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

Prostate Cancer Clinical Trial

— REACTIVATE  

Official title:

Real World Evaluation of Access-driven Canadian Treatment Sequences in Progressive Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281147
• Other study ID #: 20949
• Status: Completed
• Start date: February 24, 2020
• Est. completion date: June 22, 2021

Study information

• Verified date: June 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4301
• Est. completion date: June 22, 2021
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Exclusion Criteria:

• No formal exclusion criteria will be applied in order to capture real world use of Ra-223

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY88-8223)
Follow clinical administration

Locations

Country	Name	City	State
Canada	Multiple Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Event-free survival (EFS)	The length of time from the start of 2nd line life-prolonging therapy to the earliest occurrence of one of the following: A change in life-prolonging treatment; Death from any cause	Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Secondary	Time to External Beam Radiation Therapy (EBRT)	From the start of the 1st life-prolonging therapy (index date) until the first use of EBRT	Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Secondary	Total incidence of EBRT	Total number of EBRT treatments received over the course of the patient's journey starting from the initiation of 2nd line life-prolonging therapy (index date) until death.	Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Secondary	Time to first hospitalization	Measured from the start of the 2nd line life-prolonging therapy (index date) until the first overnight hospital stay.	Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Secondary	Number of overnight hospital stays	Measured from the initiation of 2nd line life-prolonging therapy (index date) until death	Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Secondary	Average length of hospital stays (number of days)	Measured from the initiation of 2nd line life -prolonging therapy (index date) until death	Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Secondary	Time to first Emergency Room (ER) visit	Measured from the start of 2nd line life-prolonging therapy (index date) until the first ER visit.	Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Secondary	Number of visits to the ER	Measured from the initiation of 2nd line life-prolonging therapy (index date) until death	Retrospective analysis from 01-Jan-2012 to 31-Dec-2017