mpMRI在临床上重要的乳腺癌诊断（ISUP级别组≥2级，csPCa）方面有很大进展，大多数目前的指南都推荐使用。Proclarix®是一种新的CE标记的生物标志物检测工具，有助于识别csPCa。该研究的目的是评估Proclarix单独或结合mpMRI预测csPCa的临床表现。该研究包括来自伦敦大学学院（UCL）和巴塞罗那瓦尔德布森大学医院的721名接受mpMRI随后进行活检的男性的血样。样品是盲测的。使用前列腺体积、Proclarix和mpMRI结果训练了Proclarix-MRI模型，使用UCL队列（n=159）进行验证，使用瓦尔德布森队列（n=562）进行验证。根据活检结果将其诊断表现与可用的临床参数和风险计算器进行比较。验证队列中Proclarix-MRI模型的临床表现与训练队列没有显著差异，并且对csPCa的灵敏度为90％，NPV为90％，PPV为66％。 Proclarix-MRI得分的特异性（68％）明显优于MRI-ERSPC风险评分（51％），Proclarix（27％）或仅mpMRI（28％）（p＜0.001）。另外，发现仅Proclarix在MRI PI-RADS 3子组中表现良好，其特异性（25％对13％，p=0.004）超过了PSA密度，灵敏度为100％。与mpMRI和前列腺体积结合使用时，Proclarix可可靠地预测csPCa，并排除没有或慢性癌症的男性。取得了三分之二的不必要活检的大幅减少。在男性中，Proclarix可以进一步用于高信心地可靠检测到PI-RADS 3 mpMRI不定的csPCa。尽管取得了这些令人鼓舞的结果，仍需要进一步验证。本文受版权保护。保留所有权利。

The use of mpMRI has been a significant advance in the diagnosis of clinically significant prostate cancer (ISUP Grade Group ≥2, csPCa) and is recommended in most current guidelines. Proclarix® is a novel CE-marked biomarker test aiding in the identification of csPCa. The aim of the study was the assessment of the clinical performance of Proclarix alone or in combination with mpMRI to predict csPCa.The study included blood samples from 721 men undergoing mpMRI followed by biopsy at University College London (UCL), London, and Vall d'Hebron University Hospital, Barcelona. Samples were tested blindly. The Proclarix-MRI model combining prostate volume, Proclarix and mpMRI results was trained using the UCL cohort (n=159) and validated in the Vall d'Hebron cohort (n=562). Its diagnostic performance was established in correlation to biopsy outcome and compared to available clinical parameters and risk calculators.Clinical performance of the Proclarix-MRI model in the validation cohort did not significantly differ from the training cohort and resulted in a sensitivity for csPCa of 90%, 90% NPV and 66% PPV. The Proclarix-MRI score's specificity (68%) was significantly (p<0.001) better compared to MRI-ERSPC risk score (51%), Proclarix (27%) or mpMRI (28%) alone. In addition, Proclarix by itself was found to be useful in the MRI PI-RADS 3 subgroup by outperforming PSA density in terms of specificity (25% vs 13%, p=0.004) at 100% sensitivity.When combined with mpMRI and prostate volume, Proclarix reliably predicted csPCa and ruled out men with no or indolent cancer. A large reduction of two thirds of unneeded biopsies was achieved. Proclarix can further be used with high confidence to reliably detect csPCa in men with an indeterminate PI-RADS 3 mpMRI. Despite these encouraging results, further validation is needed.This article is protected by copyright. All rights reserved.