Liu Yi-Yang, Mao Xing-Jun, Xia Jia-Dong
Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China.
Department of Urology, Baoying People's Hospital, Yangzhou, Jiangsu 225800, China.
Zhonghua Nan Ke Xue. 2024 Jul;30(7):597-603.
To explore the clinical value of prostatic exosomal protein (PSEP) and PSA in the diagnosis of PCa with PSA in the gray zone (4－10 μg/L) and Prostate Imaging Reporting and Data System category 3 (PI-RADS-3) lesions.
From 2019 to 2022, 211 patients with the PSA gray zone and PI-RADS-3 lesions underwent prostate multi-parameter MRI, prostate needle biopsy or transurethral resection/enucleation of the prostate. We collected the baseline urine samples from the patients, examined the content of PSEP in the urine by ELISA and evaluated the performance of PSEP and PSA in the diagnosis of PCa.
Among the total number of patients, 57 were confirmed with PCa (the positive group) and the other 154 with benign prostate conditions (the negative group) by biopsy pathology. The free PSA level (fPSA), free to total PSA ratio (f/tPSA) and PSEP content were dramatically lower in the positive than in the negative group (all P< 0.01). Uni- and multivariate analyses showed f/tPSA and PSEP to be independent factors for predicting PCa with the PSA gray zone and PI-RADS-3 lesions, with the AUC values of 0.70 and 0.78, best cutoff values of 0.18 and 1.45 μg/L, sensitivity of 84.21% and 70.18%, and specificity of 58.44% and 77.27%, respectively (P< 0.01). The multivariate model with combined use of f/tPSA and PSEP (AUC: 0.82, best cutoff value: 0.31, sensitivity: 82.46%, specificity: 75.32%) outperformed either f/tPSA or PSEP alone in the diagnosis of PCa with the PSA gray zone and PI-RADS-3 lesions (P< 0.01, P = 0.04).
For patients with the PSA gray zone and PI-RADS-3 lesions, f/tPSA and PSEP are significant predictors of PCa. The multivariate model of PSEP combined with f/tPSA can replace f/tPSA in the detection of PCa to improve diagnostic performance and avoid unnecessary prostate biopsy.
探讨前列腺外泌体蛋白（PSEP）和前列腺特异性抗原（PSA）在诊断前列腺特异抗原处于灰色区间（4－10μg/L）且前列腺影像报告和数据系统分类为3类（PI-RADS-3）病变的前列腺癌（PCa）中的临床价值。
2019年至2022年，211例PSA处于灰色区间且有PI-RADS-3病变的患者接受了前列腺多参数磁共振成像、前列腺穿刺活检或经尿道前列腺切除术/剜除术。我们收集了患者的基线尿液样本，采用酶联免疫吸附测定法检测尿液中PSEP的含量，并评估PSEP和PSA在诊断PCa中的性能。
在所有患者中，经活检病理确诊57例为PCa（阳性组），另外154例为良性前列腺疾病（阴性组）。阳性组的游离PSA水平（fPSA）、游离与总PSA比值（f/tPSA）和PSEP含量显著低于阴性组（均P<0.01）。单因素和多因素分析显示，f/tPSA和PSEP是预测PSA处于灰色区间且有PI-RADS-3病变的PCa的独立因素，其曲线下面积（AUC）值分别为0.70和0.78，最佳临界值分别为0.18和1.45μg/L，灵敏度分别为84.21%和70.18%，特异性分别为58.44%和77.27%（P<0.01）。联合使用f/tPSA和PSEP的多因素模型（AUC：0.82，最佳临界值：0.31，灵敏度：82.46%，特异性：75.32%）在诊断PSA处于灰色区间且有PI-RADS-3病变的PCa方面优于单独使用f/tPSA或PSEP（P<0.01，P = 0.04）。
对于PSA处于灰色区间且有PI-RADS-3病变的患者，f/tPSA和PSEP是PCa的重要预测指标。PSEP联合f/tPSA的多因素模型在PCa检测中可替代f/tPSA，以提高诊断性能并避免不必要的前列腺活检。
