NCT03563014

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 24, 2018

Last Update Submit

May 19, 2020

Conditions

Prostatic Neoplasms, Castration-Resistant

Keywords

Radium-223Metastatic castration-resistant prostate cancerCRPCPhase IV

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections

    Retrospectively analysis from 22 December 2013 to 01 June 2018

Secondary Outcomes (13)

  • 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)

    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

    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

    Retrospectively analysis from 22 December 2013 to 01 June 2018

  • The occurrence of progression post first dose of Radium-223

    Retrospectively analysis from 22 December 2013 to 01 June 2018

  • The occurrence of SSE related hospitalizations

    Retrospectively analysis from 22 December 2013 to 01 June 2018

  • +8 more secondary outcomes

Study Arms (1)

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)

Interventions

Radium-223 (Xofigo, Bay88-8223)DRUG

Follow the physician's prescription in routine clinical practice.

Radium-223 (Xofigo, Bay88-8223)

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many Locations

Multiple Locations, Belgium

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

Radium-223radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Prostatic NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 20, 2018

Study Start

July 31, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

May 20, 2020

Record last verified: 2020-05

Locations

BE(1)