Trial Condition(s):

Prostatic Neoplasm

Treatment Patterns in Metastatic Prostate Cancer

Bayer Identifier:

18695

ClinicalTrials.gov Identifier:

NCT02729103

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study will evaluate treatment patterns, mortality, healthcare resource utilization, and costs in patients with prostate cancer with bone metastases (primary objectives). Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this patient population (secondary objective). The study is descriptive in nature and is meant to provide a greater understanding of the patterns of therapy observed in real-world clinical practice (in the absence of clear guideline recommendations with regards to treatment sequencing), to contribute to a greater understanding of the major cost drivers (thus better-informing payers), and to examine real-world mortality in such patients.

Inclusion Criteria
- Subjects with at least one claim with a primary diagnosis of prostate cancer (International Classification of Diseases(ICD) Clinical Modification (CM)185.xx )and any of the below on same day or after the prostate cancer claim:
-- At least one inpatient claim with a primary or secondary diagnosis indicating bone metastases  (ICD 9 CM 198.5 or Healthcare Common Procedure Coding System (HCPCS) code for a treatment indicative of bone metastases  
OR
--At least two outpatient claims with a primary or secondary diagnosis indicating bone metastases  (ICD 9 CM 198.5 or HCPCS code for a treatment indicative of bone metastases, with a minimum  of 30 days between claims.
Exclusion Criteria
-Subjects with a diagnosis of a cancer other than prostate cancer – defined as the presence of one inpatient or two outpatient claims with a primary or secondary diagnosis of malignant neoplasms (ICD-9-CM 140.xx-171.xx, 174.xx-184.xx,186.xx-195.xx,200.xx-209.3x, 230.xx-239.xx) – in the 12-month pre-index period.
- Subjects with any claim for a primary or secondary diagnosis indicating bone metastases (ICD-9-CM 198.5) or any treatment indicative of bone metastases in the 12-month pre-index period.
- Patients who had a SRE  in the 12-month pre-index period.
- Subjects without continuous enrollment for at least 12 months before the index date.
- Subjects without continuous eligibility for at least 6 months after the index date.
- Subjects that are female.
- Subjects that have negative costs.
- Subjects that are less than 45 years of age on the index date.

Trial Summary

Enrollment Goal
565
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
N/A
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Whippany, United States

Status
Completed
 

Trial Design