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.

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> 20 ng / mL）与全身⁶⁸ Ga检测到的骨转移发生率之间的关系。-前列腺特异性膜抗原（PSMA）-11 PET / CT，并评估是否将⁶⁸ Ga-PSMA-11 PET / CT成像领域扩大到包括顶点和下肢（全身采集）是否会影响骨转移检测率，以及病人管理。方法：这是对5项前瞻性研究（NCT02940262，NCT03368547，NCT03042312，NCT04050215和NCT03515577）招募的388位前列腺癌患者的回顾性分析。从顶点到脚趾均进行了^68次Ga-PSMA-11 PET / CT扫描，以进行初次分期（n= 93/388，占24％），生化复发（BCR）定位（n = 225/388，占58％），或在全身治疗之前或期间重新分期转移性疾病（M1）（n = 70/388，占18％）。 2017年和2018年5月。结果： 388名患者中有321名（83％）的⁶⁸ Ga-PSMA-11研究阳性。388名患者中有105名（27％）发现了PSMA阳性骨病变，其发生率与血清PSA水平呈正相关（<10 ng / mL，21％； 10–20 ng / mL，41％；≥20 ng / mL，41％；P<0.001）。对于所有三个适应症，都保持了这种关联：初始分期，BCR和再分期M1。骨转移最常发生在M1分期，然后是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没有显着相关性（P = 0.22）。PSMA阳性区域的平均数目也随血清PSA水平的增加而增加（P <0.001）。388个中的18个（5％）和388个中的18个（5％）的病变分别位于眶上上方和股骨近端三分之一以下。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：骨转移评估为⁶⁸即使血清PSA水平低的患者也普遍使用Ga-PSMA-11 PET / CT。因此，由于⁶⁸ Ga-PSMA-11 PET / CT可能为在低血清PSA水平下进行准确的骨分期提供更多信息，因此应重新审视前列腺癌患者当前的骨评估指南。在⁶⁸ Ga-PSMA-11 PET / CT成像中包括整个身体（从顶点到脚趾），发现6％的患者出现了额外的骨病变，但并未显着影响患者的治疗。