{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T22:44:59Z","timestamp":1778539499352,"version":"3.51.4"},"reference-count":29,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,9,29]],"date-time":"2023-09-29T00:00:00Z","timestamp":1695945600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJUI Compass"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The use of multiparametric magnetic resonance imaging (mpMRI) has been widely adopted in the diagnostic work\u2010up for suspicious prostate cancer (PCa) and is recommended in most current guidelines. However, mpMRI lesions are often indeterminate and\/or turn out to be false\u2010positive on prostate biopsy. The aim of this work was to evaluate Proclarix, a biomarker test for the detection of relevant PCa, regarding its diagnostic value in all men before biopsy and in men with indeterminate lesions on mpMRI (PI\u2010RADS 3) during work\u2010up for PCa.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>Men undergoing mpMRI\u2010targeted and systematic biopsy of the prostate were prospectively enrolled. The Proclarix test was evaluated for the detection accuracy of clinically significant PCa (csPCa) defined as Grade Group\u2009\u2265\u20092 and its association to mpMRI results. Further, Proclarix's performance was also tested when adapted to prostate volume (Proclarix density) and performance compared to PSA density (PSAD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 150 men with a median age of 65\u2009years and median PSA of 5.8\u00a0ng\/mL were included in this study. CsPCa was diagnosed in 65 (43%) men. Proclarix was significantly associated with csPCa and higher PI\u2010RADS score (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). At the pre\u2010defined cut\u2010off of 10%, Proclarix's sensitivity for csPCa was 94%, specificity 19%, negative predictive value 80% and positive predictive value 47%. Proclarix density showed the highest AUC for the detection of csPCa of 0.77 (95%CI: 0.69\u20130.85) compared to PSA, PSAD and Proclarix alone. Proclarix was able to identify all six csPCa in men with PI\u2010RADS 3 lesions (<jats:italic>n<\/jats:italic>\u2009=\u200928), whereas PSAD missed two out of six. At optimized cut\u2010offs, Proclarix density outperformed PSAD by potentially avoiding 41% of unnecessary biopsies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Proclarix demonstrates high sensitivity in detecting csPCa but may still result in unnecessary biopsies. However, Proclarix density was able to outperform PSAD and Proclarix and was found to be useful in men with PI\u2010RADS 3 findings by safely avoiding unnecessary biopsies without missing csPCa.<\/jats:p><\/jats:sec>","DOI":"10.1002\/bco2.293","type":"journal-article","created":{"date-parts":[[2023,9,30]],"date-time":"2023-09-30T01:39:08Z","timestamp":1696037948000},"page":"297-303","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of Proclarix in the diagnostic work\u2010up of prostate cancer"],"prefix":"10.1002","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6965-449X","authenticated-orcid":false,"given":"Basil","family":"Kaufmann","sequence":"first","affiliation":[{"name":"Department of Urology University Hospital Zurich  Zurich Switzerland"},{"name":"Milton and Carroll Petrie Department of Urology Icahn School of Medicine at Mount Sinai  New York New York 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Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7339-1458","authenticated-orcid":false,"given":"Uwe","family":"Bieri","sequence":"additional","affiliation":[{"name":"Department of Urology University Hospital Zurich  Zurich Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0862-5027","authenticated-orcid":false,"given":"Florian A.","family":"Schmid","sequence":"additional","affiliation":[{"name":"Department of Urology University Hospital Zurich  Zurich Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Franz","family":"von Stauffenberg","sequence":"additional","affiliation":[{"name":"Department of Urology University Hospital Zurich  Zurich 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