- In a nutshell, can you tell us about the trial?
DASL-HiCaP is a major international phase 3 clinical trial co-led by ANZUP Cancer Trials Group and the Sydney Clinical Trials Centre. It’s investigating whether adding an oral drug called darolutamide to standard treatment can help prevent very high-risk prostate cancer from spreading or returning.
More than 1,100 participants around the world have taken part, making this an important collaborative effort to address a significant unmet need in prostate cancer care. We’re proud that ANZUP has played a leading role in bringing researchers together to investigate a treatment that could make a real difference to people’s lives.
- We often hear the term ‘current standard of treatment’. What does that mean, and why do we need to investigate other options?
For people whose prostate cancer hasn’t spread beyond the pelvis, treatment commonly involves radiation therapy combined with hormone therapy, which lowers testosterone levels to help control the cancer.
While this approach has improved outcomes, those with very high-risk prostate cancer still face a significant risk of their cancer returning or spreading. That’s why research like DASL-HiCaP is so important. We need to keep looking for ways to improve on existing treatments and give people the best possible chance of living longer, healthier, and more fulfilling lives.
- What did the trial find when you compared the two groups?
The results were encouraging. People who received darolutamide alongside standard treatment lived longer without their cancer returning than those who received standard treatment plus a placebo.
Researchers also observed fewer prostate cancer deaths and fewer rises in PSA levels among those who received darolutamide. PSA is a protein measured in the blood, and rising levels can be a sign that prostate cancer may be returning or progressing.
These findings are an important step forward. The trial will continue to follow participants so we can better understand the treatment’s longer-term impact, including on overall survival.
- Why are these findings potentially significant for men diagnosed with very high-risk or locally advanced prostate cancer?
Prostate cancer affects over 28,000 people in Australian and New Zealand each year, and around 10,900 Australians are diagnosed with high-risk or advanced disease annually. For these people, the risk of their cancer spreading or returning can be a very real concern.
The DASL-HiCaP findings offer encouraging evidence that adding another treatment to the current approach may help keep the cancer at bay for longer. That matters not only for patients, but also for their families and loved ones.
For ANZUP, this is exactly why collaborative clinical trials are so important: they help us find better ways to treat cancer and improve outcomes for people affected by it.
- What could the longer-term implications be if this treatment approach continues to show benefits?
These results are potentially globally practice changing. If the benefits are confirmed through longer-term follow-up, this approach could help shape future treatment guidelines and potentially change how very high-risk prostate cancer is treated.
The results we have so far show an improvement in the time people live without their cancer spreading. We now need to understand whether those benefits translate into improved long-term survival.
That takes time, but it’s a great example of what can be achieved when ANZUP works with national and international research partners to tackle challenging questions in cancer care.
- What happens next, and when might this treatment become available in Australia?
Recruitment to DASL-HiCaP has closed, and researchers are continuing to follow participants to collect important longer-term data, including on overall survival. A further analysis is planned once a specified number of metastasis-free survival events has occurred.
While the findings are promising, it’s too early to say exactly when this treatment approach might become available as a standard option for people affected by this stage of prostate cancer in Australia. That will depend on the longer-term evidence and the relevant regulatory and clinical processes.
What we can say is that these results are an encouraging and huge milestone. ANZUP will continue working with its research partners to understand what they mean for future treatment and, ultimately, for people living with prostate cancer.