Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334120
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-03-21
Brief Title:
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients
Status:
RECRUITING
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:
None
Brief Summary:
This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer nmCRPC or metastatic hormone-sensitive prostate cancer mHSPC nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels
This study looks at the safety of the study drug darolutamide in Korean patients with nmCRPC or mHSPC Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC It works by attaching to the special molecules called androgen receptors AR within prostate cells and blocks hormones called androgens from attaching to AR which helps delay cancer growth
To learn more about the safety of Darolutamide the researchers will study whether the participants have adverse events An adverse event is any medical problem that a participant has during a study Doctors keep track of all adverse events that happen in studies even if they do not think the adverse events might be related to the study treatments The researchers will also learn more about how well darolutamide is working in these participants
During this study the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors
Each participant will be in this study for 1 year The whole study will last about 6 years During this time the participants will visit their doctor every 2 to 4 months as part of their usual care At these visits the doctors will do scans to check the patients cancer and take blood samples The patients will answer questions about any medications they are taking and whether they have any adverse events
This study looks at the safety of the study drug darolutamide in Korean patients with nmCRPC or mHSPC Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC It works by attaching to the special molecules called androgen receptors AR within prostate cells and blocks hormones called androgens from attaching to AR which helps delay cancer growth
To learn more about the safety of Darolutamide the researchers will study whether the participants have adverse events An adverse event is any medical problem that a participant has during a study Doctors keep track of all adverse events that happen in studies even if they do not think the adverse events might be related to the study treatments The researchers will also learn more about how well darolutamide is working in these participants
During this study the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors
Each participant will be in this study for 1 year The whole study will last about 6 years During this time the participants will visit their doctor every 2 to 4 months as part of their usual care At these visits the doctors will do scans to check the patients cancer and take blood samples The patients will answer questions about any medications they are taking and whether they have any adverse events
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