Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 205
- 试验地点
- 26
- 主要终点
- Prevalence of tissue HRR-related gene mutations
研究概览
简要总结
The purpose of this study is to investigate the prevalence of tissue homologous recombination repair (HRR)-related gene mutations (positive/negative/Variant of uncertain significance (VUS)), clinical outcome such as prostate-specific antigen-progression free survival (PSA-PFS), overall survivals (OS) and treatment pattern in mCRPC patients.
<Methods> Study design: multi-center, prospective cohort study
Data Source(s):
In this study, 155 patients (expected recruitment patients: maximum 205 patients) will be enrolled from approximately 20~30 sites in Japan. Study Population: mCRPC patients who diagnosed between 2014 and 2018. Exposure(s): N.A Outcome(s): Prevalence of tissue HRR-related gene mutations, clinical outcomes such as Over survival and PSA-PFS, Treatment pattern
Sample Size Estimations:
The target population is 155 patients based on the prevalence of HRR-related genes (BRCA1, BRCA2 and ATM) which is reported in previous global study (PROfound study).
Statistical Analysis:
This study is not intended to verify specific hypotheses, and the results are evaluated descriptively. There is no plan of interim analyses before the final analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age > 20, Japanese men at the time of informed consent.
- •Patients who provided informed consent. If the patient has died, opt-out will be applicable.
- •Patients who are diagnosed as mCRPC between January 1st in 2014 and December 31st in
- •Patients who have a FFPE tumor sample (primary or metastatic) with Formalin Neutral Buffer Solution.
- •Patients which the investigator judges to secure the enough amount of tumor samples for future laboratory test.
排除标准
- •Patients who have failed HRR-related gene mutation testing with the myChoice HRD plus in screening period.
- •Patients who have an only FFPE primary tumor sample (primary or metastatic) with unbuffered formalin including acidic formalin.
- •Patients who have taken an investigational medical product for prostate cancer from Jan 1st , 2014 to Dec 31st 2020.
结局指标
主要结局
Prevalence of tissue HRR-related gene mutations
时间窗: Baseline
Calculate number and prevalence of each HRR-related gene mutation status (Positive/Negative/VUS), respectively. Prevalence will be accompanied by 95% Clopper-Pearson confidence intervals.
次要结局
- Proportion of each treatment pattern(From index date(diagnosed as mCRPC) patients to December 31 2020)