A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 654
- 试验地点
- 67
- 主要终点
- OS
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
排除标准
- •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.
研究组 & 干预措施
SHR3680
Participants will receive SHR3680 orally
干预措施: SHR3680 (Drug)
bicalutamide
Participants will receive bicalutamide orally
干预措施: Bicalutamide (Drug)
结局指标
主要结局
OS
时间窗: Approximately 70 months
Time from randomisation to death due to any cause
rPFS
时间窗: Approximately 70 months
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
次要结局
- Time to prostate specific antigen (PSA) progression(Approximately 70 months)
- Objective response rate (ORR)(Approximately 70 months)
- Time to initiation of a new antineoplastic therapy(Approximately 70 months)
- Time to skeletal-related events(Approximately 70 months)