Treatment Patterns in Metastatic Prostate Cancer

Completed

Conditions studied: Prostatic Neoplasm

In brief

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.

Key facts

Study ID

NCT02729103

Run by

Bayer

People needed

565

Starts

2016-10-31

Expected to finish

2017-01-19

Last updated by the study team

2018-01-25

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Whippany, New Jersey, United States

Full record on ClinicalTrials.gov

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