Axel Merseburger, Director / Chairman of the Department of Urology and Polyclinic at the University Hospital Schleswig-Holstein, shared on LinkedIn:
“Proud to share our latest work, now online in European Urology: the PROTEUS substudy.
The main PROTEUS trial compared perioperative apalutamide + ADT with ADT alone. One question remained: how does treatment intensification perform against today’s standard of care, radical prostatectomy alone?
In this open-label, randomized substudy, 408 patients with high-risk localized or locally advanced prostate cancer were randomized 1:3:
- EFS: HR 0.38 (95% CI 0.26–0.55); 3-yr EFS 63% vs 41%
- RMST at 36 mo: +11.0 months event-free time
- MFS by PSMA PET or conventional imaging: HR 0.49; 3-yr 87% vs 78%
- Time to first subsequent therapy: HR 0.29; at 3 yr, 35% vs 68% needed further treatment
- Positive surgical margins: 17% vs 56%
Equally important, and part of an honest reading:
- MFS by conventional imaging does not differ yet (HR 0.74; 94% vs 92%)
- OS is immature, and PSMA-PET-based MFS is not a validated surrogate
- Grade 3–4 TEAEs occurred in 31% vs 22%, with 12 months of ADT-related toxicity to weigh
My take:
‘this supports perioperative intensification as an option for carefully selected, surgery-fit high-risk patients. Shared decision-making and better biomarker-based selection remain key.’
Thank you to Alberto Briganti all co-authors Boris Hadaschik, Eleni Efstathiou, Neal Shore et al., the study teams in Lübeck and worldwide, and above all our patients.”
Title: Treatment Effect of Perioperative (Neoadjuvant and Adjuvant) Apalutamide plus Androgen-deprivation Therapy Versus Radical Prostatectomy Alone in Patients with High-risk Localized or Locally Advanced Prostate Cancer from the PROTEUS Substudy
Authors: Steven M Yip, A Douglas Laird, Neeraj Agarwal, Stefanie Zschäbitz, Karim Fizazi, Nobuaki Matsubara, Jae Young Joung, Lawrence I Karsh, Joan Carles, André P Fay, Josep M Piulats, Peter C C Fong, Glenn Liu, Lee A Albacker, Lincoln W Pasquina, Jijumon Chelliserry, Cynthia G Healy, Xun Lin, Matko Kalac, Arun A Azad
You can also read insights about high risk prostate cancer from ESMO 2026:
You can also read about PROTEUS trial on OncoDaily.