Randomized trial of biomarker versus MRI-enhanced strategies for prostate cancer screening

Prostate cancer guidelines often recommend obtaining MRI before a biopsy, yet MRI access is limited. The STHLM3-MRI randomized clinical trial in Sweden compared biomarker-based risk estimation (Stockholm 3 risk score or PSA levels) with systematic biopsies versus an MRI-enhanced strategy (PSA levels and MRI with systematic and targeted biopsy) for the detection of clinically significant prostate cancer in a screening setting. In this randomized clinical trial of 12,743 men with no previous prostate cancer diagnosis, a blood-based biomarker (Stockholm3 risk score ≥ 0.15) combined with systematic biopsies detected clinically significant prostate cancer at levels comparable with MRI-targeted biopsies based on PSA levels. However, the biomarker-based approach resulted in more biopsies and detected a greater number of indolent cancers. The authors conclude that in regions with limited access to MRI, use of blood-based biomarkers could be a feasible alternative for prostate cancer screening.