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-naive 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 Fishers 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.
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT03749993
Funding StatementThis study was funded by the Departments of Urology and Radiology at the University Hospital of Basel.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The Swiss Association of Research Ethics Committees gave ethical approval for this work
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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors
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