This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC). The efficacy of HRS-4357 versus novel androgen receptor pathway inhibitors (ARPI) in the treatment of PSMA-positive advanced metastatic castration-resistant prostate cancer (mCRPC) will be evaluated based on radiographic progression-free survival (rPFS) assessed by the BIRC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
370
HRS-4357 injection are administered each time, with dosing for 4 to 6 cycles
ARPI (investigator's choice of any of the following agents, with the requirement that the agent has not been used previously): * Enzalutamide 160 mg orally once daily (qd) * Abiraterone 1000 mg orally once daily (qd) + Prednisone 5 mg orally twice daily (bid)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGradiographic progression-free survival (rPFS) assessed by the BIRC.
Time frame: From Baseline to primary completion date, about 24 months
OS
Time frame: From Baseline to primary completion date, about 24 months
rPFS(Investigator-Assessed)
Time frame: From Baseline to primary completion date, about 24 months
ORR (Investigator-Assessed and BIRC-Assessed)
Time frame: From Baseline to primary completion date, about 24 months
DCR(Investigator-Assessed and BIRC-Assessed)
Time frame: From Baseline to primary completion date, about 24 months
DOR(Investigator-Assessed and BIRC-Assessed)
Time frame: From Baseline to primary completion date, about 24 months
PSA50 Response Rate
Time frame: From Baseline to primary completion date, about 24 months
Time to PSA Progression
Time frame: From Baseline to primary completion date, about 24 months
Changes from baseline in scores of the EQ-5D-5L
Time frame: From Baseline to primary completion date, about 24 months
Changes from baseline in scores of the Functional FACT-P
Time frame: From Baseline to primary completion date, about 24 months
Changes from baseline in scores of the BPI-SF
Time frame: From Baseline to primary completion date, about 24 months
Assessment of the incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Baseline to primary completion date, about 24 months
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