Utility of Exosomal MicroRNAs to Predict Response to Androgen Deprivation Therapy in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment.
研究概览
简要总结
Identify exosomal micro RNA that predict responses to ADT
详细描述
- Identify novel exosomal RNA signatures at pretreatment that predict response to ADT.
The study team will collect blood samples from patients with systemic disease pretreatment (at enrollment), three months post-treatment and at the time of progression of disease (or at two years post-ADT for patients still in remission at that time point) and then perform next-generation sequencing using serum exosomal RNAs derived from these patients.
The investigators plan to identify exosomal RNAs signatures that change between pretreatment (at enrollment) and during treatment (at three months) and further explore the effect of these changes on disease response. The investigators also plan to compare exosomal RNA levels between patients relapse within the first two years versus those in remission at two years. Among patients with progression, the investigators plan to compare exosomal RNA signatures at progression of disease to signatures at pretreatment and during treatment. 2. Validate exosomal RNA markers that predict response to ADT by real-time RT-PCR.
Secondary objectives: Selected RNAs, identified through the above process will be validated using real-time RT-PCR assay to test reproducibility of RNA sequencing results. The investigators expect to select and validate approximate five RNA markers that predict duration of response to ADT.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 85 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven prostate cancer.
- •Testosterone level >30ng/ml and at least 6 months since last dose of hormonal therapy.
- •History/physical examination including a detailed description of the stage of prostate cancer within 8 weeks prior to registration.
- •CT scan of abdomen and pelvis with IV contrast and bone scan should be performed within 8 weeks prior to registration.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Patients must provide study-specific informed consent prior to study entry for this project and mandatory blood specimen for banking for future studies (future studies may include genetic testing).
排除标准
- •Received hormonal therapy less than 6 months prior to registration.
- •History of active secondary malignancy.
- •Decline hormone therapy for prostate cancer.
- •Current or previous treatment with 5-alpha reductase inhibitors within 6 months prior to enrollment.
研究组 & 干预措施
Androgen blockade
Androgen DeprivationTherapy or Complete Androgen Blockade
干预措施: Bicalutamide (Drug)
Androgen blockade
Androgen DeprivationTherapy or Complete Androgen Blockade
干预措施: Leuprolide (Drug)
Androgen blockade
Androgen DeprivationTherapy or Complete Androgen Blockade
干预措施: Goserelin (Drug)
Androgen blockade
Androgen DeprivationTherapy or Complete Androgen Blockade
干预措施: Triptorelin (Drug)
Hormonal Therapy and Chemotherapy
Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
干预措施: Bicalutamide (Drug)
Hormonal Therapy and Chemotherapy
Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
干预措施: Leuprolide (Drug)
Hormonal Therapy and Chemotherapy
Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
干预措施: Goserelin (Drug)
Hormonal Therapy and Chemotherapy
Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
干预措施: Triptorelin (Drug)
Hormonal Therapy and Chemotherapy
Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
干预措施: Docetaxel (Drug)
Hormonal Therapy and Chemotherapy
Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
干预措施: Abiraterone (Drug)
Hormonal Therapy and Chemotherapy
Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
干预措施: Apalutamide (Drug)
Hormonal Therapy and Chemotherapy
Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment.
时间窗: Up to two years
Two hundred to 300 microRNAs will be identified by RNA sequencing. This outcome measure will report the read count per million of the top-five most prevalent microRNAs that correlate with responses.
次要结局
未报告次要终点
研究者
Deepak Kilari
Associate Professor
Medical College of Wisconsin
