Selective Treatment According to Molecular Subtype of Prostate Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This is an open-label study that includes three substudies of random distribution. First, a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers. Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal phenotype), group 2 (Neuroendocrine phenotype) or group 3 (Atypical phenotype) and a random assignment will be performed to standard or experimental treatment.
详细描述
Metastatic castration-resistant prostate cancer (mCRPC) is a heterogenous disease with at least 3 intrinsic subtypes including luminal, neuroendocrine, and atypical phenotypes. Different subtypes have different prognosis and treatment sensitivity. Thus, it would be more suitable to administer different therapy in different subtypes. Therefore, the investigators designed this phase 2 randomized clinical trial to explore potential effective regimens in variable subtypes of mCRPC. Patients were first classified into Luminal type, Neuroendocrine type and Atypical type by immunohistochemistry exam of FKBP5/AR-WT/AR-v7/CgA/SYN/YAP1 in core needle biopsy and then randomized to received either standard or experimental treatment.
- Group 1 (Luminal type):
Standard treatment: Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
Experimental treatment: Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+Prednisone (5 mg, twice daily) 2. Group 2 (Neuroendocrine type):
Standard treatment: Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
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
- •Participants who have given consent form;
- •Patients with a confirmed diagnosis of mCRPC according to EAU 2018 guideline;
- •Serum testosterone must reach castration level: <50 ng per deciliter;
- •Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment.
排除标准
- •Participants who are allergic to contrast medium;
- •Patients were excluded if they planned to receive additional concurrent anticancer therapies;
- •Patients doesn't sign an informed consent form.
研究组 & 干预措施
Luminal type-1
Standard treatment
干预措施: Luminal type-1 (Drug)
Luminal type-2
Experimental treatment
干预措施: Luminal type-2 (Drug)
Neuroendocrine type-1
Standard treatment
干预措施: Neuroendocrine type-1 (Drug)
Neuroendocrine type-2
Experimental treatment
干预措施: Neuroendocrine type-2 (Drug)
Atypical type-1
Standard treatment
干预措施: Atypical type-1 (Drug)
Atypical type-2
Experimental treatment
干预措施: Atypical type-2 (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 40 months
OS was defined as the duration from the initiation of treatment to death of any cause
次要结局
- PSA-Progression free survival (pPFS)(Up to 40 months)
- Radiographic progression free survival (rPFS)(Up to 40 months)
- PSA response rate(Up to 40 months)