Trial Condition(s):
Prostate Cancer
Treatment Patterns in Castrate Resistant Prostate Cancer Patients with Bone Metastases in a Medicare Population
Bayer Identifier:
18273
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
1163
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Louisville, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Treatment Patterns in Castrate Resistant Prostate Cancer Patients with Bone Metastases
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Overall survival of mCRPC patientsmCRPC: Metastatic castrate-resistant prostate cancerTimeframe: Up to 24 months
- Number of skeletal related events (SREs) of the mCRPC patientsTimeframe: Up to 30 months
- Type of skeletal related events (SREs) of the mCRPC patientsTimeframe: Up to 30 months
- Number of patients with mCRPC with bone metastasesTimeframe: Up to 24 months
- Type of treatments associated with mCRPCTreatments could include chemotherapy or bone radiationTimeframe: Up to 24 months
- Duration for each treatment identifiedTimeframe: Up to 30 months
- Distribution of providers by treatmentDistribution of treatments for mCRPC patients will be tracked by the type of provider (oncologist, versus urologist, versus radiation oncologist, etc)Timeframe: Up to 30 months
- Clinical and demographic characteristics of the mCRPC patientsGender, 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 useTimeframe: Up to 12 months
- Treatment patterns of mCRPC patients with bone metastasesTimeframe: Up to 30 months
- Progression of the disease of mCRPC patientsTimeframe: Up to 12 months
Secondary Outcome
- All-cause healthcare resource utilization for mCRPC patientsUsing 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 claimsTimeframe: Up to 30 months
- mCRPC-specific healthcare resource utilization for mCRPC patientsHealthcare 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 claimsTimeframe: Up to 30 months
- All-cause healthcare costs for mCRPC patientsHealthcare 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)Timeframe: Up to 30 months
- mCRPC-specific healthcare costs for mCRPC patientsHealthcare 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.Timeframe: Up to 30 months
Additional Information
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