Background and objective

Biparametric magnetic resonance imaging (bpMRI), excluding dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI), is a potential replacement for multiparametric MRI (mpMRI) in diagnosing clinically significant prostate cancer (csPCa). An extensive international multireader multicase observer study was conducted to assess the noninferiority of bpMRI to mpMRI in csPCa diagnosis.

Methods

An observer study was conducted with 400 mpMRI examinations from four European centers, excluding examinations with prior prostate treatment or csPCa (Gleason grade [GG] ≥2) findings. Readers assessed bpMRI and mpMRI sequentially, assigning lesion-specific Prostate Imaging Reporting and Data System (PI-RADS) scores (3–5) and a patient-level suspicion score (0–100). The noninferiority of patient-level bpMRI versus mpMRI csPCa diagnosis was evaluated using the area under the receiver operating curve (AUROC) alongside the sensitivity and specificity at PI-RADS ≥3 with a 5% margin. The secondary outcomes included insignificant prostate cancer (GG1) diagnosis, diagnostic evaluations at alternative risk thresholds, decision curve analyses (DCAs), and subgroup analyses considering reader expertise. Histopathology and ≥3 yr of follow-up were used for the reference standard.

Key findings and limitations

Sixty-two readers (45 centers and 20 countries) participated. The prevalence of csPCa was 33% (133/400); bpMRI and mpMRI showed similar AUROC values of 0.853 (95% confidence interval [CI], 0.819–0.887) and 0.859 (95% CI, 0.826–0.893), respectively, with a noninferior difference of –0.6% (95% CI, –1.2% to 0.1%, p < 0.001). At PI-RADS ≥3, bpMRI and mpMRI had sensitivities of 88.6% (95% CI, 84.8–92.3%) and 89.4% (95% CI, 85.8–93.1%), respectively, with a noninferior difference of –0.9% (95% CI, –1.7% to 0.0%, p < 0.001), and specificities of 58.6% (95% CI, 52.3–63.1%) and 57.7% (95% CI, 52.3–63.1%), respectively, with a noninferior difference of 0.9% (95% CI, 0.0–1.8%, p < 0.001). At alternative risk thresholds, mpMRI increased sensitivity at the expense of reduced specificity. DCA demonstrated the highest net benefit for an mpMRI pathway in cancer-averse scenarios, whereas a bpMRI pathway showed greater benefit for biopsy-averse scenarios. A subgroup analysis indicated limited additional benefit of DCE MRI for nonexperts. Limitations included that biopsies were conducted based on mpMRI imaging, and reading was performed in a sequential order.

Conclusions and clinical implications

It has been found that bpMRI is noninferior to mpMRI in csPCa diagnosis at AUROC, along with the sensitivity and specificity at PI-RADS ≥3, showing its value in individuals without prior csPCa findings and prostate treatment. Additional randomized prospective studies are required to investigate the generalizability of outcomes.

中文翻译：

---

评估双参数与多参数磁共振成像诊断具有临床意义的前列腺癌：一项国际、配对、非劣效性、验证性观察者研究

 背景和目标

双参数磁共振成像 （bpMRI），不包括动态对比增强 （DCE） 磁共振成像 （MRI），在诊断有临床意义的前列腺癌 （csPCa） 方面，是多参数 MRI （mpMRI） 的潜在替代品。进行了一项广泛的国际多读者多病例观察者研究，以评估 bpMRI 在 csPCa 诊断中的非劣效性。

 方法

对来自四个欧洲中心的 400 次 mpMRI 检查进行了一项观察者研究，不包括既往前列腺治疗或 csPCa （格里森分级 [GG] ≥2） 结果的检查。读者按顺序评估 bpMRI 和 mpMRI，分配病变特异性前列腺影像学报告和数据系统 （PI-RADS） 评分 （3-5） 和患者水平的怀疑评分 （0-100）。使用受试者工作曲线下面积 （AUROC） 以及 PI-RADS ≥3 的敏感性和特异性以及 5% 的边际来评估患者水平 bpMRI 与 mpMRI csPCa 诊断的非劣效性。次要结局包括无意义的前列腺癌 （GG1） 诊断、替代风险阈值的诊断评估、决策曲线分析 （DCA） 和考虑读者专业知识的亚组分析。参考标准采用组织病理学和 ≥3 年随访。

主要发现和局限性

62 名读者（45 个中心和 20 个国家/地区）参与了调查。csPCa 的患病率为 33% （133/400）;bpMRI 和 mpMRI 显示相似的 AUROC 值分别为 0.853 （95% 置信区间 [CI]，0.819-0.887） 和 0.859 （95% CI，0.826-0.893），非劣效差异为 -0.6% （95% CI，-1.2% 至 0.1%，p < 0.001）。在 PI-RADS ≥3 时，bpMRI 和 mpMRI 的敏感性分别为 88.6%（95% CI，84.8-92.3%）和 89.4%（95% CI，85.8-93.1%），非劣效差异为 -0.9%（95% CI，-1.7% 至 0.0%，p < 0.001），特异性分别为 58.6%（95% CI，52.3-63.1%）和 57.7%（95% CI，52.3-63.1%），非劣效差异为 0.9%（95% CI， 0.0–1.8%，p < 0.001）。在替代风险阈值下，mpMRI 以降低特异性为代价提高了敏感性。DCA 证明 mpMRI 通路在厌恶癌症的情况下净获益最高，而 bpMRI 通路在厌恶活检的情况下显示出更大的获益。亚组分析表明 DCE MRI 对非专家的额外益处有限。局限性包括活检是基于 mpMRI 成像进行的，并且读数是按顺序进行的。

结论和临床意义

已经发现，在 AUROC 的 csPCa 诊断中，bpMRI 不劣于 mpMRI，PI-RADS ≥3 的敏感性和特异性也显示出其在既往没有 csPCa 发现和前列腺治疗的个体中的价值。需要额外的随机前瞻性研究来调查结果的普遍性。