The value of micro-ultrasound for prostate cancer screening: A retrospective real-world feasibility study

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Abstract Introduction Prostate cancer (PCa) screening is increasingly guided by imaging. High-resolution 29 MHz Micro-Ultrasound (MUS) offers a promising alternative to magnetic resonance imaging (MRI). Methods We retrospectively analyzed 682 consecutive men undergoing MUS and PSA testing during routine examination. Biopsy and MRI were performed according to guideline recommendations. PSA density (PSAD)-modified negative MUS included PRI-MUS categories 1, 2, or 3 with PSAD < 0.15 ng/mL 2 ; PSAD-modified positive MUS included PRI-MUS categories 3 with PSAD ≥ 0.15 ng/mL 2 , 4 or 5. Results Median age was 59 years; median PSA 1.2 ng/mL (IQR: 0.6–3.5). Biopsies were performed in 62 men, detecting PCa in 29 (47%), including 18 (29%) clinically significant PCa (csPCa). 88 men (13%) had PSAD-modified positive MUS, yielding 15 csPCa and 7 non-clinically significant PCa (ncsPCa). Among 594 men (87%) with PSAD-modified negative MUS, 3 csPCa and 4 ncsPCa were detected. Compared to PSA-based biopsy indication ≥3 ng/mL, PSAD-modified negative MUS would have avoided 13 negative, missing two csPCa and four ncsPCa. Compared to the MRI-based biopsy indication (PI-RADS ≥ 3, n = 38), PSAD-modified negative MUS ( n = 594) would have spared 3 negative biopsies, as well as 17 (24.7% of 69) MRIs due to negative biopsy, while missing 0 cases of csPCa. Additionally, MRI could have been omitted in 1csPCa case and 9 ncsPCa cases with positive MUS, and in 13 csPCa and 7 ncsPCa cases based on PSAD-modified positive MUS. The PSAD-modified-PRI-MUS-based screening pathway showed a 6.29-fold (OR = 0.16) reduction in overdiagnosis and 7.22-fold (OR = 0.14) reduction in negative biopsies/ncsPCa. MUS without PSA demonstrated an OR of 7.30 to detect csPCa. PSAD-modified-PRI-MUS score demonstrated a sensitivity of 83.3%, a specificity of 59.1%, a positive predictive value of 45.5% and a negative predictive value of 89.7% for distinguishing csPCa from benign/ncsPCa findings. Conclusion MUS enables effective PCa risk stratification in an opportunistic screening setting supporting prospective trial development. Trial Registration This study is part of the PROSTAMUS trial, registered in the DRKS/WHO registry.

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