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

Recruiting now

Conditions studied: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

In brief

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.

Key facts

Study ID

NCT07395804

Run by

Bayer

People needed

500

Starts

2026-04-14

Expected to finish

2031-02-15

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Many — Locations, Germany (enrolling)

Full record on ClinicalTrials.gov

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