check_circleStudy Completed
Metastatic hormone-sensitive prostate cancer
Bayer Identifier:
22743
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men with Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care
Trial purpose
This is an observational study in which only observations from routine clinical practices will be made. Participants will not receive any advice on treatment or any changes to healthcare as a part of the study.
In this study, medical records data of Belgian men with metastatic hormone sensitive prostate cancer (mHSPC) who had received or are receiving treatment with darolutamide in combination with androgen deprivation therapy (ADT) and docetaxel will be studied.
mHSPC is a cancer of the prostate gland, a male reproductive gland found below the bladder. Metastatic means that the cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with hormone-therapy such as androgen deprivation therapy (ADT).
ADT lowers the level of androgens, male hormones, and slows down the growth of cancer cells. However, in some cases, ADT alone is not sufficient for the treatment of mHSPC and doctors recommend a combination of treatments.
The study drug darolutamide, in combination with ADT and docetaxel is an approved treatment for mHSPC. Darolutamide aims to work by blocking the androgens signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells.
The main purpose of this study is to learn more about the real-world use of darolutamide in combination with ADT and docetaxel in Belgian men with mHSPC.
To do this, researchers will study the following information about participants who are already prescribed this combination treatment by their treating doctors in real-word condition:
• Participants’ cancer characteristics before starting the treatment, and
• Participants’ treatment history
The data will be collected between July 2024 to September 2024, from eligible participants’ medical records.
Study doctors will only look at the medical records of adult men with mHSPC in Belgium.
In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.
In this study, medical records data of Belgian men with metastatic hormone sensitive prostate cancer (mHSPC) who had received or are receiving treatment with darolutamide in combination with androgen deprivation therapy (ADT) and docetaxel will be studied.
mHSPC is a cancer of the prostate gland, a male reproductive gland found below the bladder. Metastatic means that the cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with hormone-therapy such as androgen deprivation therapy (ADT).
ADT lowers the level of androgens, male hormones, and slows down the growth of cancer cells. However, in some cases, ADT alone is not sufficient for the treatment of mHSPC and doctors recommend a combination of treatments.
The study drug darolutamide, in combination with ADT and docetaxel is an approved treatment for mHSPC. Darolutamide aims to work by blocking the androgens signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells.
The main purpose of this study is to learn more about the real-world use of darolutamide in combination with ADT and docetaxel in Belgian men with mHSPC.
To do this, researchers will study the following information about participants who are already prescribed this combination treatment by their treating doctors in real-word condition:
• Participants’ cancer characteristics before starting the treatment, and
• Participants’ treatment history
The data will be collected between July 2024 to September 2024, from eligible participants’ medical records.
Study doctors will only look at the medical records of adult men with mHSPC in Belgium.
In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
106Trial Dates
July 2024 - September 2024Phase
Phase 4Could I Receive a placebo
NoProducts
Darolutamide+ADT (BAY1841788)Accepts Healthy Volunteer
NoWhere to participate
| Status | Institution | Location |
|---|---|---|
Active, not recruiting | Many locations | Many locations, Belgium |
Primary Outcome
- Description of baseline characteristics of patients under real-word conditionsdate_rangeTime Frame:at baseline
Secondary Outcome
- The average treatment duration with darolutamide (Nubeqa, BAY1841788)date_rangeTime Frame:up to 22 months
- The therapeutic value of darolutamide (Nubeqa, BAY1841788)date_rangeTime Frame:up to 22 months
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
Health Services ResearchAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A