An Australian-led international clinical trial has found that adding darolutamide to standard treatment can help people with very high-risk localised or locally advanced prostate cancer live longer without their cancer returning or spreading.

We know that for people diagnosed with very high-risk prostate cancer, treatment can be challenging, both mentally and physically. Even when the cancer has not spread far beyond the prostate, there can still be a significant risk of it returning or spreading to other parts of the body.

Now, results from the DASL-HiCaP trial (ANZUP 1801) offers encouraging news.

The trial found that adding a medicine called darolutamide to standard radiation therapy and hormone therapy improved the time people lived without their cancer spreading or returning, compared with standard treatment alone.

So what did the trial investigate?

Around 28,800 Australians are diagnosed with prostate cancer each year, and approximately 10,900 are diagnosed with high-risk, very-high-risk or advanced disease. These are huge numbers.

For people whose prostate cancer has not spread beyond the pelvis, treatment commonly combines radiation therapy with hormone therapy. Hormone therapy lowers testosterone levels, which can help slow the growth of prostate cancer.

However, the cancer can still return or spread despite treatment. Researchers are investigating ways to reduce this risk and improve long-term outcomes.

The DASL-HiCaP trial explored whether adding darolutamide, an oral medicine that blocks signals that help prostate cancer cells grow, could improve results when used alongside standard treatment.

What did the researchers find?

The trial’s first planned analysis found that people who received darolutamide had longer metastasis-free survival than those who received a placebo alongside standard treatment.

In simple terms, this means they lived longer without their cancer being detected as having returned or spread on scans or dying from any cause related to the cancer itself.

Researchers also observed fewer prostate cancer deaths and fewer participants with rising prostate-specific antigen (PSA) levels, which can be a sign that prostate cancer is returning.

These findings are encouraging for people with very high-risk prostate cancer, who can face a substantial risk of their disease progressing even after treatment.

Successfully bringing global research together

The DASL-HiCaP trial was jointly led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and the Sydney Clinical Trials Centre at the University of Sydney, in collaboration with international research partners. The trial was funded by Bayer.

The findings highlight the importance of international collaboration in tackling areas of unmet need in prostate cancer and investigating new ways to improve treatment outcomes.

ANZUP brings together clinicians, researchers and other experts to conduct clinical trials aimed at improving the lives of people affected by bladder, kidney, testicular, penile and prostate cancers.

Every clinical trial helps build our understanding of cancer and how it can be treated. The DASL-HiCaP results are an important step in exploring better treatment options for people facing very high-risk prostate cancer.