Study to Gather Information About the Use of Healthcare Services and the Way the Disease is Cared for in Canadian Patients With Prostate Gland Cancer Which Spread Throughout the Body

NCT ID: NCT04281147

Last Updated: 2022-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4301 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-24

Study Completion Date

2021-06-22

Brief Summary

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Study to gather information about the optimal placement of Ra-223 in the order of different treatments in terms of the effect on patients and in terms of the use of healthcare services for the treatment of Canadian patients with prostate gland cancer which spread to other parts of the body. In order to collect this information real world data from prostate gland cancer patients from four Canadian administrative databases will be analyzed.

Data collected from patients treated with their 2nd line of life-prolonging therapy for Non-Metastatic Castration Resistant Prostate Cancer (mCRPC) initiated from 01 Jan 2012 to 31 Dec 2017. For patients included in the study, all available data from the beginning for their record until death, lost to follow-up or database cut-off will be included. The index date is the date of initiation of the 2nd line life-prolonging therapy for mCRPC.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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No Ra-223 received

Patients did not receive Ra-223

No interventions assigned to this group

Early Ra-223 (2nd line)

Patients received Ra-223 in 2nd line

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Type DRUG

Follow clinical administration

Late Ra-223 (3rd or later lines)

Patients received Ra-223 in 3rd or later lines

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Type DRUG

Follow clinical administration

Interventions

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Radium-223 dichloride (Xofigo, BAY88-8223)

Follow clinical administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Use of at least 2 lines of life-prolonging mCRPC therapy
* The 2nd line of life-prolonging therapy was initiated between 01-Jan-2012 to 31-Dec-2017
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Multiple Locations

Multiple Locations, , Canada

Site Status

Countries

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Canada

Other Identifiers

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20949

Identifier Type: -

Identifier Source: org_study_id

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