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)

October 23, 2024 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Multiple Locations, Belgium
        • Many locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Description of baseline characteristics of patients under real-word conditions
Time Frame: at baseline
at baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
The average treatment duration with darolutamide (Nubeqa, BAY1841788)
Time Frame: up to 22 months
up to 22 months
The therapeutic value of darolutamide (Nubeqa, BAY1841788)
Time Frame: up to 22 months
up to 22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Actual)

September 15, 2024

Study Completion (Actual)

September 15, 2024

Study Registration Dates

First Submitted

July 5, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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