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

Study Overview
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Brief Summary
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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.

Official Title
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Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Radium-223 dichloride (Xofigo, BAY88-8223)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 / Treatment patterns<br>Patients with castrated resistant prostate cancer and bone metastases | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival of mCRPC patients | mCRPC: Metastatic castrate-resistant prostate cancer | Up to 24 months | 
| Number of skeletal related events (SREs) of the mCRPC patients |  | Up to 30 months | 
| 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 | Treatments could include chemotherapy or bone radiation | Up to 24 months | 
| Duration for each treatment identified |  | Up to 30 months | 
| Distribution of providers by treatment | Distribution of treatments for mCRPC patients will be tracked by the type of provider (oncologist, versus urologist, versus radiation oncologist, etc) | Up to 30 months | 
| Clinical and demographic characteristics of the mCRPC patients | 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 | Up to 12 months | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause healthcare resource utilization for mCRPC patients | 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 | Up to 30 months | 
| mCRPC-specific healthcare resource utilization for mCRPC patients | 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 | Up to 30 months | 
| All-cause healthcare costs for mCRPC patients | 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) | Up to 30 months | 
| mCRPC-specific healthcare costs for mCRPC patients | 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. | Up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Castrated resistant prostate cancer, Patients with bone metastases