De Luca Stefano, Passera Roberto, Fiori Cristian, Bollito Enrico, Cappia Susanna, Mario Scarpa Roberto, Sottile Antonino, Franco Randone Donato, Porpiglia Francesco
Division of Urology, San Luigi Gonzaga Hospital and University of Torino, Orbassano, Italy.
Division of Nuclear Medicine, San Giovanni Battista Hospital and University of Torino, Italy.
Urol Oncol. 2015 Oct;33(10):424.e17-23. doi: 10.1016/j.urolonc.2015.05.032. Epub 2015 Jul 7.
To determine if prostate health index (PHI), prostate cancer antigen gene 3 (PCA3) score, and percentage of free prostate-specific antigen (%fPSA) may be used to differentiate asymptomatic acute and chronic prostatitis from prostate cancer (PCa), benign prostatic hyperplasia (BPH), and high-grade prostate intraepithelial neoplasia (HG-PIN) in patients with elevated PSA levels and negative findings on digital rectal examination at repeat biopsy (re-Bx).
In this prospective study, 252 patients were enrolled, undergoing PHI, PCA3 score, and %fPSA assessments before re-Bx. We used 3 multivariate logistic regression models to test the PHI, PCA3 score, and %fPSA as risk factors for prostatitis vs. PCa, vs. BPH, and vs. HG-PIN. All the analyses were performed for the whole patient cohort and for the "gray zone" of PSA (4-10ng/ml) cohort (171 individuals).
Of the 252 patients, 43 (17.1%) had diagnosis of PCa. The median PHI was significantly different between men with a negative biopsy and those with a positive biopsy (34.9 vs. 48.1, P<0.001), as for the PCA3 score (24 vs. 54, P<0.001) and %fPSA (11.8% vs. 15.8%, P = 0.012). The net benefit of using PCA3 and PHI to differentiate prostatitis and PCa was moderate, although it extended to a good range of threshold probabilities (40%-100%), whereas that from using %fPSA was negligible: this pattern was reported for the whole population as for the "gray zone" PSA cohort.
In front of a good diagnostic performance of all the 3 biomarkers in distinguishing negative biopsy vs. positive biopsy, the clinical benefit of using the PCA3 score and PHI to estimate prostatitis vs. PCa was comparable. PHI was the only determinant for prostatitis vs. BPH, whereas no biomarkers could differentiate prostate inflammation from HG-PIN.
确定前列腺健康指数(PHI)、前列腺癌抗原基因3(PCA3)评分以及游离前列腺特异性抗原百分比(%fPSA)是否可用于鉴别无症状性急性和慢性前列腺炎与前列腺癌(PCa)、良性前列腺增生(BPH)以及在重复活检(re - Bx)时直肠指检结果阴性且前列腺特异性抗原(PSA)水平升高的患者中的高级别前列腺上皮内瘤变(HG - PIN)。
在这项前瞻性研究中,纳入了252例患者,在重复活检前进行了PHI、PCA3评分和%fPSA评估。我们使用3个多变量逻辑回归模型来检验PHI、PCA3评分和%fPSA作为前列腺炎与PCa、与BPH以及与HG - PIN的危险因素。所有分析均针对整个患者队列以及PSA处于“灰色区域”(4 - 10ng/ml)的队列(171例个体)进行。
在252例患者中,43例(17.1%)被诊断为PCa。活检阴性和阳性的男性患者之间,PHI中位数有显著差异(34.9对48.1,P<0.001),PCA3评分(24对54,P<0.001)以及%fPSA(11.8%对15.8%,P = 0.012)也是如此。使用PCA3和PHI鉴别前列腺炎和PCa的净效益中等,尽管其在阈值概率的良好范围内(40% - 100%)有所扩展,而使用%fPSA的净效益可忽略不计:在整个总体以及“灰色区域”PSA队列中均呈现此模式。
鉴于这3种生物标志物在鉴别活检阴性与阳性方面均具有良好的诊断性能,使用PCA3评分和PHI评估前列腺炎与PCa的临床效益相当。PHI是鉴别前列腺炎与BPH的唯一决定因素,而没有生物标志物能够区分前列腺炎症与HG - PIN。