An observational study in Prostatic Neoplasms, sponsored by Bayer. Completed at 1 site in United States. Open to male participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2019-05-08.
Sponsored by Bayer · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 2,234 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
Men in the US older than 65 years old having CRPC
Other: Not applicable for study
Provide external perspective on background second primary cancer incidence rates for REASSURE study.
Incidence rate of second primary malignancy
Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Incidence rates of skeletal-related events
Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Proportion with a history of bone metastasis at cohort entry
Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Proportion who met the definition of castration based solely on Part D data
Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Overall survival
Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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