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

NCT02518698 | Completed

• 1 other identifier: 18273
• Study Type: observational
• Target: 1,163
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Castrated resistant prostate cancer; Patients with bone metastases

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• All-cause healthcare resource utilization for mCRPC patients

  Up to 30 months

• mCRPC-specific healthcare resource utilization for mCRPC patients

  Up to 30 months

• All-cause healthcare costs for mCRPC patients

  Up to 30 months

• mCRPC-specific healthcare costs for mCRPC patients

  Up to 30 months

Study Arms (1)

Cohort 1 / Treatment patterns

Patients with castrated resistant prostate cancer and bone metastases

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223) DRUG

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

Cohort 1 / Treatment patterns

Eligibility Criteria

• Age: 55 Years - 88 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Castrated resistant prostate cancer patients with bone metastases

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Louisville, Kentucky, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 10, 2015
• Study Start: August 31, 2015
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

US (1)