For men recently diagnosed with prostate cancer, learning that their disease is high-risk can feel like a race against time before surgery begins. High-risk prostate cancer is generally defined as disease that meets any of the following: it has grown beyond the prostate capsule or spread to nearby lymph nodes, it has a Gleason score of 4+4 (8) or higher, or the prostate-specific antigen (PSA) level is above 20.
These features mean the cancer is more likely to have already spread beyond what scans can detect, and more likely to return after surgery alone. For years, the standard approach for these men has been surgery, sometimes preceded by a short course of androgen deprivation therapy (ADT).
New Research and Treatment Options
New research now suggests that adding a second drug before surgery may lower the odds that the cancer comes back or spreads later on. The PROTEUS trial recently presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting shows that the weeks before surgery may be a critical window of opportunity to act, not just prepare.
The trial explored whether adding apalutamide to androgen deprivation therapy (ADT) could delay or prevent metastases from developing in the first place. Apalutamide is a newer type of treatment called an androgen receptor inhibitor.
The PROTEUS Trial
The PROTEUS trial was a phase 3, randomized trial that compared two treatments in more than 2,100 men with non-metastatic hormone-sensitive prostate cancer. One group received ADT plus apalutamide, while the other received ADT plus a placebo prior to undergoing surgery.
After about five years of observation, results showed that apalutamide plus ADT had better outcomes. For example, men who received apalutamide plus ADT had a 29% lower risk of their prostate cancer coming back and a 20% less risk of metastasis when compared to a placebo.
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In addition, the five-year metastasis-free survival was 78.2% with apalutamide and 73.5% for the placebo.
Men who received apalutamide plus ADT had a significantly longer metastasis-free survival, meaning they went longer without their cancer detectably spreading.
Fewer metastases means fewer symptoms, more treatment options preserved for later, and potentially longer survival. Apalutamide also has a relatively favorable side effect profile compared to some other androgen receptor inhibitors.
As older adults weigh their treatment options, this distinction in tolerability may be a relevant factor in shared decision-making with their care team.
Men with prostate cancer can find support and resources to help them handle their diagnosis and treatment options, including learning about support for patients with complex conditions.
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