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OpenTrials
Completed

NCT Number: NCT02331303

A Drug Utilization Study of Radium-223 in Sweden

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

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Key information

Conditions

Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radium-223 dichloride (Xofigo, BAY88-8223)

Other

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

  1. Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use

    Time frame: Up to 2 years

  2. Proportion of being women of Xofigo use

    Time frame: Up to 2 years

  3. Proportion of being children of Xofigo use

    Time frame: Up to 2 years

  4. Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV

    Time frame: Up to 2 years

  5. Dosage of Xofigo (kBq/kg)

    Time frame: Up to 2 years

  6. Proportion of participants of dose outside label recommendation

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Drug Utilization Study of Xofigo Use in Sweden

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2015
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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