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To identify clinically significant prostate cancer (CSPC<\/jats:styled-content>) we determined the performance of LacdiNA<\/jats:styled-content>c\u2010glycosylated prostate\u2010specific antigen (LDN<\/jats:styled-content>\u2010PSA<\/jats:styled-content>) and LDN<\/jats:styled-content>\u2010PSA<\/jats:styled-content> normalized by prostate volume (LDN<\/jats:styled-content>\u2010PSAD<\/jats:styled-content>). We retrospectively measured LDN<\/jats:styled-content>\u2010PSA<\/jats:styled-content>, total PSA<\/jats:styled-content> (tPSA<\/jats:styled-content>), and free PSA<\/jats:styled-content>\/tPSA<\/jats:styled-content> (F\/T PSA<\/jats:styled-content>) values in 718 men who underwent a Pbx in 3 academic urology clinics in Japan and Canada (Pbx cohort) and in 174 PC<\/jats:styled-content> patients who subsequently underwent radical prostatectomy in Australia (preop\u2010PSA<\/jats:styled-content> cohort). The assays were evaluated using the area under the receiver operating characteristics curve (AUC<\/jats:styled-content>) and decision curve analyses to discriminate CSPC<\/jats:styled-content>. In the Pbx cohort, LDN<\/jats:styled-content>\u2010PSAD<\/jats:styled-content> (AUC<\/jats:styled-content> 0.860) provided significantly better clinical performance for discriminating CSPC<\/jats:styled-content> compared with LDN<\/jats:styled-content>\u2010PSA<\/jats:styled-content> (AUC<\/jats:styled-content> 0.827, P<\/jats:italic>\u00a0=\u00a00.0024), PSAD<\/jats:styled-content> (AUC<\/jats:styled-content> 0.809, P\u00a0<\/jats:italic><\u00a00.0001), tPSA<\/jats:styled-content> (AUC<\/jats:styled-content> 0.712, P\u00a0<\/jats:italic><\u00a00.0001), and F\/T PSA<\/jats:styled-content> (AUC<\/jats:styled-content> 0.661, P\u00a0<\/jats:italic><\u00a00.0001). The decision curve analysis showed that using a risk threshold of 20% and adding LDN<\/jats:styled-content>\u2010PSA<\/jats:styled-content> and LDN<\/jats:styled-content>\u2010PSAD<\/jats:styled-content> to the base model (age, digital rectal examination status, tPSA<\/jats:styled-content>, and F\/T PSA<\/jats:styled-content>) permitted avoidance of even more biopsies without missing CSPC<\/jats:styled-content> (9.89% and 18.11%, respectively vs 2.23% [base model]). In the preop\u2010PSA<\/jats:styled-content> cohort, LDN<\/jats:styled-content>\u2010PSA<\/jats:styled-content> values positively correlated with tumor volume and tPSA<\/jats:styled-content> and were significantly higher in pT<\/jats:styled-content>3, pathological Gleason score\u00a0\u2265\u00a07. Limitations include limited sample size, retrospective nature, and no family history information prior to biopsy. LacdiNA<\/jats:styled-content>c\u2010glycosylated PSA<\/jats:styled-content> is significantly better than the conventional PSA<\/jats:styled-content> test in identifying patients with CSPC<\/jats:styled-content>. This study was approved by the ethics committee of each institution (\u201cThe Study about Carbohydrate Structure Change in Urological Disease\u201d; approval no. 2014\u2010195).<\/jats:p>","DOI":"10.1111\/cas.14082","type":"journal-article","created":{"date-parts":[[2019,5,30]],"date-time":"2019-05-30T13:04:11Z","timestamp":1559221451000},"page":"2573-2589","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Clinical significance of the LacdiNA<\/scp>c\u2010glycosylated prostate\u2010specific antigen assay for prostate cancer detection"],"prefix":"10.1111","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1098-407X","authenticated-orcid":false,"given":"Tohru","family":"Yoneyama","sequence":"first","affiliation":[{"name":"Department of Advanced Transplant and Regenerative Medicine Hirosaki University Graduate School of Medicine Hirosaki Japan"},{"name":"Department of Urology Hirosaki University 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