ESMO 2026: Apalutamide Reduces Metastasis Risk by 51% in Prostate Cancer
Patients treated with apalutamide plus androgen-deprivation therapy before and after surgery for high-risk localized prostate cancer experienced a 62 percent improvement in event-free survival, according to a substudy presented at the European Society for Medical Oncology Congress 2026 in Madrid, Spain.
Key Clinical Takeaways:
- Apalutamide combined with hormone therapy before and after surgery reduced the risk of metastasis or death by 51 percent compared to radical prostatectomy alone in a 408-patient trial.
- The combination therapy decreased the risk of starting subsequent therapy by 71 percent, leaving 50 percent fewer patients requiring additional treatment by 3 years.
- Findings from the substudy were presented by Alberto Briganti, MD, PhD, and published in European Urology, complementing main trial results previously shared at the American Society for Clinical Oncology Annual Meeting.
Trial Enrolls 408 Patients with High-Risk Prostate Cancer
The 1:3 randomized trial enrolled 408 patients with newly diagnosed high-risk localized or locally advanced prostate cancer. Participating individuals received apalutamide combined with androgen-deprivation therapy for six months before and six months after radical prostatectomy accompanied by pelvic lymph-node dissection. The control arm underwent standard-of-care radical prostatectomy alone. Mary-Ellen Taplin, MD, a medical oncologist at Dana-Farber Cancer Institute and principal investigator, noted that the substudy specifically addressed how this aggressive perioperative regimen compares against the standard surgical approach alone.
Apalutamide Protocol Reduces Risk of Metastasis or Death
After a median follow-up of 37.8 months, patients receiving the neoadjuvant and adjuvant apalutamide protocol demonstrated significant clinical benefits across multiple endpoints. Event-free survival events tracked in the protocol included prostate-specific antigen relapse, clinical progression, and detection on PSMA-PET or conventional imaging. Alongside the 62 percent improvement in event-free survival, the combination therapy reduced the risk of metastasis or death by 51 percent. These figures build on earlier research led by Dana-Farber and published in The New England Journal of Medicine, which established that patients receiving apalutamide plus hormone therapy prior to surgery were nine times more likely to show little to no cancer present at the time of operation compared to hormone therapy alone.
Future Treatment Implications
Side effects observed during the trial remained consistent with data from previously reported studies involving apalutamide, an androgen-receptor pathway inhibitor currently approved for metastatic castration-sensitive prostate cancer and nonmetastatic castration-resistant prostate cancer. Following the presentation in Madrid, researchers emphasized that the combined evidence supports the perioperative regimen as a viable treatment path for individuals who are fit for both surgery and systemic therapy.
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