美国的一项多机构前瞻性试验证实，4Kscore 能准确识别出患有高级别前列腺癌的男性。
A multi-institutional prospective trial in the USA confirms that the 4Kscore accurately identifies men with high-grade prostate cancer.
机构信息
Department of Urology, University of Miami Miller School of Medicine and Sylvestor Comprehensive Cancer Center, Miami, FL, USA.
Department of Urology, University of Miami Miller School of Medicine and Sylvestor Comprehensive Cancer Center, Miami, FL, USA.
出版信息
Eur Urol. 2015 Sep;68(3):464-70. doi: 10.1016/j.eururo.2014.10.021. Epub 2014 Oct 27.
BACKGROUND
The 4Kscore combines measurement of four kallikreins in blood with clinical information as a measure of the probability of significant (Gleason ≥7) prostate cancer (PCa) before prostate biopsy.
OBJECTIVE
To perform the first prospective evaluation of the 4Kscore in predicting Gleason ≥7 PCa in the USA.
DESIGN, SETTING, AND PARTICIPANTS: Prospective enrollment of 1012 men scheduled for prostate biopsy, regardless of prostate-specific antigen level or clinical findings, was conducted at 26 US urology centers between October 2013 and April 2014.
INTERVENTION
The 4Kscore.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary outcome was Gleason ≥7 PCa on prostate biopsy. The area under the receiver operating characteristic curve, risk calibration, and decision curve analysis (DCA) were determined, along with comparisons of probability cutoffs for reducing the number of biopsies and their impact on delaying diagnosis.
RESULTS AND LIMITATIONS
Gleason ≥7 PCa was found in 231 (23%) of the 1012 patients. The 4Kscore showed excellent calibration and demonstrated higher discrimination (AUC 0.82) and net benefit compared to a modified Prostate Cancer Prevention Trial Risk Calculator 2.0 model and standard of care (biopsy for all men) according to DCA. A possible reduction of 30-58% in the number biopsies was identified with delayed diagnosis in only 1.3-4.7% of Gleason ≥7 PCa cases, depending on the threshold used for biopsy. Pathological assessment was performed according to the standard of care at each site without centralized review.
CONCLUSION
The 4Kscore showed excellent diagnostic performance in detecting significant PCa. It is a useful tool in selecting men who have significant disease and are most likely to benefit from a prostate biopsy from men with no cancer or indolent cancer.
PATIENT SUMMARY
The 4Kscore provides each patient with an accurate and personalized measure of the risk of Gleason ≥7 cancer to aid in decision-making regarding the need for prostate biopsy.
背景
4Kscore 通过检测血液中的四种激肽释放酶，并结合临床信息，来衡量前列腺活检前发生显著（Gleason 分级≥7）前列腺癌（PCa）的概率。
目的
在美国首次对 4Kscore 预测 Gleason 分级≥7 PCa 的性能进行前瞻性评估。
设计、地点和参与者：2013 年 10 月至 2014 年 4 月，在美国 26 个泌尿科中心，前瞻性纳入 1012 名计划接受前列腺活检的男性患者，无论前列腺特异性抗原水平或临床发现如何。
干预措施
4Kscore。
主要结局测量指标和统计分析
主要结局是前列腺活检中发现 Gleason 分级≥7 PCa。评估了受试者工作特征曲线下面积、风险校准和决策曲线分析（DCA），比较了不同概率截断值减少活检数量的效果及其对延迟诊断的影响。
结果和局限性
1012 例患者中，231 例（23%）发现 Gleason 分级≥7 PCa。根据 DCA，4Kscore 显示出良好的校准效果，与改良前列腺癌预防试验风险计算器 2.0 模型和标准护理（所有男性均行活检）相比，具有更高的区分度（AUC 0.82）和净获益。根据活检阈值的不同，可减少 30%-58%的活检数量，而仅 1.3%-4.7%的 Gleason 分级≥7 PCa 病例出现延迟诊断。每个中心均根据标准护理进行病理评估，而未进行集中审查。
结论
4Kscore 在检测显著 PCa 方面具有出色的诊断性能。它是一种有用的工具，可用于选择那些患有显著疾病且最有可能从前列腺活检中获益的男性，同时也可以避免对无癌症或惰性癌症的男性进行不必要的活检。
患者总结
4Kscore 为每位患者提供了一种准确且个性化的 Gleason 分级≥7 癌症风险评估，有助于在是否需要进行前列腺活检方面做出决策。
Zotero 插件