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临床试验/NCT02366494
NCT02366494已完成不适用

Utility of Exosomal MicroRNAs to Predict Response to Androgen Deprivation Therapy in Prostate Cancer Patients

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2015年4月29日最近更新:
适应症
干预措施

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

  1. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deepak Kilari

Associate Professor

Medical College of Wisconsin

研究点 (1)

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