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 (BELBEQA)

Bayer

Status: Completed

Conditions: Metastatic Hormone-sensitive Prostate Cancer

Treatments: Other: Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel

Study type: Observational

Funder types: Industry

Identifiers

NCT06498921

22743

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Participation in an investigational program with interventions outside of routine clinical practice
• Contraindications according to the local reimbursement

Trial design

106 participants in 1 patient group

metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Description:

All adult men with a diagnosis of mHSPC, treated with darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel.

Treatment:

Other: Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel