check_circleStudy Completed
Metastatic castration-sensitive prostate cancer
Bayer Identifier:infoA unique number for a trial given by Bayer.
21991
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
A study called AWARENESS using data from men in Alberta to observe treatment patterns for metastatic castration-sensitive prostate cancer
Trial purpose
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.
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.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal info
960The overall number of participants needed for a trial.
Trial Dates info
January 2022 - August 2022Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 4A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
N/AA “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Completed | Databases | Many locations, Canada |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Descriptive summary of patient characteristics by cohortdate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Change in percentage of patients within each treatment cohort by yeardate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
- Overall survivaldate_rangeTime 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 cancerdate_rangeTime 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)date_rangeTime Frame:Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
- Attrition rate for each line of therapydate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
- Total incidence (number) of hospitalizationsdate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
- Total incidence (number) of emergency department visitsdate_rangeTime Frame:Retrospective analysis from 01-Jan-2016 up to 31-Dec-2020 or earlier based on database cutoff
Trial design
Trial Type info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
N/AThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
N/AAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
N/AA “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.