Background

Although multiparametric magnetic resonance imaging (MRI) has high sensitivity, its lower specificity leads to a high prevalence of false-positive lesions requiring biopsy.

Objective

To develop and externally validate a scoring system for MRI-detected Prostate Imaging Reporting and Data System (PIRADS)/Likert ≥3 lesions containing clinically significant prostate cancer (csPCa).

Design, setting, and participants

The multicentre Rapid Access to Prostate Imaging and Diagnosis (RAPID) pathway included 1189 patients referred to urology due to elevated age-specific prostate-specific antigen (PSA) and/or abnormal digital rectal examination (DRE); April 27, 2017 to October 25, 2019.

Intervention

Visual-registration or image-fusion targeted and systematic transperineal biopsies for an MRI score of ≥4 or 3 + PSA density ≥0.12 ng/ml/ml.

Outcome measurements and statistical analysis

Fourteen variables were used in multivariable logistic regression for Gleason ≥3 + 4 (primary) and Gleason ≥4 + 3, and PROMIS definition 1 (any ≥4 + 3 or ≥6 mm any grade; secondary). Nomograms were created and a decision curve analysis (DCA) was performed. Models with varying complexity were externally validated in 2374 patients from six international cohorts.

Results and limitations

The five-item Imperial RAPID risk score used age, PSA density, prior negative biopsy, prostate volume, and highest MRI score (corrected c-index for Gleason ≥3 + 4 of 0.82 and 0.80–0.86 externally). Incorporating family history, DRE, and Black ethnicity within the eight-item Imperial RAPID risk score provided similar outcomes. The DCA showed similar superiority of all models, with net benefit differences increasing in higher threshold probabilities. At 20%, 30%, and 40% of predicted Gleason ≥3 + 4 prostate cancer, the RAPID risk score was able to reduce, respectively, 11%, 21%, and 31% of biopsies against 1.8%, 6.2%, and 14% of missed csPCa (or 9.6%, 17%, and 26% of foregone biopsies, respectively).

Conclusions

The Imperial RAPID risk score provides a standardised tool for the prediction of csPCa in patients with an MRI-detected PIRADS/Likert ≥3 lesion and can support the decision for prostate biopsy.

Patient summary

In this multinational study, we developed a scoring system incorporating clinical and magnetic resonance imaging characteristics to predict which patients have prostate cancer requiring treatment and which patients can safely forego an invasive prostate biopsy. This model was validated in several other countries.

中文翻译：

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预测磁共振成像检测到前列腺成像报告和数据系统/Likert ≥ 3 病变的患者是否需要活检来检测具有临床意义的前列腺癌：帝国快速获得前列腺成像和诊断风险评分的开发和多国外部验证

背景

虽然多参数磁共振成像 (MRI) 具有高灵敏度，但其较低的特异性导致需要活检的假阳性病变的发生率很高。

客观的

开发并外部验证 MRI 检测到的前列腺成像报告和数据系统 (PIRADS)/Likert ≥3 个包含有临床意义的前列腺癌 (csPCa) 病变的评分系统。

设计、设置和参与者

多中心快速前列腺成像和诊断 (RAPID) 途径包括 1189 名因年龄特异性前列腺特异性抗原 (PSA) 升高和/或直肠指检 (DRE) 异常而转诊至泌尿科的患者；2017年4月27日至2019年10月25日。

干涉

MRI 评分≥4 或 3 + PSA 密度≥0.12 ng/ml/ml 的视觉配准或图像融合靶向和系统经会阴活检。

结果测量和统计分析

在 Gleason ≥3 + 4（主要）和 Gleason ≥4 + 3 以及 PROMIS 定义 1（任何 ≥4 + 3 或 ≥6 mm 任何级别；次要）的多变量逻辑回归中使用了 14 个变量。创建诺模图并执行决策曲线分析 (DCA)。具有不同复杂性的模型在来自六个国际队列的 2374 名患者中进行了外部验证。

结果和局限性

五项 Imperial RAPID 风险评分使用年龄、PSA 密度、既往阴性活检、前列腺体积和最高 MRI 评分（格里森≥3 + 4 的校正 c 指数为 0.82 和外部 0.80-0.86）。将家族史、DRE 和黑人种族纳入八项 Imperial RAPID 风险评分提供了类似的结果。DCA 显示出所有模型的相似优势，净收益差异在更高的阈值概率中增加。在 20%、30% 和 40% 的预测 Gleason ≥3 + 4 前列腺癌中，RAPID 风险评分能够分别减少 11%、21% 和 31% 的活检，而 1.8%、6.2% 和14% 的 csPCa 漏检（或分别为 9.6%、17% 和 26% 的放弃活检）。

结论

Imperial RAPID 风险评分为预测 MRI 检测到 PIRADS/Likert ≥ 3 病变的患者的 csPCa 提供了一个标准化工具，并且可以支持前列腺活检的决定。

患者总结

在这项跨国研究中，我们开发了一个结合临床和磁共振成像特征的评分系统，以预测哪些患者患有需要治疗的前列腺癌，以及哪些患者可以安全地放弃侵入性前列腺活检。该模型在其他几个国家得到验证。