LCCC 1231: Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 4
- 主要终点
- Proportion of pain palliation responders
研究概览
简要总结
This is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms.
详细描述
This is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms. The study aims to address several key methodological questions that will inform the design of future clinical trials with symptom endpoints in this population, including: the definition of "clinically meaningful" pain; criteria for concluding a clinically meaningful pain reduction; criteria for concluding clinically meaningful pain progression; reliable methods quantifying analgesic use (given that "equianalgesic tables" and "point scoring systems" are generally considered unreliable by pain researchers and regulatory agencies , , ); ideal recall periods for pain questions; tradeoffs of different frequencies of symptom reporting; symptom trajectories over time; and associations of pain scores with other metrics used in prostate cancer research (imaging, PSA values, circulating tumor cells, etc).
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 treatment post-androgen deprivation/antiandrogen therapy, such as the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; sipuleucel-T; Radium
- •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
Proportion of pain palliation responders
时间窗: 6 weeks
Determine the proportion of pain palliation responders and the proportion experiencing pain progression will be presented along with 95% confidence intervals.
次要结局
- Clinical significance of pain score changes(6 weeks)
- Frequency of pain reporting(7 days)
- Prevalence and trajectory of pain progression and pain palliation(3 weeks)
- Quantifying analgesic medication use(26 months)
- Web-avidity of patients(6 weeks)