NCT01160705已完成不适用
Biomarkers of Response to Taxotere in Hormone-Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 5
- 主要终点
- Presence of mRNA in circulating tumor cells as a predictor of response
研究概览
简要总结
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying blood samples in predicting how patients with prostate cancer will respond to treatment with docetaxel.
详细描述
OBJECTIVES:
Primary
- To determine if mRNA present in circulating tumor cells will help predict response in patients with hormone-refractory prostate cancer treated with docetaxel.
- In parallel with this, based on discoveries made since our protocol was initially submitted to ICORG, here we also propose to analyse serum specimens from these consenting patients for the presence of EC miRNA, mRNA and protein predictive of response to Taxotere.
Secondary
- To develop a predictive model based on the most accurate and sensitive combination of these biomarkers.
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
- •Patients must satisfy the following criteria:
- •Patients must, in the opinion of the Investigator, be suitable for treatment with Docetaxel on a weekly, biweekly or three weekly schedule.
- •Patients must be aged 18 years or over.
- •Patients must have histologically or cytologically proven adenocarcinoma of the prostate gland.
- •Patients must have evidence of locally advanced or metastatic disease (e.g. bone, pelvic mass, lymph node, liver or lung metastases).
- •Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (LHRH-agonist etc.) with evidence of treatment failure.
- •Patients must not have received prior treatment with chemotherapy.
- •Patients must be able to give written informed consent.
- •Prior radiotherapy is allowed.
- •Concomitant use of bisphosphonates is allowed.
排除标准
- •Patients who have received previous cytotoxic therapy for prostate cancer are ineligible.
- •Patients who in the judgement of their treating physician will not be able to receive therapy and follow-up according to the protocol guidelines will be ineligible.
- •Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
- •History of other primary cancer, unless:
- •Curatively resected non-melanomatous skin cancer
- •Other primary solid tumour curatively treated with no known active disease present and no curative treatment for the last year.
结局指标
主要结局
Presence of mRNA in circulating tumor cells as a predictor of response
时间窗: ongoing
次要结局
- Development of a predictive model(End of trial)
研究者
研究点 (5)
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