An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

To join this study, you need to be a man aged 18 or older with prostate cancer that has spread to other parts of your body. Your cancer must also show a certain marker called PSMA on a special scan. You should feel well enough to go about your daily activities with only minor limitations, and your doctors should expect you to live for at least nine more months.

Your blood tests for your liver and bone marrow need to be within a healthy range, as these are important for your body to handle treatments. Importantly, you must have agreed to participate by signing a consent form before any study procedures begin.

There are also specific requirements about how your cancer has spread, for example, if it's in your bones, lymph nodes, or other organs. The study team will check all these details carefully using scans and other tests to make sure the study is right for you.

If you join this study, you'll first have a screening period to check if you're suitable. This will involve blood tests, a full health check, and a special scan called a 68Ga-PSMA-11 PET/CT to confirm your cancer has the PSMA marker. You will also have bone scans.

Once enrolled, you'll be randomly assigned to one of two groups: either you'll receive the new treatment (177Lu-PSMA-617) along with your usual hormone therapy, or you'll receive only your usual hormone therapy. Usually, you wouldn't know which group you are in, but this study is 'open-label' meaning you and your doctor will know. The total study duration for each patient is around 50 months, which is a little over four years. This includes regular follow-up appointments and scans to monitor your health and how the treatment is working. Some participants may also be asked to join a separate long-term safety study.