Department of Diagnostic Imaging, St. Vincent's Public Hospital, Sydney, Australia Nuclear Medicine Operative Unit, Policlinico S. Orsola-Malpighi Hospital, Bologna, Italy
St. Vincent's Prostate Cancer Centre, St. Vincent's Clinic, Sydney, Australia Australian Prostate Cancer Research Centre, Garvan Institute of Medical Research/Kinghorn Cancer Centre, Sydney, New South Wales, Australia.
J Nucl Med. 2015 Aug;56(8):1185-90. doi: 10.2967/jnumed.115.160382. Epub 2015 Jun 25.
UNLABELLED: In prostate cancer with biochemical failure after therapy, current imaging techniques have a low detection rate at the prostate-specific antigen (PSA) levels at which targeted salvage therapy is effective. (11)C-choline and (18)F-fluoromethylcholine, though widely used, have poor sensitivity at low PSA levels. (68)Ga-PSMA (Glu-NH-CO-NH-Lys-(Ahx)-[(68)Ga-N,N'-bis[2-hydroxy-5-(carboxyethyl)benzyl]ethylenediamine-N,N'-diacetic acid]) has shown promising results in retrospective trials. Our aim was to prospectively compare the detection rates of (68)Ga-PSMA versus (18)F-fluoromethylcholine PET/CT in men who were initially managed with radical prostatectomy, radiation treatment, or both and were being considered for targeted therapy. METHODS: A sample of men with a rising PSA level after treatment, eligible for targeted treatment, was prospectively included. Patients on systemic treatment were excluded. (68)Ga-PSMA, (18)F-fluoromethylcholine PET/CT, and diagnostic CT were performed sequentially on all patients between January and April 2015, and the images were assessed by masked, experienced interpreters. The findings and their impact on management were documented, together with the results of histologic follow-up when feasible. RESULTS: In total, 38 patients were enrolled. Of these, 34 (89%) had undergone radical prostatectomy and 4 (11%) had undergone radiation treatment. Twelve (32%) had undergone salvage radiation treatment after primary radical prostatectomy. The mean PSA level was 1.74 ± 2.54 ng/mL. The scan results were positive in 26 patients (68%) and negative with both tracers in 12 patients (32%). Of the 26 positive scans, 14 (54%) were positive with (68)Ga-PSMA alone, 11 (42%) with both (18)F-fluoromethylcholine and (68)Ga-PSMA, and only 1 (4%) with (18)F-fluoromethylcholine alone. When PSA was below 0.5 ng/mL, the detection rate was 50% for (68)Ga-PSMA versus 12.5% for (18)F-fluoromethylcholine. When PSA was 0.5-2.0 ng/mL, the detection rate was 69% for (68)Ga-PSMA versus 31% for (18)F-fluoromethylcholine, and when PSA was above 2.0, the detection rate was 86% for (68)Ga-PSMA versus 57% for (18)F-fluoromethylcholine. On lesion-based analysis, (68)Ga-PSMA detected more lesions than (18)F-fluoromethylcholine (59 vs. 29, P < 0.001). The tumor-to-background ratio in positive scans was higher for (68)Ga-PSMA than for (18)F-fluoromethylcholine (28.6 for (68)Ga-PSMA vs. 9.4 for (18)F-fluoromethylcholine, P < 0.001). There was a 63% (24/38 patients) management impact, with 54% (13/24 patients) being due to (68)Ga-PSMA imaging alone. Histologic follow-up was available for 9 of 38 patients (24%), and 9 of 9 (68)Ga-PSMA-positive lesions were consistent with prostate cancer ((68)Ga-PSMA was true-positive). The lesion positive on (18)F-fluoromethylcholine imaging and negative on (68)Ga-PSMA imaging was shown at biopsy to be a false-positive (18)F-fluoromethylcholine finding ((68)Ga-PSMA was true-negative). CONCLUSION: In patients with biochemical failure and a low PSA level, (68)Ga-PSMA demonstrated a significantly higher detection rate than (18)F-fluoromethylcholine and a high overall impact on management.
背景：在接受治疗后出现生化失败的前列腺癌患者中，当前的影像学技术在 PSA 水平有效进行靶向挽救治疗时的检测率较低。（11）C-胆碱和（18）F-氟甲基胆碱虽然广泛使用，但在 PSA 水平较低时敏感性较差。（68）Ga-PSMA（Glu-NH-CO-NH-Lys-（Ahx）-[（68）Ga-N，N'-双[2-羟基-5-（羧乙基）苄基]乙二胺-N，N'-二乙酸）]）在回顾性试验中显示出有希望的结果。我们的目的是前瞻性比较（68）Ga-PSMA 与（18）F-氟甲基胆碱 PET/CT 在最初接受根治性前列腺切除术、放射治疗或两者联合治疗且正在考虑靶向治疗的男性中的检测率。
方法：前瞻性纳入了一批治疗后 PSA 水平升高、符合靶向治疗条件的男性患者。排除接受全身治疗的患者。所有患者均在 2015 年 1 月至 4 月期间先后接受（68）Ga-PSMA、（18）F-氟甲基胆碱 PET/CT 和诊断性 CT 检查，由经验丰富的阅片者进行盲法评估。记录检查结果及其对治疗管理的影响，在可行的情况下，还记录组织学随访结果。
结果：共纳入 38 例患者。其中，34 例（89%）接受了根治性前列腺切除术，4 例（11%）接受了放射治疗。12 例（32%）在初次根治性前列腺切除术后接受了挽救性放射治疗。平均 PSA 水平为 1.74±2.54ng/ml。26 例患者扫描结果为阳性，12 例患者两种示踪剂均为阴性。在 26 例阳性扫描中，14 例（54%）仅（68）Ga-PSMA 阳性，11 例（42%）（18）F-氟甲基胆碱和（68）Ga-PSMA 均阳性，仅 1 例（4%）（18）F-氟甲基胆碱阳性。当 PSA 低于 0.5ng/ml 时，（68）Ga-PSMA 的检测率为 50%，（18）F-氟甲基胆碱为 12.5%。当 PSA 在 0.5-2.0ng/ml 之间时，（68）Ga-PSMA 的检测率为 69%，（18）F-氟甲基胆碱为 31%，当 PSA 高于 2.0ng/ml 时，（68）Ga-PSMA 的检测率为 86%，（18）F-氟甲基胆碱为 57%。基于病变的分析，（68）Ga-PSMA 比（18）F-氟甲基胆碱检测到更多的病变（59 对 29，P<0.001）。阳性扫描中（68）Ga-PSMA 的肿瘤与背景比值高于（18）F-氟甲基胆碱（28.6 对 9.4，P<0.001）。管理影响率为 63%（24/38 例患者），其中 54%（13/24 例患者）归因于（68）Ga-PSMA 成像。38 例患者中有 9 例（24%）进行了组织学随访，9 例（68%）（68）Ga-PSMA 阳性病变与前列腺癌一致（（68）Ga-PSMA 为真阳性）。（18）F-氟甲基胆碱成像阳性而（68）Ga-PSMA 成像阴性的病变在活检中显示为假阳性（（68）Ga-PSMA 为真阴性）。
结论：在生化失败且 PSA 水平较低的患者中，（68）Ga-PSMA 的检测率明显高于（18）F-氟甲基胆碱，对治疗管理的总体影响较大。
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