Department of Radiology, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Turin, Italy.
Department of Radiology, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Turin, Italy; Department of Surgical Sciences, University of Turin, Turin, Italy.
Eur Urol Oncol. 2021 Dec;4(6):855-862. doi: 10.1016/j.euo.2021.03.007. Epub 2021 Apr 21.
Urological guidelines recommend multiparametric magnetic resonance imaging (mpMRI) in men with a suspicion of prostate cancer (PCa). The resulting increase in MRI demand might place health care systems under substantial stress.
To determine whether single-plane biparametric MRI (fast MRI) workup could represent an alternative to mpMRI in the detection of clinically significant (cs) PCa.
DESIGN, SETTING, AND PARTICIPANTS: Between April 2018 and February 2020, 311 biopsy-naïve men aged ≤75 yr with PSA ≤15 ng/ml and negative digital rectal examination were randomly assigned to 1.5-T fast MRI (n = 213) or mpMRI (n = 98).
All MRI examinations were classified according to Prostate Imaging-Reporting and Data System (PI-RADS) version 2. Men scored PI-RADS 1-2 underwent 12-core standard biopsy (SBx) and those with PI-RADS 4-5 on fast MRI or PI-RADS 3-5 on mpMRI underwent targeted biopsy in combination with SBx. Equivocal cases on fast MRI (PI-RADS 3) underwent mpMRI and then biopsy according to the findings.
The primary outcome was to compare the detection rate of csPCa in both study arms, setting a 10% difference for noninferiority. The secondary outcome was to assess the role of prostate-specific antigen density (PSAD) in ruling out men who could avoid biopsy among those with equivocal findings on fast MRI.
The overall MRI detection rate for csPCa was 23.5% (50/213; 95% confidence interval [CI] 18.0-29.8%) with fast MRI and 32.7% (32/98; 95% CI 23.6-42.9%) with mpMRI (difference 9.2%; p = 0.09). The reproducibility of the study could have been affected by its single-center nature.
Fast MRI followed by mpMRI in equivocal cases is not inferior to mpMRI in the detection of csPCa among biopsy-naïve men aged ≤75 yr with PSA ≤15 ng/ml and negative digital rectal examination. These findings could pave the way to broader use of MRI for PCa diagnosis.
A faster MRI (magnetic resonance imaging) protocol with no contrast agent and fewer scan sequences for examination of the prostate is not inferior to the typical MRI approach in the detection of clinically significant prostate cancer. If our findings are confirmed in other studies, fast MRI could represent a time-saving and less invasive examination for men with suspicion of prostate cancer. This trial is registered at ClinicalTrials.gov as NCT03693703.
泌尿科指南建议对怀疑患有前列腺癌（PCa）的男性进行多参数磁共振成像（mpMRI）检查。这导致 MRI 需求的增加可能会使医疗保健系统承受巨大压力。
确定单平面双参数磁共振成像（快速 MRI）检查是否可以替代 mpMRI 用于检测临床显著（cs）PCa。
设计、地点和参与者：2018 年 4 月至 2020 年 2 月，311 名年龄≤75 岁、PSA≤15ng/ml 且直肠指检阴性的活检初治男性被随机分配至 1.5-T 快速 MRI（n=213）或 mpMRI（n=98）组。
所有 MRI 检查均根据前列腺成像报告和数据系统（PI-RADS）版本 2 进行分类。PI-RADS 评分 1-2 分的男性接受 12 针标准活检（SBx），快速 MRI 评分 4-5 分或 mpMRI 评分 3-5 分的男性接受靶向活检联合 SBx。快速 MRI 评分 3 分的可疑病例进行 mpMRI 检查，然后根据检查结果进行活检。
主要结局是比较两种研究臂中 csPCa 的检出率，设定非劣效性差异为 10%。次要结局是评估前列腺特异性抗原密度（PSAD）在排除快速 MRI 检查中可疑病例中可避免活检的男性中的作用。
快速 MRI 检查 csPCa 的总检出率为 23.5%（50/213；95%置信区间 [CI] 18.0-29.8%），mpMRI 检查的检出率为 32.7%（32/98；95% CI 23.6-42.9%）（差异 9.2%；p=0.09）。该研究的可重复性可能受到其单中心性质的影响。
对于年龄≤75 岁、PSA≤15ng/ml 且直肠指检阴性的活检初治男性，在快速 MRI 检查后行 mpMRI 检查，在检测 csPCa 方面并不逊于 mpMRI 检查。这些发现可能为更广泛地将 MRI 用于 PCa 诊断铺平道路。
一种无造影剂、扫描序列更少的更快 MRI 检查前列腺的方案，在检测临床显著前列腺癌方面并不逊于典型的 MRI 方法。如果其他研究也证实了我们的发现，那么快速 MRI 可能成为怀疑患有前列腺癌的男性一种节省时间且侵袭性更小的检查方法。本研究在 ClinicalTrials.gov 注册，编号为 NCT03693703。
