Prostate-specific membrane antigen (PSMA) is highly overexpressed in prostate cancer. Many PSMA analog radiotracers for PET/CT prostate cancer staging have been developed, such as ⁶⁸Ga-PSMA-11. This radiotracer has achieved good results in multiple clinical trials, but because of the superior imaging characteristics of ¹⁸F-fluoride, ¹⁸F-PSMA-11 was developed. The aim of this study was to evaluate the administration safety and radiation dosimetry of ¹⁸F-PSMA-11. Methods: Six patients (aged 62–68 y; mean, 66 ± 2 y) with suspected prostate cancer recurrence after previous treatment were administered 2 MBq of ¹⁸F-PSMA-11 per kilogram of body weight and then underwent low-dose PET/CT imaging at 0, 20, 50, 90, and 300 min after injection. To evaluate the safety of administration, vital parameters were monitored. To assess toxicity, full blood count and biochemical parameters were determined. According to the latest International Commission on Radiological Protection recommendations, radiation dosimetry analysis was performed using IDAC-Dose 2.1. For blood activity measurement, small samples of venous blood were collected at various time points after injection. The unbound ¹⁸F-fluoride fraction was determined in plasma at 20, 50, and 90 min after administration to evaluate the defluorination rate of ¹⁸F-PSMA-11. Results: After injection, ¹⁸F-PSMA-11 cleared rapidly from the blood. At 5 h after injection, 29.0% ± 5.9% of the activity was excreted in urine. The free ¹⁸F fraction in plasma increased from 9.7% ± 1.0% 20 min after injection to 22.2% ± 1.5% 90 min after injection. The highest tracer uptake was observed in kidneys, bladder, spleen, and liver. No study drug–related adverse events were observed. The calculated mean effective dose was 12.8 ± 0.6 μSv/MBq. Conclusion: ¹⁸F-PSMA-11 can be safely administered and results in a mean effective dose of 12.8 ± 0.6 μSv/MBq. Therefore, the total radiation dose is lower than for other PSMA PET agents and in the same range as ¹⁸F-DCFPyL.

前列腺特异性膜抗原（PSMA）在前列腺癌中高度过表达。已经开发出许多用于PET / CT前列腺癌分期的PSMA模拟放射性示踪剂，例如⁶⁸ Ga-PSMA-11。该放射性示踪剂在多项临床试验中均取得了良好的结果，但是由于¹⁸ F-氟化物具有出色的成像特性，因此开发了¹⁸ F-PSMA-11。这项研究的目的是评估¹⁸ F-PSMA-11的给药安全性和放射剂量。方法：对6例先前治疗后怀疑患有前列腺癌复发的患者（年龄在62-68岁；平均年龄为66±2岁）进行了2 MBq / ^18的治疗每公斤体重F-PSMA-11，然后在注射后0、20、50、90和300分钟进行低剂量PET / CT成像。为了评估给药的安全性，监测了重要参数。为了评估毒性，确定了全血细胞计数和生化参数。根据国际放射防护委员会的最新建议，使用IDAC-Dose 2.1进行了辐射剂量分析。为了测量血液活性，在注射后的各个时间点收集了少量静脉血。在给药后20、50和90分钟在血浆中测定未结合的¹⁸ F-氟化物级分，以评估¹⁸ F-PSMA-11的脱氟速率。结果：注射后¹⁸F-PSMA-11从血液中迅速清除。注射后5小时，尿中排泄了29.0％±5.9％的活性。血浆中游离的¹⁸ F分数从注射后20分钟的9.7％±1.0％增加到注射后90分钟的22.2％±1.5％。在肾脏，膀胱，脾脏和肝脏中发现的示踪剂摄入量最高。没有观察到与研究药物有关的不良事件。计算的平均有效剂量为12.8±0.6μSv/ MBq。结论： ¹⁸ F-PSMA-11可以安全使用，平均有效剂量为12.8±0.6μSv/ MBq。因此，总辐射剂量低于其他PSMA PET试剂，并且与¹⁸ F-DCFPyL处于相同范围内。