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

NCT06498921 | Completed

• 1 other identifier: 22743
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Hormone-sensitive Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Description of baseline characteristics of patients under real-word conditions

  at baseline

Secondary Outcomes (2)

• The average treatment duration with darolutamide (Nubeqa, BAY1841788)

  up to 22 months

• The therapeutic value of darolutamide (Nubeqa, BAY1841788)

  up to 22 months

Study Arms (1)

metastatic Hormone Sensitive Prostate Cancer (mHSPC)

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

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

Interventions

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

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.

metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Belgium

Location

Related Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

MeSH Terms

Interventions

darolutamide; Androgen Antagonists; Docetaxel

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: July 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)