Apalutamide Plus ADT Improves Outcomes in High-Risk Prostate Cancer: Mary-Ellen Taplin, MD

The phase 3 PROTEUS trial data may add a new standard-of-care option for patients with high-risk localized or locally advanced prostate cancer without displacing existing treatment pathways according to Mary-Ellen Taplin, MD, FASCO, medical oncologist at Dana-Farber Cancer Institute, who led the study and presented findings at the 2026 American Society of Clinical Oncology Annual Meeting.¹

What PROTEUS Means for Shared Decision-Making

Speaking about the trial's implications for clinical practice, Taplin emphasized that PROTEUS is not intended to replace current standards but to expand the conversation between clinicians and patients. She explains that physicians will now be able to present 3 pathways to patients: perioperative androgen deprivation therapy (ADT) plus apalutamide combined with surgery; surgery alone, which carries a high relapse rate; or a longer course of ADT and radiation.

"The treating physicians and the patients will weigh the pros and cons of these 3 options, and a patient will pick what's best for them," Taplin says.

The trial enrolled patients with localized high-risk prostate cancer and also allowed enrollment of those with locally advanced disease, including patients with evidence of pelvic lymph node involvement, thereby broadening the population for whom the regimen may be relevant. That inclusion reflects the real-world complexity of patients who are candidates for radical prostatectomy and reinforces the potential reach of perioperative apalutamide plus ADT as a standard-of-care option across a wider clinical spectrum.

First Data for Apalutamide in Localized Disease

Taplin notes that these are the first phase 3 data supporting the early use of apalutamide, an androgen receptor (AR) inhibitor, in localized prostate cancer. Prior approvals for apalutamide have been limited to later-stage settings, including nonmetastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer, based on the SPARTAN and TITAN trials, respectively.²

If approved in the localized setting, apalutamide would span the full disease continuum, giving clinicians a consistent option across multiple stages of prostate cancer management.

References

1. Taplin ME, Gleave M, Shore ND, et al; PROTEUS Investigators. Perioperative apalutamide in high-risk localized prostate cancer. N Engl J Med. Published online May 31, 2026. doi:10.1056/NEJMoa2603878
2. Chi KN, Agarwal N, Bjartell A, et al; TITAN Investigators. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. 2019;381(1):13-24. doi:10.1056/NEJMoa1903307