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Completed

NCT Number: NCT02512185

Towards Optimal Prescription of Chemotherapy in Prostate Cancer

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.

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Key information

Age range

65 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Juravinski Cancer Centre, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Daily function assessed by questionnaires

    Time frame: Participants will be followed for the duration of treatment up to 2 years

    Daily function

  2. Objective physical function

    Time frame: Participants will be followed for the duration of treatment up to 2 years

    Will be assessed by 3 physical performance measures

  3. Grade 3+ toxicity using Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0

    Time frame: Participants will be followed for the duration of treatment up to 2 years

    Toxicity

  4. Number of falls provided by the participant

    Time frame: Participants will be followed for the duration of treatment up to 2 years

    Falls

  5. Body fat percentage will be measured using a Tanita 300A analyzer

    Time frame: Participants will be followed for the duration of treatment up to 2 years

    Body composition analysis

Secondary outcomes

  1. Quality of Life (QOL)

    Time frame: 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

  2. The Montreal Cognitive Assessment (MoCA test) and Trail making tests A&B

    Time frame: Participants will be followed for the duration of treatment up to 2 years

    Cognition composite

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Prostate Cancer Canada

Registry information

Official study title

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

Acronym: TOPCOP

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2015
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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