正在研究前列腺特异性膜抗原（PSMA）阳性转移性去势抵抗性前列腺癌（mCRPC）患者接受[177Lu]Lu-PSMA靶向放射配体治疗时前列腺特异性抗原（PSA）水平下降的预后价值。 PSMA-617 (177Lu-PSMA-617)。这项 3 期 VISION 试验的事后分析旨在评估 PSA 下降与接受 177Lu-PSMA-617 的患者的临床和患者报告结果之间的关联。在 831 名入组的 831 名先前接受过一种或多种雄激素治疗的 PSMA 阳性进行性 mCRPC 患者中受体途径抑制剂和一到两种紫杉烷类药物，551 名患者被随机分配至 177Lu-PSMA-617 加上方案允许的护理标准 (SoC)。根据未经证实的 PSA 较基线下降的幅度对患者亚组进行放射学无进展生存期、总生存期、放射学客观缓解率以及患者报告的健康相关生活质量 (HRQoL) 和疼痛进行分析。患者随机分配至 177Lu -PSMA-617 的最佳 PSA 下降≥0-<50% (96/551 [17%])、≥50-<90% (152/551 [28%]) 和 ≥90% (83/551 [15%]）与那些在第 12 周（包括第 12 周）相比，放射学疾病进展或死亡风险分别降低了 61%、72% 和 88%，死亡风险分别降低了 51%、70% 和 87%。根据多变量 Cox 比例风险模型中的风险比，PSA 水平增加 (160/551 [29%])。在 PSA 下降幅度较大的患者中，影像学反应更频繁，HRQoL 和疼痛评分恶化的中位时间也更长。PSA 下降的幅度与接受 177Lu-PSMA- 治疗的 mCRPC 患者的临床和患者报告结果的改善相关。 617 plus VISION 中的 SoC。因此，在 177Lu-PSMA-617 治疗期间，PSA 下降似乎对该人群具有预后价值。版权所有 © 2024 作者。由 Elsevier B.V. 出版。保留所有权利。

The prognostic value of declining prostate-specific antigen (PSA) levels is under investigation in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) receiving PSMA-targeted radioligand therapy with [177Lu]Lu-PSMA-617 (177Lu-PSMA-617). This post hoc analysis of the phase 3 VISION trial aimed to evaluate associations between PSA decline and clinical and patient-reported outcomes in patients receiving 177Lu-PSMA-617.Of 831 enrolled patients with PSMA-positive progressive mCRPC treated previously with one or more androgen receptor pathway inhibitors and one to two taxanes, 551 were randomised to 177Lu-PSMA-617 plus protocol-permitted standard of care (SoC). Radiographic progression-free survival, overall survival, radiographic objective response rate, and patient-reported health-related quality of life (HRQoL) and pain were analysed in subgroups of patients categorised by the magnitude of unconfirmed PSA decline from baseline.Patients randomised to 177Lu-PSMA-617 with the best PSA declines of ≥0-<50% (96/551 [17%]), ≥50-<90% (152/551 [28%]), and ≥90% (83/551 [15%]) up to and including week 12 had 61%, 72%, and 88% reduced risks of radiographic disease progression or death, and 51%, 70%, and 87% reduced risks of death, respectively, versus those with increased PSA levels (160/551 [29%]), based on hazard ratios in a multivariate Cox proportional hazard model. In patients with greater PSA declines, radiographic responses were more frequent and median time to worsening in HRQoL and pain scores were longer.The magnitude of PSA decline was associated with improvement in clinical and patient-reported outcomes in patients with mCRPC receiving 177Lu-PSMA-617 plus SoC in VISION. PSA decline therefore appears to have a prognostic value during 177Lu-PSMA-617 treatment in this population.Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.