TOward Personalizing Care for Older Men With mCRPC - Understanding and Predicting Treatment Toxicities (the TOPCOP Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 4
- 主要终点
- Daily function assessed by questionnaires
研究概览
简要总结
This study will examine the impact of modern treatments for metastatic Castrate Resistant Prostate Cancer (mCRPC) on several relevant 'geriatric' domains such as daily function, objective physical function, and falls. Additionally, the investigators study whether frailty is associated with worse outcomes, and whether it is possible to predict the risk of severe chemotherapy toxicity in older men.
详细描述
Our primary aims are (a) to examine the impact of pre-treatment frailty on 'elder-relevant' outcomes including daily function, objective physical function, falls, quality of life (QOL), and early treatment discontinuation; (b) to determine whether the Hurria/Cancer and Aging Research Group (CARG) tool is able to predict severe (grade 3+) chemotherapy toxicity in men starting chemotherapy. Our secondary aim is to understand the impact of abiraterone and enzalutamide on 'elder-relevant' outcomes.
This is a prospective multicentre observational study. The investigators will enroll men age 65 or older with mCRPC who are starting (a) first-line chemotherapy; (b) abiraterone; or (c) enzalutamide. Assessments will occur prior to starting treatment and every 2 months thereafter until the end of treatment.
As treatment options become more complex in older men with mCRPC, understanding and predicting a wide range of treatment toxicities is important and will aid decision-making and management.
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
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •At least 65 years of age
- •Diagnosed with prostate cancer with evidence of clinical and/or radiographic evidence of progression despite adequate androgen deprivation therapy and achievement of castration (total testosterone level <1.7 nmol/L measured within 6 months of enrollment)
- •Among men starting either abiraterone or enzalutamide, no prior chemotherapy/abiraterone/enzalutamide. Among men starting first-line chemotherapy, commencing docetaxel but can have had either prior abiraterone or enzalutamide
排除标准
- •Unable to speak English fluently.
- •Severe neuropsychiatric abnormalities that prevent study participation.
- •Limited life expectancy (<3 months) as estimated by the primary oncologist.
结局指标
主要结局
Daily function assessed by questionnaires
时间窗: Participants will be followed for the duration of treatment up to 2 years
Daily function
Objective physical function
时间窗: Participants will be followed for the duration of treatment up to 2 years
Will be assessed by 3 physical performance measures
Grade 3+ toxicity using Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0
时间窗: Participants will be followed for the duration of treatment up to 2 years
Toxicity
Number of falls provided by the participant
时间窗: Participants will be followed for the duration of treatment up to 2 years
Falls
Body fat percentage will be measured using a Tanita 300A analyzer
时间窗: Participants will be followed for the duration of treatment up to 2 years
Body composition analysis
次要结局
- Quality of Life (QOL)(Participants will be followed for the duration of treatment up to 2 years)
- The Montreal Cognitive Assessment (MoCA test) and Trail making tests A&B(Participants will be followed for the duration of treatment up to 2 years)