Dataset related to article "Assessing the Role of High-resolution Microultrasound Among Naïve Patients with Negative Multiparametric Magnetic Resonance Imaging and a Persistently High Suspicion of Prostate Cancer"

This record contains raw data related to article “Assessing the Role of High-resolution Microultrasound Among Naïve Patients with Negative Multiparametric Magnetic Resonance Imaging and a Persistently High Suspicion of Prostate Cancer"

Abstract

Background: Multiparametric magnetic resonance imaging (mpMRI) is an invaluable diagnostic tool in the decision-making for prostate biopsies (PBx). However, a non-negligible proportion of patients with negative MRI (nMRI) may still harbour prostate cancer (PCa).

Objective: To assess whether microultrasound (micro-US) can help in substratifying the presence of PCa and clinically significant PCa (csPCa; ie, any Gleason score ≥7 PCa) in patients with nMRI despite a persistently high clinical suspicion of PCa.

Design setting and participants: A total of 125 biopsy-naïve patients who underwent micro-US-guided PBx with the ExactVu system for a persistently high suspicion of PCa despite nMRI were prospectively enrolled.

Intervention: The Prostate Risk Identification using micro-US (PRI-MUS) protocol was used to identify suspicious areas; PBx included targeted sampling of PRI-MUS ≥3 areas and systematic sampling.

Outcome measurements and statistical analysis: The primary endpoint was the assessment of micro-US diagnostic accuracy in detecting csPCa. Secondary endpoints included determining the proportion of patients with nMRI who may avoid PBx after micro-US or transrectal US, presence of cribriform and intraductal patterns on biopsy core examination, predictors of csPCa in patients presenting with nMRI, and comparing micro-US-targeted and systematic PBx in identifying csPCa.

Results and limitations: Considering csPCa detection rate, micro-US showed optimal sensitivity and negative predictive value (respectively, 97.1% and 96.4%), while specificity and positive predictive value were 29.7% and 34.0%, respectively. Twenty-eight (22.4%) patients with a negative micro-US examination could have avoided PBx with one (2.9%) missed csPCa. Cribriform and intraductal patterns were found in 14 (41.2%) and four (11.8%) of csPCa patients, respectively. In multivariable logistic regression models, positive micro-US, age, digital rectal examination, and prostate-specific antigen density ≥0.15 emerged as independent predictors of PCa. Targeted and systematic sampling identified 33 (97.1%) and 26 (76.5%) csPCa cases, respectively. The main limitation of the current study is represented by its retrospective single-centre nature on an operator-dependent technology.

Conclusions: Micro-US represents a valuable tool to rule out the presence of csPCa among patients with a persistent clinical suspicion despite nMRI.

Patient summary:  According to our results, microultrasound (micro-US) may represent an effective tool for the diagnosis of clinically significant prostate cancer in patients with negative magnetic resonance imaging (nMRI), providing high sensitivity and negative predictive value. Further randomised studies are needed to confirm the potential role of micro-US in the diagnostic pathway of patients with a persistent suspicion of prostate cancer despite nMRI.

本数据集包含与论文《高分辨率微超声在磁共振成像阴性且持续高度疑似前列腺癌的初治患者中的评估价值》相关的原始数据。

摘要

背景：多参数磁共振成像（multiparametric magnetic resonance imaging, mpMRI）是前列腺活检（prostate biopsies, PBx）决策环节中极具价值的诊断工具。然而，磁共振成像阴性（negative MRI, nMRI）患者中仍有相当比例可能隐匿存在前列腺癌（prostate cancer, PCa）。

目的：旨在评估对于磁共振成像阴性且持续高度疑似前列腺癌的患者，微超声（microultrasound, micro-US）是否能够辅助分层检出前列腺癌及临床显著性前列腺癌（clinically significant PCa, csPCa，即格里森评分≥7分的前列腺癌）的存在情况。

研究设计、场景与研究对象：本研究前瞻性纳入125例初治活检患者，这些患者因磁共振成像阴性但仍持续高度疑似前列腺癌，接受了ExactVu系统引导下的微超声辅助前列腺活检。

干预措施：采用基于微超声的前列腺风险识别方案（Prostate Risk Identification using micro-US, PRI-MUS）识别可疑病灶；前列腺活检包括对PRI-MUS评分≥3的区域进行靶向穿刺，以及系统穿刺采样。

结局指标与统计学分析：主要终点为评估微超声检出临床显著性前列腺癌的诊断准确性。次要终点包括：磁共振成像阴性患者经微超声或经直肠超声检查后可避免前列腺活检的比例；活检标本中筛状结构与导管内结构的检出情况；磁共振成像阴性患者中临床显著性前列腺癌的预测因素；对比微超声靶向穿刺与系统穿刺在检出临床显著性前列腺癌中的诊断效能。

结果与局限性：就临床显著性前列腺癌检出率而言，微超声展现出优异的灵敏度与阴性预测值（分别为97.1%与96.4%），而特异度与阳性预测值分别为29.7%与34.0%。28例（22.4%）微超声检查阴性的患者可避免接受前列腺活检，其中仅1例（2.9%）漏诊了临床显著性前列腺癌。筛状结构与导管内结构分别在14例（41.2%）与4例（11.8%）的临床显著性前列腺癌患者中被检出。多变量logistic回归模型显示，微超声结果阳性、年龄、直肠指检异常及前列腺特异性抗原密度≥0.15是前列腺癌的独立预测因素。靶向穿刺与系统穿刺分别检出33例（97.1%）与26例（76.5%）的临床显著性前列腺癌病例。本研究的主要局限性为单中心回顾性设计，且所采用的技术依赖于操作者经验。

结论：微超声是一项极具价值的诊断工具，可用于排除磁共振成像阴性且持续高度疑似前列腺癌患者体内临床显著性前列腺癌的存在。

患者总结：根据本研究结果，微超声（micro-US）可作为磁共振成像阴性患者诊断临床显著性前列腺癌的有效工具，其具备较高的灵敏度与阴性预测值。未来仍需开展随机对照研究，以证实微超声在磁共振成像阴性但持续疑似前列腺癌患者的诊断流程中的潜在应用价值。