Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
研究概览
简要总结
The usual approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
The study approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
详细描述
- Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind prostate cancer patients.
- Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind prostate cancer patients.
- Calculate drug target gene SNPs in all 600 recruited double blind prostate cancer patients.
- Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
- Correlate everyone patient drug target gene SNP to everyone patient drug safety.
- Mutually compare the usual approach group SNPs (300 double blind random group separated prostate cancer patients) with the study approach group SNPs (300 double blind random group separated prostate cancer patients).
- Confirm the relationship between drug target gene SNPs and drug efficacy.
- Confirm the relationship between drug target gene SNPs and drug safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
No-placebo and random and double blind
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Select 600 localized Prostate Cancer Patients without prostate resection
- •Dosage Duration at least 90 days
- •The usual approach group - Recruit 300 double blind random group separated prostate cancer patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet, like as the usual approach group.
- •The study approach group - Recruit 300 double blind random group separated prostate cancer patients currently used the Combined Chemotherapy on China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet, like as the study approach group.
- •Inclusion Criteria:
- •Clinical diagnosis of Prostate Cancer (PC)
- •Cancer in the prostate only
- •Prior therapy without orchiectomy
- •Prior therapy without prostate resection
- •Prior different chemotherapy must-need stop
- •Have no other cancer at the same time
- •Sign an informed consent form
- •Receive blood-drawing
排除标准
- •Treatment with other anti-cancer therapies and the therapies cannot be stopped currently
- •The patients with other serious intercurrent illness or infectious diseases
- •Have more than one different kind of cancer at the same time
- •Serious Allergy to Drugs
- •Serious Bleed Tendency
- •Serious Risks or Serious Adverse Events of the drug product label
- •Serious Risks or Serious Adverse Events of NCI Table of Side Effects
- •The prohibition of drug products
- •Have no therapeutic effects
- •Follow up to the most current label and plan for safety monitoring
研究组 & 干预措施
Abiraterone - Usual
- ZYTIGA - Abiraterone
- Combined Chemotherapy
- ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet
- Usual Approach Group
干预措施: Abiraterone - Usual (Drug)
Abiraterone - Study
- China Import - Abiraterone
- Combined Chemotherapy
- China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet
- Usual Approach Group
干预措施: Abiraterone - Study (Drug)
结局指标
主要结局
Measure and Report Abiraterone Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
时间窗: Up to 12 weeks
* Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy on ZYTIGA - Abiraterone tablet plus Prednisone tablet plus BICALUTAMIDE tablet to be the usual approach group. * Recruit 300 double blind random group separated PC patients currently using the Combined Chemotherapy on China Import - Abiraterone tablet plus Prednisone tablet plus BICALUTAMIDE tablet to be the study approach group. * Measure above every PC patient specific Abiraterone drug target (CYP17) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every PC patient specific CYP17 SNP genotype in whole genome DNA sequence. * Measure above every PC patient specific Abiraterone drug target (SULT2A1) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every PC patient specific SULT2A1 SNP genotype in whole genome DNA sequence.
次要结局
未报告次要终点
研究者
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair
Medicine Invention Design, Inc