Worldwide prostate cancer trial continues to strongly recruit

In March this year ANZUP was excited to announce the DASL-HiCaP trial was open for recruitment. The ANZUP-led study will be investigating if a new tablet drug, darolutamide, combined with the current standard of care treatments, can improve outcomes for men with high risk prostate cancer that has not spread beyond the prostate area.

Just one month after opening the trial the first patient was recruited. This marked the beginning of the journey to recruit and follow up 1,100 eligible patients over 100 cancer centres across Australia, New Zealand, US, Canada, Europe and Ireland.

Since April 2020 the DASL-HiCaP trial has steadily recruited patients, with 74 patients now enrolled and 22 sites open.

However, two factors may have had some impact on recruitment:

1. Since the onset of COVID-19 there has been either a reduced diagnoses or delayed diagnosis of prostate cancer as less men are presenting for PSA tests, MRIs and biopsies. This is definitely more common in Victoria than other states.

2. Some hospital sites who are taking part in the study have delayed opening but this has been due to individual circumstances.

As COVID-19 cases and restrictions are now reducing, the recruitment barriers should resolve and even more prostate cancer patients join this promising trial.

Prostate cancer remains the most common cancer diagnosed in Australian men with an estimated 16,741 cases in 2020 and an estimated 3,152 deaths from prostate cancer. The outcomes of the trial will be measured in terms of whether the addition of darolutamide decreases the risk of spread of prostate cancer to other parts of the body as well as improving quality of life and potentially decrease the risk of prostate cancer death. Men with high risk prostate cancer should always consider their options carefully. They should seek advice regarding the pros and cons of surgery, radiation treatment and hormonal treatment. As part of that they could consider DASL-HiCaP if their doctor considers them suitable.

In the coming months we are looking to reach more study milestones with the trial set to open in Canada, and in Ireland, the UK and US in early 2021.

Our thanks to study chairs Professor Chris Sweeney and Dr Tamim Niazi for leading this important trial.

“It has been great to see this important trial for men with high-risk localised prostate cancer able to be activated and start recruiting during this COVID-19 period. Congratulations to everyone involved and we look forward to opening the trial internationally later this year.”

Professor Lisa Horvath, Professor Scott Williams & Professor Shomik Sengupta DASL-HiCaP ANZ Leads