A Local Retrospective Observational Study to Evaluate the... | NCT03563014

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

NCT03563014

Sponsor

Bayer

Status

Completed

Last Update Posted

May 20, 2020Actual

Enrollment

164Actual

Phase

Not provided

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

Radium-223 (Xofigo, Bay88-8223)

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2018Actual

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

May 24, 2018

First Submission Date that Met QC Criteria

Jun 19, 2018

First Posted Date

Jun 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2020

Last Update Posted Date

May 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

164Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Radium-223 (Xofigo, Bay88-8223)	Drug	Follow the physician's prescription in routine clinical practice.	Radium-223 (Xofigo, Bay88-8223)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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)		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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D064129	Prostatic Neoplasms, Castration-Resistant

Ancestor Terms

ID	Term
D011471	Prostatic Neoplasms
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000615150	Radium-223
C581106	radium Ra 223 dichloride

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided