Clinical trial NCT04281147: 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
Official title: Real World Evaluation of Access-driven Canadian Treatment Sequences in Progressive Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Metastatic castrate resistant prostate cancer mCRPC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-02-24
Enrollment: 4301
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Secondary outcomes:
measure: Event-free survival (EFS)
timeFrame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
measure: Time to External Beam Radiation Therapy (EBRT)
timeFrame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
measure: Total incidence of EBRT
timeFrame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
measure: Time to first hospitalization
timeFrame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
measure: Number of overnight hospital stays
timeFrame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
measure: Average length of hospital stays (number of days)
timeFrame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
measure: Time to first Emergency Room (ER) visit
timeFrame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
measure: Number of visits to the ER
timeFrame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Other outcomes:
Locations:
city: Multiple Locations
country: Canada
facility: Multiple Locations
Study officials:
References: