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Treatment Patterns in Metastatic Prostate Cancer

24. januar 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

565

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

45 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

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
Intervensjon / Behandling
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.
Legemiddel: Xofigo (Radium 223 dichloride,BAY88-8223)
Retrospective claims analysis. Descriptive analyses of treatment patterns.
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).
Legemiddel: Xofigo (Radium 223 dichloride,BAY88-8223)
Retrospective claims analysis. Descriptive analyses of treatment patterns.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Distribution of treatment types among lines of therapy
Tidsramme: Up to 6 months
Possible Treatment Types: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
Up to 6 months
Time to treatment (days)
Tidsramme: Up to 6 months
Up to 6 months
Duration of treatment (days)
Tidsramme: Up to 6 months
Up to 6 months
Number of patients on each drug or drug combination
Tidsramme: Up to 6 months
Drug: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
Up to 6 months
Number of inpatient visits per patient
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Length of hospital stay (days) among those with an inpatient visit
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Number of outpatient visits per patient
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Number of emergency room (ER) visits per patient
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Number of physician office visits per patient
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Number of medication prescriptions per patient
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Number of patients by provider type
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Number of claims per patient
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Total costs of healthcare
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Medical costs of healthcare
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Pharmacy costs of healthcare
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Per-patient-per-month (PPPM)) costs of healthcare
Tidsramme: Upto 6 month post index period
Upto 6 month post index period
Mortality rate
Tidsramme: Up to 6 months
Up to 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Opioid/analgesic use among lines of therapy(Y/N)
Tidsramme: Up to 6 months
Opioid and analgesics use among lines of therapy (e.g. 1st, 2nd, 3rd)
Up to 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bayer

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)

31. oktober 2016

Primær fullføring (Faktiske)

19. januar 2017

Studiet fullført (Faktiske)

19. januar 2017

Datoer for studieregistrering

Først innsendt

16. mars 2016

Først innsendt som oppfylte QC-kriteriene

31. mars 2016

Først lagt ut (Anslag)

6. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. januar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. januar 2018

Sist bekreftet

1. januar 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 18695

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