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Patients were classified as csPCa and clinically insignificant (negative and insignificant PCa). Logistic regression was performed to assess the csPCa risk at different PSAd cut-offs across different prostate volume subgroups (&lt;\u200940, 40\u201360, 60\u201380, &gt;\u200980\u2009mL) and PI-RADS categories. The effect of prostate volume on PSAd performance was evaluated using ROC analysis. To assess robustness, we performed an 80:20 split-sample internal validation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      747\/2190 (34.1%) patients had PCa, including 571 (26.1%) with csPCa. Regardless of PSAd, csPCa risk exceeded 30% for PI-RADS 4 and 50% for PI-RADS 5. At a 10% csPCa risk threshold, the optimal PSAd cut-offs were 0.20\u2009ng\/mL\u00b2 for PI-RADS 1\u20132 and 0.12\u2009ng\/mL\u00b2 for PI-RADS 3. Logistic regression showed a significant inverse correlation between prostate volume and csPCa probability. Notably, 79% of csPCa patients with prostate volume \u2264\u200940\u2009mL had a PSAd \u2265\u20090.15\u2009ng\/mL\u00b2, compared to only 22.4% with volumes \u2265\u200960\u2009mL. PSAd performed significantly worse for larger glands (\u2265\u200960\u2009mL), with AUCs of 0.70 versus 0.84 (\u2264\u200940\u2009mL) and 0.82 (40\u201360\u2009mL), both\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The optimal PSAd cut-offs for guiding biopsy decisions were 0.20\u2009ng\/mL\u00b2 for PI-RADS 1\u20132 and 0.12\u2009ng\/mL\u00b2 for PI-RADS 3. When using PSAd to guide biopsy decision for PI-RADS 1\u20133 patients with large prostates (&gt;\u200960\u2009mL), caution is warranted, as PSAd becomes significantly less accurate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Key Points<\/jats:title>\n                    <jats:p>\n                      <jats:bold>\n                        <jats:italic>Question<\/jats:italic>\n                      <\/jats:bold>\n                      <jats:italic>The optimal PSA-density thresholds for biopsy decisions in PI-RADS 1\u20133 patients remain uncertain, and data on the impact of prostate volume on its performance are limited<\/jats:italic>\n                      .\n                    <\/jats:p>\n                    <jats:p>\n                      <jats:bold>\n                        <jats:italic>Findings<\/jats:italic>\n                      <\/jats:bold>\n                      <jats:italic>Optimal PSA-density thresholds were 0.20\u2009ng\/mL\u00b2 for PI-RADS 1\u20132 and 0.12\u2009ng\/mL\u00b2 for PI-RADS 3. Diagnostic performance of PSA-density decreased significantly in men with larger glands (\u2265\u200960\u2009mL)<\/jats:italic>\n                      .\n                    <\/jats:p>\n                    <jats:p>\n                      <jats:bold>\n                        <jats:italic>Clinical relevance<\/jats:italic>\n                      <\/jats:bold>\n                      <jats:italic>PSA-density cut-offs of 0.20 (PI-RADS 1\u20132) and 0.12\u2009ng\/mL\u00b2 (PI-RADS 3) can guide biopsy decisions. In PI-RADS 1\u20133 patients with large prostate (\u2265\u200960\u2009mL), PSA-density becomes significantly less predictive, and low values may not reliably exclude csPCa<\/jats:italic>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00330-025-12272-y","type":"journal-article","created":{"date-parts":[[2026,1,4]],"date-time":"2026-01-04T03:18:58Z","timestamp":1767496738000},"page":"4503-4512","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["The effects of prostate volume and PI-RADS category on optimal PSA-density thresholds for biopsy decision-making"],"prefix":"10.1007","volume":"36","author":[{"given":"Selahattin","family":"Durmaz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shun-Chin Jim","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kang-Lung","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amreen","family":"Shakur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iztok","family":"Caglic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1180-1474","authenticated-orcid":false,"given":"Tristan","family":"Barrett","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,4]]},"reference":[{"key":"12272_CR1","doi-asserted-by":"publisher","first-page":"1075","DOI":"10.1016\/S0140-6736(21)00950-8","volume":"398","author":"S Sandhu","year":"2021","unstructured":"Sandhu S, Moore CM, Chiong E, Beltran H, Bristow RG, Williams SG (2021) Prostate cancer. 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He is one of the authors.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Statistics and biometry"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"This single-center retrospective study was approved by the Local Ethics Committee (HRA and Health and Care Research Wales (HCRW), IRAS #313163), with the requirement for written informed consent waived.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Study subjects or cohorts overlap"}},{"order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Methodology"}}]}}