{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T02:58:36Z","timestamp":1780369116134,"version":"3.54.1"},"reference-count":32,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2026,3,2]],"date-time":"2026-03-02T00:00:00Z","timestamp":1772409600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003196","name":"Ministry of Health","doi-asserted-by":"publisher","award":["GR-2018-12366240"],"award-info":[{"award-number":["GR-2018-12366240"]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background: The PROSPET-BX trial compared [68Ga]PSMA-11 PET\/CT (PSMA-PET) with multiparametric MRI (mpMRI) in parallel in men with suspicion of prostate cancer (PCa) after at least one previously negative biopsy (ClinicalTrials.gov: NCT05297162; GR-2018-12366240). In this study, we performed the cost analysis of the two imaging modalities with respect to the detection of clinically significant PCa (csPCa). Methods: We analyzed the data from patients enrolled in the trial who met the inclusion criteria. For the cost analysis, we identified six competing triage strategies, each defined as a binary decision rule for referral to prostate biopsy: (1) biopsy-all; (2) elevated PSA-density (PSAD; biopsy if PSAD &gt; 0.15 ng\/mL\/cc; (3) mpMRI positive (PIRADS 3\u20135); (4) PSMA-PET positive (PRIMARY 3\u20135); (5) mpMRI or PSMA-PET positive; (6) PSAD and mpMRI. For each strategy, we yielded sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy for csPCa. Direct hospital costs were modeled from a provider perspective, incorporating testing and procedural costs. Unit costs (in EUR) were sourced from our institutional accounting records. Pairwise cost-effectiveness comparisons were performed using incremental cost-effectiveness ratio (ICER) and incremental net benefit (INB). Results: Among the six triage strategies evaluated, the \u201cbiopsy-all\u201d approach achieved perfect sensitivity, whereas the PSAD + mpMRI pathway was the most parsimonious strategy but missed 14 csPCa cases (53.8%). The combined \u201cmpMRI or PSMA-PET\u201d strategy maximized detection (22 cPCa, missing only 4) at an intermediate cost (EUR 81.991 total; EUR 3.727 per csPCa). The pairwise comparison of each strategy with mpMRI alone showed for the mpMRI or PSMA-PET pathway a low ICER (~EUR 2.900\/extra csPCa), with consistently positive and increasing INB across higher WTP (willingness-to-pay). Therefore, this combination provided the most favorable cost-effectiveness profile, balancing detection, efficiency, and cost. Conclusions: To the best of our knowledge, this is the first cost analysis study to compare different strategies incorporating PSMA-PET in the re-biopsy setting, demonstrating that the combined \u201cmpMRI or PSMA-PET\u201d pathway is the most cost-effective diagnostic pathway for csPCa detection.<\/jats:p>","DOI":"10.3390\/cancers18050806","type":"journal-article","created":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T16:18:45Z","timestamp":1772554725000},"page":"806","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Cost Analysis of PSMA-PET in the PROSPET-BX Trial"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9732-1094","authenticated-orcid":false,"given":"Egesta","family":"Lopci","sequence":"first","affiliation":[{"name":"Nuclear-Medicine Unit, IRCCS\u2014Humanitas Research Hospital, 20089 Rozzano, MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cesare","family":"Saitta","sequence":"additional","affiliation":[{"name":"Urology Unit, IRCCS\u2014Humanitas Research Hospital, 20089 Rozzano, MI, Italy"},{"name":"Department of Biomedical Sciences, Humanitas University, 20072 Pieve Emanuele, MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Saita","sequence":"additional","affiliation":[{"name":"Urology Unit, IRCCS\u2014Humanitas Research Hospital, 20089 Rozzano, MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4928-3550","authenticated-orcid":false,"given":"Elena","family":"Vanni","sequence":"additional","affiliation":[{"name":"Business Operating Office, IRCCS\u2014Humanitas Research Hospital, 20089 Rozzano, MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Santandrea","sequence":"additional","affiliation":[{"name":"Business Operating Office, IRCCS\u2014Humanitas Research Hospital, 20089 Rozzano, MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca","family":"Disconzi","sequence":"additional","affiliation":[{"name":"Radiology Department, IRCCS\u2014Humanitas Research Hospital, 20089 Rozzano, MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vittorio","family":"Fasulo","sequence":"additional","affiliation":[{"name":"Urology Unit, IRCCS\u2014Humanitas Research Hospital, 20089 Rozzano, MI, Italy"},{"name":"Department of Biomedical Sciences, Humanitas University, 20072 Pieve Emanuele, MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicol\u00f2","family":"Buffi","sequence":"additional","affiliation":[{"name":"Urology Unit, IRCCS\u2014Humanitas Research Hospital, 20089 Rozzano, MI, Italy"},{"name":"Department of Biomedical Sciences, Humanitas University, 20072 Pieve Emanuele, MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4411-3715","authenticated-orcid":false,"given":"Massimo","family":"Lazzeri","sequence":"additional","affiliation":[{"name":"Urology Unit, IRCCS\u2014Humanitas Research Hospital, 20089 Rozzano, MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3939-4521","authenticated-orcid":false,"given":"Giovanni","family":"Lughezzani","sequence":"additional","affiliation":[{"name":"Urology Unit, IRCCS\u2014Humanitas Research Hospital, 20089 Rozzano, MI, Italy"},{"name":"Department of Biomedical Sciences, Humanitas University, 20072 Pieve Emanuele, MI, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,3,2]]},"reference":[{"key":"ref_1","unstructured":"EAU Guidelines (2025, March 01). 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