Drug Before Therapy Improves High-Risk Prostate Cancer Outcomes
Men diagnosed with high-risk prostate cancer may have a new option to consider before surgery. A clinical trial known as PROTEUS found that adding the drug apalutamide to standard hormone therapy reduced the risk of cancer returning or spreading in patients with high-risk, non-metastatic disease.
What the Trial Found
The study tracked more than 2,100 men with high-risk, non-metastatic hormone-sensitive prostate cancer who were scheduled for surgery. One group received androgen deprivation therapy (ADT) plus apalutamide before their operation. The other received ADT plus a placebo.
After roughly five years of follow-up, the group taking apalutamide showed meaningfully better results. Those receiving the drug had a 29% lower risk of their cancer coming back and a 20% reduction in the chance of metastasis developing.
The five-year metastasis-free survival rate was 78.2% for the apalutamide group compared to 73.5% for the placebo group.
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How Apalutamide Works
Apalutamide belongs to a class of drugs called androgen receptor inhibitors. It works by blocking signals from male hormones like testosterone that can fuel prostate cancer growth. Even when ADT successfully lowers androgen levels, some cancer cells can still respond to residual hormones. The drug is already approved by the U.S. Food and Drug Administration for a different stage of prostate cancer under the brand name Erleada.
The PROTEUS trial tested whether using the drug earlier could change the disease trajectory. It was a phase 3 randomized trial, which represents the strongest level of clinical evidence.
Side Effects to Consider
ADT alone carries its own burden, including hot flashes, fatigue, loss of libido, bone density loss, and cardiovascular effects. The drug has a relatively favorable profile compared to some other androgen receptor inhibitors, with lower rates of fatigue, falls, and cognitive effects.
For older men weighing treatment options, the tolerability differences may matter. Patients should discuss their individual health profile—including age, cardiovascular history, and bone health—with their oncologist before deciding whether to add apalutamide to their treatment plan.
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What Patients Should Discuss
For men recently diagnosed with high-risk prostate cancer, the findings raise a practical question: Is ADT alone still the right approach before surgery, or should apalutamide be added? Patients are encouraged to ask their oncologist whether the drug is appropriate for their specific disease characteristics and what the evidence shows for their situation.
Doctors also recommend asking about advanced imaging techniques such as PSMA PET scans. These tests can detect cancer spread that conventional imaging misses, which matters for determining whether someone truly has non-metastatic disease and what treatment path makes sense.
The trial results were presented at the 2026 American Society of Clinical Oncology Annual Meeting.
