PROTEUS Trial Design and Key Efficacy Results in Prostate Cancer

This opening segment sets up the PROTEUS trial for viewers. Dr. Shreyas Kalantri, incoming faculty at University of Cincinnati, walks Dr. Matthew Karr, third-year hematology oncology fellow at Rutgers Cancer Institute, through the phase 3, double-blind, placebo-controlled study, which enrolled roughly 2,100 patients with high-risk or locally advanced prostate cancer. Patients were randomized to apalutamide plus ADT or ADT plus placebo, each given for six months before and after surgery. Dr. Kalantri details the trial's efficacy data: an 8.9% pathologic complete response rate with apalutamide plus ADT versus 1% with ADT alone, and five-year metastasis-free survival of 78.2% versus 73.5%. He places these results in context, noting surgery and radiation remain the historical backbone of treatment, with PROTEUS introducing perioperative systemic therapy as a new option for appropriate surgical candidates.