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Poster display session

2184 - A phase 2 trial of ODM-201 maintenance therapy in patients with metastatic castration resistant prostate cancer (mCRPC) previously treated with a AR targeting agent and non-progressive on a second line taxane (SAKK 08/16)


10 Sep 2017


Poster display session


Clinical Research;  Prostate Cancer


Silke Gillessen


Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370


S. Gillessen1, S. Hayoz2, A. Fuhrer2, C. Biaggi Rudolf2, A. Pedrazzini3, G. Procopio4, R. Cathomas5

Author affiliations

  • 1 Oncology/hematology, Kantonsspital St. Gallen, 9007 - St. Gallen/CH
  • 2 Coordinating Center, Swiss Group for Clinical Cancer Research (SAKK), 3008 - Bern/CH
  • 3 Medical Oncology, Fondazione Oncologia Lago Maggiore, Locarno/CH
  • 4 Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 5 Hämatologie/onkologie, Kantonsspital Graubünden, 7000 - Chur/CH


Abstract 2184


Treatment with the AR targeting agents abiraterone or enzalutamide followed by a taxane is currently the most used treatment for men with mCRPC. Further treatment after response to chemotherapy is only indicated in case of disease progression, with limited treatment options available. ODM-201 (Darolutamide) is a second-generation oral androgen receptor antagonist which has demonstrated a good safety profile and antitumor activity in mCRPC. This trial evaluates whether the immediate use of darolutamide after successful chemotherapy can prolong radiographic progression-free survival (rPFS) compared with watchful waiting in patients with mCRPC.

Trial design

This is a multicenter, randomized, double-blind, placebo-controlled phase 2 trial (NCT02933801) conducted in approximately 19 sites in Switzerland and Italy. Patients with mCRPC are required to have been previously treated with abiraterone or enzalutamide and have no evidence of disease progression on docetaxel or cabazitaxel. Patients (N = 88) will be randomized 1:1 to receive 600 mg darolutamide BID or placebo BID, both with best supportive care, until disease progression. Patients will be stratified by country, WHO performance status (0, 1 vs 2), presence/absence of visceral metastases, enzalutamide vs abiraterone prior to chemotherapy, and planned start of trial treatment after last taxane dose (

Clinical trial identification


Legal entity responsible for the study

Swiss Group for Clinical Cancer Research (SAKK)


Bayer HealthCare Pharmaceuticals Inc.


S. Gillessen: Advisory Boards: AAA International, Active Biotech, Astellas, Bayer, Bristol-Myers Squibb, Curevac, Dendreon Corporation, Ferring, Glaxo Smith Kline, Innocrin Pharmaceuticals, Janssen Cilag, MaxiVAX, Millennium Pharmaceuticals, Novartis, Pfizer, Orion, Roche, Sanofi Aventis R. Cathomas: Advisory Board for Bayer, Janssen, Astellas, Sanofi, Pfizer, Novartis, Roche, Amgen, AstraZeneca, BMS, MSD. All other authors have declared no conflicts of interest.

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