NCT02788409

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,234 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
OTHER	Not applicable for study	Provide external perspective on background second primary cancer incidence rates for REASSURE study.

Timeline

• Start date: 2016-05-15
• Primary completion: 2018-05-09
• Completion: 2018-05-09
• First posted: 2016-06-02
• Last updated: 2019-05-08

Locations

1 site across 1 country: United States