This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival(rPFS) based on BICR assessment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
660
dalpiciclib+ abiraterone+ prednisone
placebo+abirarerone+prenisone
Adverse event (AE) incidence
Time frame: approximately 63 months
PK: Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss)
Time frame: approximately 6 months
rPFS
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
Time frame: approximately 63 months
PSA response rate
In patients who had not started androgen deprivation prior to randomization, the proportion of patients whose PSA levels were ≥ 90% lower than baseline by the end of the study treatment week
Time frame: approximately 63 months
ORR
Objective response rate+ The proportion of participants evaluated according to RECIST v1.1 and PCWG3 criteria that achieved predetermined tumor volume reduction and maintained the minimum duration was the sum of the proportion of complete and partial responses
Time frame: approximately 63 months
Time to PSA progression
Time from randomisation to the first time of PSA progression
Time frame: approximately 63 months
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