Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Background incidence study

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Prostate cancer
Population studied

Short description of the study population

Men aged 65 and older in the US enrolled in Medicare with castrate resistant prostate cancer identified after January 1, 2006.

The study cohort included men who meet all of the following 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] 1 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 on the cohort entry date

Age groups

Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Prostate cancer patients

Estimated number of subjects

15750
Study design details

Main study objective

Incidence of second primary malignancies in patients with castration resistent prostate cancer

Outcomes

Estimation of the collective incidence rate of all second primary malignancies (other than nonmelanoma skin cancer) among men with CRPC (Castration-Resistant Prostate Cancer) &Estimation of the individual incidence rates of selected second primary malignancies, Estimation of the proportion of men with CRPC who have a diagnostic code for bone metastases in their Medicare claims before development of CRPCEstimation of the proportion of men with CRPC who received bone-directed therapies before development of CRPCEstimation of the proportion of men with CRPC + Medicare Part D coverage who received only oral androgen deprivation therapyOverall survival

Data analysis plan

Characteristics of study subjects will be described. The incidence of second primary malignancies will be calculated. Overall survival will be described.
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