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Completed

NCT Number: NCT02729103

Treatment Patterns in Metastatic Prostate Cancer

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.

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Key information

Conditions

Prostatic Neoplasm Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Whippany, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xofigo (Radium 223 dichloride,BAY88-8223)

Drug

Retrospective claims analysis. Descriptive analyses of treatment patterns.

Primary outcomes

  1. Distribution of treatment types among lines of therapy

    Time frame: 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

  2. Time to treatment (days)

    Time frame: Up to 6 months

  3. Duration of treatment (days)

    Time frame: Up to 6 months

  4. Number of patients on each drug or drug combination

    Time frame: Up to 6 months

    Drug: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy

  5. Number of inpatient visits per patient

    Time frame: Upto 6 month post index period

  6. Length of hospital stay (days) among those with an inpatient visit

    Time frame: Upto 6 month post index period

  7. Number of outpatient visits per patient

    Time frame: Upto 6 month post index period

  8. Number of emergency room (ER) visits per patient

    Time frame: Upto 6 month post index period

  9. Number of physician office visits per patient

    Time frame: Upto 6 month post index period

  10. Number of medication prescriptions per patient

    Time frame: Upto 6 month post index period

  11. Number of patients by provider type

    Time frame: Upto 6 month post index period

  12. Number of claims per patient

    Time frame: Upto 6 month post index period

  13. Total costs of healthcare

    Time frame: Upto 6 month post index period

  14. Medical costs of healthcare

    Time frame: Upto 6 month post index period

  15. Pharmacy costs of healthcare

    Time frame: Upto 6 month post index period

  16. Per-patient-per-month (PPPM)) costs of healthcare

    Time frame: Upto 6 month post index period

  17. Mortality rate

    Time frame: Up to 6 months

Secondary outcomes

  1. Opioid/analgesic use among lines of therapy(Y/N)

    Time frame: Up to 6 months

    Opioid and analgesics use among lines of therapy (e.g. 1st, 2nd, 3rd)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients With Prostate Cancer With Bone Metastases: A Retrospective Database Analysis .

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2016
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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