Current treatment protocols for ¹⁷⁷Lu-labeled PSMA-617 therapies were cautiously derived from dosimetry data, but their practical appropriateness has not yet been proven clinically. We retrospectively report our clinical observations using 4 different treatment activities. Methods: Forty patients with advanced prostate cancer and positive uptake in prostate-specific membrane antigen (PSMA) imaging were treated with 4 GBq of ¹⁷⁷Lu activity/80 nmol of precursor, 6 GBq of ¹⁷⁷Lu activity/120 nmol of precursor, 7.4 GBq of ¹⁷⁷Lu activity/150 nmol of precursor, or 9.3 GBq of ¹⁷⁷Lu activity/150 nmol of precursor (10 patients per group) every 2 mo. Safety was checked every 2 wk by laboratory tests, the prostate-specific antigen response was checked every 4 wk, and other effects were assessed by anamnesis. Results: The initial prostate-specific antigen response showed no correlation with treatment activity. However, 2 of 10, 4 of 10, 4 of 10, and 7 of 10 patients receiving doses of 4, 6, 7.4, and 9.3 GBq, respectively, were in partial remission 8 wk after completing all 3 cycles. This finding would be in line with but—because of low patient numbers—would not prove a positive dose–response relationship. Acute hematologic toxicity was also not correlated with treatment activity, and no more than 1 patient per group had grade 3/4 toxicity. Nevertheless, in contrast to the findings for the other groups, the mean platelet count in the 9.3-GBq group decreased chronically over time. Conclusion: If patients with diffuse red marrow infiltration and extensive chemotherapeutic pretreatments are excluded, then treatment activities of up to 3 injections of 9.3 GBq of ¹⁷⁷Lu-PSMA-617 every 2 mo are tolerated well. Further dose escalation should be conducted with care, as the highest dose seems to be close to the maximum tolerable dose.

目前从剂量学数据中谨慎得出^177种Lu标记的PSMA-617疗法的治疗方案，但是它们的实际适用性尚未得到临床证实。我们使用4种不同的治疗活动回顾性报告我们的临床观察结果。方法：对40例晚期前列腺癌患者，前列腺摄取特异性前列腺抗原（PSMA）显像，分别接受4 GBq的¹⁷⁷ Lu活性/ 80 nmol前体，6 GBq的¹⁷⁷ Lu活性/ 120 nmol前体，7.4 GBq。的¹⁷⁷路活性/ 150纳摩尔的前体，或9.3吉贝的¹⁷⁷每2个月Lu活性/ 150 nmol前体（每组10位患者）。通过实验室测试每2周检查一次安全性，每4周检查一次前列腺特异性抗原反应，并通过回忆检查评估其他效果。结果：最初的前列腺特异性抗原反应显示与治疗活性无关。但是，分别接受4、6、7.4和9.3 GBq剂量的10名患者中的10名患者中有2名，10名患者中的4名，10名患者中的4名和10名患者中的7名在完成所有3个周期后均在8周内部分缓解。这一发现与患者人数少是一致的，但由于剂量-反应关系不佳。急性血液学毒性也与治疗活性无关，每组不超过1名患者具有3/4级毒性。然而，与其他组的发现相反，9.3-GBq组的平均血小板计数随时间逐渐降低。结论：如果例弥漫红骨髓浸润和广泛的化学治疗预处理被排除在外，然后向上的治疗活动，以9.3吉贝的3次注射¹⁷⁷路-PSMA-617每2个月良好耐受。应谨慎进行进一步的剂量升级，因为最高剂量似乎接近最大可耐受剂量。