Trial Condition(s):
Prostate Cancer
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 (REACTIVATE)
Bayer Identifier:
20949
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Multiple Locations Many Locations, Canada | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
3
Primary Outcome
- Overall survivalThe length of time from the date of initiation of 2nd line life-prolonging therapy to death due to any causeTimeframe: 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 causeTimeframe: 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 EBRTTimeframe: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
- Total incidence of EBRTTotal 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.Timeframe: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
- Time to first hospitalizationMeasured from the start of the 2nd line life-prolonging therapy (index date) until the first overnight hospital stay.Timeframe: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
- Number of overnight hospital staysMeasured from the initiation of 2nd line life-prolonging therapy (index date) until deathTimeframe: 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 deathTimeframe: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
- Time to first Emergency Room (ER) visitMeasured from the start of 2nd line life-prolonging therapy (index date) until the first ER visit.Timeframe: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
- Number of visits to the ERMeasured from the initiation of 2nd line life-prolonging therapy (index date) until deathTimeframe: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Additional Information
Not Available
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