{"title":"FPSAD和PI-RADS v2.1对tPSA水平4 ~ 10 ng/mL有临床意义的前列腺癌患者的诊断价值。","authors":"Wei Guo, Ping Tan, Yan He, Xinyu Yi","doi":"10.2147/CMAR.S542803","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong> To evaluate the incremental diagnostic value of combining free prostate-specific antigen density (FPSAD) with Prostate Imaging Reporting and Data System version 2.1 (PI-RADS v2.1) for clinically significant prostate cancer (csPCa,defined as Gleason score≥3+4) in the diagnostic gray zone (tPSA 4-10 ng/mL).</p><p><strong>Methods: </strong>This retrospective study analyzed 137 patients (75 with csPCa and 62 with non-clinically significant prostate cancer (ncsPCa) who underwent transperineal prostate biopsy at Xiangtan Central Hospital between January 2022 and January 2024. PI-RADS v2.1 scores were assigned based on magnetic resonance (MR) imaging, and prostate volume (PV) and FPSAD were calculated. Statistical analyses included chi-square/Fisher's exact tests for categorical variables and independent <i>t</i>-tests for continuous variables. Logistic regression identified independent predictors of csPCa, and a nomogram model was developed. Model performance was evaluated using calibration curves and receiver operating characteristic (ROC) analysis.</p><p><strong>Results: </strong> Significant differences were observed in FPSAD, PI-RADS v2.1 scores, and free PSA (fPSA) between the csPCa and ncsPCa groups (<i>P</i> < 0.01). FPSAD (OR = 1.95, 95% CI: 1.22-2.22, <i>P</i> < 0.01) and PI-RADS v2.1 scores (OR = 2.41, 95% CI: 1.57-3.70, <i>P</i> < 0.01) were independent predictors of csPCa. The combined FPSAD and PI-RADS v2.1 model demonstrated superior diagnostic performance (AUC =0.829) compared to FPSAD alone (AUC = 0.69) or PI-RADS v2.1 alone (AUC = 0.773) (<i>P</i> < 0.01), with 91% sensitivity and 32% fewer unnecessary biopsies than PI-RADS≥3 criteria. In PI-RADS 3 subgroup (n=41), FPSAD correctly reclassified 13/18 (72.2%) indeterminate cases.</p><p><strong>Conclusion: </strong> For Asian men with tPSA 4-10 ng/mL, the FPSAD+PI-RADS algorithm (cutoffs: >0.017 and ≥4) provides 15-20% higher accuracy than either marker alone, while reducing biopsies by 25%. This approach is particularly valuable for PI-RADS 3 cases, where it resolved >65% of diagnostic uncertainties in our cohort.</p>","PeriodicalId":9479,"journal":{"name":"Cancer Management and Research","volume":"17 ","pages":"2199-2206"},"PeriodicalIF":2.6000,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12493845/pdf/","citationCount":"0","resultStr":"{\"title\":\"Diagnostic Value of FPSAD and PI-RADS v2.1 for Clinically Significant Prostate Cancer in Patients with tPSA Levels of 4-10 ng/mL.\",\"authors\":\"Wei Guo, Ping Tan, Yan He, Xinyu Yi\",\"doi\":\"10.2147/CMAR.S542803\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong> To evaluate the incremental diagnostic value of combining free prostate-specific antigen density (FPSAD) with Prostate Imaging Reporting and Data System version 2.1 (PI-RADS v2.1) for clinically significant prostate cancer (csPCa,defined as Gleason score≥3+4) in the diagnostic gray zone (tPSA 4-10 ng/mL).</p><p><strong>Methods: </strong>This retrospective study analyzed 137 patients (75 with csPCa and 62 with non-clinically significant prostate cancer (ncsPCa) who underwent transperineal prostate biopsy at Xiangtan Central Hospital between January 2022 and January 2024. PI-RADS v2.1 scores were assigned based on magnetic resonance (MR) imaging, and prostate volume (PV) and FPSAD were calculated. Statistical analyses included chi-square/Fisher's exact tests for categorical variables and independent <i>t</i>-tests for continuous variables. Logistic regression identified independent predictors of csPCa, and a nomogram model was developed. Model performance was evaluated using calibration curves and receiver operating characteristic (ROC) analysis.</p><p><strong>Results: </strong> Significant differences were observed in FPSAD, PI-RADS v2.1 scores, and free PSA (fPSA) between the csPCa and ncsPCa groups (<i>P</i> < 0.01). FPSAD (OR = 1.95, 95% CI: 1.22-2.22, <i>P</i> < 0.01) and PI-RADS v2.1 scores (OR = 2.41, 95% CI: 1.57-3.70, <i>P</i> < 0.01) were independent predictors of csPCa. The combined FPSAD and PI-RADS v2.1 model demonstrated superior diagnostic performance (AUC =0.829) compared to FPSAD alone (AUC = 0.69) or PI-RADS v2.1 alone (AUC = 0.773) (<i>P</i> < 0.01), with 91% sensitivity and 32% fewer unnecessary biopsies than PI-RADS≥3 criteria. In PI-RADS 3 subgroup (n=41), FPSAD correctly reclassified 13/18 (72.2%) indeterminate cases.</p><p><strong>Conclusion: </strong> For Asian men with tPSA 4-10 ng/mL, the FPSAD+PI-RADS algorithm (cutoffs: >0.017 and ≥4) provides 15-20% higher accuracy than either marker alone, while reducing biopsies by 25%. This approach is particularly valuable for PI-RADS 3 cases, where it resolved >65% of diagnostic uncertainties in our cohort.</p>\",\"PeriodicalId\":9479,\"journal\":{\"name\":\"Cancer Management and Research\",\"volume\":\"17 \",\"pages\":\"2199-2206\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-09-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12493845/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer Management and Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/CMAR.S542803\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Management and Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/CMAR.S542803","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
Diagnostic Value of FPSAD and PI-RADS v2.1 for Clinically Significant Prostate Cancer in Patients with tPSA Levels of 4-10 ng/mL.
Objective: To evaluate the incremental diagnostic value of combining free prostate-specific antigen density (FPSAD) with Prostate Imaging Reporting and Data System version 2.1 (PI-RADS v2.1) for clinically significant prostate cancer (csPCa,defined as Gleason score≥3+4) in the diagnostic gray zone (tPSA 4-10 ng/mL).
Methods: This retrospective study analyzed 137 patients (75 with csPCa and 62 with non-clinically significant prostate cancer (ncsPCa) who underwent transperineal prostate biopsy at Xiangtan Central Hospital between January 2022 and January 2024. PI-RADS v2.1 scores were assigned based on magnetic resonance (MR) imaging, and prostate volume (PV) and FPSAD were calculated. Statistical analyses included chi-square/Fisher's exact tests for categorical variables and independent t-tests for continuous variables. Logistic regression identified independent predictors of csPCa, and a nomogram model was developed. Model performance was evaluated using calibration curves and receiver operating characteristic (ROC) analysis.
Results: Significant differences were observed in FPSAD, PI-RADS v2.1 scores, and free PSA (fPSA) between the csPCa and ncsPCa groups (P < 0.01). FPSAD (OR = 1.95, 95% CI: 1.22-2.22, P < 0.01) and PI-RADS v2.1 scores (OR = 2.41, 95% CI: 1.57-3.70, P < 0.01) were independent predictors of csPCa. The combined FPSAD and PI-RADS v2.1 model demonstrated superior diagnostic performance (AUC =0.829) compared to FPSAD alone (AUC = 0.69) or PI-RADS v2.1 alone (AUC = 0.773) (P < 0.01), with 91% sensitivity and 32% fewer unnecessary biopsies than PI-RADS≥3 criteria. In PI-RADS 3 subgroup (n=41), FPSAD correctly reclassified 13/18 (72.2%) indeterminate cases.
Conclusion: For Asian men with tPSA 4-10 ng/mL, the FPSAD+PI-RADS algorithm (cutoffs: >0.017 and ≥4) provides 15-20% higher accuracy than either marker alone, while reducing biopsies by 25%. This approach is particularly valuable for PI-RADS 3 cases, where it resolved >65% of diagnostic uncertainties in our cohort.
期刊介绍：
Cancer Management and Research is an international, peer reviewed, open access journal focusing on cancer research and the optimal use of preventative and integrated treatment interventions to achieve improved outcomes, enhanced survival, and quality of life for cancer patients. Specific topics covered in the journal include:
◦Epidemiology, detection and screening
◦Cellular research and biomarkers
◦Identification of biotargets and agents with novel mechanisms of action
◦Optimal clinical use of existing anticancer agents, including combination therapies
◦Radiation and surgery
◦Palliative care
◦Patient adherence, quality of life, satisfaction
The journal welcomes submitted papers covering original research, basic science, clinical & epidemiological studies, reviews & evaluations, guidelines, expert opinion and commentary, and case series that shed novel insights on a disease or disease subtype.
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