do_not_disturb_altRecruitment Complete
Metastatic hormone-sensitive prostate cancer
Bayer Identifier:infoA unique number for a trial given by Bayer.
22917
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
An Observational Study to Learn More About Treatment Patterns and Factors Determining the Choice of Treatment in Canadian Men with Metastatic Hormone Sensitive Prostate Cancer in Routine Medical Care
Trial purpose
This is an observational study in which only data are collected from adult Canadian men with metastatic hormone sensitive prostate cancer (mHSPC) are studied. Participants will not receive any advice on treatment or any changes to the healthcare.
Metastatic hormone sensitive prostate cancer is a cancer of the prostate gland, a male reproductive gland found below the bladder. Metastatic means that cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with anti-hormonal therapy such as androgen deprivation therapy (ADT).
ADT lowers the level of testosterone and slows down the growth of cancer cells. However, in some cases, ADT alone is not sufficient and doctors recommend combining it with treatments like Androgen Receptor Pathway Inhibitors (ARPi) and/or docetaxel to stop the growth of cancer cells.
ARPi slow down the growth of the cancer cells by blocking a sex hormone called the androgens from attaching to the protein found in the cancer cells. ARPi includes medicines like apalutamide, darolutamide, and enzalutamide.
Docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells. ADT, ARPi, and docetaxel are approved treatments for men with mHSPC in Canada.
The participants in this study are already receiving treatment for mHSPC as part of their routine medical care from their doctors.
Metastatic hormone sensitive prostate cancer is a cancer of the prostate gland, a male reproductive gland found below the bladder. Metastatic means that cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with anti-hormonal therapy such as androgen deprivation therapy (ADT).
ADT lowers the level of testosterone and slows down the growth of cancer cells. However, in some cases, ADT alone is not sufficient and doctors recommend combining it with treatments like Androgen Receptor Pathway Inhibitors (ARPi) and/or docetaxel to stop the growth of cancer cells.
ARPi slow down the growth of the cancer cells by blocking a sex hormone called the androgens from attaching to the protein found in the cancer cells. ARPi includes medicines like apalutamide, darolutamide, and enzalutamide.
Docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells. ADT, ARPi, and docetaxel are approved treatments for men with mHSPC in Canada.
The participants in this study are already receiving treatment for mHSPC as part of their routine medical care from their doctors.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal info
700The overall number of participants needed for a trial.
Trial Dates info
February 2025 - December 2026Trial 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
N/AA phase is a step in the research of a new treatment.
Could I Receive a placebo info
N/AA “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
Darolutamide+ADT (BAY1841788)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
N/AA 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 |
|---|---|---|
Active, not recruiting | Pentavere | Toronto, M6G 1A1, 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.
- Treatment intensification in patients with mHSPCThe primary outcome of interest is utilization of treatment intensification in patients with mHSPC, including: Frequencies and percentages of patients in each treatment cohortdate_rangeTime Frame:January 2018 until June 2026
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.
- Demographics: age in yearsData utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiationdate_rangeTime Frame:January 2018 until June 2026
- Clinical characteristics: date of diagnosis of prostate cancerData utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiationdate_rangeTime Frame:January 2018 until June 2026
- Clinical characteristics: date of mHSPC diagnosis (as confirmed by radiographic evidence of metastasis with CI or PSMA-PET, and histologically confirmed carcinoma)Data utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiationdate_rangeTime Frame:January 2018 until June 2026
- Clinical characteristics: year of mHSPC diagnosisData utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiationdate_rangeTime Frame:January 2018 until June 2026
- Clinical characteristics: Eastern Cooperative Oncology Group (ECOG) scoreData utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiationdate_rangeTime Frame:January 2018 until June 2026
- Clinical characteristics: Gleason scoreData utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiationdate_rangeTime Frame:January 2018 until June 2026
- Clinical characteristics: comorbidities (Charlson Comorbidity Index)Data utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiationdate_rangeTime Frame:January 2018 until June 2026
- Clinical characteristics: disease volume/risk at baselineData utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiationdate_rangeTime Frame:January 2018 until June 2026
- Clinical characteristics: radiological evidence of metastases (number and site) at time of initial mHSPC diagnosisData utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiationdate_rangeTime Frame:January 2018 until June 2026
- Physician characteristics: practice sizePhysician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the clinicians.date_rangeTime Frame:January 2018 until June 2026
- Physician characteristics: years in practicePhysician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the cliniciansdate_rangeTime Frame:January 2018 until June 2026
- Physician characteristics: number of patients seen annually with prostate cancerPhysician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the cliniciansdate_rangeTime Frame:January 2018 until June 2026
- Physician characteristics: treatment areas of expertisePhysician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the clinicians.date_rangeTime Frame:January 2018 until June 2026
- Reasons for treatment discontinuation and/or changing treatment by treatment cohortReasons for treatment discontinuation and/or changing treatment by treatment cohort, including: o Frequency and percentages of patients discontinuing/changing treatment due to AEs (and treatment-relatedness, if possible) o Frequency and percentages of patients discontinuing/changing treatment due to progression to mCRPC o Frequency and percentages of patients discontinuing treatment due to death o Frequency and percentages of patients discontinuing/changing treatment due to any other reasondate_rangeTime Frame:January 2018 until June 2026
- Time to treatment discontinuation (TTD)TTD will be measured from start of study treatment (index date 2) until discontinuation of ADT in monotherapy regimens or discontinuation of ARPi in doublet or triplet regimens or discontinuation of docetaxel within < 6 cycles in the docetaxel regimens. Treatment discontinuation will be defined as the last date treatment is givendate_rangeTime Frame:January 2018 until June 2026
- mCRPC real-world progression free survival (rwPFS)rwPFS will be measured from mHSPC diagnosis (index date 1) until date of progression as documented in physician notes or rising PSA levels (using PCW3 definition) despite castrate testosterone levels, where available, or date of deathdate_rangeTime Frame:January 2018 until June 2026
- Referral patterns for intensification among patients with mHSPCDetermine if the study can identify a pattern in which mHSPC patients can be candidates for intensification therapy, based on the patient data.date_rangeTime Frame:January 2018 until June 2026
- Docetaxel dosage adjustmentsdate_rangeTime Frame:January 2018 until June 2026
Trial design
Trial Type info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
N/AAn 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.