Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer

To join this study, you need to be a man aged 18 or over with a confirmed diagnosis of prostate cancer that has spread and is not responding to hormone therapy. Your testosterone levels must be low, and you should be continuing with hormone treatment or have already had surgery to remove your testicles. You will also need to have tried at least one other type of hormone treatment for your prostate cancer, such as abiraterone or enzalutamide. Your general health should be good enough to take part in a study, including good blood test results for your bone marrow, liver, and kidneys, and you must be able to swallow the study medication.

There are some reasons why you wouldn't be able to join. For example, if you have a history of problems with your pituitary or adrenal glands, or if you have cancer that has spread to your brain. You also can't join if you have certain active infections, poorly controlled diabetes or blood pressure issues, or serious heart or blood vessel problems. Certain abnormal blood test results for potassium or sodium, or a heart rhythm problem called a prolonged QTcF interval, would also exclude you. The medical team will check all these details carefully.

As this is an early-stage study, taking part would involve regular visits to the hospital for check-ups, blood tests, and scans to see how you are doing and how your body is reacting to the new medicine, ODM-208. You would be taking the study medication. Doctors will carefully monitor your health and any side effects. The exact number of visits and the full duration of your participation would be explained in detail by the study team, but typically, early studies involve close monitoring over several months, followed by longer-term follow--up to understand the drug's effects.