澳大利亚彼得麦克卡勒姆癌症中心Michael S Hofman课题组分析了前列腺特异性膜抗原（PSMA）PET-CT对高危前列腺癌患者诊断的准确性。相关论文发表在2020年3月22日出版的《柳叶刀》杂志上。

当对高危局限性前列腺癌的患者进行分期时，使用CT和骨扫描的常规成像灵敏度不足。为了探讨PSMA PET-CT的新型成像是否可以提高准确性并影响治疗，研究组进行了一项多中心、双臂、随机研究。

2017年3月22日至2018年11月2日，研究组在澳大利亚的十家医院招募了302名经活检证实为前列腺癌且具有高风险特征的男性。将其随机分组，其中152名接受常规的CT和骨扫描成像，150名接受镓68 PSMA-11 PET-CT。

在295名（98%）接受随访的男性中，有87名（30%）患有盆腔淋巴结或远处转移病。PSMA PET-CT的准确度比传统成像技术高27%。PSMA PET-CT的敏感性和特异性分别为85%和98%，均显著高于常规成像（38%和91%）。

亚组分析亦显示了PSMA PET-CT的优势。一线常规影像学降低了管理改变的频率。常规成像的放射线暴露为19.2 mSv，显著高于PSMA PET-CT（8.4 mSv）。在接受二线影像学检查的患者中，常规成像后136名患者中有7名（5%）发生了管理变化，而PSMA PET-CT后146名患者中有39名（27%）。

总之，PSMA PET-CT可替代传统成像，结合了CT和骨扫描结果，准确性高。

附：英文原文

Title: Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multi-centre study

Author: Michael S Hofman, Nathan Lawrentschuk, Roslyn J Francis, Colin Tang, Ian Vela, Paul Thomas, Natalie Rutherford, Jarad M Martin, Mark Frydenberg, Ramdave Shakher, Lih-Ming Wong, Kim Taubman, Sze Ting Lee, Edward Hsiao, Paul Roach, Michelle Nottage, Ian Kirkwood, Dickon Hayne, Emma Link, Petra Marusic, Anetta Matera, Alan Herschtal, Amir Iravani, Rodney J Hicks, Scott Williams, Declan G Murphy

Issue&Volume: 2020-03-22

Abstract: Background

Conventional imaging using CT and bone scan has insufficient sensitivity when staging men with high-risk localised prostate cancer. We aimed to investigate whether novel imaging using prostate-specific membrane antigen (PSMA) PET-CT might improve accuracy and affect management.

Methods

In this multicentre, two-arm, randomised study, we recruited men with biopsy-proven prostate cancer and high-risk features at ten hospitals in Australia. Patients were randomly assigned to conventional imaging with CT and bone scanning or gallium-68 PSMA-11 PET-CT. First-line imaging was done within 21 days following randomisation. Patients crossed over unless three or more distant metastases were identified. The primary outcome was accuracy of first-line imaging for identifying either pelvic nodal or distant-metastatic disease defined by the receiver-operating curve using a predefined reference-standard including histopathology, imaging, and biochemistry at 6-month follow-up. This trial is registered with the Australian New Zealand Clinical Trials Registry, ANZCTR12617000005358.

Findings

From March 22, 2017 to Nov 02, 2018, 339 men were assessed for eligibility and 302 men were randomly assigned. 152 (50%) men were randomly assigned to conventional imaging and 150 (50%) to PSMA PET-CT. Of 295 (98%) men with follow-up, 87 (30%) had pelvic nodal or distant metastatic disease. PSMA PET-CT had a 27% (95% CI 23–31) greater accuracy than that of conventional imaging (92% [88–95] vs 65% [60–69]; p<0·0001). We found a lower sensitivity (38% [24–52] vs 85% [74–96]) and specificity (91% [85–97] vs 98% [95–100]) for conventional imaging compared with PSMA PET-CT. Subgroup analyses also showed the superiority of PSMA PET-CT (area under the curve of the receiver operating characteristic curve 91% vs 59% [32% absolute difference; 28–35] for patients with pelvic nodal metastases, and 95% vs 74% [22% absolute difference; 18–26] for patients with distant metastases). First-line conventional imaging conferred management change less frequently (23 [15%] men [10–22] vs 41 [28%] men [21–36]; p=0·008) and had more equivocal findings (23% [17–31] vs 7% [4–13]) than PSMA PET-CT did. Radiation exposure was 10·9 mSv (95% CI 9·8–12·0) higher for conventional imaging than for PSMA PET-CT (19·2 mSv vs 8·4 mSv; p<0·001). We found high reporter agreement for PSMA PET-CT (κ=0·87 for nodal and κ=0·88 for distant metastases). In patients who underwent second-line image, management change occurred in seven (5%) of 136 patients following conventional imaging, and in 39 (27%) of 146 following PSMA PET-CT.

Interpretation

PSMA PET-CT is a suitable replacement for conventional imaging, providing superior accuracy, to the combined findings of CT and bone scanning.

DOI: 10.1016/S0140-6736(20)30314-7

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30314-7/fulltext