Prostatic Neoplasms Clinical Trial
Official title:
Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US
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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