Department of Urology, St Vincent's Health, Melbourne, Australia; Department of Surgery, University of Melbourne, Melbourne, Australia.
Department of Medical Imaging, St Vincent's Health, Melbourne, Australia; Faculty of Medicine, University of Melbourne, Melbourne, Australia.
Eur Urol Oncol. 2024 Oct;7(5):1015-1023. doi: 10.1016/j.euo.2024.01.002. Epub 2024 Jan 27.
Multiparametric magnetic resonance imaging (mpMRI) of the prostate is used for prostate cancer diagnosis. However, mpMRI has lower sensitivity for small tumours. Prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA-PET/CT) offers increased sensitivity over conventional imaging. This study aims to determine whether the diagnostic accuracy of 18F-DCFPyL PSMA-PET/CT was superior to that of mpMRI for detecting prostate cancer (PCa) at biopsy.
Between 2020 and 2021, a prospective multicentre single-arm phase 3 imaging trial enrolled patients with clinical suspicion for PCa to have both mpMRI and PSMA-PET/CT (thorax to thigh), with reviewers blinded to the results of other imaging. Multiparametric MRI was considered positive for Prostate Imaging Reporting and Data System (PIRADS) 3-5. PSMA-PET/CT was assessed quantitatively (positive maximum standardised uptake value [SUVmax] >7) and qualitatively (five-point lexicon of certainty). Patients underwent targeted and systematic biopsy, with the technique at the discretion of the treating urologist. Clinically significant PCa (csPCa) was defined as International Society of Urological Pathology grade group (GG) ≥2. The primary outcome was the diagnostic accuracy for detecting PCa, reported as sensitivity, specificity, negative predictive value (NPV), and area under the curve (AUC) of the receiver operating curve. The secondary endpoints included a comparison of the diagnostic accuracy for detecting csPCa, assessing gains in combining PMSA-PET/CT with mpMRI to mpMRI alone.
Of the 236 patients completing both mpMRI and PSMA-PET/CT, 184 (76.7%) had biopsy. Biopsy histology was benign (n = 73), GG 1 (n = 27), and GG ≥2 (n = 84). The diagnostic accuracy of mpMRI for detecting PCa (AUC 0.76; 95% confidence interval [CI] 0.69, 0.82) was higher than that of PSMA-PET/CT (AUC 0.63; 95% CI 0.56, 0.70, p = 0.03). The diagnostic accuracy of mpMRI for detecting csPCa (AUC 0.72; 95% CI 0.67, 0.78) was higher than that of PSMA-PET/CT (AUC 0.62; 95% CI 0.55, 0.69) but not statistically significant (p = 0.27). A combination of PSMA-PET/CT and mpMRI showed excellent sensitivity (98.8%, 95% CI 93.5%, 100%) and NPV (96%, 95% CI 79.6%, 99.9%) over mpMRI alone (86.9% and 80.7%, respectively, p = 0.01). Thirty-two patients (13.6%) had metastatic disease. They tended to be older (68.4 vs 65.1 yr, p = 0.023), and have higher prostate-specific antigen (PSA; median PSA 9.6 vs 6.2ng/ml, p < 0.001) and abnormal prostate on digital rectal examination (78.2% vs 44.1%, p < 0.001).
Multiparametric MRI had superior diagnostic accuracy to PSMA-PET/CT for detecting PCa, though the difference is not significant in case of csPCa detection. A combination of mpMRI and PSMA-PET/CT showed improved sensitivity and NPV. PSMA-PET/CT could be considered for diagnostic use in patients unable to have mpMRI or those with concerning clinical features but negative mpMRI.
In this trial, we compared the ability of 18F-labelled prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA-PET/CT) with that of multiparametric magnetic resonance imaging (mpMRI) to diagnose prostate cancer by biopsy in a prostate-specific antigen screening population. We found that MRI was superior to PSMA to diagnose prostate cancer, though there was no difference in ability to diagnose clinically significant prostate cancer. PSMA-PET/CT could be considered for diagnostic use in patients unable to have mpMRI or those with concerning clinical features but negative mpMRI. Combining MRI with PSMA-PET increases the negative predictive value over MRI alone and may help men avoid invasive prostate biopsy.
前列腺多参数磁共振成像（mpMRI）用于前列腺癌的诊断。然而，mpMRI 对小肿瘤的敏感性较低。前列腺特异性膜抗原正电子发射断层扫描/计算机断层扫描（PSMA-PET/CT）的敏感性高于常规成像。本研究旨在确定 18F-DCFPyL PSMA-PET/CT 的诊断准确性是否优于 mpMRI 用于检测前列腺癌（PCa）活检。
在 2020 年至 2021 年期间，一项前瞻性多中心单臂 3 期成像试验招募了疑似患有 PCa 的患者进行 mpMRI 和 PSMA-PET/CT（从胸部到大腿），阅片者对其他成像结果不知情。多参数 MRI 被认为是前列腺成像报告和数据系统（PIRADS）3-5 阳性。PSMA-PET/CT 进行了定量评估（阳性最大标准摄取值 [SUVmax] >7）和定性评估（五个确定性词汇）。患者接受了靶向和系统活检，技术由主治泌尿科医生决定。临床显著前列腺癌（csPCa）定义为国际泌尿病理学会分级组（GG）≥2。主要结局是检测 PCa 的诊断准确性，以敏感性、特异性、阴性预测值（NPV）和受试者工作特征曲线（ROC）的曲线下面积（AUC）报告。次要终点包括比较检测 csPCa 的诊断准确性，评估将 PSMA-PET/CT 与 mpMRI 结合与仅使用 mpMRI 相比的优势。
在完成 mpMRI 和 PSMA-PET/CT 的 236 名患者中，184 名（76.7%）进行了活检。活检组织学结果为良性（n=73）、GG 1（n=27）和 GG≥2（n=84）。mpMRI 检测 PCa 的诊断准确性（AUC 0.76；95%置信区间 [CI] 0.69，0.82）高于 PSMA-PET/CT（AUC 0.63；95%CI 0.56，0.70，p=0.03）。mpMRI 检测 csPCa 的诊断准确性（AUC 0.72；95%CI 0.67，0.78）高于 PSMA-PET/CT（AUC 0.62；95%CI 0.55，0.69），但无统计学意义（p=0.27）。PSMA-PET/CT 和 mpMRI 的组合显示出优异的敏感性（98.8%，95%CI 93.5%，100%）和 NPV（96%，95%CI 79.6%，99.9%），优于单独使用 mpMRI（分别为 86.9%和 80.7%，p=0.01）。32 名患者（13.6%）患有转移性疾病。他们往往年龄较大（68.4 岁 vs 65.1 岁，p=0.023），前列腺特异性抗原（PSA）水平较高（中位 PSA 9.6 vs 6.2ng/ml，p<0.001），直肠指检前列腺异常（78.2% vs 44.1%，p<0.001）。
mpMRI 检测 PCa 的诊断准确性优于 PSMA-PET/CT，尽管在检测 csPCa 方面差异不显著。mpMRI 和 PSMA-PET/CT 的组合显示出改善的敏感性和 NPV。在无法进行 mpMRI 或有可疑临床特征但 mpMRI 阴性的患者中，PSMA-PET/CT 可考虑用于诊断。
在这项试验中，我们比较了 18F 标记的前列腺特异性膜抗原正电子发射断层扫描/计算机断层扫描（PSMA-PET/CT）与多参数磁共振成像（mpMRI）在前列腺特异性抗原筛查人群中通过活检诊断前列腺癌的能力。我们发现 MRI 优于 PSMA 诊断前列腺癌，尽管在诊断临床显著前列腺癌方面没有差异。在无法进行 mpMRI 或有可疑临床特征但 mpMRI 阴性的患者中，PSMA-PET/CT 可考虑用于诊断。将 MRI 与 PSMA-PET/CT 相结合可提高阴性预测值，可能有助于男性避免进行有创的前列腺活检。
