Study 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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Products

Unspecified

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Waltham, United States

Primary Outcome

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

Secondary Outcome

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