- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02512185
Towards Optimal Prescription of Chemotherapy in Prostate Cancer (TOPCOP)
TOward Personalizing Care for Older Men With mCRPC - Understanding and Predicting Treatment Toxicities (the TOPCOP Study)
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8V 5C2
- Juravinski Cancer Centre
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Kingston, Ontario, 캐나다, K7L 2V7
- Kingston Health Sciences Centre -KGH
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Cancer Centre
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Toronto, Ontario, 캐나다, M4N 3M5
- Odette Cancer Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Chemotherapy
Men starting first-line chemotherapy for mCRPC (typically Docetaxel and Prednisone)
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Abiraterone
Men with mCRPC starting Abiraterone
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Enzalutamide
Men with mCRPC starting Enzalutamide
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Daily function assessed by questionnaires
기간: Participants will be followed for the duration of treatment up to 2 years
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Daily function
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Participants will be followed for the duration of treatment up to 2 years
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Objective physical function
기간: Participants will be followed for the duration of treatment up to 2 years
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Will be assessed by 3 physical performance measures
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Participants will be followed for the duration of treatment up to 2 years
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Grade 3+ toxicity using Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0
기간: Participants will be followed for the duration of treatment up to 2 years
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Toxicity
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Participants will be followed for the duration of treatment up to 2 years
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Number of falls provided by the participant
기간: Participants will be followed for the duration of treatment up to 2 years
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Falls
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Participants will be followed for the duration of treatment up to 2 years
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Body fat percentage will be measured using a Tanita 300A analyzer
기간: Participants will be followed for the duration of treatment up to 2 years
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Body composition analysis
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Participants will be followed for the duration of treatment up to 2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Quality of Life (QOL)
기간: Participants will be followed for the duration of treatment up to 2 years
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FACT-G and FACT-P (specific for prostate cancer) questionnaires will be administered
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Participants will be followed for the duration of treatment up to 2 years
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The Montreal Cognitive Assessment (MoCA test) and Trail making tests A&B
기간: Participants will be followed for the duration of treatment up to 2 years
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Cognition composite
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Participants will be followed for the duration of treatment up to 2 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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