Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles, CA, USA; Institute of Urologic Oncology, University of California Los Angeles, Los Angeles, CA, USA; Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA, USA.
Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California Los Angeles, Los Angeles, CA, USA; Nuclear Medicine, Department of Medical Sciences, University of Turin, Turin, Italy.
Lancet Oncol. 2019 Sep;20(9):1286-1294. doi: 10.1016/S1470-2045(19)30415-2. Epub 2019 Jul 30.
National Comprehensive Cancer Network guidelines consider F-fluciclovine PET-CT for prostate cancer biochemical recurrence localisation after radical prostatectomy, whereas European Association of Urology guidelines recommend prostate-specific membrane antigen (PSMA) PET-CT. To the best of our knowledge, no prospective head-to-head comparison between these tests has been done so far. The aim of this study was to compare prospectively paired F-fluciclovine and PSMA PET-CT scans for localising biochemical recurrence of prostate cancer after radical prostatectomy in patients with low prostate-specific antigen (PSA) concentrations (<2·0 ng/mL).
This was a prospective, single-centre, open-label, single-arm comparative study done at University of California Los Angeles (Los Angeles, CA, USA). Patients older than 18 years of age with prostate cancer biochemical recurrence after radical prostatectomy and PSA levels ranging from 0·2 to 2·0 ng/mL without any prior salvage therapy and with a Karnofsky performance status of at least 50 were eligible. Patients underwent F-fluciclovine (reference test) and PSMA (index test) PET-CT scans within 15 days. Detection rate of biochemical recurrence at the patient level and by anatomical region was the primary endpoint. A statistical power analysis demonstrated that a sample size of 50 patients was needed to show a 22% difference in detection rates in favour of PSMA (test for superiority). Each PET scan was interpreted by three independent masked readers and a consensus majority interpretation was generated (two vs one) to determine positive findings. This study is registered with ClinicalTrials.gov, number NCT02940262, and is complete.
Between Feb 26, 2018, and Sept 20, 2018, 143 patients were screened for eligibility, of whom 50 patients were enrolled into the study. Median follow-up was 8 months (IQR 7-9). The primary endpoint was met; detection rates were significantly lower with F-fluciclovine PET-CT (13 [26%; 95% CI 15-40] of 50) than with PSMA PET-CT (28 [56%; 41-70] of 50), with an odds ratio (OR) of 4·8 (95% CI 1·6-19·2; p=0·0026) at the patient level; in the subanalysis of the pelvic nodes region (four [8%; 2-19] with F-fluciclovine vs 15 [30%; 18-45] with PSMA PET-CT; OR 12·0 [1·8-513·0], p=0·0034); and in the subanalysis of any extrapelvic lesions (none [0%; 0-6] vs eight [16%; 7-29]; OR non-estimable [95% CI non-estimable], p=0·0078).
With higher detection rates, PSMA should be the PET tracer of choice when PET-CT imaging is considered for subsequent treatment management decisions in patients with prostate cancer and biochemical recurrence after radical prostatectomy and low PSA concentrations (≤2·0 ng/mL). Further research is needed to investigate whether higher detection rates translate into improved oncological outcomes.
None.
美国国家综合癌症网络指南认为，对于根治性前列腺切除术后生化复发的前列腺癌，氟[^18^F] 氟代胸腺嘧啶 PET-CT 是一种选择，而欧洲泌尿外科学会指南则建议使用前列腺特异性膜抗原（PSMA）PET-CT。据我们所知，目前还没有这两种检测方法的前瞻性头对头比较。本研究旨在前瞻性比较氟[^18^F] 氟代胸腺嘧啶和 PSMA PET-CT 扫描在根治性前列腺切除术后生化复发的前列腺癌患者中的定位效果，这些患者的前列腺特异性抗原（PSA）浓度较低（<2.0ng/mL）。
这是一项在美国加利福尼亚大学洛杉矶分校（洛杉矶，CA，美国）进行的前瞻性、单中心、开放标签、单臂比较研究。年龄大于 18 岁，根治性前列腺切除术后生化复发，PSA 水平在 0.2 至 2.0ng/mL 之间，没有任何先前的挽救性治疗，卡诺夫斯基表现状态至少为 50 的患者有资格参加。患者在 15 天内接受氟[^18^F] 氟代胸腺嘧啶（参考测试）和 PSMA（索引测试）PET-CT 扫描。主要终点是患者水平和解剖区域的生化复发检测率。统计能力分析表明，需要 50 例患者的样本量才能显示出 PSMA（优效性检验）检测率提高 22%的差异。每次 PET 扫描均由三位独立的盲法读者进行解读，并生成多数解读的共识（两位 vs 一位）来确定阳性发现。这项研究在 ClinicalTrials.gov 注册，编号为 NCT02940262，已经完成。
2018 年 2 月 26 日至 2018 年 9 月 20 日，有 143 名患者接受了资格筛选，其中 50 名患者入组本研究。中位随访时间为 8 个月（IQR 7-9）。主要终点达到；氟[^18^F] 氟代胸腺嘧啶 PET-CT 的检测率明显低于 PSMA PET-CT（50 例中有 13 例[26%；95%CI 15-40]与 50 例中有 28 例[56%；41-70]），比值比（OR）为 4.8（95%CI 1.6-19.2；p=0.0026）；在盆腔淋巴结区域的亚分析中（氟[^18^F] 氟代胸腺嘧啶有 4 例[8%；2-19]，PSMA PET-CT 有 15 例[30%；18-45]）；在任何盆腔外病变的亚分析中（氟[^18^F] 氟代胸腺嘧啶无[0%；0-6]，PSMA PET-CT 有 8 例[16%；7-29]），OR 无法估计[95%CI 无法估计]，p=0.0078）。
对于 PSA 浓度（≤2.0ng/mL）较低的前列腺癌根治性前列腺切除术后生化复发患者，PSMA 应作为 PET 示踪剂的首选，因为当考虑进行 PET-CT 成像以进行后续治疗管理决策时，PSMA 的检测率更高。需要进一步研究以探讨更高的检测率是否能转化为改善的肿瘤学结果。
无。
