建议：Proclarix 是一种新型的基于血液的检测方法，旨在支持前列腺癌活检决策中的挑战性问题。本研究旨在对 Proclarix 进行真实世界的前瞻性研究。

PROPOSe: A Real-life Prospective Study of Proclarix, a Novel Blood-based Test to Support Challenging Biopsy Decision-making in Prostate Cancer.

机构信息

Martini-Klinik, University Hospital Hamburg-Eppendorf, Hamburg, Germany.

Medical University Innsbruck, Department of Urology, Innsbruck, Austria.

出版信息

Eur Urol Oncol. 2022 Jun;5(3):321-327. doi: 10.1016/j.euo.2020.12.003. Epub 2021 Jan 6.

DOI:10.1016/j.euo.2020.12.003

PMID:33422560

Abstract

BACKGROUND

Prostate-specific antigen (PSA)-based detection of prostate cancer (PCa) often leads to negative biopsy results or detection of clinically insignificant PCa, more frequently in the PSA range of 2-10 ng/ml, in men with increased prostate volume and normal digital rectal examination (DRE).

OBJECTIVE

This study evaluated the accuracy of Proclarix, a novel blood-based diagnostic test, to help in biopsy decision-making in this challenging patient population.

DESIGN, SETTING, AND PARTICIPANTS: Ten clinical sites prospectively enrolled 457 men presenting for prostate biopsy with PSA between 2 and 10 ng/ml, normal DRE, and prostate volume ≥35 cm. Transrectal ultrasound-guided and multiparametric magnetic resonance imaging (mpMRI)-guided biopsy techniques were allowed.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Serum samples were tested blindly at the end of the study. Diagnostic performance of Proclarix risk score was established in correlation to systematic biopsy outcome and its performance compared with %free PSA (%fPSA) and the European Randomised Study of Screening for Prostate Cancer (ERSPC) risk calculator (RC) as well as Proclarix density compared with PSA density in men undergoing mpMRI.

RESULTS AND LIMITATIONS

The sensitivity of Proclarix risk score for clinically significant PCa (csPCa) defined as grade group (GG) ≥2 was 91% (n = 362), with higher specificity than both %fPSA (22% vs 14%; difference = 8% [95% confidence interval {CI}, 2.6-14%], p = 0.005) and RC (22% vs 15%; difference = 7% [95% CI, 0.7-12%], p = 0.028). In the subset of men undergoing mpMRI-fusion biopsy (n = 121), the specificity of Proclarix risk score was significantly higher than PSA density (26% vs 8%; difference = 18% [95% CI, 7-28%], p < 0.001), and at equal sensitivity of 97%, Proclarix density had an even higher specificity of 33% [95% CI, 23-43%].

CONCLUSIONS

In a routine use setting, Proclarix accurately discriminated csPCa from no or insignificant PCa in the most challenging patients. Proclarix represents a valuable rule-out test in the diagnostic algorithm for PCa, alone or in combination with mpMRI.

PATIENT SUMMARY

Proclarix is a novel blood-based test with the potential to accurately rule out clinically significant prostate cancer, and therefore to reduce the number of unneeded biopsies.

摘要

背景

基于前列腺特异性抗原（PSA）的前列腺癌（PCa）检测常导致前列腺体积增大和直肠指检（DRE）正常的 2-10ng/ml PSA 范围内的男性出现阴性活检结果或检测到临床意义不大的 PCa，尤其是在 PSA 范围内。

目的

本研究评估了 Proclarix 的准确性，Proclarix 是一种新型的基于血液的诊断检测方法，有助于在这个具有挑战性的患者群体中进行活检决策。

设计、地点和参与者：10 个临床中心前瞻性地招募了 457 名 PSA 为 2-10ng/ml、DRE 正常、前列腺体积≥35cm 的男性进行前列腺活检。允许进行经直肠超声引导和多参数磁共振成像（mpMRI）引导活检技术。

结局测量和统计分析

在研究结束时对血清样本进行了盲法检测。Proclarix 风险评分的诊断性能与系统活检结果相关联，并与游离前列腺特异性抗原（%fPSA）和欧洲前列腺癌筛查随机研究（ERSPC）风险计算器（RC）进行了比较，以及与接受 mpMRI 的男性中的 PSA 密度相比，Proclarix 密度。

结果和局限性

Proclarix 风险评分对临床显著前列腺癌（csPCa）的敏感性为 91%（n=362），特异性高于 %fPSA（22%比 14%；差异=8%[95%置信区间{CI}，2.6-14%]，p=0.005）和 RC（22%比 15%；差异=7%[95% CI，0.7-12%]，p=0.028）。在接受 mpMRI-融合活检的男性亚组（n=121）中，Proclarix 风险评分的特异性明显高于 PSA 密度（26%比 8%；差异=18%[95% CI，7-28%]，p<0.001），而在敏感性相同的情况下，Proclarix 密度的特异性更高，为 33%[95% CI，23-43%]。