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

NCT04281147 | Completed

• 1 other identifier: 20949
• Study Type: observational
• Target: 4,301
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Metastatic castrate resistant prostate cancer mCRPC

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The length of time from the date of initiation of 2nd line life-prolonging therapy to death due to any cause

  Retrospective analysis from 01-Jan-2012 to 31-Dec-2017

Secondary Outcomes (8)

• Event-free survival (EFS)

  Retrospective analysis from 01-Jan-2012 to 31-Dec-2017

• Time to External Beam Radiation Therapy (EBRT)

  Retrospective analysis from 01-Jan-2012 to 31-Dec-2017

• Total incidence of EBRT

  Retrospective analysis from 01-Jan-2012 to 31-Dec-2017

• Time to first hospitalization

  Retrospective analysis from 01-Jan-2012 to 31-Dec-2017

• Number of overnight hospital stays

  Retrospective analysis from 01-Jan-2012 to 31-Dec-2017

Study Arms (3)

No Ra-223 received

Patients did not receive Ra-223

Early Ra-223 (2nd line)

Patients received Ra-223 in 2nd line

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Late Ra-223 (3rd or later lines)

Patients received Ra-223 in 3rd or later lines

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223) DRUG

Follow clinical administration

Early Ra-223 (2nd line); Late Ra-223 (3rd or later lines)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with mCRPC and at least 2 lines of life-prolonging therapy initiated between 01 Jan 2012 to 31 Dec 2017. No formal exclusion criteria will be applied in order to capture real world use of Ra-223.

You may qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Multiple Locations

Multiple Locations, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: February 24, 2020
• Primary Completion: June 22, 2021
• Study Completion: June 22, 2021
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)