NCT06498921

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

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
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Hormone-sensitive Prostate Cancer

Interventions

Type	Name	Description
OTHER	Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel	No treatment will be provided to participants in the study. The decision on initiation of darolutamide (Nubeqa, BAY1841788) in combination with ADT and doctaxel and duration of treatment is solely at the discretion of the treating physician, guided by the recommendations outlined in the local product information.

Timeline

• Start date: 2024-07-15
• Primary completion: 2024-09-15
• Completion: 2024-09-15
• First posted: 2024-07-12
• Last updated: 2024-10-24

Locations

1 site across 1 country: Belgium