Howard Smith’s urologist told him his prostate cancer was not the kind you die with: “It’s the one that’s going to kill you.”

Interim findings from the DASL-HiCaP trial (ANZUP 1801) report that adding darolutamide (Nubeqa®) to standard of care decreases the risk of spread of prostate cancer in people affected with very high-...

A major Australian-led clinical trial has demonstrated that adding darolutamide to standard treatments for high-risk prostate cancer significantly reduces the risk of cancer relapse and metastasis. The phase 3 global trial, known as DASL-HiCaP, involved 1,106 participants with very aggressive prostate cancer or cancer that had spread to pelvic lymph nodes. All participants received standard androgen deprivation therapy (ADT) and radiation therapy, with half also receiving darolutamide and the other half a placebo. After four years, 95% of the darolutamide group remained free of metastatic prostate cancer compared to 88% in the placebo group. The treatment also reduced prostate cancer deaths from 14% to 5% over the same period. Professor Christopher Sweeney, co-chair of the trial, described the results as "a very strong treatment effect" that leads to more men living longer without prostate cancer. The findings suggest that darolutamide, currently subsidised only for metastatic or treatment-resistant prostate cancer, could be expanded to include high-risk patients who have undergone surgery or radiation. Howard Smith, a trial participant who was diagnosed with aggressive prostate cancer, shared his experience of initially feeling "doomed" but now being cancer-free for two years with a PSA level of 0.01. The trial results, not yet peer-reviewed, will be presented at the European Society of Medical Oncology Congress in Madrid. The research team is now working with regulators to expand the Pharmaceutical Benefits Scheme listing for darolutamide to cover high-risk prostate cancer patients. Common side effects of the drug include fatigue, skin rash, diarrhea, high blood pressure, and elevated liver enzymes. The study highlights the potential to improve outcomes for the estimated 38% of prostate cancer cases diagnosed annually in Australia that are classified as high-risk, very-high-risk, or advanced disease.