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 in very high risk, clinically localised prostate cancer.

A randomised phase 3 double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in very high risk, clinically localised prostate cancer. 

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Jeremy Millar

Key inclusion data

Inclusion including: EITHER planned for primary RT and judged to be at very high risk for recurrence based on any of the following: Grade Group 4 AND one or more of the following: clinical T2b-4 OR MRI with seminal vesicle invasion OR extracapsular extension OR PSA* > 20ng/mL, OR Pelvic nodal involvement (involvement of lymph nodes (LNs) at or below the bifurcation of the aorta into the common iliac arteries) OR Post-radical prostatectomy ? 365 days prior to randomisation and planned for RT with PSA* ? 0.1 ng/mL that has risen or remained stable (within ? 0.05 ng/mL) since a previous level at least 1 week earlier, judged to be at very high risk for recurrence based on any of the following: Grade Group 5, OR Grade Group 4 AND pT3a or higher, OR Pelvic nodal involvement (involvement of LNs at or below the bifurcation of the aorta into the common iliac arteries). Exclusion including: Prostate cancer with predominant non-adenocarcinoma features; Involvement of LNs by conventional CT imaging superior to the common iliac artery bifurcation, and/or outside the pelvis (distant LNs); Evidence of metastatic disease; PSA > 100 ng/mL at any time.