此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Towards Optimal Prescription of Chemotherapy in Prostate Cancer (TOPCOP)

2020年8月18日更新者：University Health Network, Toronto

TOward Personalizing Care for Older Men With mCRPC - Understanding and Predicting Treatment Toxicities (the TOPCOP Study)

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.

研究概览

地位

完全的

条件

前列腺癌

详细说明

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.

研究类型

观察性的

注册 (实际的)

206

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

加拿大
- Ontario
  - Hamilton、Ontario、加拿大、L8V 5C2
    - Juravinski Cancer Centre
  - Kingston、Ontario、加拿大、K7L 2V7
    - Kingston Health Sciences Centre -KGH
  - Toronto、Ontario、加拿大、M5G 2M9
    - Princess Margaret Cancer Centre
  - Toronto、Ontario、加拿大、M4N 3M5
    - Odette Cancer Centre

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

男性

取样方法

概率样本

研究人群

Men 65 and older starting first line chemotherapy, or Abiraterone, or Enzalutamide for mCRPC

描述

Inclusion Criteria:

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

Exclusion Criteria:

Unable to speak English fluently.
Severe neuropsychiatric abnormalities that prevent study participation.
Limited life expectancy (<3 months) as estimated by the primary oncologist.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Chemotherapy Men starting first-line chemotherapy for mCRPC (typically Docetaxel and Prednisone)
Abiraterone Men with mCRPC starting Abiraterone
Enzalutamide Men with mCRPC starting Enzalutamide

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Daily function assessed by questionnaires 大体时间：Participants will be followed for the duration of treatment up to 2 years	Daily function	Participants will be followed for the duration of treatment up to 2 years
Objective physical function 大体时间：Participants will be followed for the duration of treatment up to 2 years	Will be assessed by 3 physical performance measures	Participants will be followed for the duration of treatment up to 2 years
Grade 3+ toxicity using Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0 大体时间：Participants will be followed for the duration of treatment up to 2 years	Toxicity	Participants will be followed for the duration of treatment up to 2 years
Number of falls provided by the participant 大体时间：Participants will be followed for the duration of treatment up to 2 years	Falls	Participants will be followed for the duration of treatment up to 2 years
Body fat percentage will be measured using a Tanita 300A analyzer 大体时间：Participants will be followed for the duration of treatment up to 2 years	Body composition analysis	Participants will be followed for the duration of treatment up to 2 years

次要结果测量

结果测量	措施说明	大体时间
Quality of Life (QOL) 大体时间：Participants will be followed for the duration of treatment up to 2 years	FACT-G and FACT-P (specific for prostate cancer) questionnaires will be administered	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 大体时间：Participants will be followed for the duration of treatment up to 2 years	Cognition composite	Participants will be followed for the duration of treatment up to 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Health Network, Toronto

合作者

Prostate Cancer Canada

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年7月1日

初级完成 (实际的)

2019年4月30日

研究完成 (实际的)

2019年12月31日

研究注册日期

首次提交

2015年7月17日

首先提交符合 QC 标准的

2015年7月29日

首次发布 (估计)

2015年7月30日

研究记录更新

最后更新发布 (实际的)

2020年8月19日

上次提交的符合 QC 标准的更新

2020年8月18日

最后验证

2020年8月1日