前列腺健康指数显著减少了PSA为2 - 10 ng/mL和PSA>10 ng/mL患者的不必要前列腺活检：一项中国多中心研究的结果

Prostate health index significantly reduced unnecessary prostate biopsies in patients with PSA 2-10 ng/mL and PSA >10 ng/mL: Results from a Multicenter Study in China.

作者信息

Na Rong, Ye Dingwei, Qi Jun, Liu Fang, Helfand Brian T, Brendler Charles B, Conran Carly A, Packiam Vignesh, Gong Jian, Wu Yishuo, Zheng Siqun L, Mo Zengnan, Ding Qiang, Sun Yinghao, Xu Jianfeng

机构信息

Department of Urology, Huashan Hospital, Fudan University, Shanghai, PR China.

Fudan Institute of Urology, Huashan Hospital, Fudan University, Shanghai, PR China.

出版信息

Prostate. 2017 Aug;77(11):1221-1229. doi: 10.1002/pros.23382. Epub 2017 Jun 30.

DOI:10.1002/pros.23382

PMID:28664580

Abstract

BACKGROUND

The performance of prostate health index (phi) in predicting prostate biopsy outcomes has been well established for patients with prostate-specific antigen (PSA) values between 2 and 10 ng/mL. However, the performance of phi remains unknown in patients with PSA >10 ng/mL, the vast majority in Chinese biopsy patients. We aimed to assess the ability of phi to predict prostate cancer (PCa) and high-grade disease (Gleason Score ≥7) on biopsy in a Chinese population.

METHODS

This is a prospective, observational, multi-center study of consecutive patients who underwent a transrectal ultrasound guided prostate biopsy at four hospitals in Shanghai, China from August 2013 to December 2014.

RESULTS

In the cohort of 1538 patients, the detection rate of PCa was 40.2%. phi had a significantly better predictive performance for PCa than total PSA (tPSA). The areas under the receiver operating characteristic curve (AUC) were 0.90 and 0.79 for phi and tPSA, respectively, P < 0.0001. A considerable proportion of patients in the cohort had PSAs >10 ng/mL (N = 838, 54.5%). The detection rates of PCa were 35.9% and 57.7% in patients with tPSA 10.1-20 and 20.1-50 ng/mL, respectively. The AUCs of phi (0.79 and 0.89, for these two groups, respectively) were also significantly higher than tPSA (0.57 and 0.63, respectively), both P < 0.0001. If a phi ≤35 was used as the cutoff, 599/1538 (39%) biopsies could have been avoided at a cost of missing small numbers of PCa patients: 49 (7.93%) PCa patients, including 18 (3.69%) high-grade tumors.

CONCLUSIONS

Results from this study suggest that phi can be used to predict PCa and high-grade disease in Chinese men with high PSA levels (>10 ng/mL).

摘要

背景

前列腺健康指数（phi）在预测前列腺特异性抗原（PSA）值介于2至10 ng/mL的患者前列腺活检结果方面的表现已得到充分证实。然而，对于PSA>10 ng/mL的患者（中国活检患者中的绝大多数），phi的表现仍不清楚。我们旨在评估phi在中国人群中预测前列腺活检中前列腺癌（PCa）和高级别疾病（Gleason评分≥7）的能力。

方法

这是一项前瞻性、观察性、多中心研究，研究对象为2013年8月至2014年12月在中国上海四家医院接受经直肠超声引导下前列腺活检的连续患者。

结果

在1538例患者队列中，PCa的检出率为40.2%。phi对PCa的预测性能明显优于总PSA（tPSA）。phi和tPSA的受试者工作特征曲线下面积（AUC）分别为0.90和0.79，P<0.0001。队列中相当一部分患者的PSA>10 ng/mL（N = 838，54.5%）。tPSA为10.1 - 20和20.1 - 50 ng/mL的患者中，PCa的检出率分别为35.9%和57.7%。这两组phi的AUC（分别为0.79和0.89）也显著高于tPSA（分别为0.57和0.63），P均<0.0001。如果将phi≤35作为临界值，1538例活检中有599例（39%）可以避免，代价是漏诊少量PCa患者：49例（7.93%）PCa患者，包括18例（3.69%）高级别肿瘤。