The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study,European Urology

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The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study
European Urology ( IF 23.4 ) Pub Date : 2021-08-28 , DOI: 10.1016/j.eururo.2021.08.002
Louise Emmett ₁ , James Buteau ₂ , Nathan Papa ₃ , Daniel Moon ₄ , James Thompson ₅ , Matthew J Roberts ₆ , Kris Rasiah ₇ , David A Pattison ₆ , John Yaxley ₈ , Paul Thomas ₆ , Anthony C Hutton ₉ , Shikha Agrawal ₁₀ , Amer Amin ₁₀ , Alexandar Blazevski ₁₀ , Venu Chalasani ₇ , Bao Ho ₁₁ , Andrew Nguyen ₁₁ , Victor Liu ₁₁ , Jonathan Lee ₁₁ , Gemma Sheehan-Dare ₁₁ , Raji Kooner ₁₂ , Geoff Coughlin ₈ , Lyn Chan ₁₁ , Thomas Cusick ₁₀ , Benjamin Namdarian ₁₂ , Jada Kapoor ₄ , Omar Alghazo ₄ , Henry H Woo ₁₃ , Nathan Lawrentschuk ₄ , Declan Murphy ₄ , Michael S Hofman ₂ , Phillip Stricker ₁₄

Affiliation

Department of Theranostics and Nuclear Medicine, St Vincent's Hospital Sydney, Darlinghurst, NSW, Australia; Garvan Institute of Medical Research, Sydney, NSW, Australia.
Department of Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer, Melbourne, VIC, Australia.
School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.
Department of Urology, St. George Hospital, Kogarah, NSW, Australia; St. Vincent's Prostate Cancer Centre, Darlinghurst, NSW, Australia.
Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.
Department of Urology, Royal North Shore Hospital, Sydney, NSW, Australia.
Wesley Urology Clinic, The Wesley Hospital, Brisbane, QLD, Australia.
Department of Urology, St. George Hospital, Kogarah, NSW, Australia.
Garvan Institute of Medical Research, Sydney, NSW, Australia.
Department of Theranostics and Nuclear Medicine, St Vincent's Hospital Sydney, Darlinghurst, NSW, Australia.
Department of Urology, St. Vincent's Hospital Sydney, Darlinghurst, NSW, Australia.
Sydney Adventist Hospital, Sydney, NSW, Australia.
St. Vincent's Prostate Cancer Centre, Darlinghurst, NSW, Australia.

Background

Multiparametric magnetic resonance imaging (MRI) is validated for the detection of clinically significant prostate cancer (csPCa), although patients with negative/equivocal MRI undergo biopsy for false negative concerns. In addition, ⁶⁸Ga-PSMA-11 positron emission tomography/computed tomography (prostate-specific membrane antigen [PSMA]) may also identify csPCa accurately.

Objective

This trial aimed to determine whether the combination of PSMA + MRI was superior to MRI in diagnostic performance for detecting csPCa.

Design, setting, and participants

A prospective multicentre phase II imaging trial was conducted. A total of 296 men were enrolled with suspected prostate cancer, with no prior biopsy or MRI, recent MRI (6 mo), and planned transperineal biopsy based on clinical risk and MRI. In all, 291 men underwent MRI, pelvic-only PSMA, and systematic ± targeted biopsy.

Outcome measurements and statistical analysis

Sensitivity, specificity, and predictive values (negative predictive value [NPV] and positive predictive value) for csPCa were determined for MRI, PSMA, and PSMA + MRI. PSMA + MRI was defined as negative for PSMA negative Prostate Imaging Reporting and Data System (PI-RADS) 2/3 and positive for either MRI PI-RADS 4/5 or PSMA positive PI-RADS 2/3; csPCa was any International Society of Urological Pathology (ISUP) grade group ≥2 malignancy.

Results and limitations

Of the patients, 56% (n = 162) had csPCa; 67% had PI-RADS 3–5, 73% were PSMA positive, and 81% were combined PSMA + MRI positive. Combined PSMA + MRI improved NPV compared with MRI alone (91% vs 72%, test ratio = 1.27 [1.11–1.39], p < 0.001). Sensitivity also improved (97% vs 83%, p < 0.001); however, specificity was reduced (40% vs 53%, p = 0.011). Five csPCa cases were missed with PSMA + MRI (four ISUP 2 and one ISUP 3). Of all men, 19% (56/291) were PSMA + MRI negative (38% of PI-RADS 2/3) and could potentially have avoided biopsy, risking delayed csPCa detection in 3.1% men with csPCa (5/162) or 1.7% (5/291) overall.

Conclusions

PSMA + MRI improved NPV and sensitivity for csPCa in an MRI triaged population. Further randomised studies will determine whether biopsy can safely be omitted in men with a high clinical suspicion of csPCa but negative combined imaging.

Patient summary

The combination of magnetic resonance imaging (MRI) + prostate-specific membrane antigen positron emission tomography reduces false negatives for clinically significant prostate cancer (csPCa) compared with MRI, potentially allowing a reduction in the number of prostate biopsies required to diagnose csPCa.

中文翻译：

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对多参数磁共振成像分诊在前列腺癌诊断中的附加诊断价值（初级）：一项前瞻性多中心研究

背景

多参数磁共振成像 (MRI) 经验证可用于检测有临床意义的前列腺癌 (csPCa)，尽管 MRI 阴性/模棱两可的患者因假阴性问题而接受活检。此外，⁶⁸ Ga-PSMA-11 正电子发射断层扫描/计算机断层扫描（前列腺特异性膜抗原 [PSMA]）也可以准确识别 csPCa。

客观的

该试验旨在确定 PSMA + MRI 的组合在检测 csPCa 的诊断性能方面是否优于 MRI。

设计、设置和参与者

进行了一项前瞻性多中心 II 期影像学试验。共有 296 名男性被怀疑患有前列腺癌，之前没有进行过活检或 MRI，最近没有进行过 MRI（6 个月），并且根据临床风险和 MRI 计划进行经会阴活检。总共有 291 名男性接受了 MRI、仅盆腔 PSMA 和系统性±靶向活检。

结果测量和统计分析

对 MRI、PSMA 和 PSMA + MRI 确定 csPCa 的敏感性、特异性和预测值（阴性预测值 [NPV] 和阳性预测值）。PSMA + MRI 被定义为 PSMA阴性前列腺成像报告和数据系统 (PI-RADS) 2/3阴性和 MRI PI-RADS 4/5 或 PSMA 阳性 PI-RADS 2/3 阳性；csPCa 是任何国际泌尿病理学会 (ISUP) 分级组≥2 级恶性肿瘤。

结果和局限性

在这些患者中，56% ( n = 162) 患有 csPCa；67% 为 PI-RADS 3-5，73% 为 PSMA 阳性，81% 为 PSMA + MRI 阳性。与单独的 MRI 相比，联合 PSMA + MRI 提高了 NPV（91% 对 72%，测试比率 = 1.27 [1.11–1.39]，p < 0.001）。灵敏度也有所提高（97% 对 83%，p < 0.001）；然而，特异性降低（40% 对 53%，p = 0.011）。PSMA + MRI 漏诊了 5 例 csPCa 病例（4 例 ISUP 2 和 1 例 ISUP 3）。在所有男性中，19% (56/291) 为 PSMA + MRI 阴性（38% 的 PI-RADS 2/3）并且可能避免活检，这可能导致 3.1% 的 csPCa 男性 (5/162) 延迟 csPCa 检测或总体为 1.7% (5/291)。