Department of Urology, National Taiwan University Hospital, Taiwan.
Department of Urology, National Taiwan University Hospital, Taiwan; Department of Urology, Taipei Veterans General Hospital, Yuanshan Branch, Taiwan.
J Formos Med Assoc. 2019 Jan;118(1 Pt 2):260-267. doi: 10.1016/j.jfma.2018.05.001. Epub 2018 May 18.
BACKGROUND/PURPOSE: Prostate specific antigen (PSA) with low specificity that causes unnecessary prostate biopsies increases clinical morbidities, psychological stress, and medical expenses. We aimed to test the accuracy and cutoff value of Prostate Health Index (PHI) in men for prostate cancer detection.
We prospectively enrolled 213 men who underwent prostate biopsy with PSA≦10 ng/ml or abnormal findings on digital rectal examination. Total PSA (tPSA), free PSA (fPSA) and p2PSA levels were measured by serum samples before prostate biopsy. PHI was calculated as (p2PSA/fPSA) × √tPSA. Multivariable logistic regression analyses were used to predict the risk of cancer and detect clinically significant prostate cancer.
33 (27.0%) patients were confirmed with the diagnoses of prostate cancer by prostate biopsy. The levels of p2PSA, %p2PSA, and PHI showed statistically significant differences between prostate cancer patients and non-cancer patients. %p2PSA and PHI had the highest area under the receiver operating characteristic curve (AUC) of 0.723 and 0.772 (both p < 0.001), respectively, predicting cancer detection at biopsy than other predictors (tPSA, fPSA, %fPSA, and PSA density (AUC: 0.544, 0.538, 0.593, and 0.664, respectively). In multivariable logistic regression, %p2PSA had a statistical significant odds ratio 8.51 (p = 0.003) and PHI had an odds ratio with marginal significance 4.18 (p = 0.06).
%p2PSA and PHI increased the diagnostic accuracy with significantly greater sensitivity and specificity than tPSA. We determined an optimal cut-off value of PHI among Taiwanese population. These findings support the usefulness in the decisional process of prostate biopsy.
背景/目的：前列腺特异性抗原（PSA）特异性低，导致不必要的前列腺活检增加了临床发病率、心理压力和医疗费用。我们旨在测试前列腺健康指数（PHI）在男性前列腺癌检测中的准确性和临界值。
我们前瞻性地招募了 213 名前列腺活检的男性，这些男性的 PSA 值≦10ng/ml 或直肠指检异常。在前列腺活检前，通过血清样本测量总 PSA（tPSA）、游离 PSA（fPSA）和 p2PSA 水平。PHI 通过（p2PSA/fPSA）×√tPSA 计算得出。多变量逻辑回归分析用于预测癌症风险和检测临床显著前列腺癌。
33 名（27.0%）患者经前列腺活检确诊为前列腺癌。前列腺癌患者和非癌症患者的 p2PSA、%p2PSA 和 PHI 水平存在统计学差异。%p2PSA 和 PHI 在预测活检时癌症检测方面具有最高的受试者工作特征曲线下面积（AUC），分别为 0.723 和 0.772（均 p<0.001），优于其他预测因子（tPSA、fPSA、%fPSA 和 PSA 密度 AUC：0.544、0.538、0.593 和 0.664）。在多变量逻辑回归中，%p2PSA 具有统计学显著的优势比 8.51（p=0.003），而 PHI 具有边际显著的优势比 4.18（p=0.06）。
%p2PSA 和 PHI 提高了诊断准确性，具有显著更高的敏感性和特异性，优于 tPSA。我们确定了台湾人群中 PHI 的最佳临界值。这些发现支持在前列腺活检决策过程中的有用性。
