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
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer
- Interventions
- Other: Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
- Registration Number
- NCT06498921
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 106
- Patients diagnosed with mHSPC
- Patients treated with darolutamide (Nubeqa, BAY1841788) in combination with ADT and docetaxel according to local reimbursement
- Initiation of treatment with darolutamide (Nubeqa, BAY1841788) in this indication between the index date (should be before 15MAR2024) and start of data collection.
- Participation in an investigational program with interventions outside of routine clinical practice
- Contraindications according to the local reimbursement
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description metastatic Hormone Sensitive Prostate Cancer (mHSPC) Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel All adult men with a diagnosis of mHSPC, treated with darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel.
- Primary Outcome Measures
Name Time Method Description of baseline characteristics of patients under real-word conditions at baseline
- Secondary Outcome Measures
Name Time Method The average treatment duration with darolutamide (Nubeqa, BAY1841788) up to 22 months The therapeutic value of darolutamide (Nubeqa, BAY1841788) up to 22 months
Trial Locations
- Locations (1)
Many locations
🇧🇪Multiple Locations, Belgium