我们的目的是确定血清前列腺特异性抗原（PSA）水平类别（<5、5-10、10-20和>20ng/mL）与通过全身68Ga-前列腺特异性膜抗原（PSMA）-11PET/CT检测到的骨转移发生率之间的关系，并评估是否扩大68Ga-PSMA-11PET/CT成像范围以包括顶点和下肢转移（全身检测率和患者采集）影响骨转移。方法：对5项前瞻性研究（NCT02940262、NCT03368547、NCT03042312、NCT04050215和NCT03515577）中的388例前列腺癌患者进行回顾性分析。所有人都接受了从顶点到脚趾的68Ga-PSMA-11PET/CT扫描，以进行初步分期（n=93/388，24％），生化复发（BCR）定位（n=225/388，58%），或在2017年9月至2018年5月期间在系统治疗之前或期间重新评估转移性疾病（M1）（n=70/388，18％）。结果：总的来说，388名患者中的321名(83%)具有阳性68Ga-PSMA-11研究。在388例患者中有105例（27％）中发现了PSMA阳性骨病变，发病率与血清PSA水平呈正相关(<10ng/mL，21%；10-20ng/mL，41%；≥20ng/mL，41%;P<0.001)。所有3种适应症都保持了这种关联：初始分期，BCR,并重新调整M1。骨转移最常见的是M1，其次是BCR和初始分期。骨转移发生率与国家综合癌症网络风险评分无显著相关性(P=0.22)。PSMA阳性区域的平均数量也随着血清PSA水平而增加（P<0.001）。388中的18例（5％）和388中的18例（5％）在眶上脊以上和股骨近端三分之一以下有病变，分别。388例患者中只有1例（0.26%）的全身PET采集对管理有影响。结论：用68Ga-PSMA-11PET/CT评估的骨转移即使在血清PSA水平较低的患者中也很普遍。因此,由于68Ga-PSMA-11PET/CT可能为低血清PSA水平下的准确骨分期提供额外信息,因此应重新审视前列腺癌患者骨评估的现行指南.包括68Ga-PSMA-11PET/CT成像中的全身（从顶点到脚趾）显示6％的患者有额外的骨病变，但不会显著影响患者管理。
Our purpose was to determine the relationship between serum prostate-specific antigen (PSA) level categories (<5, 5-10, 10-20, and >20 ng/mL) and the incidence of bone metastases detected by total-body 68Ga-prostate-specific membrane antigen (PSMA)-11 PET/CT and to assess if expanding the 68Ga-PSMA-11 PET/CT imaging field to include the vertex and lower extremities (total-body acquisition) affects bone metastasis detection rates and patient management. Methods: This was a retrospective analysis of 388 prostate cancer patients enrolled in 5 prospective studies (NCT02940262, NCT03368547, NCT03042312, NCT04050215, and NCT03515577). All underwent 68Ga-PSMA-11 PET/CT scans acquired from vertex to toes for primary staging (n = 93/388, 24%), biochemical recurrence (BCR) localization (n = 225/388, 58%), or restaging metastatic disease (M1) before or during systemic therapy (n = 70/388, 18%) between September 2017 and May 2018. Results: In total, 321 of 388 patients (83%) had a positive 68Ga-PSMA-11 study. PSMA-positive bone lesions were found in 105 of 388 (27%) patients, with an incidence that was positively associated with serum PSA level (<10 ng/mL, 21%; 10-20 ng/mL, 41%; ≥20 ng/mL, 41%; P < 0.001). This association was maintained for all 3 indications: initial staging, BCR, and restaging M1. Bone metastases occurred most frequently in restaging M1, followed by BCR and initial staging. Bone metastasis incidence was not significantly associated with National Comprehensive Cancer Network risk score (P = 0.22). The average number of PSMA-positive regions also increased with serum PSA level (P < 0.001). Eighteen of 388 (5%) and 18 of 388 (5%) had lesions above the superior orbital ridge and below the proximal third of the femur, respectively. There was only 1 of 388 patients (0.26%) in whom the total-body PET acquisition had an impact on management. Conclusion: Bone metastases as assessed with 68Ga-PSMA-11 PET/CT are prevalent even in patients with low serum PSA levels. Therefore, current
guidelines for bone assessments in prostate cancer patients should be revisited because 68Ga-PSMA-11 PET/CT may provide additional information for accurate bone staging at low serum PSA levels. Including the total body (from vertex to toes) in 68Ga-PSMA-11 PET/CT imaging revealed additional bone lesions in 6% of patients, but without significantly affecting patient management.
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