Skip to Accessibility Tools Skip to Content Skip to Footer

FDA Approves New Drug for Metastatic Castration-Sensitive Prostate Cancer

The FDA approved apalutamide (Erleada) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC). This provides an important addition to the prostate cancer treatment toolbox since mCSPC often does not respond to testosterone deprivation drugs (also called androgen-deprivation therapy, or ADT) alone.1 Initially, apalutamide was approved in 2018 for non-metastatic castration-resistant prostate cancer.2 New drugs for metastatic prostate cancer are important since once cancer spreads from the initial site, it is harder to treat effectively.

What is metastatic castration-sensitive prostate cancer?

Treating prostate cancer varies depending on how aggressive the cancer is, how advanced it is, and a person’s overall health.4 When prostate cancer is classified as “metastatic”, it means the cancer has spread to other areas of the body outside of the prostate. “Castration-sensitive” means the cancer slows its growth or stops growing when testosterone (androgen) levels in the body are lowered. This is done either by drugs or by removal of the testicles (orchiectomy). This means that while mCSPC has spread to other parts of the body besides the prostate, treatments that target testosterone levels in the body to lower them, as well as treatments that block testosterone receptors, may be beneficial. Sometimes this is also referred to as metastatic hormone-sensitive prostate cancer (mHSPC).3

How was apalutamide studied?

Apalutamide was approved based on the phase III TITAN trial. The trial consisted of 1,052 patients with mCSPC who received either oral apalutamide daily plus ADT, or placebo plus ADT.1 The main endpoints of the trial that scientists were measuring were radiographic progression-free survival (rPFS) and overall survival (OS).1 In other words, they were measuring the survival without the disease spreading further, as well as overall survival rates.

Apalutamide with ADT resulted in better overall survival than ADT alone, with a reduction in mortality risk of 33 percent.1 There was also a 52 percent reduction in the risk of radiographic progression-free survival.1 Those taking the combination also had more significant declines in prostate-specific antigen (PSA) levels than those taking placebo.1

How to take apalutamide

Apalutamide is an androgen receptor (AR) inhibitor. This means the drug inhibits androgen, or testosterone, in the body. The FDA’s recommended dose for apalutamide is 240 mg (4 tablets of 60 mg each), taken by mouth once a day. It can be taken with or without food. Men with metastatic castration-sensitive prostate cancer should also receive a gonadotropin-releasing hormone analog (a drug that can help slow the progression of testosterone-receptor positive or sensitive cancers) while taking apalutamide or undergo a bilateral orchiectomy.1

As with any medication, there are possible adverse reactions or effects. Common adverse side effects seen in the trial include fatigue, rash, high blood pressure, diarrhea, joint pain, lowered appetite, weight loss, fall, and fracture.2 This doesn’t mean that everyone taking the drug will have these effects, but it’s something to keep in mind. Talk to your doctor to learn more.

  1. Targeted Oncology. FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer. Available at: Published September 18, 2019. Accessed September 18, 2019.
  2. FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer. US Food & Drug Administration. Published September 18, 2019. Accessed September 18, 2019.
  3. Treatment Advances in Metastatic Hormone-Sensitive Prostate Cancer. UroToday. n.d. Accessed September 18, 2019.
  4. Prostate Cancer: Diagnosis & Treatment. Mayo Clinic. Published April 17, 2019. Accessed September 18, 2019.