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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 / Treatment patterns | Patients with castrated resistant prostate cancer and bone metastases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Castrated resistant prostate cancer patients with bone metastases
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisville | Kentucky | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
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| Treatment patterns of mCRPC patients with bone metastases | Up to 30 months |
| Progression of the disease of mCRPC patients | Up to 12 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 |
| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |