¹⁷⁷Lu-vipivotide tetraxetan prostate-specific membrane antigen (¹⁷⁷Lu-PSMA) therapy is under current scientific investigation and aims to become established in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, real-world evidence in treatment comparison is scant. Methods: We relied on the FRAMCAP database and compared cabazitaxel versus ¹⁷⁷Lu-PSMA therapy in mCRPC patients regarding progression-free survival (PFS) and overall survival (OS). Sensitivity analyses addressed second- to fourth-line mCRPC treatment to approximate current phase III patient selection criteria. Results: Of 373 patients, 14% received cabazitaxel, 65% received ¹⁷⁷Lu-PSMA, and 21% received both. Patients undergoing ¹⁷⁷Lu-PSMA therapy were significantly older than cabazitaxel patients (median, 72 y vs. 66 y; P < 0.01), and a higher proportion had an Eastern Cooperative Oncology Group score of 2 or more (12% vs. 5.0%, P = 0.1). Rates of a prostate-specific antigen decline of at least 50% were 32% versus 0% for ¹⁷⁷Lu-PSMA versus cabazitaxel. In outcome analyses, significant superior median PFS was observed for ¹⁷⁷Lu-PSMA versus cabazitaxel (13.4 mo vs. 7.1 mo, P < 0.001), even after multivariable adjustment (hazard ratio, 0.38; P < 0.001). Regarding OS, rates also significantly differed, with median OS of 14.7 mo versus 16.5 mo versus 29.6 mo for cabazitaxel versus ¹⁷⁷Lu-PSMA versus both treatments (P < 0.01). In sensitivity analyses of second- to fourth-line mCRPC treatment, PFS rates and median OS rates for cabazitaxel versus ¹⁷⁷Lu-PSMA versus both therapies qualitatively remained the same as for the entire cohort. Conclusion: In a real-world setting, ¹⁷⁷Lu-PSMA provides significantly better PFS and qualitatively better OS rates than does cabazitaxel chemotherapy and should therefore be considered a valuable treatment option for advanced mCRPC patients according to the European Medicines Agency approval.

¹⁷⁷ 元Lu-vipivotide 四西坦前列腺特异性膜抗原 （¹⁷⁷Lu-PSMA） 疗法目前正在进行科学研究，旨在用于治疗转移性去势抵抗性前列腺癌 （mCRPC）。然而，治疗比较的真实世界证据很少。方法：我们依靠 FRAMCAP 数据库，比较了卡巴他赛与 ¹⁷⁷Lu-PSMA 治疗在 mCRPC 患者中的无进展生存期 （PFS） 和总生存期 （OS）。敏感性分析针对二线至四线 mCRPC 治疗，以接近当前的 III 期患者选择标准。结果：在 373 例患者中，14% 接受卡巴他赛治疗，65% 接受 ¹⁷⁷Lu-PSMA，21% 接受两者治疗。接受 ¹⁷⁷Lu-PSMA 治疗的患者明显比卡巴他赛患者年龄大 （中位数，72 岁对 66 岁;P < 0.01），Eastern Cooperative Oncology Group 评分为 2 分或以上的比例较高 （12% vs. 5.0%，P = 0.1）。前列腺特异性抗原下降至少 50% 的比率为 32%，而 ¹⁷⁷Lu-PSMA 与卡巴他赛的比率为 0%。在结果分析中，即使在多变量调整后（风险比，0.38;P < 0.001）。关于 OS，发生率也存在显著差异，卡巴他赛与 ¹⁷⁷Lu-PSMA 与两种治疗的中位 OS 分别为 14.7 个月、16.5 个月和 29.6 个月 （P < 0.01）。 在二线至四线 mCRPC 治疗的敏感性分析中，卡巴他赛与 ¹⁷⁷Lu-PSMA 与两种疗法相比的 PFS 发生率和中位 OS 发生率与整个队列定性相同。结论：在现实世界中，与卡巴他赛化疗相比，177 Lu-PSMA 的 PFS 和质量上优于卡巴他赛化疗，因此应根据欧洲药品管理局的批准，¹⁷⁷Lu-PSMA 可被视为晚期 mCRPC 患者的有价值的治疗选择。