Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases in a Medicare Population
- Registration Number
- NCT02518698
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1163
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 / Treatment patterns Radium-223 dichloride (Xofigo, BAY88-8223) Patients with castrated resistant prostate cancer and bone metastases
- Primary Outcome Measures
Name Time Method Overall survival of mCRPC patients Up to 24 months mCRPC: Metastatic castrate-resistant prostate cancer
Number of skeletal related events (SREs) of the mCRPC patients Up to 30 months Duration for each treatment identified Up to 30 months Clinical and demographic characteristics of the mCRPC patients 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
Type of skeletal related events (SREs) of the mCRPC patients Up to 30 months Number of patients with mCRPC with bone metastases Up to 24 months Type of treatments associated with mCRPC Up to 24 months Treatments could include chemotherapy or bone radiation
Distribution of providers by treatment 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)
Treatment patterns of mCRPC patients with bone metastases Up to 30 months Progression of the disease of mCRPC patients Up to 12 months
- Secondary Outcome Measures
Name Time Method All-cause healthcare resource utilization for mCRPC patients 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
All-cause healthcare costs for mCRPC patients 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)
mCRPC-specific healthcare costs for mCRPC patients 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.
mCRPC-specific healthcare resource utilization for mCRPC patients 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