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Poster display

2899 - Efficacy and safety of enzalutamide plus androgen deprivation therapy vs placebo plus androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer: the ongoing ARCHES trial


09 Oct 2016


Poster display


Arnulf Stenzl


Annals of Oncology (2016) 27 (6): 243-265. 10.1093/annonc/mdw372


A. Stenzl1, A. Krivoshik2, B. Baron3, M. Hirmand4, A. Armstrong5

Author affiliations

  • 1 Urology, University Hospital, 72076 - Tübingen/DE
  • 2 Medical Oncology, Astellas Pharma Global Development, Astellas Pharma, Inc., Northbrook/US
  • 3 Data Science, Astellas Pharma, Inc., Leiden/NL
  • 4 Development, Medivation, Inc., San Francisco/US
  • 5 Medicine, Duke Cancer Institute, Durham/US


Abstract 2899


Androgen deprivation therapy (ADT) and docetaxel (DOC) chemotherapy are the preferred initial treatments for fit men with newly diagnosed metastatic prostate cancer (mPC), based on recent data from Phase 3 trials (STAMPEDE, CHAARTED). The concurrent use of combined androgen blockade antiandrogens (eg bicalutamide) may provide more-durable disease control than ADT alone, but the role of more-potent antiandrogen therapy in contemporary practice in the DOC chemotherapy setting is unknown. Enzalutamide (ENZA), a potent androgen receptor blocker, improves progression-free and overall survival (OS) in the metastatic castration-resistant setting. The efficacy and safety of ENZA plus ADT in the metastatic hormone-sensitive PC (mHSPC) setting will be assessed.

Trial design

ARCHES is a multinational, Phase 3, randomised, double-blind, placebo-controlled efficacy and safety trial of ENZA (160 mg once daily) plus ADT vs placebo plus ADT in men with mHSPC. All men will be required to maintain ADT during study treatment, by either using a luteinising hormone-releasing hormone agonist/antagonist (LHRHa) or having undergone a bilateral orchiectomy. About 1100 men with histologically or cytologically confirmed PC and mPC, documented by a positive bone scan or metastatic lesions on a CT or MRI scan, will be enrolled from about 250 global centres and randomised centrally 1:1. Randomisation will be stratified by disease volume (low vs high) and prior DOC therapy for prostate cancer (no prior DOC, 1–5 cycles, 6 cycles). For men receiving DOC, ENZA treatment will begin following DOC chemotherapy. Bicalutamide treatment will be permitted only when given concurrently with LHRHa for the prevention of flare-ups. The primary end point is radiographic progression-free survival (defined as the time from randomisation to the first objective evidence of radiographic disease progression [assessed by central review] or death, whichever occurs first). Secondary end points include OS, time to castration resistance and safety. All men will be followed for OS. As of 15 April 2016, four men have been randomised.

Clinical trial identification

EudraCT 2015-003869-28.

Legal entity responsible for the study

Astellas Pharma, Inc. and Medivation, Inc.


Astellas Pharma, Inc. and Medivation, Inc.


A. Stenzl: Advisory board member: Ipsen Pharma, Janssen, Alere. Corporate-sponsored research: Johnson & Johnson, Amgen Inc, Bayer AG, CureVac, Immatics Biotechnologies GmbH, Novartis AG, Karl Storz AG.

A. Krivoshik: Employee of Astellas. Owns Abbott and Abbvie stock.

B. Baron: Employee of Astellas.

M. Hirmand: Employee of Medivation. Owns Medivation stock.

A. Armstrong: Advisory board member: Medivation, Janssen, Eisai, Bayer. Corporate-sponsored research: Sanofi Aventis, Medivation/Astellas, Janssen, Bayer, Dendreon, Gilead, Active Biotech, Bristol Myers Squibb, Novartis, Pfizer. Speaker for Dendreon and Sanofi.

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