WHAT IS NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER?

Your doctor may have talked to you about non-metastatic castration-resistant prostate cancer, or cancer that has not spread to other parts of the body and no longer responds to ADT. ADT refers to a medical or surgical treatment that lowers testosterone to delay the growth of prostate cancer.

If you have non-metastatic castration-resistant cancer, NUBEQA^® may be able to help

See clinical study results with NUBEQA

Understanding non-metastatic castration-resistant prostate cancer

Non-metastatic means that the cancer has not spread to other parts of the body. ADT, or hormone therapy, is a mainstay of treatment in prostate cancer. Over time, however, prostate cancer can keep growing even when the amount of testosterone in the body is reduced to very low levels. When this happens, the level of prostate-specific antigen, or PSA, in the bloodstream may rise even if you are on ADT. At this point, the prostate cancer is considered castration-resistant, which means it no longer responds to ADT.

Men with non-metastatic castration-resistant prostate cancer may not show symptoms. This makes PSA testing important, both to diagnose non-metastatic castration-resistant prostate cancer and to determine the appropriate next steps for treatment.

Treatment goals in non-metastatic castration-resistant prostate cancer generally include:

Delaying the cancer from spreading

Extending life

Delaying disease-related pain

Delaying the need for chemotherapy

Ultimately, your treatment goals are personal decisions to be made between you and your care team.

What is the difference between metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer?

There are 2 main differences:

Metastatic castration-sensitive prostate cancer means that the prostate cancer has spread to other parts of the body. Non-metastatic prostate cancer means that the prostate cancer has not spread.
Metastatic castration-sensitive prostate cancer is castration-sensitive, meaning the prostate cancer responds to ADT, or hormone therapy. Non-metastatic castration-resistant prostate cancer is not castration-sensitive, meaning the level of prostate-specific antigen in the bloodstream may rise even if you are on ADT, making it castration-resistant. Although the disease may develop a resistance to ADT, it's still important to continue ADT to keep testosterone levels low.

Graphic showcasing differences between metastatic and non-metastatic prostate cancer

Learn more about metastatic castration-sensitive prostate cancer

Download our patient brochure to learn more about these types of prostate cancer and NUBEQA

Download patient brochure (ENGLISH)

Download patient brochure (SPANISH)

Important Safety Information

Before taking NUBEQA, tell your healthcare provider about all your medical conditions, including if you:

have heart problems, high blood pressure, diabetes, or high amounts of fat or cholesterol in your blood (dyslipidemia)
have a history of seizures, brain injury, stroke, or brain tumors
have kidney or liver problems
are pregnant or plan to become pregnant. NUBEQA can cause harm to your unborn baby and loss of pregnancy (miscarriage)
have a partner who may become pregnant. Males who have female partners who may become pregnant should use effective birth control (contraception) during treatment and for 1 week after the last dose of NUBEQA. Talk with your healthcare provider about birth control methods
are breastfeeding or plan to breastfeed. It is not known if NUBEQA passes into breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NUBEQA may affect the way other medicines work and other medicines may affect how NUBEQA works.

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

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.

NUBEQA may cause serious side effects, including:

Heart disease. Blockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with NUBEQA. Your healthcare provider will monitor you for signs and symptoms of heart problems during your treatment with NUBEQA. Call your healthcare provider or get medical help right away if you get chest pain or discomfort at rest or with activity, or shortness of breath during your treatment with NUBEQA.
Seizure. Treatment with NUBEQA may increase your 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 loss of consciousness or seizure during treatment with NUBEQA.

The most common side effects of NUBEQA include:

increase in liver function tests
decreased white blood cells (neutropenia)
feeling more tired than usual

The most common side effects of NUBEQA in combination with docetaxel include:

constipation
rash
decreased appetite
bleeding
weight gain
high blood pressure
decreased red blood cells (anemia)
high blood sugar levels
decreased white blood cells
increase in liver function tests
low blood calcium levels

NUBEQA 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.

These are not all the possible side effects of NUBEQA.

Call your healthcare provider for medical advice about side effects. You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see the full Prescribing Information.

WHAT IS NUBEQA<sup>®</sup>?

NUBEQA^® (darolutamide) is a prescription medicine used to treat adults with 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
that has spread to other parts of the body and responds to a medical or surgical treatment that lowers testosterone
that has spread to other parts of the body and responds to a medical or surgical treatment that lowers testosterone in combination with docetaxel.

It is not known if NUBEQA is safe and effective in females or children.

Date of last update: 7/2/2025

WHAT IS NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER?

Important Safety Information

WHAT IS NUBEQA<sup>&reg;</sup>?

WHAT IS NUBEQA<sup>®</sup>?