Objective: The Prostate Cancer Prevention Trial risk calculator (PCPT-RC) is an online tool for assessing the risk of prostate cancer (PCa) based on age, race, serum PSA, biopsy history, family history, and other factors. This study aimed to investigate the value, sensitivity and specificity of the PCPT-RC 2.0 in assessing the risk of PCa in the Chinese high-risk population.
Methods: This study included 622 patients with the high risk of PCa characterized by high serum PSA (PSA >3 μg/L) or abnormality in digital rectal examination or imaging of the prostate. According to the results of prostate biopsy, we divided the patients into a PCa and a non-PCa group and used the PCPT-RC 2.0 for evaluation of all the cases followed by statistical analysis.
Results: PCa was detected in 264 (42.4%) of the 622 patients, including 126 cases of high-grade malignancy. Compared with the non-PCa group, the PCa patients showed a significantly older age (［68.40 ± 7.30］ vs ［72.80 ± 7.20］ yr, P <0.001), higher serum PSA level (［11.20 ± 7.76］ vs ［15.06 ± 10.65］, P <0.001), and higher PCPT risk score (［37.0 ± 10.8］% vs ［44.4 ± 12.6］%, P <0.001). The PCPT risk score exhibited a greater area under the ROC curve than the level of serum PSA in evaluating the risk of PCa (0.67 vs 0.61, P <0.05), but no statistically significant difference between the two in predicting the risk of high-grade malignancy (0.67 vs 0.66, P >0.05).
Conclusions: The PCPT risk score is valuable in predicting the risk of PCa in China, which may play a better role than the serum PSA level in screening PCa and avoid unnecessary prostate biopsy, though its advantage is not so obvious in identifying high-grade malignancy. A prediction tool needs to be established for evaluating the risk of PCa in the Chinese population.
目的： 前列腺癌预防试验（PCPT） 风险计算器是结合年龄、种族、血清PSA水平、穿刺活检史、家族史等因子对罹患前列腺癌风险进行评估的在线工具。本研究使用PCPT风险计算器RC 2.0评价中国高危人群（高基线PSA、直肠指检阳性、影像学阳性）的前列腺癌风险，检验其敏感性、特异性。方法： 选择2010年5月至2016年2月具有罹患前列腺癌风险的高危患者916例，该组患者的特征：较高的血清PSA水平（PSA>3 μg/L）或直肠指检异常或前列腺影像学检查异常，均进行前列腺穿刺活检，由于部分患者的数据缺失，实际纳入本研究的患者共计622例。按照前列腺穿刺结果将患者分为前列腺癌组与前列腺穿刺活检阴性组，使用在线工具PCPT RC2.0对每例患者进行评价，并进行统计学分析。结果： 622例患者中前列腺癌264例（42.4%），其中高级别前列腺癌126例。前列腺癌组年龄为(72.8±7.2)岁，前列腺穿刺活检阴性组为(68.4±7.3)岁，两者具有统计学差异（P<0.01）；前列腺癌组血清PSA为(15.06±10.65) μg/L，前列腺穿刺活检阴性组为(11.20±7.76) μg/L，两者有统计学差异（P<0.01）；前列腺癌组PCPT评分为(44.4±12.6)%，前列腺穿刺活检阴性组为(37.0±10.8)%，两者有统计学差异（P<0.01）。前列腺癌的发病率随着年龄、PSA水平、PCPT评分的升高而增加。PCPT风险计算器在评价前列腺癌风险上的ROC曲线下面积为0.669，血清PSA的曲线下面积为0.612，PCPT风险计算器评分明显大于血清PSA，两者有统计学差异（P<0.05）。在高级别前列腺癌的评价上PCPT评分的ROC曲线下面积0.668，而血清PSA为0.656，两者无统计学差异。结论： PCPT风险计算器在中国罹患前列腺癌的高危人群有良好的验证，对于前列腺癌的筛查优于血清PSA，能够避免不适当的前列腺穿刺活检，但对于高级别前列腺癌的评价优势不明显，应该建立适用于中国人群的前列腺癌风险预测工具。.
Keywords: Prostate Cancer Prevention Trial risk calculator; evaluation; prostate biopsy; prostate-specific antigen; prostate cancer.