Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498921
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Retrospective Observational Study With Nubeqa Darolutamide for the Treatment of Adult Men With Metastatic Hormone Sensitive Prostate Cancer mHSPC in Combination With ADT and Docetaxel in BELGIUM
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BELBEQA
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None