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| Name | Class |
|---|---|
| RTI Health Solutions | OTHER |
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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.
Xofigo (radium-223 dichloride) is an alpha-emitting pharmaceutical, which was approved for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The long-term safety profile of Xofigo is evaluated in the prospective REASSURE study, which estimates the incidence rates of second primary malignancies in patients with CRPC receiving Xofigo.
To provide context on that, this retrospective study is conducted to estimate background rates of second primary malignancies among patients with CRPC similar to those who are treated with Xofigo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medicare CRPC | Men in the US older than 65 years old having CRPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable for study | Other | Provide external perspective on background second primary cancer incidence rates for REASSURE study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of second primary malignancy | Retrospective analysis between 1-Jan-2000 and 31-Dec-2013 | |
| Incidence rates of skeletal-related events | Retrospective analysis between 1-Jan-2000 and 31-Dec-2013 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion with a history of bone metastasis at cohort entry | Retrospective analysis between 1-Jan-2000 and 31-Dec-2013 | |
| Proportion who met the definition of castration based solely on Part D data | Retrospective analysis between 1-Jan-2000 and 31-Dec-2013 |
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Inclusion Criteria:
Exclusion Criteria:
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The cohort will include men who are enrolled in both Medicare Parts A and B for at least 1 year before the cohort entry date, have a primary site code of prostate cancer in SEER data, have surgical castration or androgen deprivation therapy after prostate cancer diagnosis, have evidence that prostate cancer was resistant to the castration as indicated by starting a second-line systemic therapy, and have an cohort entry date of 01 January 2006 or later on which they are aged 65 years or older. All eligible subjects will be selected; there will be no sampling. (The probability of selecting each eligible patient is equal to 1)
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Waltham | Massachusetts | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Overall survival | Retrospective analysis between 1-Jan-2000 and 31-Dec-2013 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |