This trial is active, not recruiting.

Condition neoplasms
Treatment radium - 223 (xofigo)
Sponsor Bayer
Start date April 2015
End date December 2017
Trial size 200 participants
Trial identifier NCT02331303, 17399


The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
This is a single-arm descriptive observational drug utilization study based on secondary data collection of patients treated with Xofigo in Sweden. This study will include patients receiving treatment of Xofigo at certified nuclear medicine centers across Sweden during a two year period.
radium - 223 (xofigo)
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.

Primary Outcomes

Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use
time frame: Up to 2 years
Proportion of being women of Xofigo use
time frame: Up to 2 years
Proportion of being children of Xofigo use
time frame: Up to 2 years
Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV
time frame: Up to 2 years
Dosage of Xofigo (kBq/kg)
time frame: Up to 2 years
Proportion of participants of dose outside label recommendation
time frame: Up to 2 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title A Drug Utilization Study of Xofigo Use in Sweden
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Bayer.