopsy rate (179 of 272) were detected and 49 were diagnosed with ISUP 1 cancers. The Stockholm3 strategy diagnosed 32 csPCa cases, with 89 biopsied and 27 ISUP 1 cancers. SNG-2020 detected 32 csPCa and 33 ISUP 1 cancer patients, with 99 men biopsied, and the MRI strategy detected 30 csPCa and 35 ISUP 1 cancer cases by biopsying 123 men. The latter two strategies generated more MRI scans than the Stockholm3 strategy ( = 270 vs 33).

Conclusions: Previous guidelines provide high detection of significant cancer but at high biopsy rates and detection of insignificant cancer. The Stockholm3 test may improve diagnostic precision compared with the current guidelines or using only MRI.

Patient Summary: The Stockholm3 test facilitates detection of significant cancer, and reduces the number of biopsies and detection of insignificant cancer.