A new phase III, randomized, controlled trial was carried out to assess the efficacy of ¹⁷⁷Lu-PSMA-617 in patients with taxane-naive metastatic castration-resistant prostate cancer (mCRPC). A total of 468 patients with PSMA⁺ mCRPC who experienced disease progression after receiving an androgen receptor pathway inhibitor (ARPI) were randomly allocated to receive ¹⁷⁷Lu-PSMA-617 or a different ARPI. Treatment with ¹⁷⁷Lu-PSMA-617 resulted in improved median radiographic progression-free survival (PFS) compared with a change of ARPI (11.60 months (95% CI 9.30–14.19) versus 5.59 months (95% CI 4.21–5.95)), with a good safety profile. These results showed that ¹⁷⁷Lu-PSMA-617 prolonged radiographic PFS and could be a valid therapeutic alternative for patients considered for a change of ARPI.

进行了一项新的 III 期随机对照试验，以评估 ¹⁷⁷Lu-PSMA-617 在紫杉烷类初治转移性去势抵抗性前列腺癌 （mCRPC） 患者中的疗效。共有 468 例在接受雄激素受体通路抑制剂 （ARPI） 后出现疾病进展的 PSMA⁺ mCRPC 患者被随机分配接受 ¹⁷⁷个 Lu-PSMA-617 或不同的 ARPI。与 ARPI 变化 （11.60 个月 （95% CI 9.30-14.19） 对比 5.59 个月 （95% CI 4.21-5.95）） 相比，¹⁷⁷Lu-PSMA-617 治疗导致中位影像学无进展生存期 （PFS） 改善，具有良好的安全性。这些结果表明，¹⁷⁷Lu-PSMA-617 延长了放射学 PFS，对于考虑改变 ARPI 的患者来说，可能是一种有效的治疗选择。