check_circleStudy Completed

Prostatic neoplasms

Bayer Identifier:

18673

ClinicalTrials.gov Identifier:

NCT02788409

EudraCT Number:

Not Available

EU CT Number:

Not Available
Incidence of Second Primary Malignancies in Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US

Trial purpose

This study is conducted to estimate population-based incidence rates of second primary malignancies among patients with CRPC similar to those treated with Xofigo. These rates will provide context for second primary malignancy incidence rates from the REASSURE study.
Furthermore this study aims to provide further information about the documentation of bone metastases in Medicare data and the extent of use of only oral androgen deprivation drugs among patients with Medicare Part D coverage, as well as to estimate overall survival of the study population.

Key Participants Requirements

Sex

Male

Age

65 - N/A
  • - Enrolled in both Medicare Parts A and B for at least 1 year before the cohort entry date (minimum lookback period for comorbidities and treatments)
    - Primary site code of prostate cancer (International Classification of Diseases for Oncology, Third Edition [ICD-O-3] topography code C61.9) in SEER data
    - Surgical castration or androgen deprivation therapy after prostate cancer diagnosis; androgen deprivation therapy will be indicated by the use of any of the following drugs: abarelix, bicalutamide, buserelin, cyproterone, degarelix, diethylstilbestrol, estramustine, flutamide, gonadorelin, goserelin, histrelin, leuprolide, medroxyprogesterone, megestrol, nafarelin, nilutamide, polyestradiol, triptorelin
    - Evidence that prostate cancer was resistant to surgical castration or androgen deprivation therapy (“castration-resistant prostate cancer”), as indicated by starting one of the following second-line systemic therapies (cohort entry date): abiraterone, cabazitaxel, docetaxel, enzalutamide, mitoxantrone, or sipuleucel-T
    - Cohort entry date 01 January 2006 or later
    - Age 65 years or older in the US on the cohort entry date
  • - Enrollment in an HMO (Health Maintenance Organization) in the year before the cohort entry date
    - Diagnosis of any cancer other than prostate cancer or nonmelanoma skin cancer on or before the cohort entry date
    - Any diagnostic code for metastases other than bone metastases or lymph node metastases on or before the cohort entry date
    - Any claim for treatment with Xofigo on or before the cohort entry date.

Trial summary

Enrollment Goal
2234
Trial Dates
May 2016 - May 2018
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Waltham, United States

Primary Outcome

  • Incidence rate of second primary malignancy
    date_rangeTime Frame:
    Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
    enhanced_encryption
    Safety Issue:
    No
  • Incidence rates of skeletal-related events
    date_rangeTime Frame:
    Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Proportion with a history of bone metastasis at cohort entry
    date_rangeTime Frame:
    Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
    enhanced_encryption
    Safety Issue:
    No
  • Proportion who met the definition of castration based solely on Part D data
    date_rangeTime Frame:
    Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival
    date_rangeTime Frame:
    Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
    enhanced_encryption
    Safety Issue:
    No

Trial design

Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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