A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

This study is for men aged 18 and over who have prostate cancer that has spread. To be considered, your prostate cancer must have been confirmed by a doctor, and it needs to have continued to grow despite hormone therapy in the last six months. Doctors also need to see clear signs that the cancer has spread, either in your bones or other soft tissues.

You would need to have already been treated with one or two types of hormone-blocking medicines (called ARPIs) for at least eight weeks, and the cancer must have progressed after these treatments. We also need a recent tissue sample from your cancer that wasn't previously treated with radiation.

However, there are reasons why you might not be able to join. For example, if you can't swallow pills, have certain lung conditions, serious heart problems, or have previously had particular chemotherapy or antibody treatments that caused severe side effects. The medical team will check all these details carefully to make sure the study is right for you.

If you join this study, you'll be given either the new medicine, ifinatamab deruxtecan, or standard chemotherapy (docetaxel and prednisone). The specific details about hospital visits, tests, and how often you'd receive medicine would be explained by the study team. You would also receive what's called a 'rescue medication' if needed.

Taking part would involve regular check-ups, scans, and blood tests to monitor your health and how the treatment is working. These appointments are important to ensure your safety and to gather necessary information for the study. The total length of your participation would depend on how your treatment is going, and the study team would discuss this with you. They will explain everything clearly before you decide to join.