What Patients Should Know About NUBEQA’s Growing Importance in Prostate Cancer Care

This type of treatment has become an increasingly important part of therapy for advanced prostate cancer.

NUBEQA was originally approved by the U.S. Food and Drug Administration in 2019 for non-metastatic castration-resistant prostate cancer, meaning prostate cancer that had stopped responding adequately to hormone suppression but had not yet been seen spreading to distant parts of the body.

“NUBEQA, or darolutamide, is the fourth in a list of novel hormonal agents — or second generation androgen receptor directed therapies that we now have in the market,” says Dr. David Wise, medical oncologist, cancer researcher and director of urologic medical oncology at NYU Langone Perlmutter Cancer Center.

“It really was developed in a very specific way,” Dr. Wise explains to SurvivorNet. “And the most recent approval, which has really led to its incorporation into the standard of care for many men, is its incorporation into the triplet therapy paradigm for men who are diagnosed with metastatic hormone sensitive prostate cancer.”

When is NUBEQA Used in Advanced Prostate Cancer Treatment?

One of the most important updates for patients occurred on June 3, 2025.

The FDA approved darolutamide for men with metastatic castration-sensitive prostate cancer, or mCSPC, based on results of the phase 3 ARANOTE trial. This means darolutamide can now be combined with ADT without automatically requiring docetaxel chemotherapy.

Researchers studying the trial found that adding darolutamide reduced the risk of radiographic progression or death by 46% compared with ADT alone.

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In statistical terms, the hazard ratio was 0.54. The benefit was seen across important patient groups, including men with both high-volume and low-volume metastatic disease.

Darolutamide also delayed progression to metastatic castration-resistant prostate cancer, the stage at which the cancer begins growing despite testosterone suppression.

Dr. Wise continues to describe the specificities that warrant the use of NUBEQA, which was first approved by the Food and Drug Administration (FDA) in July 2019 for non-metastatic castration-resistant prostate cancer (when cancer has not spread but is no longer responding to hormone therapy), and then subsequently approved for use in the following specific metastatic cases in August 2022.

For many years, treatment for metastatic hormone-sensitive prostate cancer centered on ADT. Doctors now know that adding another effective therapy early can substantially delay progression and, with several treatment approaches, improve outcomes.

The question is increasingly which additional treatment — or combination of treatments — is right for a particular patient. For some men, chemotherapy is appropriate.

For others — because of age, frailty, other medical problems, the extent of their disease or simply the balance of risks and benefits — doctors may favor intensive hormonal treatment without chemotherapy.

“At the time of initial diagnosis, if a man has more than four bone metastases with one outside the spine or pelvic area or with metastasis in the lung or liver, and the oncologist believes that these men need chemotherapy and hormonal suppression, we now have data that these men should not be treated with just those two medications, or that doublet,” Dr. Wise says.

“The chemo-hormonal therapy doublet should not be the standard anymore. It should always be a triplet of chemotherapy plus hormonal suppression plus NUBEQA.”

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NUBEQA is Only Used When Advanced Prostate Cancer Patients Require Chemotherapy

Dr. Wise clarifies that not all men with metastatic hormone-sensitive prostate cancer need chemotherapy. In many instances, there are men who don’t.

“There are many men with low volume disease who are asymptomatic,” he says, meaning that they are not showing symptoms, or who “have a minimal burden of disease.”

Additionally, men who are older “and more frail and may really have their quality of life unnecessarily diminished with chemotherapy” may opt to forego chemo, or rather, their doctors may advise them to forego that treatment.

“If the oncologist deems that that patient should be treated with hormonal suppression, the most common of which is leoprolide or relogolix, and docetaxel, which is chemotherapy, then that man should also be treated with maintenance darolutamide, NUBEQA.”

NUBEQA Has Shown Improved Side Effects in Trials Compared to Other Therapies

Though NUBEQA has shown “a similar side effect profile” compared to the “other next generation hormonal therapies,” according to Dr. Wise, those side effects were shown to have “an impressive improvement” during trials.

“So that’s really been the big change,” he says. “Probably the most talked about — is the lower rates of fatigue and mental fog that are observed with darolutamide (NUBEQA), at least based on the trials that were reported in non-metastatic but hormone-resistant prostate cancer, where we did see an impressive improvement relative to hormonal suppression alone.”

“Across the board, the bane of chemotherapy is fatigue,” Dr. Neal Shore, Medical Director for the Carolina Urologic Research Center in Myrtle Beach, told SurvivorNet in a previous conversation. “Nubeqa, which is otherwise well-tolerated, is no exception.”

As Dr. Shore points out: “Fatigue is often compounded by the patient’s advanced age.”

Other common side effects include:

• Arm, leg, hand, or foot pain
• Rash
• A decrease in white blood cell count (neutropenia)
• Changes in liver function
• A rise in blood pressure
• A lowered ability to fight infections

It’s important to get in touch with your doctor right away if you experience any of the following side effects:

• Severe ongoing nausea or diarrhea
• Painful or difficult urination
• Blood in your urine
• Severe headache, blurred vision, pounding in your neck or ears
• Slowed heart rate, weak pulse, fainting, slow breathing
• Signs of a blood clot in the lung, which can be experienced as chest pain, sudden cough, wheezing, and rapid breathing
• Signs of a lung infection, which can be experienced with fever, chills, cough with mucus, chest pain, shortness of breath

Get emergency help right away if you experience signs of an allergic reaction to Nubeqa, which includes:

• Hives
• Difficulty breathing
• Swelling of your face, lips, tongue, or throat

Questions to Ask Your Doctor

Here are some questions you may consider asking your doctor to help understand your situation and whether this drug may make sense for you:

• Am I eligible to take Nubeqa alone or with another drug?
• What side effects can I expect and how will we manage them?
• Am I more or less likely to respond to this treatment?
• What part of my treatment is covered by insurance, and how much can I expect to pay out of pocket?
• Are there any clinical trials I should consider?

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