e-Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2020

DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801). A randomised phase 3 double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation. (#411)

Shomik Sengupta 1 2 3 , Tamim Niazi 4 5 , Scott Williams 6 , Ian D Davis 3 7 , Martin Stockler 8 , Andrew J Martin 8 , Karen Bracken 8 , Felicia T Roncolato 8 9 , Margaret McJannett 3 , Lisa Horvath 10 , Simon Hughes 11 , Ray Mc Dermott 12 , James Catto 13 , Paul Kelly 14 , Wendy Parulekar 15 , Scott Morgan 16 , Ricardo Rendon 17 , Christopher J Sweeney 18
  1. Monash University, Melbourne, Victoria, Australia
  2. Urology Department, Eastern Health, Melbourne, Australia
  3. Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), Sydney, New South Wales, Australia
  4. Jewish General Hospital, Montreal, Canada
  5. McGill University, Montreal, Canada
  6. Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
  7. Monash University, Box Hill, VIC, Australia
  8. NHRMC Clinical Trial Centre, Sydney, New South Wales, Australia
  9. Macarthur Cancer Therapy Centre, Sydney, New South Wales, Australia
  10. Chris O’Brien Lifehouse, Sydney, New South Wales, Australia
  11. Guy's Cancer, Guy's & St. Thomas' NHS Foundation Trust, London, United Kingdom
  12. Cancer Trials Ireland, Dublin, Ireland
  13. Academic Urology Unit, University of Sheffield, Sheffield, United Kingdom
  14. Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre, Cork, Ireland
  15. Canadian Cancer Trials Group, Kingston, Canada
  16. The Ottawa Hospital Cancer Centre, Ottawa, Canada
  17. Nova Scotia Health Authority and Dalhousie University, Halifax, Nova Scotia, Canada
  18. Dana-Farber Cancer Institute, Boston, USA


Radiation therapy (RT), plus androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA), is standard of care for men with very high-risk localised prostate cancer (PC), or with very high-risk features and persistent PSA after radical prostatectomy (RP). Despite this, incurable distant metastases develop within 5 years in 15% of men with very high-risk features. Darolutamide is a structurally distinct oral androgen receptor antagonist with low blood-brain-barrier penetration, low potential for drug-drug interactions, and a favourable safety profile. Our aim is to determine the efficacy of adding darolutamide to ADT and RT in the setting of either primary definitive therapy, or adjuvant therapy for very high-risk PC.



This study is a randomised (1:1) phase III placebo-controlled, double-blind trial for men planned for RT who have very high-risk localised PC; or very high-risk features with PSA persistence or rise within one year following RP. The trial will be stratified by: RP; use of adjuvant docetaxel; pelvic nodal involvement. 1100 participants will be randomised to darolutamide 600 mg or placebo twice daily for 96 weeks. Participants will receive LHRHA for 96 weeks, plus RT starting week 8-24 from randomisation. Participants are allowed nonsteroidal antiandrogen (up to 90 days) in addition to LHRHA up until randomisation. Early treatment with up to 6 cycles of docetaxel completed at least 4 weeks prior to RT is permitted. The primary endpoint is metastasis-free survival, with secondary endpoints overall survival, PC-specific survival, PSA-progression free survival, time to subsequent hormonal therapy, time to castration-resistance, frequency and severity of adverse events, health related quality of life, fear of recurrence. Tertiary endpoints include incremental cost-effectiveness, and identification of prognostic and/or predictive biomarkers of treatment response, safety and resistance to study treatment.