NCT07395804Recruiting
How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany
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
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 2 Feb 2026
- Start date
- 14 Apr 2026
- Primary completion date
- 15 Feb 2031
- Lead sponsor
- Bayer
- Diseases
- Prostate cancer
- NCT number
- NCT07395804
What you commit to
- Study type: Observational
- Planned participants: 500
- From 14 Apr 2026 to the primary completion date, 15 Feb 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Other prior systemic hormonal or anti-cancer treatment for mHSPC
Other illness
- Hypersensitivity to darolutamide or any other excipient
- Participation in an investigational program for prostate cancer with interventions outside of routine clinical practice
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Many Coordinator of this site? Confirm its status | Locations | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.