Diagnostic Value of FPSAD and PI-RADS v2.1 for Clinically Significant Prostate Cancer in Patients with tPSA Levels of 4-10 ng/mL.

IF 2.6 4区医学 Q3 ONCOLOGY

Cancer Management and Research Pub Date : 2025-09-29 eCollection Date: 2025-01-01 DOI:10.2147/CMAR.S542803

Wei Guo, Ping Tan, Yan He, Xinyu Yi

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Abstract

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.

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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。

目的：评价游离前列腺特异性抗原密度（FPSAD）联合前列腺影像学报告与数据系统2.1版（PI-RADS v2.1）对诊断灰色地带（tPSA 4-10 ng/mL）临床显著性前列腺癌（csPCa，定义为Gleason评分≥3+4）的增值诊断价值。方法：回顾性分析2022年1月至2024年1月在湘潭市中心医院行经会阴前列腺活检的137例患者，其中75例为csPCa， 62例为非临床显著性前列腺癌（ncsPCa）。根据磁共振（MR）成像评分PI-RADS v2.1分，计算前列腺体积（PV）和FPSAD。统计分析包括分类变量的卡方/费雪精确检验和连续变量的独立t检验。Logistic回归确定了csPCa的独立预测因子，并建立了nomogram模型。采用校正曲线和受试者工作特征（ROC）分析对模型性能进行评价。结果：csPCa组与ncsPCa组FPSAD、PI-RADS v2.1评分及游离PSA （fPSA）比较，差异均有统计学意义（P < 0.01）。FPSAD （OR = 1.95, 95% CI: 1.22 ~ 2.22, P < 0.01）和PI-RADS v2.1评分（OR = 2.41, 95% CI: 1.57 ~ 3.70, P < 0.01）是csPCa的独立预测因子。与单独使用FPSAD （AUC = 0.69）或单独使用PI-RADS v2.1 （AUC = 0.773）相比，联合使用FPSAD和PI-RADS v2.1模型的诊断性能（AUC =0.829）更优越（P < 0.01），灵敏度为91%，比PI-RADS≥3标准减少32%的不必要活检。在PI-RADS 3亚组（n=41）中，FPSAD正确地重新分类了13/18（72.2%）不确定病例。结论：对于tPSA为4-10 ng/mL的亚洲男性，FPSAD+PI-RADS算法（截止值：>0.017和≥4）比单独使用任何一种标记物的准确率高15-20%，同时减少25%的活检。这种方法对PI-RADS 3病例特别有价值，在我们的队列中，它解决了65%的诊断不确定性。

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来源期刊

Cancer Management and Research Medicine-Oncology

CiteScore

7.40

自引率

0.00%

发文量

448

审稿时长

16 weeks

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.