Metastatic Castration-sensitive Prostate CancerNCT05149131
A Study Called AWARENESS Using Data From Men in Alberta to Observe Treatment Patterns for Metastatic Castration-sensitive Prostate Cancer
An observational study of Metastatic Castration-sensitive Prostate Cancer, run by Bayer at 1 site in Canada.
Trial summary
This is an observational study in which patient data from the past on men with metastatic castration-sensitive prostate cancer is studied. Metastatic castration-sensitive prostate cancer (mCSPC) is a type of advanced prostate cancer that has spread to other parts of the body, and still responds to treatment that… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-sensitive Prostate Cancer
- What is being tested?
- ADT (Eligard®*) with or without treatment intensification
- How many people
- 960 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2022to 16 Aug 2022
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study will include all mCSPC patients in the province of Alberta that initiated and received at least one dose of guideline recommended life-prolonging therapy for mCSPC (docetaxel, abiraterone, enzalutamide, apalutamide, or ADT alone) from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff, inclusive. Patients with de novo metastatic disease are easily identifiable by diagnosis with metastatic disease. Patients who relapse with metastatic disease may be more challenging to identify. The study will start by reporting on results for de novo mCSPC patients only while feasibility assessment is done to determine if these patients can be identified, and if so, they will be added to the study population.
Who may be able to join
- Male patients
- Diagnosed with mCSPC
- Residents of Alberta, Canada
- Initiating ADT with or without treatment intensification from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Who cannot join
- There are no formal exclusion criteria in order to capture real-world utilization of ADT with or without treatment intensification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A reAl-World Evidence Study Using Alberta Population Based Data to Describe Treatment Patterns for Metastatic castRation sENsitivE proState Cancer patientS (AWARENESS)
This is an observational study in which patient data from the past on men with metastatic castration-sensitive prostate cancer is studied.
Metastatic castration-sensitive prostate cancer (mCSPC) is a type of advanced prostate cancer that has spread to other parts of the body, and still responds to treatment that lowers testosterone levels.
Read more
Cancer is a condition in which the body cannot control the growth of cells. The extra cells can form tumors in organs or other parts of the body. If tumors form in the prostate, male hormones (androgens) can sometimes help the cancer spread and grow. The main hormone that does this is called testosterone and is mainly made in the testicles. Men with prostate cancer can have treatments to try to lower the levels of testosterone in the body. One possible treatment is surgery to remove the testicles. Another option is taking treatments to lower the levels of testosterone in the body. These are called androgen deprivation therapy (ADT). In men with mCSPC, ADT can help to stop the cancer from growing and spreading. Men with mCSPC can also receive "treatment intensification". This means that they receive ADT as well as other treatments for their prostate cancer. Other studies that looked at treatment of mCSPC in Canada have found that most men with mCSPC do not receive treatment intensification.
In this study, the researchers want to collect more data about the men who had mCSPC and the types of treatment they received for their mCSPC. The researchers will look at the health information of adult men in Alberta, Canada who had at least 1 dose of treatment for their mCSPC between January 2016 and December 2020 or earlier.
The study will first look at the health information of men whose cancer had metastasized or spread to other parts of the body, beyond the prostate, at the time they were diagnosed with prostate cancer.
And later, if feasible to do, the study may also look at the health information from men who were diagnosed with prostate cancer that was limited to the prostate, and over time spread to other parts of the body.
The researchers will collect information from databases, a census, and pharmacy records. This will help the researchers learn more about:
- whether the men received ADT alone, or ADT with treatment intensification
- additional information about the men, including their age, income, level of education, residential area (urban or rural) and the more information about the treatments received
- how the men's symptoms affected their daily lives
- how severe the men's cancer was
- changes in laboratory values as markers for changes to the blood, liver, kidney, bone or other organs
- need for additional treatment
- where the men's cancer may have spread to in other parts of the body.
There will be no required visits with a study doctor or required tests in this study since it's reviewing patient data from the past.
The researchers will collect this information for about 7 months. The entire study will take about 10 months to finish.
- Being tested
- ADT (Eligard®*) with or without treatment intensification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADT (Eligard®*) with or without treatment intensificationDrug
Abiraterone acetate (Zytiga®) Enzalutamide (Xtandi®) Apalutamide (Erleada®) Docetaxel (Taxotere®)
*may be substituted with leuroprolide gel, buserelin, goserelin, triptorelin, histrelin, cyproterone or degarelix
| Study group | Role | What they receive |
|---|---|---|
| mCSPC patients in the province of Alberta | mCSPC patients who initiated and received at least one dose of guideline recommended life-prolonging therapy for mCSPC (docetaxel, abiraterone, enzalutamide, apalutamide, or ADT alone) from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff, inclusive. Receives: Drug: ADT (Eligard®*) with or without treatment intensification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive summary of patient characteristics by cohort
Measured: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Secondary outcomes (7)
Change in percentage of patients within each treatment cohort by year
Measured: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Overall survival
Measured: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Percentage of patients that died due to cancer
Measured: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Percentage of patients that received subsequent life-prolonging therapies (LPT)
Measured: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Attrition rate for each line of therapy
Measured: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Total incidence (number) of hospitalizations
Measured: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Total incidence (number) of emergency department visits
Measured: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start17 Jan 2022
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-sensitive 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
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149131
- Sponsor's protocol ID
- 21991
- Status last verified
- Feb 2024
- First submitted
- 25 Nov 2021
- Last updated
- 9 Feb 2024
- 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.vivli.org 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 member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A reAl-World Evidence Study Using Alberta Population Based Data to Describe Treatment Patterns for Metastatic castRation sENsitivE proState Cancer patientS (AWARENESS)
- ClinicalTrials.gov ID
- NCT05149131
- Acronym / sponsor ID
- 21991
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 8 Dec 2021 (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.
This is an observational study in which patient data from the past on men with metastatic castration-sensitive prostate cancer is studied.
Metastatic castration-sensitive prostate cancer (mCSPC) is a type of advanced prostate cancer that has spread to other parts of the body, and still responds to treatment that lowers testosterone levels.
Cancer is a condition in which the body cannot control the growth of cells. The extra cells can form tumors in organs or other parts of the body. If tumors form in the prostate, male hormones (androgens) can sometimes help the cancer spread and grow. The main hormone that does this is called testosterone and is mainly made in the testicles. Men with prostate cancer can have treatments to try to lower the levels of testosterone in the body. One possible treatment is surgery to remove the testicles. Another option is taking treatments to lower the levels of testosterone in the body. These are called androgen deprivation therapy (ADT). In men with mCSPC, ADT can help to stop the cancer from growing and spreading. Men with mCSPC can also receive "treatment intensification". This means that they receive ADT as well as other treatments for their prostate cancer. Other studies that looked at treatment of mCSPC in Canada have found that most men with mCSPC do not receive treatment intensification.
In this study, the researchers want to collect more data about the men who had mCSPC and the types of treatment they received for their mCSPC. The researchers will look at the health information of adult men in Alberta, Canada who had at least 1 dose of treatment for their mCSPC between January 2016 and December 2020 or earlier.
The study will first look at the health information of men whose cancer had metastasized or spread to other parts of the body, beyond the prostate, at the time they were diagnosed with prostate cancer.
And later, if feasible to do, the study may also look at the health information from men who were diagnosed with prostate cancer that was limited to the prostate, and over time spread to other parts of the body.
The researchers will collect information from databases, a census, and pharmacy records. This will help the researchers learn more about:
- whether the men received ADT alone, or ADT with treatment intensification
- additional information about the men, including their age, income, level of education, residential area (urban or rural) and the more information about the treatments received
- how the men's symptoms affected their daily lives
- how severe the men's cancer was
- changes in laboratory values as markers for changes to the blood, liver, kidney, bone or other organs
- need for additional treatment
- where the men's cancer may have spread to in other parts of the body.
There will be no required visits with a study doctor or required tests in this study since it's reviewing patient data from the past.
The researchers will collect this information for about 7 months. The entire study will take about 10 months to finish.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mCSPC patients in the province of Alberta | – | Drug: ADT (Eligard®*) with or without treatment intensificationmCSPC patients who initiated and received at least one dose of guideline recommended life-prolonging therapy for mCSPC (docetaxel, abiraterone, enzalutamide, apalutamide, or ADT alone) from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff, inclusive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include all mCSPC patients in the province of Alberta that initiated and received at least one dose of guideline recommended life-prolonging therapy for mCSPC (docetaxel, abiraterone, enzalutamide, apalutamide, or ADT alone) from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff, inclusive. Patients with de novo metastatic disease are easily identifiable by diagnosis with metastatic disease. Patients who relapse with metastatic disease may be more challenging to identify. The study will start by reporting on results for de novo mCSPC patients only while feasibility assessment is done to determine if these patients can be identified, and if so, they will be added to the study population.
Key inclusion criteria (4 listed)
- Male patients
- Diagnosed with mCSPC
- Residents of Alberta, Canada
- Initiating ADT with or without treatment intensification from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Key exclusion criteria (1 listed)
- There are no formal exclusion criteria in order to capture real-world utilization of ADT with or without treatment intensification
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 |
|---|---|---|
| ADT (Eligard®*) with or without treatment intensificationAbiraterone acetate (Zytiga®) Enzalutamide (Xtandi®) Apalutamide (Erleada®) Docetaxel (Taxotere®) *may be substituted with leuroprolide gel, buserelin, goserelin, triptorelin, histrelin, cyproterone or degarelix | Drug | mCSPC patients in the province of Alberta |
Primary outcome
Descriptive summary of patient characteristics by cohort
Time frame: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
7 secondary outcomes
Change in percentage of patients within each treatment cohort by year
Time frame: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Overall survival
Time frame: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Percentage of patients that died due to cancer
Time frame: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Percentage of patients that received subsequent life-prolonging therapies (LPT)
Time frame: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Attrition rate for each line of therapy
Time frame: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Total incidence (number) of hospitalizations
Time frame: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Total incidence (number) of emergency department visits
Time frame: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
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 9 Feb 2024.
- 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.vivli.org 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 member 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 Metastatic Castration-sensitive 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 4 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 9 Feb 2024. 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?
Descriptive summary of patient characteristics by cohort (time frame: Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff). 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 9 Feb 2024.