Prostate cancer drug shows 58% reduction in relapse for high-risk patients in Australian-led trial

Darolutamide added to standard therapy dramatically cuts spread of aggressive disease, researchers say

By LineZotpaper AI staff

Published24 October 2026

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A major Australian-led global trial has found that adding the hormone-blocking drug darolutamide to standard treatment reduces the risk of relapse by 58% in men with very high-risk prostate cancer, prompting calls to change the standard of care for this group. The findings, involving 1106 participants, were due to be announced at the European Society of Medical Oncology Congress in Madrid.

An Australian-led prostate cancer trial has reported that adding the drug darolutamide (Nubeqa) to standard therapies for men with aggressive or treatment-resistant prostate cancer led to a 58 per cent drop in the cancer relapsing and spreading to other organs and tissue four years later.

The DASL-HiCaP trial enrolled 1106 participants with very aggressive cancer or cancer that had spread to lymph nodes in the pelvis. All had undergone radical prostatectomy or primary radiation therapy and received androgen deprivation therapy (ADT) and radiation. Half also took darolutamide, the other half a placebo. The median age was 71.

After four years, 95 per cent of the darolutamide group had not developed metastatic prostate cancer compared to 88 per cent of the placebo group. Fewer darolutamide participants died of prostate cancer (5 per cent versus 14 per cent), and deaths from other causes did not differ between the two arms. Side effects were similar in both groups.

Professor Christopher Sweeney, co-chair of the trial and director of the South Australian immunoGENomics Cancer Institute at the University of Adelaide, said: "We've seen a very strong treatment effect with decreasing relapses substantially. Ultimately, we know this leads to more men living longer and dying without prostate cancer."

Howard Smith, a trial participant now aged 71, recalled thinking "Well, I'm doomed" upon learning his prostate cancer had spread to nearby glands. After his PSA level jumped from 23 to 35 in five months and a biopsy confirmed aggressive cancer, his urologist told him it was "the one that's going to kill you." Smith chose radiation therapy and was enrolled in the trial. He has been cancer-free for two years with a PSA of 0.01. He does not know whether he received darolutamide or a placebo.

Darolutamide is an androgen receptor pathway inhibitor that binds to receptors on prostate cancer cells, blocking testosterone or similar hormones from fuelling growth. It is currently subsidised via the Pharmaceutical Benefits Scheme only for metastatic or treatment-resistant prostate cancer.

Professor Henry Woo, director of uro-oncology at Chris O'Brien Lifehouse, called the results "quite profound" and said "for men with very bad disease, this will change the standard of care."

Professor Ian Davis, chairman of the Australian and New Zealand Urogenital and Prostate Cancer Trials Group, said the encouraging findings contribute to understanding how outcomes for these patients may be improved.

Sweeney said an open question was what data Australian and international regulators would need to approve darolutamide for men at very high risk of relapse. Bayer Australia, the supplier, would need to apply for an expanded PBS listing.

The trial results have not yet been peer-reviewed.

Analysis

Why This Matters

Thousands of men with high-risk prostate cancer could benefit from a change in standard care, potentially saving lives.
The drug is already available in Australia for later-stage disease; expanding its use could prevent relapse and progression earlier.
The findings underscore the value of large, randomised trials in refining cancer treatment protocols.

Background

Prostate cancer is the most diagnosed cancer among Australian men, with more than 28,800 cases estimated in 2025. Of these, about 38 per cent are high-risk, very-high-risk, or advanced at diagnosis. Standard treatment for high-risk disease includes radiation and androgen deprivation therapy, but many men still relapse. Darolutamide belongs to a class of drugs that block androgen receptors; its role in non-metastatic high-risk disease has now been tested in this global phase 3 trial, which was led by Australian researchers and sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group.

Key Perspectives

Professor Christopher Sweeney, trial co-chair: "We've seen a very strong treatment effect with decreasing relapses substantially. Ultimately, we know this leads to more men living longer and dying without prostate cancer." Professor Henry Woo, director of uro-oncology at Chris O'Brien Lifehouse: The results are "quite profound" and will change the standard of care for men with very bad disease. Howard Smith, trial participant: "From my end, it's turned out exceptionally well." He is cancer-free two years after treatment. Professor Ian Davis, chairman of ANZUP Cancer Trials Group: The encouraging findings contribute to our understanding of how outcomes for these patients may be improved.

What to Watch

Whether Bayer Australia applies to expand the PBS listing for darolutamide to cover very-high-risk patients.
How Australian and international medicines regulators respond to the data, and whether they require further evidence before approving the new indication.
The long-term survival data still being collected from trial participants, which will clarify the drug's full benefit.

Sources

‘Well, I’m doomed’: How this cancer treatment can help men live longer · Brisbane Times
‘Well, I’m doomed’: How this cancer treatment can help men live longer · The Age
‘Well, I’m doomed’: How this cancer treatment can help men live longer · The Sydney Morning Herald

Checked

12 claims in this story checked against 1 source: 11 supported.

Show each claim

Partly supportedThe Australian-led trial found a 58% reduction in relapse among high-risk patients.Brisbane Times - Latest News: “Adding the medication darolutamide (Nubeqa) to standard therapies for men with aggressive or treatment-resistant prostate cancer led to a 58 per cent drop in the cancer relapsing and spreading to other organs and tissue four years later”
SupportedAdding darolutamide to standard therapy dramatically cuts the spread of aggressive disease, researchers say.Brisbane Times - Latest News: “A major Australian-led prostate cancer trial found a hormone-blocking drug dramatically reduced the risk of relapse among very high-risk men”
SupportedThe trial result prompted calls to change the standard of care for this group.Brisbane Times - Latest News: “A major Australian-led prostate cancer trial found a hormone-blocking drug dramatically reduced the risk of relapse among very high-risk men, prompting calls to change the standard of care for these patients”
SupportedThe trial involved 1,106 participants, and its findings were due to be announced at the ESMO Congress in Madrid.Brisbane Times - Latest News: “All 1106 trial participants had very aggressive cancer, or their CT scans showed cancer had spread to lymph nodes in their pelvis”
SupportedThe trial included men with very aggressive cancer or cancer spread to pelvic lymph nodes; all received ADT and radiation, and half also received darolutamide while the rest received placebo.Brisbane Times - Latest News: “All participants received ADT and radiation therapies. Half also took darolutamide, the other half a placebo.”
SupportedAfter four years, 95% of the darolutamide group and 88% of the placebo group had not developed metastatic prostate cancer.Brisbane Times - Latest News: “After four years, 95 per cent of the darolutamide group had not developed metastatic prostate cancer compared to 88 per cent of the placebo group.”
SupportedProstate cancer deaths were 5% in the darolutamide group versus 14% in the placebo group, while deaths from other causes did not differ between the arms.Brisbane Times - Latest News: “Fewer darolutamide participants had died of prostate cancer compared to those given a placebo (5 per cent versus 14 per cent), and deaths from other causes were no different between the two trial arms.”
SupportedSweeney said, “We've seen a very strong treatment effect with decreasing relapses substantially. Ultimately, we know this leads to more men living longer and dying without prostate cancer.”Brisbane Times - Latest News: ““We’ve seen a very strong treatment effect with decreasing relapses substantially,” said co-chair of the DASL-HiCaP trial, Professor Christopher Sweeney. “Ultimately, we know this leads to more men living longer and dying without prostate cancer,” he said.”
SupportedSmith's urologist told him the cancer was “the one that's going to kill you.”Brisbane Times - Latest News: ““This is not the one that you’re going to die with. This is the one that’s going to kill you.””
SupportedWoo called the results “quite profound” and said the findings would change the standard of care for men with very bad disease.Brisbane Times - Latest News: “Professor Henry Woo, director of uro-oncology at Chris O’Brien Lifehouse said the results were “quite profound”. “We’re not talking about all prostate cancer patients, but for men with very bad disease, this will change the standard of care,” Woo said.”
SupportedSmith has been cancer-free for two years with a PSA of 0.01 and does not know whether he received darolutamide or placebo.Brisbane Times - Latest News: “Smith does not know whether he received darolutamide or a placebo in the double-blind trial”
SupportedThe results had not yet been peer-reviewed.Brisbane Times - Latest News: “The trial results – not yet been peer-reviewed – will be announced on Saturday at the European Society of Medical Oncology Congress in Madrid, Spain.”

Correction

24 October 2026An earlier version of this story said the trial findings had been presented at the European Society of Medical Oncology Congress in Madrid. The source reported that they were due to be announced, not that the presentation had taken place.