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Completed

NCT Number: NCT02518698

Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases in a Medicare Population

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.

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Key information

Conditions

Prostate Cancer 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

55 year–88 year

Sex eligibility

Male

Study type

Observational

Primary location

Louisville, Kentucky, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Radium-223 dichloride (Xofigo, BAY88-8223)

Drug

Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223)

Primary outcomes

  1. Overall survival of mCRPC patients

    Time frame: Up to 24 months

    mCRPC: Metastatic castrate-resistant prostate cancer

  2. Number of skeletal related events (SREs) of the mCRPC patients

    Time frame: Up to 30 months

  3. Type of skeletal related events (SREs) of the mCRPC patients

    Time frame: Up to 30 months

  4. Number of patients with mCRPC with bone metastases

    Time frame: Up to 24 months

  5. Type of treatments associated with mCRPC

    Time frame: Up to 24 months

    Treatments could include chemotherapy or bone radiation

  6. Duration for each treatment identified

    Time frame: Up to 30 months

  7. Distribution of providers by treatment

    Time frame: Up to 30 months

    Distribution of treatments for mCRPC patients will be tracked by the type of provider (oncologist, versus urologist, versus radiation oncologist, etc)

  8. Clinical and demographic characteristics of the mCRPC patients

    Time frame: Up to 12 months

    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

  9. Treatment patterns of mCRPC patients with bone metastases

    Time frame: Up to 30 months

  10. Progression of the disease of mCRPC patients

    Time frame: Up to 12 months

Secondary outcomes

  1. All-cause healthcare resource utilization for mCRPC patients

    Time frame: Up to 30 months

    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

  2. mCRPC-specific healthcare resource utilization for mCRPC patients

    Time frame: Up to 30 months

    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

  3. All-cause healthcare costs for mCRPC patients

    Time frame: Up to 30 months

    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)

  4. mCRPC-specific healthcare costs for mCRPC patients

    Time frame: Up to 30 months

    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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 10, 2015
Registry last updated
Sep 18, 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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