check_circleStudy Completed

Prostatic Neoplasm

Bayer Identifier:

18695

ClinicalTrials.gov Identifier:

NCT02729103

EudraCT Number:

Not Available

EU CT Number:

Not Available
Treatment Patterns in Metastatic Prostate Cancer

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.

Key Participants Requirements

Sex

Male

Age

45 - N/A
  • - 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.
  • -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
565
Trial Dates
October 2016 - January 2017
Phase
N/A
Could I Receive a placebo
No
Products
N/A
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Whippany, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to treatment (days)
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Duration of treatment (days)
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of inpatient visits per patient
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Length of hospital stay (days) among those with an inpatient visit
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Number of outpatient visits per patient
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Number of emergency room (ER) visits per patient
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Number of physician office visits per patient
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Number of medication prescriptions per patient
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients by provider type
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Number of claims per patient
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Total costs of healthcare
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Medical costs of healthcare
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacy costs of healthcare
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Per-patient-per-month (PPPM)) costs of healthcare
    date_rangeTime Frame:
    Upto 6 month post index period
    enhanced_encryption
    Safety Issue:
    No
  • Mortality rate
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Opioid/analgesic use among lines of therapy(Y/N)
    Opioid and analgesics use among lines of therapy (e.g. 1st, 2nd, 3rd)
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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