Prostate cancer and prostatic diseases · 2026
The value of micro-ultrasound for prostate cancer screening: A retrospective real-world feasibility study.
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Wendler Johann Jakob, Bechstein Jonas, Buckendahl John, Kruck Stephan, Samtleben Christian, Liehr Bernd Uwe, Porsch Markus, Cash Hannes
Аннотация
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/mL2; PSAD-modified positive MUS included PRI-MUS categories 3 with PSAD ≥ 0.15 ng/mL2, 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.
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/mL2; PSAD-modified positive MUS included PRI-MUS categories 3 with PSAD ≥ 0.15 ng/mL2, 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.