Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Hormone-sensitive Prostate Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-07-12
Enrollment: 106
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The source population of this study consists of all adult men with a diagnosis of mHSPC, treated with darolutamide (Nubeqa, BAY1841788) in combination with ADT and docetaxel, for this indication.

mHSPC stands for metastatic Hormone Sensitive Prostate Cancer. ADT stands for androgen deprivation therapy.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Description of baseline characteristics of patients under real-word conditions
timeFrame: at baseline
Secondary outcomes:
measure: The average treatment duration with darolutamide (Nubeqa, BAY1841788)
timeFrame: up to 22 months
measure: The therapeutic value of darolutamide (Nubeqa, BAY1841788)
timeFrame: up to 22 months
Other outcomes:
Locations:
city: Multiple Locations
country: Belgium
facility: Many locations
Study officials:
References: