11 The addition of apalutamide to ADT resulted in a signicant 18.7-month increase in median event-free survival, improving from 38.4 months with ADT alone to 57.1 months with the combination. This was largely driven by lower rates of biochemical failure (77% vs 80%) and locoregional recurrence with the inclusion of apalutamide. The combination also signicantly delayed the development of distant metastasis, with 83% of patients remaining metastasis free at 5 years compared with 76% in the ADT alone arm. One year of perioperative combination therapy spared patient from subsequent therapy for a median of 6.2 years vs 3.5 years with ADT alone. Recovery of testosterone levels after completion of the therapy, was around 80% at 8 months. The lead investigator, Dr Mary-Ellen Taplin who presented the trial at ASCO has stated: “These results have the potential to be practice changing and support perioperative apalutamide plus ADT as a new standard of care for patients with high-risk localized prostate cancer who are candidates for radical prostatectomy.” The discussant, Dr Declan Murphy agreed that he would be incorporating this regimen into his practice for high-risk localized prostate cancer. Quoting Dr Murphy: “All of this adds up to a much better patient journey.” Conclusion: PROTEUS is a landmark trial and will continue to deliver data over the coming months and years. The forthcoming PROTEUS updates will focus on patient-reported outcomes, biomarker analyses, and correlation of major pathologic response with MFS as well as a substudy that compares apalutamide, ADT, and surgery vs surgery alone. The future: We are looking forward to the results of the ATLAS study. A randomized, double-blind, placebo-controlled, phase 3 trial of apalutamide (ARN-509) in patients with highrisk localized or locally advanced prostate cancer receiving primary radiation therapy. This ongoing study is evaluating the efcacy and safety of adding apalutamide to GnRH analogues (ADT) and external bean radiation therapy (EBRT) vs ADT alone concurrent with radiation therapy (RT), in patients with high-risk localized or locally advanced prostate cancer. The trial will include 1 500 patients and will assess whether the addition of apalutamide, to a GnRH agonist will improve metastasis-free survival in high-risk patients treated with primary RT.
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