check_circleStudy Completed

Prostate Cancer

Bayer Identifier:

20949

ClinicalTrials.gov Identifier:

NCT04281147

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

NaN - N/A
  • - 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

Trial summary

Enrollment Goal
4301
Trial Dates
February 2020 - June 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Multiple LocationsMany Locations, Canada

Primary Outcome

  • Overall survival
    The length of time from the date of initiation of 2nd line life-prolonging therapy to death due to any cause
    date_rangeTime Frame:
    Retrospective analysis from 01-Jan-2012 to 31-Dec-2017

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
  • Time to External Beam Radiation Therapy (EBRT)
    From the start of the 1st life-prolonging therapy (index date) until the first use of EBRT
    date_rangeTime Frame:
    Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
  • 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.
    date_rangeTime Frame:
    Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
  • Time to first hospitalization
    Measured from the start of the 2nd line life-prolonging therapy (index date) until the first overnight hospital stay.
    date_rangeTime Frame:
    Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
  • Number of overnight hospital stays
    Measured from the initiation of 2nd line life-prolonging therapy (index date) until death
    date_rangeTime Frame:
    Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
  • Average length of hospital stays (number of days)
    Measured from the initiation of 2nd line life -prolonging therapy (index date) until death
    date_rangeTime Frame:
    Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
  • Time to first Emergency Room (ER) visit
    Measured from the start of 2nd line life-prolonging therapy (index date) until the first ER visit.
    date_rangeTime Frame:
    Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
  • Number of visits to the ER
    Measured from the initiation of 2nd line life-prolonging therapy (index date) until death
    date_rangeTime Frame:
    Retrospective analysis from 01-Jan-2012 to 31-Dec-2017

Trial design

Real World Evaluation of Access-driven Canadian Treatment Sequences in Progressive Prostate Cancer
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A