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Completed

NCT Number: 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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Multiple Locations

Multiple Locations, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radium-223 dichloride (Xofigo, BAY88-8223)

Drug

Follow clinical administration

Primary outcomes

  1. Overall survival

    Time frame: 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 outcomes

  1. Event-free survival (EFS)

    Time frame: 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 cause

  2. Time to External Beam Radiation Therapy (EBRT)

    Time frame: 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

  3. Total incidence of EBRT

    Time frame: 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.

  4. Time to first hospitalization

    Time frame: 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.

  5. Number of overnight hospital stays

    Time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017

    Measured from the initiation of 2nd line life-prolonging therapy (index date) until death

  6. Average length of hospital stays (number of days)

    Time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017

    Measured from the initiation of 2nd line life -prolonging therapy (index date) until death

  7. Time to first Emergency Room (ER) visit

    Time frame: 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.

  8. Number of visits to the ER

    Time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017

    Measured from the initiation of 2nd line life-prolonging therapy (index date) until death

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: REACTIVATE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2020
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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