NCT01617174撤回不适用
Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- pain score
研究概览
简要总结
The first goal of this study is to learn more about the experience of pain and other symptoms in men being treated for advanced prostate cancer. The second goal of the study is to identify reliable ways of measuring pain which will be used in future clinical trials of treatments for advanced prostate cancer.
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
- •The subject must be ≥ 18 years old on the day of consent.
- •The subject is able to understand written and spoken English.
- •The patient must have histologically or cytologically confirmed prostate adenocarcinoma.
- •The subject must have castration-resistant prostate cancer (CRPC).
- •The subject must have metastatic disease involving bone, seen on radiographic imaging (bone scan, CT scan, PET scan, or MRI).
- •The subject must be in a castrate state (e.g., currently receiving androgen deprivation therapy or have had an orchiectomy).
- •The subject must be starting any line of systemic treatment post-androgen deprivation/antiandrogen therapy, with any of the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; a clinical trial.
- •The subject owns or has regular access to a telephone (cellular or land line).
- •The subject is willing and able to self-report pain and analgesic use via an automated telephone system.
- •The subject is willing and able to provide informed consent.
排除标准
- •The subject has small cell or predominantly neuroendocrine differentiated prostate tumor.
结局指标
主要结局
pain score
时间窗: 2 years
Pain score changes will be correlated with each of the following: patient rating of change in pain, as well as changes in patient functional status, analgesic use, and various measures of disease status (imaging, PSA, circulating tumor cells). The distribution-based approach is to estimate meaningful change as one-half a standard deviation of the sample mean pain score.
次要结局
未报告次要终点
研究者
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