Opportunistic PSA-free prostate cancer screening utilising biparametric MRI (VISIONING)

Background Literature suggests that prostate MRI exhibits better predictive capabilities compared to prostate-specific antigen (PSA) in detecting prostate cancer (PCa). Based on this, our present study investigates biparametric MRI (bpMRI) as a PSA-independent screening tool for PCa. Objective The primary endpoint was to assess the efforts and effectiveness of identifying 20 participants with clinically significant prostate cancer (csPCa) using bpMRI. Design, Setting, and Participants Biopsy-naïve men aged over 45 years were included. All participants underwent 3 Tesla bpMRI, PSA and digital rectal examination (DRE). Targeted-only biopsy was performed in participants with a suspicious lesion (PI-RADS≥3). Men with a negative bpMRI but suspicious DRE or elevated PSA had template biopsies. Pre-intended protocol adjustments were made post-interim analysis for PI-RADS 3 lesions: follow-up mpMRI after 6 months, biopsy only if lesions persisted or upgraded. Outcome Measurements and Statistical Analysis Biopsy results underwent comparison using Fisher’s exact test and univariable logistic regression to pinpoint prognostic factors for positive biopsy. Results and Limitations A total of 229 participants were enrolled in this analysis. Among these, 77 displayed suspicious PI-RADS lesions. A total of 79 participants underwent a biopsy. PCa was detected in 29 participants, of whom 21 had csPCa. BpMRI detected all 21 csPCa, whereas PSA and DRE missed 66.7%. Protocol adjustment led to a 54.6 % biopsy reduction in PI-RADS 3 lesions. Overall, 10.9 bpMRIs were needed to identify one participant with csPCa. A major limitation of the study is the lack of a control cohort undergoing template biopsies. Conclusions Opportunistic screening utilising bpMRI as primary tool reveals participants with csPCa that traditional methods might overlook, even at low PSA levels. Patient summary Screening with bpMRI and targeted biopsy identified csPCa in every 11 th man, regardless of PSA levels. Preselecting patients based on PSA > 1 ng/ml and positive family history of PCa as well as other potential blood tests may further improve the effectiveness of bpMRI in this setting.