[Translation] A prospective, open-label study evaluating the efficacy, safety, pharmacokinetics, and radiation dosimetry of [177Lu]Lu-PSMA-617 in Chinese adult men with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) Label, Multicenter, Single Arm, Phase II Study
本研究的目的是在既往接受过1 -2种紫杉类药物方案治疗且接受过至少1种新型雄激素受体通路抑制剂(ARPI)治疗的进展性PSMA阳性mCRPC中国受试者中评估在最佳支持/最佳标准治疗(BSC/BSoC)基础上加用[177Lu] Lu-PSMA-617的疗效、安全性、耐受性、药代动力学(PK)和放射剂量学。此外,还评估了[68Ga] Ga-PSMA-11的安全性、PK和放射剂量学。
本研究的数据将用于桥接全球关键性III期研究(VISION,AAA617A12301),并支持[177Lu] Lu-PSMA-617作为mCRPC的新型抗癌疗法(即放射配体疗法)在中国注册。
[Translation] The purpose of this study was to evaluate the clinical efficacy in Chinese subjects with progressive PSMA-positive mCRPC who were previously treated with 1-2 taxane regimens and received at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy. Efficacy, safety, tolerability, pharmacokinetics (PK) and radiation dosimetry of [177Lu]Lu-PSMA-617 added to best support/best standard of care (BSC/BSoC). In addition, the safety, PK and radiation dosimetry of [68Ga]Ga-PSMA-11 were evaluated.
Data from this study will be used to bridge the global pivotal Phase III study (VISION, AAA617A12301) and support the registration of [177Lu]Lu-PSMA-617 as a novel anticancer therapy (i.e. radioligand therapy) for mCRPC in China.