Metastatic Hormone-sensitive Prostate Cancer (mHSPC)23146NCT07395804
How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany
An observational study of Metastatic Hormone-sensitive Prostate Cancer (mHSPC), run by Bayer at 1 site in Germany.
Trial summary
Prostate cancer is a disease where cells in the prostate gland grow out of control. When prostate cancer has spread to other parts of the body but still responds to hormone treatment, it is called metastatic hormone-sensitive prostate cancer (mHSPC). 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 (mHSPC)
- What is being tested?
- darolutamide plus ADT treatment
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 14 Apr 2026to 15 Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Men with metastatic hormone-sensitive mHSPC fulfilling the inclusion and exclusion criteria
Who may be able to join
- Male patients aged ≥ 18 years
- Diagnosis of mHSPC with histological or cytological evidence for adenocarcinoma of prostate
- Metastatic disease by conventional or new generation imaging
- Physician decision to initiate treatment with Darolutamide+ADT was made as per investigator's routine treatment practice prior to enrollment in the study
- Signed informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).
Who cannot join
- Darolutamide treatment started more than 30 days prior to study enrollment
- ADT treatment started more than 12 weeks before the start of treatment with darolutamide plus ADT
- Hypersensitivity to darolutamide or any other excipient
- Other prior systemic hormonal or anti-cancer treatment for mHSPC
- Participation in an investigational program for prostate cancer with interventions outside of routine clinical practice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: DAROlutamide DoUBlet Therapy in Daily Practice (DARO-DUB) - Real-world Evaluation of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Treated With Darolutamide Plus ADT in Germany
Prostate cancer is a disease where cells in the prostate gland grow out of control. When prostate cancer has spread to other parts of the body but still responds to hormone treatment, it is called metastatic hormone-sensitive prostate cancer (mHSPC).
The usual treatment for this stage of prostate cancer is hormone therapy (called androgen-deprivation therapy or ADT) combined with another medicine that blocks the effect of male hormones on cancer cells, known as an androgen-receptor pathway inhibitor. Darolutamide is a newer type of androgen-receptor inhibitor.
Read more
The main goal of this study is to find out how well a combination of two treatments-darolutamide and hormone therapy (also called androgen-deprivation therapy or ADT)-works for men in Germany who have advanced prostate cancer that has spread to other parts of the body and still responds to hormone treatment. The study will look at how many men have very low or undetectable levels of a protein called prostate-specific antigen (PSA) in their blood after 12 months of treatment. PSA is a marker that doctors use to check how active prostate cancer is.
The study will also look at how long men live after starting this treatment, and will collect information about their health, the type of prostate cancer they have, and any other medicines they are taking. The study will last for 5 years. At the start of the study, the study doctor will collect information about each patient's background, such as age, other health problems, and details about their prostate cancer. This information will be taken from the patient's medical records if available. If some information is missing, the doctor may ask the patient directly.
Other information will be collected as the study goes on. This includes details about the patient's treatment, how they are doing during their regular medical visits, and any changes in their health. These check-ups and data collection will happen as part of the patient's usual care, including at the beginning of treatment, during treatment visits, follow-up visits, and at the end of the study observation period.
- Being tested
- darolutamide plus ADT treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darolutamide plus ADT treatmentDrug
2*300 mg darolutamide twice daily + ADT treatment
| Study group | Role | What they receive |
|---|---|---|
| Men with mHSPC fulfilling the inclusion and exclusion criteria | Not described Receives: Drug: darolutamide plus ADT treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with PSA < 0.2 ng/mL
Measured: 12 months
Secondary outcomes (14)
Number of deaths or participants with end of observation
Measured: up to 60 months
Number of participants with PSA < 0.2 ng/mL
Measured: 3, 6, and 9 months
Number of participants with certain demographic characteristics
- age
- race
Measured: at study start
Number of participants with certain clinical characteristics
- comorbities
- Gleason score/ISUP
- PSA prior therapy
- prostate cancer volume and risk
- type of metastatic disease
- ECOG performance
Measured: at study start
Number of participants with certain testosterone value
Measured: at study start
Duration of Darolutamide+ADT treatment
Measured: up to 60 months
Timing of Darolutamide+ADT treatment start
Measured: up to 60 months
Kind of ADT treatment
Measured: up to 60 months
Number of participants who change ADT treatment
Measured: up to 60 months
Number of participants who change dosage of Darolutamide treatment
Measured: up to 60 months
Number of participants with certain reasons for darolutamide plus ADT treatment discontinuation
Measured: up to 60 months
Number of participants with certain subsequent anti-cancer therapies
Measured: up to 60 months
Number of participants with treatment-emergent adverse events
Measured: from start of treatment up to 60 months
Number of participants with certain concomitant medication at study start and changes during treatment with darolutamide plus ADT
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start14 Apr 2026
- Primary completion15 Feb 2031 (estimated)
- Study completion15 Feb 2031 (estimated)
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 Cancer (mHSPC)Studies 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395804
- Sponsor's protocol ID
- 23146
- Acronym
- 23146
- Status last verified
- 21 May 2026
- First submitted
- 2 Feb 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The 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 the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAROlutamide DoUBlet Therapy in Daily Practice (DARO-DUB) - Real-world Evaluation of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Treated With Darolutamide Plus ADT in Germany
- ClinicalTrials.gov ID
- NCT07395804
- Acronym / sponsor ID
- 23146 / 23146
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 15 Feb 2031 (estimated)
- Study completion
- 15 Feb 2031 (estimated)
- First posted
- 9 Feb 2026 (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.
Prostate cancer is a disease where cells in the prostate gland grow out of control. When prostate cancer has spread to other parts of the body but still responds to hormone treatment, it is called metastatic hormone-sensitive prostate cancer (mHSPC).
The usual treatment for this stage of prostate cancer is hormone therapy (called androgen-deprivation therapy or ADT) combined with another medicine that blocks the effect of male hormones on cancer cells, known as an androgen-receptor pathway inhibitor. Darolutamide is a newer type of androgen-receptor inhibitor.
The main goal of this study is to find out how well a combination of two treatments-darolutamide and hormone therapy (also called androgen-deprivation therapy or ADT)-works for men in Germany who have advanced prostate cancer that has spread to other parts of the body and still responds to hormone treatment. The study will look at how many men have very low or undetectable levels of a protein called prostate-specific antigen (PSA) in their blood after 12 months of treatment. PSA is a marker that doctors use to check how active prostate cancer is.
The study will also look at how long men live after starting this treatment, and will collect information about their health, the type of prostate cancer they have, and any other medicines they are taking. The study will last for 5 years. At the start of the study, the study doctor will collect information about each patient's background, such as age, other health problems, and details about their prostate cancer. This information will be taken from the patient's medical records if available. If some information is missing, the doctor may ask the patient directly.
Other information will be collected as the study goes on. This includes details about the patient's treatment, how they are doing during their regular medical visits, and any changes in their health. These check-ups and data collection will happen as part of the patient's usual care, including at the beginning of treatment, during treatment visits, follow-up visits, and at the end of the study observation period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with mHSPC fulfilling the inclusion and exclusion criteria | – | Drug: darolutamide plus ADT treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with metastatic hormone-sensitive mHSPC fulfilling the inclusion and exclusion criteria
Key inclusion criteria (5 listed)
- Male patients aged ≥ 18 years
- Diagnosis of mHSPC with histological or cytological evidence for adenocarcinoma of prostate
- Metastatic disease by conventional or new generation imaging
Key exclusion criteria (5 listed)
- Darolutamide treatment started more than 30 days prior to study enrollment
- ADT treatment started more than 12 weeks before the start of treatment with darolutamide plus ADT
- Hypersensitivity to darolutamide or any other excipient
- Other prior systemic hormonal or anti-cancer treatment for mHSPC
- Participation in an investigational program for prostate cancer with interventions outside of routine clinical practice
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 plus ADT treatment2*300 mg darolutamide twice daily + ADT treatment | Drug | Men with mHSPC fulfilling the inclusion and exclusion criteria |
Primary outcome
Number of participants with PSA < 0.2 ng/mL
Time frame: 12 months
14 secondary outcomes
Number of deaths or participants with end of observation
Time frame: up to 60 months
Number of participants with PSA < 0.2 ng/mL
Time frame: 3, 6, and 9 months
Number of participants with certain demographic characteristics
Time frame: at study start
Number of participants with certain clinical characteristics
Time frame: at study start
Number of participants with certain testosterone value
Time frame: at study start
Duration of Darolutamide+ADT treatment
Time frame: up to 60 months
Timing of Darolutamide+ADT treatment start
Time frame: up to 60 months
Kind of ADT treatment
Time frame: up to 60 months
Number of participants who change ADT treatment
Time frame: up to 60 months
Number of participants who change dosage of Darolutamide treatment
Time frame: up to 60 months
Number of participants with certain reasons for darolutamide plus ADT treatment discontinuation
Time frame: up to 60 months
Number of participants with certain subsequent anti-cancer therapies
Time frame: up to 60 months
Number of participants with treatment-emergent adverse events
Time frame: from start of treatment up to 60 months
Number of participants with certain concomitant medication at study start and changes during treatment with darolutamide plus ADT
Time frame: up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The 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 the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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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.
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 (mHSPC), run by Bayer at 1 site in Germany.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 May 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact (18888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with PSA < 0.2 ng/mL (time frame: 12 months). 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 29 May 2026.