Overview

Treatment Patterns in Metastatic Prostate Cancer

Status:
Completed
Trial end date:
2017-01-19
Target enrollment:
0
Participant gender:
Male
Summary
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Radium Ra 223 dichloride
Criteria
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.