Trial Condition(s):
Prostatic Neoplasms, Castration-Resistant
Healthcare costs of mCRPC in university hospitals in Japan
Bayer Identifier:
18530
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The study was a local, retrospective, observational, single-cohort study based on secondary data and was conducted to determine the healthcare costs in metastatic castration resistant prostate cancer (mCRPC) in national university hospitals in Japan.
Inclusion Criteria
- Patients who have been coded as having “Malignant neoplasm of prostate" (ICD-10, C61) at least once - Of the above patients those with at least one confirmed bone metastases site coded as “Secondary malignant neoplasm of other and unspecified sites" (ICD-10, C79) - Of the above patients those who have been coded as having “Bone metastatic prostate cancer" (ICD-10, C795) and received Androgen Deprivation Therapy (ADT) at least once since diagnosis or CRPC treatment (Abiraterone acetate, Enzalutamide, Docetaxel, Cabazitaxel) at least once since diagnosis. - Patients who have been coded as having “Castration-resistant prostate cancer” (ICD-10, C61 and Japanese 8848040)
Exclusion Criteria
- Patients who have been observed less than 6 months
Trial Summary
Enrollment Goal
4001
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No
Where to Participate
Locations
| Locations |
|---|
Trial Design
Healthcare costs of metastases castration resistant prostate cancer (mCRPC) in national university hospitals in Japan
Trial Type:
Observational
Intervention Type:
N/A
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Mean and median medical costs per month for mCRPC patients, including the breakdown of the medical costsTimeframe: Up to 1 year
- Healthcare resource use (hospital ward/ intensive care unit/ inpatient visit) per year as a consequence of mCRPC diagnosisTimeframe: Up to 1 year
- Diagnostic patterns before and after mCRPC diagnosisIncludes imaging or laboratory examinationsTimeframe: Up to 1 year
- Skeletal related events (SREs) frequency, rate, and treatment patterns.Timeframe: Up to 1 year
Secondary Outcome
- Correlation between frequency of skeletal related events and medical costs per monthTimeframe: Up to 1 year
- Correlation between frequency of skeletal related events and medication typeTimeframe: Up to 1 year
- Correlation between patient disease status and treatment patternsTimeframe: Up to 1 year
- Correlation between patient disease status and medical costs per monthTimeframe: Up to 1 year
Additional Information
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