Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Lesion heterogeneity on dual-tracer PET/CT
研究概览
简要总结
By incorporating dual-tracer PET/CT (PSMA and FDG) and ctDNA, we aimed to evaluate lesion heterogeneity and genomic change of mCRPC patients receiving novel hormonal therapy. The relationship between treatment response and different molecular characterization, as well as imaging features would also be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as mCRPC according to EAU-ESTRO-SIOG 2016 and PSA > 10ng/ml;
- •No previous treatment with novel hormonal therapy;
- •Normal organ function, WBC >= 3000/mm3 or Neutrophil >= 1500/mm3;
- •Aged 18 to 85 years old when issuing written informed consent;
- •Life expectancy > 12 months.
- •Consent and able to carry out follow-up visit and cooperate with all other study procedures.
排除标准
- •Severe disease or other medical conditions suggesting a high risk of death within 1 year, which may interfere with follow-up. Decided by investigator;
- •Diagnosed with any other malignant tumor within 3 years before enrollment;
- •Unable to provide necessary follow-up information;
- •Other conditions that are judged as ineligible by the investigator.
研究组 & 干预措施
mCRPC
Patients would be treated with 1000mg abiraterone qd. Patients would be treated with 5mg prednisone bid. Patients would get medical or surgical castration.
干预措施: Androgen deprivation therapy (Drug)
mCRPC
Patients would be treated with 1000mg abiraterone qd. Patients would be treated with 5mg prednisone bid. Patients would get medical or surgical castration.
干预措施: Abiraterone (Drug)
mCRPC
Patients would be treated with 1000mg abiraterone qd. Patients would be treated with 5mg prednisone bid. Patients would get medical or surgical castration.
干预措施: Prednisone (Drug)
结局指标
主要结局
Lesion heterogeneity on dual-tracer PET/CT
时间窗: 90 days
Genomic change
时间窗: 30 days
次要结局
未报告次要终点