Studies of Cell-Free DNA and RNA in Blood From Patients Being Treated for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Time to start of another treatment
研究概览
简要总结
This research trial studies cell-free deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in blood from patients with prostate cancer that does not respond to hormone therapy and has spread to other places in the body. Studying samples of blood from patients with prostate cancer may help doctors to learn more about the changes that occur in tumor cells over time and how they become resistant to anti-cancer drugs.
详细描述
PRIMARY OBJECTIVES:
I. To document the appearance of androgen receptor isoform splice variant 7 (AR-V7) expression over the course of therapy in castration-resistant prostate cancer (CRPC).
II. To determine whether detectable AR-V7 is associated with a shortened duration of treatment benefit of abiraterone or enzalutamide.
SECONDARY OBJECTIVES:
I. To determine how the presence and expression level of AR-V7 impacts response to docetaxel.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of histologically confirmed prostate adenocarcinoma and falling into one of the following 5 groups:
- •Currently receiving ADT (previously untreated for metastatic disease)
- •These patients will be grouped into 3 cohorts: having received ADT for 3-6 months; for 1-2 years; and for > 3 years
- •Scheduled to begin treatment with ADT (previously untreated for metastatic disease)
- •Scheduled to begin treatment with enzalutamide (castration resistant / has received ADT / may have received abiraterone)
- •Scheduled to begin treatment with abiraterone (castration resistant / has received ADT / may have received enzalutamide)
- •Scheduled to begin treatment with docetaxel (castration resistant / has received ADT / has received enzalutamide and/or abiraterone)
- •Have been diagnosed with either hormone-naive or castrate-resistant metastatic disease
- •Ability and willingness to provide written and informed consent
排除标准
- •Patients who receive combined ADT with docetaxel for hormone-naive metastatic prostate cancer
- •Patients on intermittent ADT
结局指标
主要结局
Time to start of another treatment
时间窗: Time from start of treatment until the time that the patient begins another therapy, assessed up to 3 years
Change in AR-V7 presence
时间窗: Baseline to 3 years
Each of the 4 longitudinal cohorts will be analyzed separately (at least initially). Kaplan-Meier-like curves (likely adjusted for interval censoring) will be used to display the development of AR-V7 positivity. To complement the analysis of Cohort A, an exact logistic regression analysis will be used with the data from Cohort X with AR-V7 splice variant positivity as the dependent variable and time since start of ADT as the independent variable. Logistic regression will be used to assess the association between AR-V7 status at start of treatment and overall response to treatment.
Expression level of AR-V7 in serum cfRNA assessed by quantitative RT-PCR
时间窗: Up to 3 years
Detectable AR-V7 will be associated with a shortened duration of treatment benefit (ADT, abiraterone, enzalutamide, docetaxel). Each of the 4 longitudinal cohorts will be analyzed separately (at least initially). A regression analysis based on the Cox proportional hazards model (if proportional hazards holds) will be used to assess the association between AR-V7 and time to new treatment. Initially, only the baseline AR-V7 status will be used. Next, AR-V7 will be included as a time dependent covariate; the model used may be modified to accommodate competing risks (if too many switch treatment p
次要结局
- Expression levels of AR-Vs (other than AR-V7) in serum cfRNA assessed by quantitative RT-PCR(Up to 3 years)
- Tumor response as measured by Prostate Cancer Working Group(Up to 3 years)