Trial Condition(s):
Prostatic Neoplasm
Treatment Patterns in Metastatic Prostate Cancer
Bayer Identifier:
18695
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Whippany, United States | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients with Prostate Cancer with Bone Metastases: A Retrospective Database Analysis .
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Distribution of treatment types among lines of therapyPossible Treatment Types: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapyTimeframe: Up to 6 months
- Time to treatment (days)Timeframe: Up to 6 months
- Duration of treatment (days)Timeframe: Up to 6 months
- Number of patients on each drug or drug combinationDrug: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapyTimeframe: Up to 6 months
- Number of inpatient visits per patientTimeframe: Upto 6 month post index period
- Length of hospital stay (days) among those with an inpatient visitTimeframe: Upto 6 month post index period
- Number of outpatient visits per patientTimeframe: Upto 6 month post index period
- Number of emergency room (ER) visits per patientTimeframe: Upto 6 month post index period
- Number of physician office visits per patientTimeframe: Upto 6 month post index period
- Number of medication prescriptions per patientTimeframe: Upto 6 month post index period
- Number of patients by provider typeTimeframe: Upto 6 month post index period
- Number of claims per patientTimeframe: Upto 6 month post index period
- Total costs of healthcareTimeframe: Upto 6 month post index period
- Medical costs of healthcareTimeframe: Upto 6 month post index period
- Pharmacy costs of healthcareTimeframe: Upto 6 month post index period
- Per-patient-per-month (PPPM)) costs of healthcareTimeframe: Upto 6 month post index period
- Mortality rateTimeframe: Up to 6 months
Secondary Outcome
- Opioid/analgesic use among lines of therapy(Y/N)Opioid and analgesics use among lines of therapy (e.g. 1st, 2nd, 3rd)Timeframe: Up to 6 months
Additional Information
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