Afya Research Africa (ARA): A JBI Centre of Excellence, Nairobi, Kenya.
Moi University School of Medicine, Eldoret, Kenya.
JBI Evid Synth. 2021 Jun;19(6):1263-1291. doi: 10.11124/JBISRIR-D-19-00194.
The objective of this review was to determine the diagnostic accuracy of [-2]proPSA (p2PSA) and the Prostate Health Index compared to the Gleason score in determining the aggressiveness of prostate cancer.
Prostate cancer is the most commonly diagnosed cancer in men. However, the utility of currently available biomarkers for determining the aggressive form of the disease remains unknown. This review sought to determine the diagnostic accuracy of two new biomarkers in determining the aggressive form of prostate cancer.
Diagnostic accuracy studies that enrolled men of any age and any prostate specific antigen (PSA) level with histologically confirmed prostate cancer in which Prostate Health Index and p2PSA were assessed in comparison to Gleason score for the determination of aggressive prostate cancer were considered for inclusion. There was no time limitation on study inclusion.
A three-step search strategy was utilized to identify both published and unpublished studies in the English language in the following sources: PubMed, Cochrane Central Register of Controlled Trials, CINAHL, Web of Science, Google Scholar, MedNar, and SIGLE. Databases were searched from inception to January 2019. Study selection, critical appraisal, data extraction, and data synthesis were done according to the approach recommended by JBI.
A total of 12 studies (n = 8462) that recruited men with aggressive prostate cancer were considered in this review. The majority of included subjects had a total PSA level of 2 to 10ng/mL. The sensitivity of the Prostate Health Index ranged from 67% to 97% while specificity ranged from 6% to 64%. At a Prostate Health Index threshold of 25 and below (three studies, n = 3222), pooled sensitivity was 97% (95% confidence interval [CI], 95% to 98%) and specificity was 10% (95% CI, 6% to 16%). At a Prostate Health Index threshold of between 26 and 35 (six studies, n = 6030), pooled sensitivity was 87% (95% CI, 8% to 91%) and specificity was 45% (95% CI, 39% to 50%). At a Prostate Health Index threshold of 36 and above (five studies, n = 1476), pooled sensitivity was 72% (95% CI, 64% to 79%) and specificity was 74% (95% CI, 68% to 80%). Only one study assessed p2PSA. Sensitivity ranged from 80% to 95%, and specificity ranged from 9.9% to 27.9% with increasing threshold values from 7.9 to 10.9ng/mL.
Overall, both Prostate Health Index and p2PSA have acceptable accuracy for the determination of the likelihood of aggressive prostate cancer. However, the inverse relationship between sensitivity and specificity makes it difficult to determine an optimum cut-off value for positivity. Further research is warranted to determine their utility in the management of prostate cancer.
本综述旨在确定 [-2] 前列腺特异性抗原（p2PSA）和前列腺健康指数（Prostate Health Index，简称 PHI）与格里森评分（Gleason score）相比，在确定前列腺癌侵袭性方面的诊断准确性。
前列腺癌是男性最常见的癌症。然而，目前用于确定侵袭性疾病的生物标志物的实用性仍不清楚。本综述旨在确定两种新生物标志物在确定前列腺癌侵袭性方面的诊断准确性。
纳入了评估前列腺健康指数和 p2PSA 以确定侵袭性前列腺癌的年龄和任何前列腺特异性抗原（PSA）水平的男性的诊断准确性研究，这些研究均经组织学证实患有前列腺癌。研究无时间限制。
采用三步式搜索策略，在以下来源中搜索英文出版和未出版的研究：PubMed、Cochrane 对照试验中心注册库、CINAHL、Web of Science、Google Scholar、MedNar 和 SIGLE。从成立到 2019 年 1 月，数据库进行了搜索。根据 JBI 推荐的方法进行研究选择、批判性评价、数据提取和数据综合。
共纳入了 12 项（n = 8462）纳入侵袭性前列腺癌男性的研究。大多数纳入的研究对象的总 PSA 水平为 2 至 10ng/mL。前列腺健康指数的敏感性范围为 67%至 97%，特异性范围为 6%至 64%。在前列腺健康指数阈值为 25 及以下（三项研究，n = 3222）时，汇总敏感性为 97%（95%置信区间[CI]，95%至 98%），特异性为 10%（95% CI，6%至 16%）。在前列腺健康指数阈值为 26 至 35 之间（六项研究，n = 6030）时，汇总敏感性为 87%（95% CI，8%至 91%），特异性为 45%（95% CI，39%至 50%）。在前列腺健康指数阈值为 36 及以上（五项研究，n = 1476）时，汇总敏感性为 72%（95% CI，64%至 79%），特异性为 74%（95% CI，68%至 80%）。只有一项研究评估了 p2PSA。敏感性范围为 80%至 95%，特异性范围为 9.9%至 27.9%，随着阈值从 7.9 至 10.9ng/mL 的增加而降低。
总的来说，前列腺健康指数和 p2PSA 在确定前列腺癌侵袭性方面都具有可接受的准确性。然而，敏感性和特异性之间的反比关系使得确定阳性的最佳截断值变得困难。需要进一步的研究来确定它们在前列腺癌管理中的效用。
