Dr Paul Kelly
Consultant Radiation Oncologist & Medical Director, Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre & Co-Chair of the Cancer Trials Ireland Genitourinary Disease Specific Sub-Group
An ongoing trial known as ‘Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate’ (DASL-HiCaP) can potentially benefit men with aggressive prostate cancer types in addition to standard treatment.
DASL-HiCaP is a prostate cancer trial for patients with aggressive types of prostate cancer that remain confined to the prostate area. The purpose of this study is to see if a new drug — combined with modern radiotherapy and hormonal treatment — can improve outcomes for people with localised prostate cancer that is considered to have a high risk of recurrence.
Improving treatment for aggressive prostate cancer
The trial is randomised and controlled. This means that, in addition to the best standard treatments, half the participants in the trial will receive the new drug, and the other half will receive a placebo — a substance that has no active medicine in it. To be clear: All patients receive the current standard of care plus or minus the drug being studied.
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 this type of prostate cancer compared to standard treatment.
The drug has already been shown to be beneficial in men with advanced prostate cancer, and the question to be answered by this trial is: Will this drug improve the rate of cure for patients with localised but aggressive prostate cancer?
Will this drug improve the rate of cure for patients with localised but aggressive prostate cancer?
Additional outcomes the trial aims to determine
- The impact of the new medicine on prevention of recurrence and survival
- How safe the new treatment is
- Whether the medication is cost-effective
- The effects of the new treatment on quality of life
- Differences in the costs of care for people on the new treatment
- Tests that might identify people who are more or less likely to benefit from this kind of treatment
Clinical trials ongoing in sites across Ireland
The study opened here in the summer of 2021 and has recruited participants at nine sites around the country: Bons/UPMC Cork, St. Luke’s Rathgar, Mater Misericordiae University Hospital, Mater Private Hospital, Tallaght University Hospital, SLRON at St. James’s Hospital, Cork University Hospital, Galway University Hospital, and the Beacon Hospital.
The trial has now recruited over 1,000 patients globally and is on target to complete recruitment by the end of June this year. This includes a significant contribution of 76 participants, so far, randomised across Ireland and the UK. If successful and properly distributed, it can improve outcomes for prostate cancer patients and complement existing treatment.