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. 2025 May;85(6):603-611.
doi: 10.1002/pros.24862. Epub 2025 Jan 28.

Optimizing Prostate Cancer Diagnostic Work-Up Through Micro-Ultrasound: Minimizing Unnecessary Procedures and Reducing Overdiagnoses

Edoardo Beatrici  1   2 , Fabio De Carne  1   2 , Nicola Frego  1   2 , Stefano Moretto  1   2 , Marco Paciotti  2 , Vittorio Fasulo  2 , Alessandro Uleri  1   2 , Giuseppe Garofano  1   2 , Pier Paolo Avolio  1   2 , Giuseppe Chiarelli  1   2 , Roberto Contieri  1   2 , Paola Arena  1   2 , Cesare Saitta  1   2 , Federica Sordelli  1   2 , Alberto Saita  2 , Rodolfo Hurle  2 , Paolo Casale  2 , NicolòMaria Buffi  1   2 , Massimo Lazzeri  2 , Giovanni Lughezzani  1   2
Affiliations

Optimizing Prostate Cancer Diagnostic Work-Up Through Micro-Ultrasound: Minimizing Unnecessary Procedures and Reducing Overdiagnoses

Edoardo Beatrici et al. Prostate. 2025 May.

Abstract

Introduction: We aim to critically assess Microultrasound (mUS) clinical performance in an outpatient setting, focusing on its ability to reduce unnecessary diagnostic procedures, potentially reshape prostate cancer (PCa) diagnostic protocols, and increase the ability to rule out clinically significant (Gleason Score ≥ 3 + 4) PCa (csPCa).

Materials and methods: Between November 2018 and April 2022, we conducted a prospective study involving men who underwent mUS examination due to clinical symptoms, PSA elevation, or opportunistic early detection of PCa. Experienced urologists performed mUS assessments in an outpatient setting using the prostate risk identification using micro-ultrasound (PRI-MUS) protocol to identify lesions suspicious of csPCa (PRI-MUS score ≥ 3). Men with negative mUS results were followed through consistent phone follow-up calls and visits until October 2023 to assess their diagnostic and therapeutic pathways. Using Cox regression models adjusted for PSA levels, DRE results, age, and previous biopsy history, we calculated the hazard ratio (HR) for biopsy-free (BFS), defined as the time from mUS to biopsy or last follow-up, cancer-free survival (CFS), and clinically significant cancer-free survival (csCFS) within the cohort based on mUS results.

Results: Overall, 425 men were enrolled. The median (IQR) age was 66 (59-72) years, PSA levels were 5.7 (4.0-7.9) ng/mL, prostate volume was 44 (31.5-62.1) mL, and the median follow-up was 39 months (27-53). mUS identified lesions suggesting csPCa in 201/425 (47.3%) men. Overall, mUS resulted negative in 224/425 (52.7%) men, of whom 207/224 (92.4%) did not undergo subsequent mpMRI, while 22/224 (9.8%) proceeded with mpMRI according to the referring physician's decision. The latter detected suspicious lesions in 12/22 cases (54.5%), but only 2/12 (16.7%) were confirmed by biopsy as csPCa. Among those with negative mUS results, 192/224 (85.7%) men avoided additional biopsies during follow-up. Men with negative mUS results exhibited superior BFS (aHR: 0.17; p < 0.001), CFS (aHR:0.12; p < 0.001), and csCFS (aHR:0.09; p < 0.001) survival rates compared to their mUS-positive counterparts.

Conclusions: Our findings suggest that mUS can potentially refine patient stratification and transform PCa screening and diagnostic protocols. Pending validation by other studies, a wider implementation of mUS could optimize resource allocation, minimize wastage, and reserve additional costly tests.

Keywords: diagnosis; prostate cancer; screening; ultrasound.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Kaplan‐Meier survival curves, illustrating the difference in biopsy‐free survival between the groups based on mUS results. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 2
Figure 2
Kaplan‐Meier survival curves, illustrating the difference in cancer‐free survival between the groups based on mUS results. [Color figure can be viewed at wileyonlinelibrary.com]
Figure 3
Figure 3
Kaplan‐Meier survival curves, illustrating the difference in clinically significant‐cancer‐free survival between the groups based on mUS results. [Color figure can be viewed at wileyonlinelibrary.com]
See this image and copyright information in PMC

References

    1. Siegel R. L., Giaquinto A. N., and Jemal A., “Cancer Statistics, 2024,” CA: A Cancer Journal for Clinicians 74, no. 1 (2024): 12–49, 10.3322/caac.21820. - DOI - PubMed
    1. Potosky A. L., “The Role of Increasing Detection in the Rising Incidence of Prostate Cancer,” JAMA: The Journal of the American Medical Association 273, no. 7 (1995): 548–552, 10.1001/jama.1995.03520310046028. - DOI - PubMed
    1. Loeb S., Bjurlin M. A., Nicholson J., et al., “Overdiagnosis and Overtreatment of Prostate Cancer,” European Urology 65, no. 6 (2014): 1046–1055, 10.1016/j.eururo.2013.12.062. - DOI - PMC - PubMed
    1. Moses K. A., Sprenkle P. C., Bahler C., et al., “NCCN Guidelines® Insights: Prostate Cancer Early Detection, Version 1.2023: Featured Updates to the NCCN Guidelines,” Journal of the National Comprehensive Cancer Network 21, no. 3 (2023): 236–246, 10.6004/jnccn.2023.0014. - DOI - PubMed
    1. Van Poppel H., Roobol M. J., Chapple C. R., et al., “Prostate‐Specific Antigen Testing as Part of a Risk‐Adapted Early Detection Strategy for Prostate Cancer: European Association of Urology Position and Recommendations for 2021,” European Urology 80, no. 6 (2021): 703–711, 10.1016/j.eururo.2021.07.024. - DOI - PubMed

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