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

Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

• Study Type: Observational
• Enrollment (Actual): 1163

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Castrated resistant prostate cancer patients with bone metastases

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 / Treatment patterns; Patients with castrated resistant prostate cancer and bone metastases	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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2015
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 10, 2015

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Castrated resistant prostate cancer; Patients with bone metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplastic Processes; Prostatic Neoplasms; Neoplasm Metastasis; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 18273