Prospective Study of Diagnostic Accuracy Comparing Prostate Cancer Detection by Transrectal Ultrasound-Guided Biopsy Versus Magnetic Resonance (MR) Imaging with Subsequent MR-guided Biopsy in Men Without Previous Prostate Biopsies
Prospective Study of Diagnostic Accuracy Comparing Prostate Cancer Detection by Transrectal Ultrasound-Guided Biopsy Versus Magnetic Resonance (MR) Imaging with Subsequent MR-guided Biopsy in Men Without Previous Prostate Biopsies
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DOI：
10.1016/j.eururo.2014.03.002
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发表时间：
2014-07-01
期刊：
影响因子：
23.4
通讯作者：
Thompson, Leslie C.
中科院分区：
文献类型：
--
作者：
Pokorny, Morgan R.;De Rooij, Maarten;Thompson, Leslie C.
背景：目前前列腺癌（PCa）的诊断采用经直肠超声引导活检（TRUSGB）。 TRUSGB 会导致采样错误，从而导致诊断延迟、惰性 PCa 的过度检测和错误分类。多参数磁共振成像 (mpMRI) 的进展表明，成像和选择性磁共振 (MR) 引导活检 (MRGB) 可能优于 TRUSGB。 目的：比较磁共振成像 (MRI) 途径与 TRUSGB 的诊断功效。 设计、设置和参与者：从 7 月份开始，共有 223 名连续接受过活检的男性转诊至泌尿科医生，前列腺特异性抗原升高，参与了一项单机构、前瞻性、研究者盲法诊断研究2012 年至 2013 年 1 月。干预：所有参与者均接受 mpMRI 和 TRUSGB。 mpMRI 上具有模棱两可或可疑病变的男性也接受了 MRGB。 结果测量和统计分析：主要结果是 PCa 检测。次要结果是活检和根治性前列腺切除术标本的组织病理学细节、不良事件和 MRI 读取器性能。估计敏感性、特异性、阴性预测值 (NPV) 和阳性预测值，并以数字（百分比）或中位数（四分位距）呈现基本统计数据。结果和局限性：在 223 名男性中，142 名 (63.7%) 患有 PCa。 TRUSGB 在 223 名男性 (56.5%) 中检测到 126 例 PCa 病例，其中 47 名 (37.3%) 被列为低风险。 MRGB 在 142 名男性 (69.7%) 中检测到 99 例 PCa 病例，其 mpMRI 模棱两可或可疑，其中 6 例 (6.1%) 为低风险。 MRGB 途径将活检需求减少了 51%，将低危 PCa 的诊断率减少了 89.4%，将中/高危 PCa 的检出率增加了 17.7%。 TRUSGB 和 MRGB 对于中/高风险疾病的估计 NPV 分别为 71.9% 和 96.9%。主要限制是缺乏长期随访。结论：我们发现 mpMRI/MRGB 减少了低风险 PCa 的检出率，减少了需要活检的男性数量，同时提高了中/高风险 PCa 的总体检出率。患者总结：我们将标准前列腺活检的结果与基于磁共振 (MR) 图像的靶向活检诊断途径对前列腺特异性抗原升高的男性进行了比较。我们的结果表明 MR 途径对患者有利。需要对负面调查进行跟进。
Background: The current diagnosis of prostate cancer (PCa) uses transrectal ultrasound-guided biopsy (TRUSGB). TRUSGB leads to sampling errors causing delayed diagnosis, overdetection of indolent PCa, and misclassification. Advances in multiparametric magnetic resonance imaging (mpMRI) suggest that imaging and selective magnetic resonance (MR)-guided biopsy (MRGB) may be superior to TRUSGB.Objective: To compare the diagnostic efficacy of the magnetic resonance imaging (MRI) pathway with TRUSGB.Design, setting, and participants: A total of 223 consecutive biopsy-naive men referred to a urologist with elevated prostate-specific antigen participated in a single-institution, prospective, investigator-blinded, diagnostic study from July 2012 through January 2013.Intervention: All participants had mpMRI and TRUSGB. Men with equivocal or suspicious lesions on mpMRI also underwent MRGB.Outcome measurements and statistical analysis: The primary outcome was PCa detection. Secondary outcomes were histopathologic details of biopsy and radical prostatectomy specimens, adverse events, and MRI reader performance. Sensitivity, specificity, negative predictive values (NPVs), and positive predictive values were estimated and basic statistics presented by number (percentage) or median (interquartile range).Results and limitations: Of 223 men, 142 (63.7%) had PCa. TRUSGB detected 126 cases of PCa in 223 men (56.5%) including 47 (37.3%) classed as low risk. MRGB detected 99 cases of PCa in 142 men (69.7%) with equivocal or suspicious mpMRI, of which 6 (6.1%) were low risk. The MRGB pathway reduced the need for biopsy by 51%, decreased the diagnosis of low-risk PCa by 89.4%, and increased the detection of intermediate/high-risk PCa by 17.7%. The estimated NPVs of TRUSGB and MRGB for intermediate/high-risk disease were 71.9% and 96.9%, respectively. The main limitation is the lack of long follow-up.Conclusions: We found that mpMRI/MRGB reduces the detection of low-risk PCa and reduces the number of men requiring biopsy while improving the overall rate of detection of intermediate/high-risk PCa.Patient summary: We compared the results of standard prostate biopsies with a magnetic resonance (MR) image-based targeted biopsy diagnostic pathway in men with elevated prostate-specific antigen. Our results suggest patient benefits of the MR pathway. Follow-up of negative investigations is required.