Background/Objectives:Validation of predictive models (PMs) is crucial to be implemented in new populations or when advances in diagnostic approaches occurred. The aim of this study is to validate the BCN-MRI PM for sPCa when a highly effective prostate biopsy protocol is used.Methods:A prospective cohort of 457 men suspected of having PCa, for whom MRI results were reported with the Prostate Imaging-Reporting and Data System (PI-RADS) v 2.1, underwent a per 0.5 mm-core mapping targeted biopsy of suspicious lesions and perilesional areas, followed by a 12-core-systematic biopsy. These procedures took place between 1 February 2022, and 29 February 2024, at a reference center for prostate biopsy. The individual likelihood of sPCa was assessed through the BCN-MRI risk calculator.Results:The overall sPCa detection rate was 58.3%. The calibration curve of the BCN-MRI PM showed an appropriate accuracy between expected and observed probabilities with a discrimination ability for sPCa yielding an area under the curve (AUC) of 0.862 (95% CI 0.828–0.896) comparable to the AUC of 0.858 (95% CI 0.833–0.883) observed in the development cohort. The application of the BCN-MRI PM provided a net benefit over performing biopsies on all men, avoiding 24.9% of prostate biopsies at 95% sensitivity for sPCa, compared to the 23.7% reduction observed in the development cohort.Conclusions:We conclude that the BCN-MRI PM is ready to be implemented when this biopsy protocol is employed.
背景/目的：预测模型（PMs）的验证对于在新人群中实施或诊断方法取得进展时至关重要。本研究旨在验证在使用高效前列腺活检方案时，BCN-MRI预测模型对显著性前列腺癌（sPCa）的预测效能。方法：前瞻性纳入457名疑似前列腺癌（PCa）的男性患者，所有患者均采用前列腺影像报告和数据系统（PI-RADS）v 2.1版本进行MRI结果报告，并接受了针对可疑病灶及病灶周围区域每0.5毫米核心的靶向穿刺活检，随后进行12针系统性活检。这些操作于2022年2月1日至2024年2月29日期间在一家前列腺活检参考中心完成。通过BCN-MRI风险计算器评估个体患sPCa的可能性。结果：总体sPCa检出率为58.3%。BCN-MRI预测模型的校准曲线显示预期概率与观察概率之间具有良好的一致性，其区分sPCa的能力曲线下面积（AUC）为0.862（95% CI 0.828–0.896），与开发队列中观察到的AUC 0.858（95% CI 0.833–0.883）相当。应用BCN-MRI预测模型相比对所有男性进行活检具有净获益，在sPCa检测灵敏度为95%时，可避免24.9%的前列腺活检，而开发队列中观察到的活检减少率为23.7%。结论：我们得出结论，当采用此活检方案时，BCN-MRI预测模型已具备实施条件。
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