Metastatic Hormone-sensitive Prostate Cancer (mHSPC)DADOXNCT06010914
A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer
An observational study of Metastatic Hormone-sensitive Prostate Cancer (mHSPC), run by Bayer at 1 site in Japan.
Trial summary
This is an observational study in which only data are collected from participants receiving their usual treatment. In this study, data will be collected and studied from men with 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)
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 9 Oct 2023to 31 Jan 2027
- 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: Male patients with a diagnosis of mHSPC will be enrolled after the decision for treatment with darolutamide in combination with docetaxel and ADT has been made by the physician or a delegate.
Who may be able to join
- Men over the age of 18 years
- Histologically or cytologically confirmed adenocarcinoma prostate cancer
- Metastatic disease confirmed either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan
- Patients diagnosed with mHSPC by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with darolutamide plus ADT and docetaxel therapy by the investigator under routine clinical practice
- ADT (GnRH agonist/antagonist or orchiectomy) before or simultaneous treatment with darolutamide
- Signed informed consent
Who cannot join
- Participation in an investigational program with interventions outside of routine clinical practice
- Contraindications according to the local marketing authorization
- Previous treatment with darolutamide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation of Darolutamide in Addition to Standard Androgen Deprivation Therapy (ADT) and Docetaxel in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
This is an observational study in which only data are collected from participants receiving their usual treatment.
In this study, data will be collected and studied from men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is a common cancer in men that starts in 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 testosterone, a male hormone, and slows down the growth of cancer cells.
Read more
Men with mHSPC and who have been decided by their own doctors to be treated with darolutamide in combination with ADT and docetaxel can join this study. Darolutamide works by blocking the testosterone signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer. It works by stopping the growth and spread of cancer cells.
Darolutamide in combination with docetaxel and ADT is an approved treatment for men with mHSPC. It was approved based on a study called ARASENS. More information is needed on how safe darolutamide is when given with ADT and docetaxel in Japanese men with mHSPC.
The main purpose of this study is to collect information about the safety of this combination treatment in Japanese participants with mHSPC under real-world conditions.
The main information that researchers will collect:
Number and severity of heart-related medical problems participants have during the treatment
Other information that researchers will collect:
Number and severity of all medical problems participants have during the study
Age and other information about the participants such as their illness, medical history, and other medicines taken at the same time
Treatment pattern of darolutamide such as the amount of medicine given, the duration for which it is given, and any changes made to the treatment
Data will be collected from August 2023 to July 2026. Researchers will observe participants from the start of darolutamide treatment until 30 days after they receive their last dose of docetaxel, which is expected to be approximately 6 months for each participant.
In this study, data from regular health visits will be collected. No visits or tests are required as part of this study.
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Following the manner of observational study, no intervention will be provided in the study.
The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.
| Study group | Role | What they receive |
|---|---|---|
| mHSPC patients to treat with darolutamide in combination with docetaxel and ADT | Patients over the age of 18 years with a diagnosis of mHSPC and for whom a decision to treat with darolutamide in combination with docetaxel and ADT has been made by the treating physician before study enrollment. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with cardiac treatment-emergent adverse events (TEAEs)
Incidence of cardiac disorders (TEAEs based on MedDRA SOC), including severity, seriousness, onset date and outcome.
Measured: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Outcomes of cardiac TEAEs
Causal relationship (i.e. if a specific AE is related to daroluatmide) between darolutamide and cardiac disorders.
Measured: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Dose modifications due to cardiac TEAEs
Action taken related to darolutamide (dose modifications and time periods).
Measured: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Secondary outcomes (5)
Number of participants with adverse events (AEs)
Occurrence of AEs, including severity, seriousness, onset date and outcome. Adverse event (AE): Any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship (association) with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the product, whether or not related to the product.
Measured: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Patient demographics/characteristics
All background data such as patient demographics, diagnosis and prior treatment, past medical history, concomitant diseases, and concomitant medications.
- Baseline characteristics (vital signs, Gleason Score, ECOG PS, PSA)
- Prostate cancer history
- Prior and ongoing Co-morbidities
- Darolutamide, GnRH agonist/antagonist, docetaxel use:
- Initiation and termination dates and reasons for ending treatment.
Measured: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Descriptive summary of dosing patterns of darolutamide
Measured: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Outcomes of AEs
Causal relationship (i.e. if a specific AE is related to daroluatmide) between darolutamide and AE/ADR, and action taken related to darolutamide (dose modifications and time periods).
Measured: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Dose modifications due to AEs
Dosing patterns.
Measured: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start9 Oct 2023
- Primary completion16 Mar 2026
- Study completion31 Jan 2027 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010914
- Sponsor's protocol ID
- 22523
- Acronym
- DADOX
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2023
- Last updated
- 18 Jun 2026
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Darolutamide in Addition to Standard Androgen Deprivation Therapy (ADT) and Docetaxel in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- ClinicalTrials.gov ID
- NCT06010914
- Acronym / sponsor ID
- DADOX / 22523
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 25 Aug 2023 (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 data are collected from participants receiving their usual treatment.
In this study, data will be collected and studied from men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is a common cancer in men that starts in 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 testosterone, a male hormone, and slows down the growth of cancer cells.
Men with mHSPC and who have been decided by their own doctors to be treated with darolutamide in combination with ADT and docetaxel can join this study. Darolutamide works by blocking the testosterone signals to slow the growth of the cancer cells. Docetaxel is a medicine used to treat different types of cancer. It works by stopping the growth and spread of cancer cells.
Darolutamide in combination with docetaxel and ADT is an approved treatment for men with mHSPC. It was approved based on a study called ARASENS. More information is needed on how safe darolutamide is when given with ADT and docetaxel in Japanese men with mHSPC.
The main purpose of this study is to collect information about the safety of this combination treatment in Japanese participants with mHSPC under real-world conditions.
The main information that researchers will collect:
Number and severity of heart-related medical problems participants have during the treatment
Other information that researchers will collect:
Number and severity of all medical problems participants have during the study
Age and other information about the participants such as their illness, medical history, and other medicines taken at the same time
Treatment pattern of darolutamide such as the amount of medicine given, the duration for which it is given, and any changes made to the treatment
Data will be collected from August 2023 to July 2026. Researchers will observe participants from the start of darolutamide treatment until 30 days after they receive their last dose of docetaxel, which is expected to be approximately 6 months for each participant.
In this study, data from regular health visits will be collected. No visits or tests are required as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mHSPC patients to treat with darolutamide in combination with docetaxel and ADT | – | Other: No InterventionPatients over the age of 18 years with a diagnosis of mHSPC and for whom a decision to treat with darolutamide in combination with docetaxel and ADT has been made by the treating physician before study enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients with a diagnosis of mHSPC will be enrolled after the decision for treatment with darolutamide in combination with docetaxel and ADT has been made by the physician or a delegate.
Key inclusion criteria (6 listed)
- Men over the age of 18 years
- Histologically or cytologically confirmed adenocarcinoma prostate cancer
- Metastatic disease confirmed either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan
- Patients diagnosed with mHSPC by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with darolutamide plus ADT and docetaxel therapy by the investigator under routine clinical practice
- ADT (GnRH agonist/antagonist or orchiectomy) before or simultaneous treatment with darolutamide
Key exclusion criteria (3 listed)
- Participation in an investigational program with interventions outside of routine clinical practice
- Contraindications according to the local marketing authorization
- Previous treatment with darolutamide
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 |
|---|---|---|
| No InterventionFollowing the manner of observational study, no intervention will be provided in the study. The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information. | Other | mHSPC patients to treat with darolutamide in combination with docetaxel and ADT |
Primary outcome
Number of participants with cardiac treatment-emergent adverse events (TEAEs)
Time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Incidence of cardiac disorders (TEAEs based on MedDRA SOC), including severity, seriousness, onset date and outcome.
Outcomes of cardiac TEAEs
Time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Causal relationship (i.e. if a specific AE is related to daroluatmide) between darolutamide and cardiac disorders.
Dose modifications due to cardiac TEAEs
Time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Action taken related to darolutamide (dose modifications and time periods).
5 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Patient demographics/characteristics
Time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Descriptive summary of dosing patterns of darolutamide
Time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Outcomes of AEs
Time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
Dose modifications due to AEs
Time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel
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 18 Jun 2026.
- 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.
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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. 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 (mHSPC), run by Bayer at 1 site in Japan.
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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 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 Japan. 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?
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?
Number of participants with cardiac treatment-emergent adverse events (TEAEs) (time frame: From the start of darolutamide treatment to 30 days after the last dose of docetaxel). The study lists 3 primary outcomes in all. 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 18 Jun 2026.