Apalutamide Plus ADT Improves Outcomes in High-Risk Localized Prostate Cancer
Clinical Summary:
- Design/Population: The phase 3 PROTEUS trial evaulated apalutamide plus androgen deprivation therapy in patients with newly diagnosed high-risk localized or locally advanced prostate cancer who underwent radical prostatectomy with pelvic lymph node dissection.
- Key Outcomes: Apalutamide plus androgen deprivation therapy significantly improved response and survival outcomes compared to placebo.
- Clinical Relevance: Perioperative apalutamide plus androgen deprivation therapy may increase the curative potential of radical prostatectomy in high-risk localized or locally advanced prostate cancer, supporting this combined systemic and surgical approach as a potential new standard of care.
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute, Boston, Massachusetts, discusses results from the phase 3 PROTEUS trial evaluating perioperative apalutamide plus androgen deprivation therapy (ADT) in patients with high-risk localized or locally advanced prostate cancer.
Results demonstrated that the addition of apalutamide significantly improved both pathologic response rates and metastasis-free survival, while also favorably impacting event-free survival, time to distant metastasis, and the need for subsequent therapy.
Dr Taplin presented these results in a plenary session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
Source:
Taplin ME, Gleave M, Shore ND, et al. Perioperative (neoadjuvant and adjuvant) apalutamide (APA) + androgen deprivation therapy (ADT) vs placebo (PBO) + ADT with radical prostatectomy (RP) in high-risk localized or locally advanced prostate cancer (HR LPC/LAPC): Final analysis of the PROTEUS phase 3 study. Presented at the ASCO Annual Meeting. May 29 - June 2, 2026. Chicago, Illinois. LBA1.
