The aim of this study is to compare the safety and efficacy of SHR3680 with bicalutamide in the treatment of patients with hormone sensitive prostate cancer.
This is an open, multicenter, randomized phase III trial. This clinical study compares the efficacy and safety of SHR3680 with bicalutamide in the patients with hormone sensitive prostate cancer. Approximately 572 patients who meet the entry criteria will be randomly assigned in a 1:1 ratio to SHR3680 or bicalutamide treatment. Primary endpoints of the study are radiological progress-free survival (rPFS) and overall survival (OS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
654
Tablet. Specifications of 80 mg; orally, once a day
Tablet. Specifications of 50 mg; orally, once a day
rPFS
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
Time frame: Approximately 70 months
OS
Time from randomisation to death due to any cause
Time frame: Approximately 70 months
Time to prostate specific antigen (PSA) progression
Time from randomisation to the first time of PSA progression according to the criterion of PCGW3
Time frame: Approximately 70 months
Time to skeletal-related events
Time from randomisation to the first occurrence of a fracture or treatment for the fracture. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery
Time frame: Approximately 70 months
Objective response rate (ORR)
The percentage of subjects 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: Approximately 70 months
Time to initiation of a new antineoplastic therapy
Time from randomisation to the initiation of antineoplastic subsequent to the study treatment
Time frame: Approximately 70 months
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