check_circleStudy Completed

Prostate Cancer

Bayer Identifier:

18273

ClinicalTrials.gov Identifier:

NCT02518698

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

Male

Age

55 - 88 Years
  • - 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.
  • - 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
August 2015 - September 2017
Phase
N/A
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Louisville, United States

Primary Outcome

  • Overall survival of mCRPC patients
    mCRPC: Metastatic castrate-resistant prostate cancer
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of skeletal related events (SREs) of the mCRPC patients
    date_rangeTime Frame:
    Up to 30 months
    enhanced_encryption
    Safety Issue:
    No
  • Type of skeletal related events (SREs) of the mCRPC patients
    date_rangeTime Frame:
    Up to 30 months
  • Number of patients with mCRPC with bone metastases
    date_rangeTime Frame:
    Up to 24 months
  • Type of treatments associated with mCRPC
    Treatments could include chemotherapy or bone radiation
    date_rangeTime Frame:
    Up to 24 months
  • Duration for each treatment identified
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Up to 12 months
  • Treatment patterns of mCRPC patients with bone metastases
    date_rangeTime Frame:
    Up to 30 months
  • Progression of the disease of mCRPC patients
    date_rangeTime Frame:
    Up to 12 months

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Up to 30 months
  • mCRPC-specific healthcare resource utilization for mCRPC patients
    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
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Up to 30 months

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
N/A

Additional Information

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