How a New Prostate Cancer Treatment Works in Real-World Care

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What is this trial?

This real-world study is following men in Germany who are being treated with darolutamide combined with standard hormone therapy for advanced prostate cancer that has spread to other parts of the body. Darolutamide is a newer type of medication that helps block male hormones from fueling cancer cell growth. The study will track how well this medication combination works over 5 years by measuring PSA levels in the blood and monitoring how patients do.

Doctors want to understand how effective this medication combination is in everyday clinical practice — not just in controlled research settings. By studying real patients receiving this treatment through their normal medical care, researchers can learn whether it truly helps men live longer and achieve better cancer control.

Do you qualify?

You likely qualify if…

you are a man aged 18 or older
you have been diagnosed with advanced prostate cancer that has spread to other parts of your body and still responds to hormone therapy
you have imaging scans confirming your cancer has spread (metastatic disease)
your doctor has decided to treat you with darolutamide plus hormone therapy as part of your routine care
you are willing to sign a consent form giving permission to use your medical information for this study

You likely don't qualify if…

you have already been taking darolutamide for more than 30 days before joining the study
you started hormone therapy more than 12 weeks before starting darolutamide
you are allergic to darolutamide or any ingredient in the medication
you have received other hormone treatments or anti-cancer drugs for this type of advanced prostate cancer in the past
you are currently enrolled in another prostate cancer research study that involves experimental treatments outside of routine care

What participation looks like

You would continue receiving your regular medical care with darolutamide and hormone therapy as your doctor has prescribed. During your normal clinic visits over the next 5 years, your doctors will collect information from your medical records and talk with you about your health, any side effects, and how you are doing. Your blood work (including PSA levels) will be monitored as part of your regular care. The study does not require extra visits or procedures — all data collection happens during your routine appointments.

How a New Prostate Cancer Treatment Works in Real-World Care

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)