Treatment Patterns in Metastatic Prostate Cancer

Prostatic Neoplasm Clinical Trial

Official title:

Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients With Prostate Cancer With Bone Metastases: A Retrospective Database Analysis .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729103
• Other study ID #: 18695
• Status: Completed
• Phase: N/A
• First received: March 16, 2016
• Last updated: January 24, 2018
• Start date: October 31, 2016
• Est. completion date: January 19, 2017

Study information

• Verified date: January 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 565
• Est. completion date: January 19, 2017
• Est. primary completion date: January 19, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Drug:
• Xofigo (Radium 223 dichloride,BAY88-8223)
Retrospective claims analysis. Descriptive analyses of treatment patterns.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of treatment types among lines of therapy	Possible Treatment Types: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy	Up to 6 months
Primary	Time to treatment (days)		Up to 6 months
Primary	Duration of treatment (days)		Up to 6 months
Primary	Number of patients on each drug or drug combination	Drug: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy	Up to 6 months
Primary	Number of inpatient visits per patient		Upto 6 month post index period
Primary	Length of hospital stay (days) among those with an inpatient visit		Upto 6 month post index period
Primary	Number of outpatient visits per patient		Upto 6 month post index period
Primary	Number of emergency room (ER) visits per patient		Upto 6 month post index period
Primary	Number of physician office visits per patient		Upto 6 month post index period
Primary	Number of medication prescriptions per patient		Upto 6 month post index period
Primary	Number of patients by provider type		Upto 6 month post index period
Primary	Number of claims per patient		Upto 6 month post index period
Primary	Total costs of healthcare		Upto 6 month post index period
Primary	Medical costs of healthcare		Upto 6 month post index period
Primary	Pharmacy costs of healthcare		Upto 6 month post index period
Primary	Per-patient-per-month (PPPM)) costs of healthcare		Upto 6 month post index period
Primary	Mortality rate		Up to 6 months
Secondary	Opioid/analgesic use among lines of therapy(Y/N)	Opioid and analgesics use among lines of therapy (e.g. 1st, 2nd, 3rd)	Up to 6 months

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