{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T11:19:41Z","timestamp":1778498381769,"version":"3.51.4"},"reference-count":38,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T00:00:00Z","timestamp":1776902400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Proteomedix AG"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background and Objective: Active surveillance (AS) describes the active monitoring of men with low- to intermediate-risk prostate cancer (PCa), before active management (AM) is needed due to disease progression. A substantial proportion of patients require a transition to AM within a few years of diagnosis. Proclarix is a blood-based diagnostic test that predicts clinically significant PCa (csPCa) and the Proclarix risk score has been shown to correlate with tumor aggressiveness. This study aimed to assess whether Proclarix can predict the likelihood of transition from AS to AM and to compare it to PSA density (PSAD). Methods: We retrospectively evaluated the Proclarix risk scores in serum samples from a Danish cohort of 132 men recruited from the PerPros prostate biobank. Most participants had low- to intermediate-risk PCa and were considered eligible for AS at diagnosis. Blood samples were collected before the initial biopsies, and clinical follow-up data were available for every patient for a minimum of 3 and up to 9.5 years. The primary endpoint was the ability of the Proclarix risk score to predict the transition from AS to AM. The secondary endpoint was to assess whether Proclarix could identify patients at risk of progression to csPCa. For both endpoints, PSA density was also included in the analysis for comparison. Results: Overall, 48 of 132 men (36%) transitioned from AS to AM during follow-up. A baseline Proclarix risk score of \u226550% was associated with a 79% estimated cumulative probability of switching to AM (HR = 4.4, 95% CI: 2.3\u20138.3, p &lt; 0.001), compared to the 58% (HR = 3.1, 95% CI: 1.7\u20135.7, p &lt; 0.001) for PSAD At the 5-year follow-up, 82% of men with a Proclarix score \u2265 50% and 57% with PSAD \u2265 0.15 ng\/mL\/cm3 had progressed to AM. Additionally, 67% and 54% of men showed progression to csPCa with, respectively, Proclarix and PSAD at the confirmatory biopsy. In contrast, among men with a Proclarix score &lt; 50%, only 28% progressed to AM and 32% to csPCa, whereas for PSAD &lt; 0.15 ng\/mL\/cm3, 17% transitioned to AM and 23% progressed to csPCa. Conclusions: The Proclarix risk score may support clinical decision-making in AS by identifying patients at higher risk of progression and informing follow-up intensity. However, the results should be confirmed in a larger prospective study.<\/jats:p>","DOI":"10.3390\/cancers18091348","type":"journal-article","created":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T17:04:59Z","timestamp":1776963899000},"page":"1348","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Prognostic Value of Proclarix in Prostate Cancer Patients Under Active Surveillance: Predicting Transition to Active Treatment and Disease Progression in a Danish Cohort"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8145-8325","authenticated-orcid":false,"given":"Alcibiade","family":"Athanasiou","sequence":"first","affiliation":[{"name":"Proteomedix AG, 8952 Schlieren, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7476-671X","authenticated-orcid":false,"given":"Torben F.","family":"Hansen","sequence":"additional","affiliation":[{"name":"Department of Oncology, Lillebaelt Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark"},{"name":"Department of Regional Health Research, University of Southern Denmark, 5230 Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6668-4714","authenticated-orcid":false,"given":"Jonna S.","family":"Madsen","sequence":"additional","affiliation":[{"name":"Department of Regional Health Research, University of Southern Denmark, 5230 Odense, Denmark"},{"name":"Department of Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7622-8402","authenticated-orcid":false,"given":"Mads H.","family":"Poulsen","sequence":"additional","affiliation":[{"name":"Department of Regional Health Research, University of Southern Denmark, 5230 Odense, Denmark"},{"name":"Department of Urology, Esbjerg and Grindsted Hospital, University Hospital of Southern Denmark, 6700 Esbjerg, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mike Allan","family":"Mortensen","sequence":"additional","affiliation":[{"name":"Department of Urology, Odense University Hospital of Southern Denmark, 5000 Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-9522-7023","authenticated-orcid":false,"given":"Gitte E.","family":"Kissow","sequence":"additional","affiliation":[{"name":"Urological Research Center, Department of Urology, Lillebaelt Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5894-9479","authenticated-orcid":false,"given":"Louise F.","family":"\u00d8bro","sequence":"additional","affiliation":[{"name":"Department of Regional Health Research, University of Southern Denmark, 5230 Odense, Denmark"},{"name":"Urological Research Center, Department of Urology, Lillebaelt Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7962-1640","authenticated-orcid":false,"given":"Palle J.","family":"Osther","sequence":"additional","affiliation":[{"name":"Department of Regional Health Research, University of Southern Denmark, 5230 Odense, Denmark"},{"name":"Urological Research Center, Department of Urology, Lillebaelt Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4955-1295","authenticated-orcid":false,"given":"Ralph","family":"Schiess","sequence":"additional","affiliation":[{"name":"Proteomedix AG, 8952 Schlieren, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8895-6394","authenticated-orcid":false,"given":"Ahmed H.","family":"Zedan","sequence":"additional","affiliation":[{"name":"Department of Oncology, Lillebaelt Hospital, University Hospital of Southern Denmark, 7100 Vejle, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,4,23]]},"reference":[{"key":"ref_1","unstructured":"Mottet, N., Cornford, P., van den Bergh, R.C.N., Briers, E., Expert Patient Advocate (European Prostate Cancer Coalition\/Europa, UOMO), Eberli, D., De Meerleer, G., De Santis, M., Gillessen, S., and Grummet, J. 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Open."}],"container-title":["Cancers"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2072-6694\/18\/9\/1348\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T11:00:43Z","timestamp":1778497243000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2072-6694\/18\/9\/1348"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,23]]},"references-count":38,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2026,5]]}},"alternative-id":["cancers18091348"],"URL":"https:\/\/doi.org\/10.3390\/cancers18091348","relation":{},"ISSN":["2072-6694"],"issn-type":[{"value":"2072-6694","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,23]]}}}