Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases in a Medicare Population

Prostate Cancer Clinical Trial

Official title:

Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518698
• Other study ID #: 18273
• Status: Completed
• Start date: August 31, 2015
• Est. completion date: September 30, 2017

Study information

• Verified date: September 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1163
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY88-8223)
Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival of mCRPC patients	mCRPC: Metastatic castrate-resistant prostate cancer	Up to 24 months
Primary	Number of skeletal related events (SREs) of the mCRPC patients		Up to 30 months
Primary	Type of skeletal related events (SREs) of the mCRPC patients		Up to 30 months
Primary	Number of patients with mCRPC with bone metastases		Up to 24 months
Primary	Type of treatments associated with mCRPC	Treatments could include chemotherapy or bone radiation	Up to 24 months
Primary	Duration for each treatment identified		Up to 30 months
Primary	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)	Up to 30 months
Primary	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	Up to 12 months
Primary	Treatment patterns of mCRPC patients with bone metastases		Up to 30 months
Primary	Progression of the disease of mCRPC patients		Up to 12 months
Secondary	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	Up to 30 months
Secondary	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	Up to 30 months
Secondary	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)	Up to 30 months
Secondary	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.	Up to 30 months

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