A Drug Utilization Study of Radium-223 in Sweden

NCT02331303 | Completed

• 1 other identifier: 17399
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (6)

• 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

• 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

Study Arms (1)

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)

Interventions

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.

Group1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients receiving Xofigo in a clinical trial will not be included in this study

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Stockholm, Sweden

Location

MeSH Terms

Conditions

Neoplasms

Interventions

radium Ra 223 dichloride

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2015
• First Posted: January 6, 2015
• Study Start: April 15, 2015
• Primary Completion: December 19, 2017
• Study Completion: December 19, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

SE (1)