ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

This study is looking for men who have been recently diagnosed with prostate cancer that has spread to other parts of the body. You must be at least 18 years old and have a confirmed diagnosis from a biopsy.

A key part of this study is that it's for men who might find stronger chemotherapy-type treatments, or other specific hormone-blocking drugs, too difficult because of their general health. To find out if this applies to you, the doctors will check a few things like how easily you can do daily tasks, your weight, and how quickly you can do a short walking test.

Your blood tests (for blood counts, liver, and kidney function) would also need to be within healthy ranges. If you're interested, the study doctors would go through all these details with you to see if the study is a good fit.

If you join this study, you'll be randomly assigned to one of two groups: either you'll receive the new drug (darolutamide) plus standard hormone therapy, or a dummy pill (placebo) plus standard hormone therapy. You'll take the medication twice a day by mouth. You won't know which group you're in, and neither will your doctors, to ensure unbiased results.

You'll have regular visits to the clinic for check-ups, scans, and blood tests to see how you're responding to treatment and to monitor your general health. This treatment will continue for as long as it is helping you, or until you experience side effects that make it too difficult to continue, or if you decide to stop. After you stop the study treatment, the study team will continue to check on your health and any long-term effects for up to 10 years.