Neoplasms
Conditions
Brief summary
The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden.
Interventions
OTHERRadium-223 dichloride (Xofigo, BAY88-8223)
Xofigo was approved in the US and EU for the following indication: Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Xofigo is contraindicated in women who are or may become pregnant.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients receiving Xofigo with data recorded at nuclear medicine centers in Sweden between 01 July 2014 and 30 June 2016 will be included in the study
Exclusion criteria
* Patients receiving Xofigo in a clinical trial will not be included in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV | Up to 2 years |
| Dosage of Xofigo (kBq/kg) | Up to 2 years |
| Proportion of participants of dose outside label recommendation | Up to 2 years |
| Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use | Up to 2 years |
| Proportion of being women of Xofigo use | Up to 2 years |
| Proportion of being children of Xofigo use | Up to 2 years |
Countries
Sweden
Outcome results
None listed