Clinical trial NCT02729103: Treatment Patterns in Metastatic Prostate Cancer
Official title: Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients With Prostate Cancer With Bone Metastases: A Retrospective Database Analysis .
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasm
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 565
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Part 1 - Assessment of treatment patterns, healthcare resource utilization, and costs The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.

Part 2 - Assessment of mortality The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Distribution of treatment types among lines of therapy
timeFrame: Up to 6 months
measure: Time to treatment (days)
timeFrame: Up to 6 months
measure: Duration of treatment (days)
timeFrame: Up to 6 months
measure: Number of patients on each drug or drug combination
timeFrame: Up to 6 months
measure: Number of inpatient visits per patient
timeFrame: Upto 6 month post index period
measure: Length of hospital stay (days) among those with an inpatient visit
timeFrame: Upto 6 month post index period
measure: Number of outpatient visits per patient
timeFrame: Upto 6 month post index period
measure: Number of emergency room (ER) visits per patient
timeFrame: Upto 6 month post index period
measure: Number of physician office visits per patient
timeFrame: Upto 6 month post index period
measure: Number of medication prescriptions per patient
timeFrame: Upto 6 month post index period
measure: Number of patients by provider type
timeFrame: Upto 6 month post index period
measure: Number of claims per patient
timeFrame: Upto 6 month post index period
measure: Total costs of healthcare
timeFrame: Upto 6 month post index period
measure: Medical costs of healthcare
timeFrame: Upto 6 month post index period
measure: Pharmacy costs of healthcare
timeFrame: Upto 6 month post index period
measure: Per-patient-per-month (PPPM)) costs of healthcare
timeFrame: Upto 6 month post index period
measure: Mortality rate
timeFrame: Up to 6 months
Secondary outcomes:
measure: Opioid/analgesic use among lines of therapy(Y/N)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Whippany
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: