[Translation] A randomized, open-label, controlled, multicenter phase III clinical trial comparing HRS-4357 with novel androgen receptor pathway inhibitors for the treatment of PSMA-positive progressive metastatic castration-resistant prostate cancer.
主要目的
1. 通过盲态独立影像评审委员会(BIRC)评估的影像学无进展生存期(rPFS)来评价HRS-4357对比新型雄激素受体通路抑制剂(ARPI)用于PSMA阳性的晚期转移性去势抵抗性前列腺癌(mCRPC)治疗的有效性。
次要目的
1. 通过总生存期(OS)、研究者评估的影像学无进展生存期(rPFS)、BIRC和研究者评估的总缓解率(ORR)、疾病控制率(DCR)和缓解持续时间(DOR)、PSA50缓解率、至PSA进展时间、至首次发生症状性骨事件的时间(TTSSE)来评价HRS-4357对比ARPI用于PSMA阳性的晚期mCRPC治疗的有效性;
2. 评价HRS-4357对比ARPI用于PSMA阳性的晚期mCRPC治疗的患者报告结局;
3. 评价HRS-4357对比ARPI用于PSMA阳性的晚期mCRPC治疗的安全性和耐受性。
[Translation] Primary Objectives:
1. To evaluate the efficacy of HRS-4357 versus a novel androgen receptor pathway inhibitor (ARPI) in the treatment of PSMA-positive advanced metastatic castration-resistant prostate cancer (mCRPC) using radiographic progression-free survival (rPFS) assessed by a blinded independent imaging review committee (BIRC).
Secondary Objectives:
1. To evaluate the efficacy of HRS-4357 versus ARPI in the treatment of PSMA-positive advanced mCRPC using overall survival (OS), investigator-assessed radiographic progression-free survival (rPFS), BIRC and investigator-assessed overall response rate (ORR), disease control rate (DCR), duration of response (DOR), PSA50 response rate, time to PSA progression, and time to first symptomatic bone event (TTSSE).
2. To evaluate patient-reported outcomes of HRS-4357 versus ARPI in the treatment of PSMA-positive advanced mCRPC.
3. To evaluate the safety and tolerability of HRS-4357 versus ARPI in the treatment of PSMA-positive advanced mCRPC.