Prostate CancerREACTIVATENCT04281147
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
An observational study of Prostate Cancer, run by Bayer at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radium-223 dichloride (Xofigo, BAY88-8223)
- How many people
- 4,301 participants
- Where
- 1 siteCanada
- Study dates
- 24 Feb 2020to 22 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- No formal exclusion criteria will be applied in order to capture real world use of Ra-223
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Radium-223 dichloride (Xofigo, BAY88-8223)
- Keywords
- Metastatic castrate resistant prostate cancer mCRPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223 dichloride (Xofigo, BAY88-8223)Drug
Follow clinical administration
| Study group | Role | What they receive |
|---|---|---|
| No Ra-223 received | Patients did not receive Ra-223 | |
| Early Ra-223 (2nd line) | Patients received Ra-223 in 2nd line Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223) | |
| Late Ra-223 (3rd or later lines) | Patients received Ra-223 in 3rd or later lines Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The length of time from the date of initiation of 2nd line life-prolonging therapy to death due to any cause
Measured: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Secondary outcomes (8)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start24 Feb 2020
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281147
- Sponsor's protocol ID
- 20949
- Acronym
- REACTIVATE
- Status last verified
- Jun 2022
- First submitted
- 20 Feb 2020
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evaluation of Access-driven Canadian Treatment Sequences in Progressive Prostate Cancer
- ClinicalTrials.gov ID
- NCT04281147
- Acronym / sponsor ID
- REACTIVATE / 20949
- Conditions
- Prostate Cancer
- Keywords
- Metastatic castrate resistant prostate cancer mCRPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,301 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Ra-223 received | – | –Patients did not receive Ra-223 |
| Early Ra-223 (2nd line) | – | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)Patients received Ra-223 in 2nd line |
| Late Ra-223 (3rd or later lines) | – | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)Patients received Ra-223 in 3rd or later lines |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- No formal exclusion criteria will be applied in order to capture real world use of Ra-223
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223)Follow clinical administration | Drug | Early Ra-223 (2nd line), Late Ra-223 (3rd or later lines) |
Primary outcome
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
8 secondary outcomes
Event-free survival (EFS)
Time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Time to External Beam Radiation Therapy (EBRT)
Time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Total incidence of EBRT
Time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Time to first hospitalization
Time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Number of overnight hospital stays
Time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Average length of hospital stays (number of days)
Time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Time to first Emergency Room (ER) visit
Time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Number of visits to the ER
Time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Bayer at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.