Treatment Patterns in Metastatic Prostate Cancer
24. januar 2018 opdateret af: Bayer
Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients With Prostate Cancer With Bone Metastases: A Retrospective Database Analysis .
This study will evaluate treatment patterns, mortality, healthcare resource utilization, and costs in patients with prostate cancer with bone metastases (primary objectives).
Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this patient population (secondary objective).
The study is descriptive in nature and is meant to provide a greater understanding of the patterns of therapy observed in real-world clinical practice (in the absence of clear guideline recommendations with regards to treatment sequencing), to contribute to a greater understanding of the major cost drivers (thus better-informing payers), and to examine real-world mortality in such patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
565
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New Jersey
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Whippany, New Jersey, 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
45 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Part 1 - Assessment of treatment patterns, healthcare resource utilization, and costs The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
Part 2 - Assessment of mortality The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
Beskrivelse
Inclusion Criteria:
- Subjects with at least one claim with a primary diagnosis of prostate cancer (International Classification of Diseases(ICD) Clinical Modification (CM)185.xx )and any of the below on same day or after the prostate cancer claim:
- At least one inpatient claim with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or Healthcare Common Procedure Coding System (HCPCS) code for a treatment indicative of bone metastases OR
- At least two outpatient claims with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or HCPCS code for a treatment indicative of bone metastases, with a minimum of 30 days between claims.
Exclusion Criteria:
- Subjects with a diagnosis of a cancer other than prostate cancer - defined as the presence of one inpatient or two outpatient claims with a primary or secondary diagnosis of malignant neoplasms (ICD-9-CM 140.xx-171.xx, 174.xx-184.xx,186.xx-195.xx,200.xx-209.3x, 230.xx-239.xx) - in the 12-month pre-index period.
- Subjects with any claim for a primary or secondary diagnosis indicating bone metastases (ICD-9-CM 198.5) or any treatment indicative of bone metastases in the 12-month pre-index period.
- Patients who had a SRE in the 12-month pre-index period.
- Subjects without continuous enrollment for at least 12 months before the index date.
- Subjects without continuous eligibility for at least 6 months after the index date.
- Subjects that are female.
- Subjects that have negative costs.
- Subjects that are less than 45 years of age on the 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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Treatment patterns, healthcare resource utilization and costs
Part 1 - Assessment of treatment patterns, healthcare resource utilization and costs.
The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population.
The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no skeletal-related events (SREs) in the 12-month pre-index period.
Additionally, all subjects must be continuously enrolled for at least 12 months before and at least 6 months after the index date.
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Retrospective claims analysis.
Descriptive analyses of treatment patterns.
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Mortality
Part 2 - Assessment of mortality.
The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population.
The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no SREs in the 12-month pre-index period.
Additionally, all subjects must be continuously enrolled for at least 12 months before the index date.
Unlike in Part 1, there will be no required minimum follow-up time after the index date (in order to assess mortality).
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Retrospective claims analysis.
Descriptive analyses of treatment patterns.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Distribution of treatment types among lines of therapy
Tidsramme: Up to 6 months
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Possible Treatment Types: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
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Up to 6 months
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Time to treatment (days)
Tidsramme: Up to 6 months
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Up to 6 months
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Duration of treatment (days)
Tidsramme: Up to 6 months
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Up to 6 months
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Number of patients on each drug or drug combination
Tidsramme: Up to 6 months
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Drug: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
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Up to 6 months
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Number of inpatient visits per patient
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Length of hospital stay (days) among those with an inpatient visit
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Number of outpatient visits per patient
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Number of emergency room (ER) visits per patient
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Number of physician office visits per patient
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Number of medication prescriptions per patient
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Number of patients by provider type
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Number of claims per patient
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Total costs of healthcare
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Medical costs of healthcare
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Pharmacy costs of healthcare
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Per-patient-per-month (PPPM)) costs of healthcare
Tidsramme: Upto 6 month post index period
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Upto 6 month post index period
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Mortality rate
Tidsramme: Up to 6 months
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Up to 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Opioid/analgesic use among lines of therapy(Y/N)
Tidsramme: Up to 6 months
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Opioid and analgesics use among lines of therapy (e.g.
1st, 2nd, 3rd)
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Up to 6 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. oktober 2016
Primær færdiggørelse (Faktiske)
19. januar 2017
Studieafslutning (Faktiske)
19. januar 2017
Datoer for studieregistrering
Først indsendt
16. marts 2016
Først indsendt, der opfyldte QC-kriterier
31. marts 2016
Først opslået (Skøn)
6. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 18695
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 .
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