An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

To join this study, you need to be at least 18 years old and planning to have radiation therapy for your prostate cancer. Your cancer must be confirmed by a biopsy and considered 'high-risk.' This usually means it's more aggressive or has grown to a certain extent within the prostate, but importantly, it shouldn't have spread to distant parts of your body. Your general health should also be good enough, meaning you don't have too many other serious health problems and your organs (like your liver and kidneys) are working well.

You wouldn't be able to join if you've already had long-term hormone therapy for prostate cancer, or if you've had certain other prostate cancer treatments like surgery to remove the prostate, chemotherapy, or previous radiation to the pelvic area. You also can't have had surgery to remove both testicles. Women are not eligible for this study, as it focuses on prostate cancer, which only affects men.

If you join this study, you'll be randomly assigned to one of several treatment groups, meaning you won't choose which treatment you receive. All groups will have radiation therapy as planned by your doctor, usually 74-80 Gy. Depending on your group, you'll also take either the study drug (apalutamide), another hormone drug (bicalutamide), or a dummy pill (placebo), along with a standard hormone injection (GnRH agonist). You'll need to take the study tablets daily and receive regular injections as directed by the study team. You'll have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. These visits will continue throughout your treatment and for a period afterwards to track your progress and any side effects. The total length of your participation, including follow-up, could be several years.