Main research purpose: To evaluate the effectiveness of Fluzoparib combined with apatinib mesylate in the treatment of patients with metastatic castration-resistant prostate cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Fluzoparib Orally twice daily(Cohort 1、Cohort 4)
Enzalutamide OR abiraterone acetate Orally once daily(Cohort 1)
Fluzoparib Orally twice daily; Apatinib Orally once daily(Cohort 2、Cohort 3、Cohort 4)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Comprehensive response rate
Comprehensive remission rate means the proportion of objective remission or PSA remission evaluated by the investigator based on the RECIST v1.1 standard and the PCWG3 standard
Time frame: up to 2 years
Radiological progression-free survival (rPFS)
The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
Time frame: up to 2 years
Objective response rate (ORR)
ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)).
Time frame: At the time point of every 8 weeks,up to 2 years
PSA response rate
PSA response rate was Defined as the proportion of subjects whose serum PSA level decreased by ≥50% from baseline after treatment.
Time frame: At the time point of every 4 weeks,up to 2 years
Time to PSA progression (PSA-TTP)
PSA-TTP was defined as the time from random (cohort 1 and 4) or first medication (cohort 2 and 3) to the first progression of PSA; PSA progression is determined according to the PCWG3 standard, and changes in PSA levels within the 12 weeks before treatment (that is, before C4D1) are not included in this Evaluation.
Time frame: At the time point of every 4 weeks,up to 2 years
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Overall Survival (OS)
Number of Participants with Overall Survival (OS)
Time frame: At the time point of every 2 months,up to 2 years