A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223 (BELFIGO)

May 19, 2020 updated by: Bayer
The aim of this non interventional study is to describe the proportion of Belgian mCRPC patients which were treated with 1 to 4 and 5 to 6 Radium-223 injections and the patient characteristics which are potentially associated with this proportion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

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

  • Belgium
      • Multiple Locations, Belgium
        • Many 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Belgian patients who were treated with Radium-223 for (metastatic) Castration Resistant Prostate Cancer

Description

Inclusion Criteria:

  • Patients with a diagnosis of castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases
  • All consecutive patients who started Radium-223 treatment between 22 December 2014 and 01 June 2017
  • Availability of medical records during the observation period (22DEC2013 - 01JUN2018)

Exclusion Criteria:

  • Patients treated with Radium-223 for any reason before 22 December 2014 (for example an interventional trial)
  • Patients participated in an investigational program with interventions outside of routine clinical practice during the radium-223 treatment period
  • Patients received other radiopharmaceuticals for the systemic concomitant use for treatment of prostate cancer or for other use during the Radium-223 treatment period

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Radium-223 (Xofigo, Bay88-8223)
Belgium patients with a diagnosis of mCRPC (no known visceral metastases) and who were treated with Radium-223 for this indication
Drug: Radium-223 (Xofigo, Bay88-8223)
Follow the physician's prescription in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections by Radium-223 line of treatment (1st, 2nd and further line)
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of prior and post life prolonging systemic anti-cancer therapies will be described
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018
The characteristics of patients according to the experience of the study centers with Radium-223
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
By stratification according to the number of months after the very first index date per center
Retrospectively analysis from 22 December 2013 to 01 June 2018
The occurrence of progression post first dose of Radium-223
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018
The occurrence of SSE related hospitalizations
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
SSE: Symptomatic Skeletal Events
Retrospectively analysis from 22 December 2013 to 01 June 2018
The frequency of SSE related hospitalizations
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of discontinuation of Radium-223
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018
The frequency of blood transfusions
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018
The overall survival in routine clinical practice
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of patients receiving first- and second-line systemic anti-cancer treatment in mCRPC
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018
The timing of progression post first dose of Radium-223
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018
The time between last Radium-223 injection and next line of systemic anti-cancer therapy
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018
The number of patients receiving next line of systemic anti-cancer therapy
Time Frame: Retrospectively analysis from 22 December 2013 to 01 June 2018
Retrospectively analysis from 22 December 2013 to 01 June 2018

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20239

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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