Clinical trial · Observational
Incidence of Second Primary Malignancies in Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US
Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Not applicable for study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Medicare CRPC
- description
- Men in the US older than 65 years old having CRPC
- interventionNames
- Other: Not applicable for study
Primary outcomes (2)
- measure
- Incidence rate of second primary malignancy
- timeFrame
- Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
- measure
- Incidence rates of skeletal-related events
- timeFrame
- Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Secondary outcomes (3)
- measure
- Proportion with a history of bone metastasis at cohort entry
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 65 Years
Show eligibility criteria text
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.References
Publications (0)
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