(BPT) – We’ve all heard of prostate cancer. Prostate cancer is the most common form of cancer in American men after skin cancer and one of the leading causes of cancer deaths. About 1 man in 9 will be diagnosed with prostate cancer during his lifetime. If you or a loved one is diagnosed, there are a few important things to know.

Risk factors for prostate cancer include: increasing age, African ancestry, family history of the disease, certain inherited genetic conditions, as well as other factors with less clear effects (ie, diet, chemical exposure, smoking).

Starting at age 50, the American Cancer Society recommends men begin screening after a risk and benefit discussion with their doctor. A PSA (prostate-specific antigen) test is a simple and important blood test, and is a critical tool used to screen and monitor patients. It’s important to talk to your doctor about your risks of prostate cancer and both the risk and potential benefits of prostate cancer screening. If you have a family history of prostate cancer, you are at greater risk of developing prostate cancer and should have informed discussions about prostate cancer screening with your healthcare provider starting at age 45.

Here are 3 things to know about this prevalent disease:

1. Delaying the spread of prostate cancer is critical. When prostate cancer is confined to the prostate gland, it is called localized prostate cancer. Treatment options depend on your individual condition and other factors, and include active surveillance, watchful waiting, surgery, and radiation therapy. Many men respond to treatment at this stage and do not need further treatment. In fact, the 5-year relative survival rate approaches 100% for patients whose prostate cancer is diagnosed at a local or regional stage, compared to 30% for prostate cancer diagnosed at a distant stage.
2. It is important to monitor the progression of your prostate cancer. For some, treatment of early stages of the disease is not enough, and the cancer may progress. These men may receive hormone treatment called androgen deprivation therapy, or ADT. This type of treatment is given to reduce or block the production and action of male hormones (androgens) in the body, such as testosterone, which can help fuel prostate cancer cells. ADT is often an effective treatment; however, after time, some prostate cancer can continue to adapt and progress, as indicated by rising PSA levels. Prostate cancer that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone is called non-metastatic castration-resistant prostate cancer, or nmCRPC. Men with nmCRPC are at risk of developing metastasis, which happens when the cancer spreads to other parts of the body. The most common sites where prostate cancer can spread are to the bones, lymph nodes, liver, lungs, and brain.
3. There are options for treatment for nmCRPC. Until recently, men with nmCRPC had limited treatment options. Today, however, there are new treatments available that may help delay the spread of cancer in certain men with nmCRPC.

ERLEADA^® (apalutamide) is the first approved treatment for prostate cancer that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone.

A clinical trial showed ERLEADA^® and ADT helped delay the spread of cancer to other parts of the body or delay death by 24.3 months for certain patients compared to placebo plus ADT. For the group who received ERLEADA^® plus ADT, the median number of months living without metastasis was 40.5 months compared to 16.2 months in the group who received placebo plus ADT. ERLEADA^® and ADT work together to lower androgens that help fuel the prostate cancer. If prescribed ERLEADA^®, you should know about some of the serious side effects associated with the therapy and talk with your doctor if you have concerns. Serious side effects can include falls, fractures, and seizures. In clinical trials, the most common side effects were: fatigue, high blood pressure (hypertension), hypothyroidism, rash, diarrhea, nausea, weight loss, joint pain (arthralgia), falls, hot flush, decreased appetite, fractures, and swelling in the limbs (peripheral edema). Please see additional Important Safety Information below.

It is critical to get informed and act, especially if you are at a greater risk or are experiencing new symptoms, so you can fully understand your options. Now you may have an option to help you keep fighting.

“I tell all my patients that it’s important for them to learn about their disease and know if it’s progressing. Don’t just research — ask, learn, and get more involved. I want patients becoming knowledgeable and part of the decision team regarding their disease with their practitioner. Additionally, it is critical for them to have a sense of urgency if the disease progresses,” says Dr. Kenneth Kernen, urologist and Director of Research at the Michigan Institute of Urology.

This content is provided by Janssen Biotech, Inc. Visit www.ERLEADA.com for more information.

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IMPORTANT SAFETY INFORMATION

Do not take ERLEADA^® (apalutamide) if you:

• are pregnant or may become pregnant. ERLEADA^® may harm your unborn baby.
• are female. ERLEADA^® is not for use in women.

Before taking ERLEADA^®, tell your healthcare provider about all your medical conditions, including if you:

• have a history of seizures, brain injury, stroke, or brain tumors.
• have a partner who is pregnant or may become pregnant. Men who are sexually active with a pregnant woman must use a condom during and for 3 months after treatment with ERLEADA^®. If your sexual partner may become pregnant, effective birth control (contraception) must be used during and for 3 months after treatment. Talk with your healthcare provider if you have questions about birth control.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERLEADA^® can interact with many other medicines.

You should not start or stop any medicine before you talk with the healthcare provider that prescribed ERLEADA^®.

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take ERLEADA^®?

• Take ERLEADA^® exactly as your healthcare provider tells you.
• Take your prescribed dose of ERLEADA^® 1 time a day, at the same time each day.
• Take ERLEADA^® with or without food.
• Swallow ERLEADA^® tablets whole.
• Your healthcare provider may change your dose if needed.
• Do not stop taking your prescribed dose of ERLEADA^® without talking with your healthcare provider first.
• If you miss a dose of ERLEADA^®, take your normal dose as soon as possible on the same day. Return to your normal schedule on the following day. You should not take extra tablets to make up the missed dose.
• You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with ERLEADA^® unless you had a surgery to lower the amount of testosterone in your body (surgical castration).
• If you take too much ERLEADA^®, call your healthcare provider or go to the nearest hospital emergency room.
• Your healthcare provider may do blood tests to check for side effects

What are the possible side effects of ERLEADA^®?

ERLEADA^® may cause serious side effects including:

• Falls and fractures. ERLEADA^® treatment can cause bones and muscles to weaken and may increase your risk for falls and fractures. Falls and fractures have happened in people during treatment with ERLEADA^®. Falls were not caused by loss of consciousness (fainting) or seizures. Your healthcare provider will monitor your risks for falls and fractures during treatment with ERLEADA^®.
• Seizure. If you take ERLEADA^®, you may be at risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have a loss of consciousness or seizure. Your healthcare provider will stop ERLEADA^® if you have a seizure during treatment.

The most common side effects of ERLEADA^® include:

• feeling very tired
• high blood pressure
• rash
• diarrhea
• nausea
• decreased appetite
• weight loss
• joint pain
• fall
• hot flash
• bone injury (fracture)
• swollen hands, ankles, or feet

ERLEADA^® may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. Do not donate sperm during treatment with ERLEADA^® and for 3 months after the last dose of ERLEADA^®.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ERLEADA^®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information for ERLEADA^®.

INDICATION

What is ERLEADA^®?

ERLEADA^® (apalutamide) is a prescription medicine used to treat prostate cancer that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone.

It is not known if ERLEADA^® is safe or effective in children.