How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany

Официальное название

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

Обзор

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.

Вмешательства

• Препарат darolutamide plus ADT treatment
  2\*300 mg darolutamide twice daily + ADT treatment

Первичные конечные точки

• Number of participants with PSA < 0.2 ng/mL [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Number of deaths or participants with end of observation [Срок оценки: up to 60 months]
• Number of participants with PSA < 0.2 ng/mL [Срок оценки: 3, 6, and 9 months]
• Number of participants with certain demographic characteristics [Срок оценки: at study start]
• Number of participants with certain clinical characteristics [Срок оценки: at study start]
• Number of participants with certain testosterone value [Срок оценки: at study start]
• Duration of Darolutamide+ADT treatment [Срок оценки: up to 60 months]
• Timing of Darolutamide+ADT treatment start [Срок оценки: up to 60 months]
• Kind of ADT treatment [Срок оценки: up to 60 months]
• Number of participants who change ADT treatment [Срок оценки: up to 60 months]
• Number of participants who change dosage of Darolutamide treatment [Срок оценки: up to 60 months]
• Number of participants with certain reasons for darolutamide plus ADT treatment discontinuation [Срок оценки: up to 60 months]
• Number of participants with certain subsequent anti-cancer therapies [Срок оценки: up to 60 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Many — Locations

Идентификаторы

NCT: NCT07395804 · 23146

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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