Incidence of Second Primary Malignancies in Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US

Completed

Conditions studied: Prostatic Neoplasms

In brief

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 facts

Study ID

NCT02788409

Run by

Bayer

People needed

2234

Starts

2016-05-15

Expected to finish

2018-05-09

Last updated by the study team

2019-05-08

Who can join

Age: 65 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Waltham, Massachusetts, United States

Full record on ClinicalTrials.gov

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