Prostate Cancer, Hormone-Dependent Prostate Cancer
Conditions
Keywords
Hormone sensitive prostate cancer, SHR3680, Anti-androgen receptor
Brief summary
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.
Detailed description
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).
Interventions
DRUGSHR3680
Tablet. Specifications of 80 mg; orally, once a day
DRUGBicalutamide
Tablet. Specifications of 50 mg; orally, once a day
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age≧18 year, male; * ECOG performance scale 0 to 1; * Histologically or cytological confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features ; * Adequate hepatic, renal, heart, and hematological functions; * Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Exclusion criteria
* Subject has received any prior radiation therapy or surgery for prostate cancer, except 1 course of palliative surgical therapy if it was used at least 4 weeks prior to day 1; * Previous use or are using a second-generation androgen receptor antagonist (enzalutamide, ARN-509, ODM-201), abiraterone, ketoconazole for prostate cancer, or other agents that will inhibit the production of androgens; * Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks prior to day 1: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels ; * Evidence of brain metastasis or primary tumors; * Planned to initiate any other anti-tumor therapies during the study; * Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption; Clinically significant cardiovascular diseases; * History of seizure or certain conditions that may predispose to seizure; * Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rPFS | Approximately 70 months | Time from randomisation to radiologically confirmed progressive disease or death due to any cause |
| OS | Approximately 70 months | Time from randomisation to death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to prostate specific antigen (PSA) progression | Approximately 70 months | Time from randomisation to the first time of PSA progression according to the criterion of PCGW3 |
| Time to skeletal-related events | Approximately 70 months | 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 |
| Objective response rate (ORR) | Approximately 70 months | 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 to initiation of a new antineoplastic therapy | Approximately 70 months | Time from randomisation to the initiation of antineoplastic subsequent to the study treatment |
Countries
Bulgaria, China, Czechia, Poland
Outcome results
None listed