A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

To join this study, you must be a man aged 18 or older with prostate cancer that has spread to other parts of your body. Doctors must have confirmed your prostate cancer diagnosis, and scans need to show that it has spread, typically to your bones. If it's only spread to one bone, further scans like CT or MRI will be needed to confirm this.

You should generally be in good health and able to carry out your normal daily activities without too much difficulty. If you've had certain other treatments for your prostate cancer, such as some chemotherapy (like Docetaxel), radiation, or surgery, there are specific timeframes and conditions you need to meet. For instance, if you received Docetaxel, it must have been no more than 6 cycles, and the last dose must have been within the last two months, with your cancer remaining stable or improving.

It's important that you haven't had other types of prostate cancer that are very rare, or prostate cancer that has spread to your brain. You also can't have had certain other anti-cancer treatments very recently, or have a history of seizures. Your doctor will carefully review all your medical information to see if this study is right for you.

If you decide to take part, the study will involve several phases. First, there's a 'screening' phase (up to 28 days) to make sure you're suitable. If you qualify, you'll then enter the 'treatment' phase. During this time, you'll receive your assigned study medication (either Apalutamide or placebo) along with your regular hormone therapy. You'll take the study medication in 28-day cycles, continuing until your cancer progresses or if the side effects become too much to handle. Neither you nor your doctor will know if you're receiving the active drug or the placebo during this main treatment phase.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. Your safety will be closely watched. After you finish the main treatment, there will be an 'end of treatment' phase (up to 30 days). Following this, there's a 'survival follow-up' phase to keep track of your health long-term. If the study shows positive results, participants might have the opportunity to continue receiving the active drug (Apalutamide) for several years in an 'Open-label Extension' phase, where everyone knows they are getting the active drug, and potentially even longer if your doctor believes you are still benefiting. The total duration of your involvement could range from several months to many years, depending on the phase you enter and how you respond to treatment.