The aim of this trial is to evaluate SHR3680 combined with Docetaxel to improve Metastatic Castration Resistant Prostate Cancer Patients whether the patient's Time to prostate specific antigen (PSA) progression is superior to SHR3680 or Docetaxel single drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGTime to prostate specific antigen (PSA) progression
Time from randomisation to the first time of PSA progression according to the criterion of PCGW3
Time frame: [Time Frame: Approximately 24 months]
Adverse Event(AE)
The type, frequency, severity, timing, seriousness, and relationship to study therapy
Time frame: [Time Frame: Approximately 24 months]
Radiographic Progression Free Survival(rPFS)
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
Time frame: [Time Frame: Approximately 24 months]
Objective response rate (ORR)
The percentage of patients with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Time frame: [Time Frame: Approximately 24 months]
PSA response rate
After the continuous therapy from randomisation to the end of the 12 weeks, the percentage of patients whose levels of PSA decreased by more than 50% compared with baseline
Time frame: [Time Frame: Approximately 3 months]
Overall Survival(OS)
Time from randomisation to death due to any cause
Time frame: [Time Frame: Approximately 24 months]
Area Under the Curve (AUC)
The single dose and multiple dose PK will be calculated as data permits including AUC
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: [Time Frame: Approximately 2 months]
Maximum Observed Plasma Concentration (Cmax)
The single-dose and multiple dose PK will be calculated as data permits including Cmax
Time frame: [Time Frame: Approximately 2 months]
Minimum Observed Plasma Concentration (Cmin)
The single-dose and multiple dose PK will be calculated as data permits including Cmin
Time frame: [Time Frame: Approximately 2 months]