check_circleStudy Completed

Prostatic Neoplasms, Castration-Resistant

Bayer Identifier:

18530

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Healthcare costs of mCRPC in university hospitals in Japan

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.

Key Participants Requirements

Sex

Male

Age

20 - N/A
  • - 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)
  • - Patients who have been observed less than 6 months

Trial summary

Enrollment Goal
4001
Trial Dates
December 2015 - May 2016
Phase
Phase 4
Could I Receive a placebo
N/A
Products
Unspecified
Accepts Healthy Volunteer
No

Primary Outcome

  • Mean and median medical costs per month for mCRPC patients, including the breakdown of the medical costs
    date_rangeTime Frame:
    Up to 1 year
  • Healthcare resource use (hospital ward/ intensive care unit/ inpatient visit) per year as a consequence of mCRPC diagnosis
    date_rangeTime Frame:
    Up to 1 year
  • Diagnostic patterns before and after mCRPC diagnosis
    Includes imaging or laboratory examinations
    date_rangeTime Frame:
    Up to 1 year
  • Skeletal related events (SREs) frequency, rate, and treatment patterns.
    date_rangeTime Frame:
    Up to 1 year

Secondary Outcome

  • Correlation between frequency of skeletal related events and medical costs per month
    date_rangeTime Frame:
    Up to 1 year
  • Correlation between frequency of skeletal related events and medication type
    date_rangeTime Frame:
    Up to 1 year
  • Correlation between patient disease status and treatment patterns
    date_rangeTime Frame:
    Up to 1 year
  • Correlation between patient disease status and medical costs per month
    date_rangeTime Frame:
    Up to 1 year

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
N/A

Additional Information

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