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
- Registration Number
- NCT04281147
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 4301
- 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
- No formal exclusion criteria will be applied in order to capture real world use of Ra-223
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Early Ra-223 (2nd line) Radium-223 dichloride (Xofigo, BAY88-8223) Patients received Ra-223 in 2nd line Late Ra-223 (3rd or later lines) Radium-223 dichloride (Xofigo, BAY88-8223) Patients received Ra-223 in 3rd or later lines
- Primary Outcome Measures
Name Time Method Overall survival Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 The length of time from the date of initiation of 2nd line life-prolonging therapy to death due to any cause
- Secondary Outcome Measures
Name Time Method Time to first hospitalization Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 Measured from the start of the 2nd line life-prolonging therapy (index date) until the first overnight hospital stay.
Event-free survival (EFS) Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 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 causeTime to External Beam Radiation Therapy (EBRT) Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 From the start of the 1st life-prolonging therapy (index date) until the first use of EBRT
Total incidence of EBRT Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 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.
Number of overnight hospital stays Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 Measured from the initiation of 2nd line life-prolonging therapy (index date) until death
Average length of hospital stays (number of days) Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 Measured from the initiation of 2nd line life -prolonging therapy (index date) until death
Time to first Emergency Room (ER) visit Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 Measured from the start of 2nd line life-prolonging therapy (index date) until the first ER visit.
Number of visits to the ER Retrospective analysis from 01-Jan-2012 to 31-Dec-2017 Measured from the initiation of 2nd line life-prolonging therapy (index date) until death
Trial Locations
- Locations (1)
Multiple Locations
🇨🇦Multiple Locations, Canada