Towards Optimal Prescription of Chemotherapy in Prostate Cancer (TOPCOP)
18. august 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
206
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre -KGH
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre
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Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Men 65 and older starting first line chemotherapy, or Abiraterone, or Enzalutamide for mCRPC
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Chemotherapy
Men starting first-line chemotherapy for mCRPC (typically Docetaxel and Prednisone)
|
|
Abiraterone
Men with mCRPC starting Abiraterone
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|
Enzalutamide
Men with mCRPC starting Enzalutamide
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Daily function assessed by questionnaires
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of Life (QOL)
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2015
Primær færdiggørelse (Faktiske)
30. april 2019
Studieafslutning (Faktiske)
31. december 2019
Datoer for studieregistrering
Først indsendt
17. juli 2015
Først indsendt, der opfyldte QC-kriterier
29. juli 2015
Først opslået (Skøn)
30. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. august 2020
Sidst verificeret
1. august 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15-9075
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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