How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: darolutamide plus ADT treatment.
- Who it may be relevant to
- Registry conditions: Metastatic Hormone-sensitive Prostate Cancer (mHSPC). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug darolutamide plus ADT treatment
2\*300 mg darolutamide twice daily + ADT treatment
Primary outcome measures
- Number of participants with PSA < 0.2 ng/mL [Time frame: 12 months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Many — Locations
Identifiers
NCT: NCT07395804 · 23146