Metastatic Hormone-sensitive Prostate CancerBELBEQANCT06498921
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
An observational study of Metastatic Hormone-sensitive Prostate Cancer, run by Bayer at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-sensitive Prostate Cancer
- What is being tested?
- Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
- How many people
- 106 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jul 2024to 15 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Participation in an investigational program with interventions outside of routine clinical practice
- Contraindications according to the local reimbursement
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Being tested
- Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of baseline characteristics of patients under real-word conditions
Measured: at baseline
Secondary outcomes (2)
The average treatment duration with darolutamide (Nubeqa, BAY1841788)
Measured: up to 22 months
The therapeutic value of darolutamide (Nubeqa, BAY1841788)
Measured: up to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start15 Jul 2024
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-sensitive Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498921
- Sponsor's protocol ID
- 22743
- Acronym
- BELBEQA
- Status last verified
- Oct 2024
- First submitted
- 5 Jul 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06498921
- Acronym / sponsor ID
- BELBEQA / 22743
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metastatic Hormone Sensitive Prostate Cancer (mHSPC) | – | Other: Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxelAll adult men with a diagnosis of mHSPC, treated with darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Participation in an investigational program with interventions outside of routine clinical practice
- Contraindications according to the local reimbursement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxelNo 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. | Other | metastatic Hormone Sensitive Prostate Cancer (mHSPC) |
Primary outcome
Description of baseline characteristics of patients under real-word conditions
Time frame: at baseline
2 secondary outcomes
The average treatment duration with darolutamide (Nubeqa, BAY1841788)
Time frame: up to 22 months
The therapeutic value of darolutamide (Nubeqa, BAY1841788)
Time frame: up to 22 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No. 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.
Related trials for Metastatic Hormone-sensitive Prostate Cancer
Not yet recruitingPhase 2
Testosterone-Informed De-Escalation in Metastatic Prostate Cancer (TIDE PC)
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Active, not recruitingPhase 4
PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer
Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer
Active, not recruitingPhase 2
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
RecruitingPhase 1
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
Hormone-refractory Prostate Cancer
Not yet recruitingPhase 1/2
RYZ711 Diagnostic Platform Study
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Hormone-sensitive Prostate Cancer, run by Bayer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of baseline characteristics of patients under real-word conditions (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.