Early Activation of a Multilevel Prostate Cancer Screening Model: Pilot Phase Results and Strategic Perspectives in Lombardy Region

<b>Background/Objectives</b>: Prostate cancer is the most frequently diagnosed cancer among men in Italy, yet no national population-based screening program exists. In response to new European Council recommendations, the Lombardy Region launched a pilot in November 2024 to assess the feasibility of a digitally enabled, risk-adapted screening model. <b>Methods</b>: Men turning 50 were invited to voluntarily self-enroll through the regional electronic health record (FSE). A digital questionnaire assessed eligibility and family history (FH); eligible individuals (97,849 men without a PSA test in the past two years in the regional database) were offered free PSA testing. Risk stratification guided follow-up: men with PSA >3 ng/mL or a positive FH were referred to urology; others were assigned 2- or 5-year recall based on PSA level. <b>Results</b>: By June 2025, 8558 men had enrolled (8.7% uptake), 6072 were eligible; 644 (10.6%) reported a positive FH. Among those tested, 58.4% had PSA < 1 ng/mL and were FH-negative, 25.8% had PSA > 1 and <3 ng/mL and were FH-negative, and 15.9% met referral criteria. Digital triage was efficient and ensured care continuity without burdening specialists. Participation varied by local health authority (ATS), depending on implementation context. Preliminary data show a 25.9% reduction in urology consultations and a 35% reduction in MRI use compared to standard care, with no biopsy rate increase. <b>Conclusions</b>: The pilot demonstrates the technical feasibility, safety, low administrative burden, and potential sustainability of digital, risk-stratified prostate cancer screening. While participation was low without active invitations, early results support expansion with improved outreach. Lombardy's experience offers a scalable, EU-aligned model for broader implementation across Italy and other health systems seeking to balance early detection with resource efficiency.