A Drug Utilization Study of Radium-223 in Sweden

January 22, 2018 updated by: Bayer

A Drug Utilization Study of Xofigo Use in Sweden

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will include patients receiving treatment of Xofigo at certified nuclear medicine centers across Sweden during a two year period. It will consist of mCRPC patients and potentially some other patient groups in whom Xofigo may be used off-label including women, children, cancer patients having bone metastasis with a diagnosis other than CRPC, and patients with repeated courses of treatment or in excess of those recommended in the label. This study will be based on data extracted from two pre-established data sources: 15 nuclear medicine centers across Sweden and the Swedish National Cancer Registry.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group1

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.
Other: Radium-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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2015

Primary Completion (Actual)

December 19, 2017

Study Completion (Actual)

December 19, 2017

Study Registration Dates

First Submitted

January 2, 2015

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17399 (City of Hope Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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