A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Summary

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.

Timeline

Start

2019-06-11

Primary completion

2026-12-01

Completion

2028-10-13

Publications

• Taplin ME, Gleave M, Shore ND, Lopez-Gitlitz A, Kretschmer A, Efstathiou E, Nguyen PL, Damiao R, Kamoto T, Ross A, Briganti A, Hadaschik BA, Heidenreich A, Juarez Soto A, Ye H, Gotto G, Rooney B, Tian SK, Wetherhold L, Miladinovic B, McCarthy SA, Evans CP, Kibel AS; PROTEUS Investigators. Perioperative Apalutamide in High-Risk Localized Prostate Cancer. N Engl J Med. 2026 May 31. doi: 10.1056/NEJMoa2603878. Online ahead of print.
• Ravi P, Kwak L, Xie W, Kelleher K, Acosta AM, McKay RR, Kibel AS, Taplin ME. Neoadjuvant Novel Hormonal Therapy Followed by Prostatectomy versus Up-Front Prostatectomy for High-Risk Prostate Cancer: A Comparative Analysis. J Urol. 2022 Oct;208(4):838-845. doi: 10.1097/JU.0000000000002803. Epub 2022 Sep 9.

Drugs

Indications