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Adding apalutamide (Erleada) to androgen deprivation therapy (ADT) before and after prostate cancer surgery helped people with high-risk localized prostate cancer live longer without the cancer metastasizing (spreading) or recurring (coming back), according to results from the phase 3 PROTEUS trial.
People who received apalutamide plus ADT had a 20 percent lower risk of metastasis or death than those who received ADT plus a placebo (inactive treatment). They also lived longer without recurrence or other cancer-related events — a median of 57.1 months versus 38.4 months.
This matters because high-risk localized prostate cancer can recur after treatment. Standard treatments often include surgery, radiation, ADT, or a combination of these approaches. But many people with high-risk disease still face a chance of recurrence.
The treatment studied in PROTEUS combined apalutamide with ADT.
ADT, a type of hormone therapy, lowers the amount of androgens (such as testosterone) in the body. Androgens can help prostate cancer cells grow.
Approved by the U.S. Food and Drug Administration (FDA) in 2018, apalutamide is an androgen receptor pathway inhibitor. It helps block prostate cancer cells from using androgen signals to grow and spread.
The trial included 2,109 people with high-risk localized prostate cancer who had not yet received treatment for their cancer. Participants were treated at 118 hospitals in 18 countries. Half received apalutamide plus ADT, and half received a placebo plus ADT.
The study met both of its main goals.
The combination also improved event-free survival, meaning that study participants who received apalutamide plus ADT didn’t experience cancer recurrence or other cancer-related events. Median event-free survival was 57.1 months with apalutamide plus ADT compared with 38.4 months with a placebo plus ADT.
As with any medical treatment, apalutamide and ADT can both cause side effects. Researchers found that participants who received both experienced more serious treatment-related side effects than those who received ADT plus a placebo.
Rash was the side effect most clearly linked to apalutamide, although most people who had a rash were able to restart the drug after the rash improved.
Common side effects of ADT for prostate cancer include:
These results may help doctors better understand how to treat high-risk localized prostate cancer earlier, before the disease has spread. For people facing treatment decisions, the findings may open conversations about new treatment options.
If you’re living with prostate cancer or have recently been diagnosed, ask your cancer care team what treatment options may be available for your individual condition. Your doctor can help explain the potential benefits and risks of each approach.
On MyProstateCancerTeam, people share their experiences with prostate cancer, get advice, and find support from others who understand.
How well is your current treatment plan working? Let others know in the comments below.
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