Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases in a Medicare Population
17. september 2018 opdateret af: Bayer
Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases
The goal of the study is to provide a detailed description of treatments for CRPC (Castrate Resistant Prostate Cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1163
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Kentucky
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Louisville, Kentucky, Forenede Stater
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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
55 år til 88 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Castrated resistant prostate cancer patients with bone metastases
Beskrivelse
Inclusion Criteria:
- First diagnosis for bone metastases for members diagnosed with prostate cancer found in the claims data during the identification period
- Members age ≥ 55 to 89 years at index
- Medicare members with medical and pharmacy coverage; and
- Continuously enrolled during the pre- and post-index periods.
Exclusion Criteria:
- Member with diagnosis of any other cancer (excluding melanoma (ICD-9 172.x) and other metastases (ICD-9 198.x)) before the index date; and
- Members age ≥ 89 years of age at index date
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 |
Intervention / Behandling |
|---|---|
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Cohort 1 / Treatment patterns
Patients with castrated resistant prostate cancer and bone metastases
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Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall survival of mCRPC patients
Tidsramme: Up to 24 months
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mCRPC: Metastatic castrate-resistant prostate cancer
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Up to 24 months
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Number of skeletal related events (SREs) of the mCRPC patients
Tidsramme: Up to 30 months
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Up to 30 months
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|
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Type of skeletal related events (SREs) of the mCRPC patients
Tidsramme: Up to 30 months
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Up to 30 months
|
|
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Number of patients with mCRPC with bone metastases
Tidsramme: Up to 24 months
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Up to 24 months
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|
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Type of treatments associated with mCRPC
Tidsramme: Up to 24 months
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Treatments could include chemotherapy or bone radiation
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Up to 24 months
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Duration for each treatment identified
Tidsramme: Up to 30 months
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Up to 30 months
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Distribution of providers by treatment
Tidsramme: Up to 30 months
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Distribution of treatments for mCRPC patients will be tracked by the type of provider (oncologist, versus urologist, versus radiation oncologist, etc)
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Up to 30 months
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Clinical and demographic characteristics of the mCRPC patients
Tidsramme: Up to 12 months
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Gender, age, geographical region and race/ethnicity, Key comorbidities will also be documented using the Deyo-Charlson Comorbidity Index (DCCI); laboratory results for Prostate-Specific Antigen (PSA) and alkaline phosphatase (ALP) testing using laboratory claims; Rx utilization including opioid use
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Up to 12 months
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Treatment patterns of mCRPC patients with bone metastases
Tidsramme: Up to 30 months
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Up to 30 months
|
|
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Progression of the disease of mCRPC patients
Tidsramme: Up to 12 months
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Up to 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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All-cause healthcare resource utilization for mCRPC patients
Tidsramme: Up to 30 months
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Using all post-index medical and pharmacy claims, compute the count of physician office visits, outpatient services, inpatient stay, length of inpatient stay, ancillary services, and count of pharmacy claims
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Up to 30 months
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mCRPC-specific healthcare resource utilization for mCRPC patients
Tidsramme: Up to 30 months
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Healthcare resource utilization will be measured using all post-index medical and pharmacy claims to create counts for physician office visits, outpatient services, inpatient stay, length of inpatient stay, ancillary services and counts of pharmacy claims
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Up to 30 months
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All-cause healthcare costs for mCRPC patients
Tidsramme: Up to 30 months
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Healthcare costs will be determined using all post-index medical and pharmacy claims.
The all-cause total (medical + pharmacy), medical and pharmacy costs will be computed.
A family of general linear model analysis will be performed (medical, pharmacy, and total costs)
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Up to 30 months
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mCRPC-specific healthcare costs for mCRPC patients
Tidsramme: Up to 30 months
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Healthcare costs will be determined using all post-index medical and pharmacy claims where a diagnosis of mCRPC appears in any of the nine diagnosis positions.
The mCRPC specific total (Medical + pharmacy), medical and pharmacy costs associated with these claims will be computed.
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Up to 30 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
31. august 2015
Primær færdiggørelse (Faktiske)
30. september 2017
Studieafslutning (Faktiske)
30. september 2017
Datoer for studieregistrering
Først indsendt
6. august 2015
Først indsendt, der opfyldte QC-kriterier
6. august 2015
Først opslået (Skøn)
10. august 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. september 2018
Sidst verificeret
1. september 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 18273
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Radium-223 dichloride (Xofigo, BAY88-8223)
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