The purpose of this study is to see if a new drug, darolutamide, combined with the current best treatments, can improve outcomes for people with prostate cancer.
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.
- Men after 18 years or older
- Planned for Primary Radiotherapy and judged to be at very high risk for recurrence
- OR Post-Radical Prostatectomy within 365 days and planned for radiotherapy with PSA great than or equal to 0.1ng/mL that has risen or remained stable (within <0.5ng/mL), judged to be at very high risk of recurrence
This is a randomised controlled trial, which means that, in addition to best standard treatments, half the participants on the study will receive darolutamide, and the other half will receive placebo, a substance that has no active medicine in it.
The main aim of the study is to see if the addition of the study medication (darolutamide) to standard treatment is better for improving the outcomes of people with your type of prostate cancer compared to standard treatment.
Participants are followed up regularly for 4-7 years.