Treatment Patterns in Metastatic Prostate Cancer

NCT02729103 | Completed

• 1 other identifier: 18695
• Study Type: observational
• Target: 565
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (17)

• 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

• Time to treatment (days)

  Up to 6 months

• Duration of treatment (days)

  Up to 6 months

• 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

• Number of inpatient visits per patient

  Upto 6 month post index period

• Length of hospital stay (days) among those with an inpatient visit

  Upto 6 month post index period

• Number of outpatient visits per patient

  Upto 6 month post index period

• Number of emergency room (ER) visits per patient

  Upto 6 month post index period

• Number of physician office visits per patient

  Upto 6 month post index period

• Number of medication prescriptions per patient

  Upto 6 month post index period

• Number of patients by provider type

  Upto 6 month post index period

• Number of claims per patient

  Upto 6 month post index period

• Total costs of healthcare

  Upto 6 month post index period

• Medical costs of healthcare

  Upto 6 month post index period

• Pharmacy costs of healthcare

  Upto 6 month post index period

• Per-patient-per-month (PPPM)) costs of healthcare

  Upto 6 month post index period

• Mortality rate

  Up to 6 months

Secondary Outcomes (1)

• Opioid/analgesic use among lines of therapy(Y/N)

  Up to 6 months

Study Arms (2)

Treatment patterns, healthcare resource utilization and costs

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. All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no skeletal-related events (SREs) in the 12-month pre-index period. Additionally, all subjects must be continuously enrolled for at least 12 months before and at least 6 months after the index date.

Drug: Xofigo (Radium 223 dichloride,BAY88-8223)

Mortality

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. All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no SREs in the 12-month pre-index period. Additionally, all subjects must be continuously enrolled for at least 12 months before the index date. Unlike in Part 1, there will be no required minimum follow-up time after the index date (in order to assess mortality).

Drug: Xofigo (Radium 223 dichloride,BAY88-8223)

Interventions

Xofigo (Radium 223 dichloride,BAY88-8223) DRUG

Retrospective claims analysis. Descriptive analyses of treatment patterns.

Mortality; Treatment patterns, healthcare resource utilization and costs

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Whippany, New Jersey, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: April 6, 2016
• Study Start: October 31, 2016
• Primary Completion: January 19, 2017
• Study Completion: January 19, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

US (1)