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)

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

• Study Type: Observational
• Enrollment (Actual): 4301

Contacts and Locations

Study Locations

• Canada
  • Multiple Locations, Canada
    • Multiple locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No Ra-223 received; Patients did not receive Ra-223
Early Ra-223 (2nd line); Patients received Ra-223 in 2nd line	Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Follow clinical administration
Late Ra-223 (3rd or later lines); Patients received Ra-223 in 3rd or later lines	Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Follow clinical administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 24, 2020
• Primary Completion (ACTUAL): June 22, 2021
• Study Completion (ACTUAL): June 22, 2021

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (ACTUAL): February 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Metastatic castrate resistant prostate cancer mCRPC
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 20949

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No