前期已经证明，前列腺特异性膜抗原（PSMA）抑制剂[177Lu]Lu-PSMA-617在化疗幼稚型转移性去势抵抗性前列腺癌患者中实现生化反应的非劣性不亚于多西他赛。在这里，我们报道一项2期随机对照试验的总生存（OS）的最终分析结果。方法：将40例化疗幼稚型PSMA阳性转移性去势抵抗性前列腺癌患者随机分配到[177Lu]Lu-PSMA-617组（n = 20）或多西他赛组（n = 20）。根据方案，共有35名患者接受了治疗。采用Kaplan-Meier曲线和Cox回归模型进行生存分析。结果：平均随访时间为33.4个月。在意图治疗分析中，[177Lu]Lu-PSMA-617组和多西他赛组的中位OS分别为15.0个月（95% CI，9.5-20.5个月）和15.0个月（95% CI，8.1-21.9个月），P = 0.905。在按纳入标准治疗分析中，中位OS分别为19.0个月（95% CI，12.3-25.7个月）和15.0个月（95% CI，8.1-21.9个月），P = 0.712。在分析的亚组间未观察到OS的显著差异。结论：在前化疗阶段早期使用[177Lu]Lu-PSMA-617的长期预后与多西他赛相当。© 2023年核医学与分子影像学协会。

The prostate-specific membrane antigen (PSMA) inhibitor [177Lu]Lu-PSMA-617 has been previously demonstrated to be noninferior to docetaxel in achieving a biochemical response in chemotherapy-naïve metastatic castration-resistant prostate cancer patients. Here, we report the final analysis of overall survival (OS) for a phase 2 randomized, controlled trial. Methods: Forty chemotherapy-naïve, PSMA-positive metastatic castration-resistant prostate cancer patients were randomly assigned to [177Lu]Lu-PSMA-617 (n = 20) or docetaxel (n = 20). Thirty-five patients received treatment per the protocol. Survival analysis was done using Kaplan-Meier curves and the Cox regression model. Results: The mean follow-up duration was 33.4 mo. In intention-to-treat analysis, the median OS for the [177Lu]Lu-PSMA-617 and docetaxel arms was 15.0 mo (95% CI, 9.5-20.5 mo) and 15.0 mo (95% CI, 8.1-21.9 mo), respectively (P = 0.905). In per-protocol analysis, the median OS was 19.0 mo (95% CI, 12.3-25.7 mo) versus 15.0 mo (95% CI, 8.1-21.9 mo), respectively (P = 0.712). No significant difference in OS was observed between the 2 arms across the analyzed subgroups. Conclusion: Long-term outcomes with [177Lu]Lu-PSMA-617 administered earlier in the prechemotherapy setting are comparable to those with docetaxel.© 2023 by the Society of Nuclear Medicine and Molecular Imaging.