Opportunistic Prostate Cancer Screening with Biparametric Magnetic Resonance Imaging (VISIONING)

BackgroundThis study investigates the use of biparametric magnetic resonance imaging (bpMRI) as primary opportunistic screening for prostate cancer (PCa) without using a prostate-specific antigen (PSA) cut-off.ObjectiveThe primary endpoint was to assess the efforts and effectiveness of identifying 20 participants with clinically significant prostate cancer (csPCa) using bpMRI.Design, setting, and participantsBiopsy-naïve men aged over 45 yr were included. All participants underwent 3 Tesla bpMRI, PSA, and digital rectal examination (DRE). Targeted-only biopsy was performed in participants with Prostate Imaging Reporting and Data System (PI-RADS) ≥3. Men with negative bpMRI but suspicious DRE or elevated PSA/PSA density had template biopsies. Preintended protocol adjustments were made after an interim analysis for PI-RADS 3 lesions: no biopsy and follow-up MRI after 6 mo and biopsy only if lesions persisted or upgraded.Outcome measurements and statistical analysisBiopsy results underwent a comparison using Fisher's exact test and univariable logistic regression to identify prognostic factors for positive biopsy.Results and limitationsA total of 229 men were enrolled in this study, of whom 79 underwent biopsy. Among these men, 77 displayed suspicious PI-RADS lesions. PCa was detected in 29 participants (12.7%), of whom 21 had csPCa (9.2%). Biparametric MRI detected 21 csPCa cases, while PSA and DRE would have missed 38.1%. Protocol adjustment led to a 54.6% biopsy reduction in PI-RADS 3 lesions. Overall, in this cohort of men with a median PSA value of 1.26 ng/ml, 10.9 bpMRI scans were needed to identify one participant with csPCa. A major limitation of the study is the lack of a control cohort undergoing systematic biopsies.ConclusionsOpportunistic screening utilising bpMRI as a primary tool has higher sensitivity in detecting csPCa than classical screening methods.Patient summaryScreening with biparametric magnetic resonance imaging (bpMRI) and targeted biopsy identified clinically significant prostate cancer in every 11th man, regardless of the prostate-specific antigen (PSA) levels. Preselecting patients based on PSA >1 ng/ml and a positive family history of prostate cancer, as well as other potential blood tests may further improve the effectiveness of bpMRI in this setting.