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TOPCOP: Towards Optimal Prescription of Chemotherapy in Prostate Cancer

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT02512185
Collaborator
Prostate Cancer Canada (Other)
206
Enrollment
4
Locations
54
Actual Duration (Months)
51.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    206 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    TOward Personalizing Care for Older Men With mCRPC - Understanding and Predicting Treatment Toxicities (the TOPCOP Study)
    Actual Study Start Date :
    Jul 1, 2015
    Actual Primary Completion Date :
    Apr 30, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Chemotherapy

    Men starting first-line chemotherapy for mCRPC (typically Docetaxel and Prednisone)
    Abiraterone

    Men with mCRPC starting Abiraterone
    Enzalutamide

    Men with mCRPC starting Enzalutamide

    Outcome Measures

    Primary Outcome Measures

    1. Daily function assessed by questionnaires [Participants will be followed for the duration of treatment up to 2 years]

      Daily function

    2. Objective physical function [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 [Participants will be followed for the duration of treatment up to 2 years]

      Toxicity

    4. Number of falls provided by the participant [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 [Participants will be followed for the duration of treatment up to 2 years]

      Body composition analysis

    Secondary Outcome Measures

    1. Quality of Life (QOL) [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 [Participants will be followed for the duration of treatment up to 2 years]

      Cognition composite

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. At least 65 years of age

    2. 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)

    3. 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:

    1. Unable to speak English fluently.

    2. Severe neuropsychiatric abnormalities that prevent study participation.

    3. Limited life expectancy (<3 months) as estimated by the primary oncologist.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Juravinski Cancer Centre Hamilton Ontario Canada L8V 5C2
    2 Kingston Health Sciences Centre -KGH Kingston Ontario Canada K7L 2V7
    3 Odette Cancer Centre Toronto Ontario Canada M4N 3M5
    4 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto
    • Prostate Cancer Canada

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT02512185
    Other Study ID Numbers:
    • 15-9075
    First Posted:
    Jul 30, 2015
    Last Update Posted:
    Aug 19, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University Health Network, Toronto
    Prostate cancer
    Chemotherapy
    mCRPC
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Aug 19, 2020