[Translation] A multicenter, randomized, controlled clinical trial of the efficacy and safety of Sipuleucel-T versus abiraterone acetate or enzalutamide in patients with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC)
主要目的:
与醋酸阿比特龙或恩杂鲁胺对比,评价sipuleucel-T治疗中国无症状或轻微症状的mCRPC患者的总生存期(OS)以及生存风险比(HR)与已有研究结果的一致性。
次要目的:
与醋酸阿比特龙或恩杂鲁胺对比,评价 sipuleucel-T在中国无症状或轻微症状的mCRPC患者中的安全性。
[Translation] main purpose:
Compared with abiraterone acetate or enzalutamide, the overall survival (OS) and survival hazard ratio (HR) of sipuleucel-T in Chinese asymptomatic or mildly symptomatic mCRPC patients were evaluated for consistency with the results of previous studies.
Secondary purpose:
To evaluate the safety of sipuleucel-T in Chinese asymptomatic or mildly symptomatic mCRPC patients compared with abiraterone acetate or enzalutamide.