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Treatment Patterns in Metastatic Prostate Cancer

24 januari 2018 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

565

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

45 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / 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.
Läkemedel: 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).
Läkemedel: Xofigo (Radium 223 dichloride,BAY88-8223)
Retrospective claims analysis. Descriptive analyses of treatment patterns.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Distribution of treatment types among lines of therapy
Tidsram: 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)
Tidsram: Up to 6 months
Up to 6 months
Duration of treatment (days)
Tidsram: Up to 6 months
Up to 6 months
Number of patients on each drug or drug combination
Tidsram: 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
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Length of hospital stay (days) among those with an inpatient visit
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Number of outpatient visits per patient
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Number of emergency room (ER) visits per patient
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Number of physician office visits per patient
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Number of medication prescriptions per patient
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Number of patients by provider type
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Number of claims per patient
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Total costs of healthcare
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Medical costs of healthcare
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Pharmacy costs of healthcare
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Per-patient-per-month (PPPM)) costs of healthcare
Tidsram: Upto 6 month post index period
Upto 6 month post index period
Mortality rate
Tidsram: Up to 6 months
Up to 6 months

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bayer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

31 oktober 2016

Primärt slutförande (Faktisk)

19 januari 2017

Avslutad studie (Faktisk)

19 januari 2017

Studieregistreringsdatum

Först inskickad

16 mars 2016

Först inskickad som uppfyllde QC-kriterierna

31 mars 2016

Första postat (Uppskatta)

6 april 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 januari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 januari 2018

Senast verifierad

1 januari 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 18695

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