Towards Optimal Prescription of Chemotherapy in Prostate Cancer (TOPCOP)
18. august 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
206
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Chemotherapy
Men starting first-line chemotherapy for mCRPC (typically Docetaxel and Prednisone)
|
|
Abiraterone
Men with mCRPC starting Abiraterone
|
|
Enzalutamide
Men with mCRPC starting Enzalutamide
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2015
Primær fullføring (Faktiske)
30. april 2019
Studiet fullført (Faktiske)
31. desember 2019
Datoer for studieregistrering
Først innsendt
17. juli 2015
Først innsendt som oppfylte QC-kriteriene
29. juli 2015
Først lagt ut (Anslag)
30. juli 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. august 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. august 2020
Sist bekreftet
1. august 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15-9075
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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