check_circleStudy Completed
Prostate Cancer
Bayer Identifier:
18273
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Treatment Patterns in Castrate Resistant Prostate Cancer Patients with Bone Metastases in a Medicare Population
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.
Key Participants Requirements
Sex
MaleAge
55 - 88 YearsTrial summary
Enrollment Goal
1163Trial Dates
August 2015 - September 2017Phase
N/ACould I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Louisville, United States |
Primary Outcome
- Overall survival of mCRPC patientsmCRPC: Metastatic castrate-resistant prostate cancerdate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of skeletal related events (SREs) of the mCRPC patientsdate_rangeTime Frame:Up to 30 monthsenhanced_encryptionNoSafety Issue:
- Type of skeletal related events (SREs) of the mCRPC patientsdate_rangeTime Frame:Up to 30 months
- Number of patients with mCRPC with bone metastasesdate_rangeTime Frame:Up to 24 months
- Type of treatments associated with mCRPCTreatments could include chemotherapy or bone radiationdate_rangeTime Frame:Up to 24 months
- Duration for each treatment identifieddate_rangeTime Frame: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)date_rangeTime Frame: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 usedate_rangeTime Frame:Up to 12 months
- Treatment patterns of mCRPC patients with bone metastasesdate_rangeTime Frame:Up to 30 months
- Progression of the disease of mCRPC patientsdate_rangeTime Frame: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 claimsdate_rangeTime Frame: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 claimsdate_rangeTime Frame: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)date_rangeTime Frame: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.date_rangeTime Frame:Up to 30 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A