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 and potentially save thousands of lives.
asserted
drug → lead → lives
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, the researchers of the global phase 3 trial reported.
asserted
researchers → add → trial
“We’ve seen a very strong treatment effect with decreasing relapses substantially,” said co-chair of the DASL-HiCaP trial, Professor Christopher Sweeney.
asserted
chair → see → trial
“Ultimately, we know this leads to more men living longer and dying without prostate cancer,” he said.
asserted
he → know → cancer
Darolutamide is only available and subsidised via the Pharmaceutical Benefits Scheme to treat metastatic or prostate cancer that is not responding to testosterone suppression, known as androgen deprivation therapy (ADT)
asserted
that → subsidise → therapy
The first analysis of the trial suggests thousands more men with prostate cancer could benefit from the medication.
uncertain
men → suggest → medication
More than 28,800 cases were diagnosed in 2025 – an estimated 38 per cent with high-risk, very-high-risk, or advanced disease every year nationally.
asserted
cases → diagnose → disease
“Adding testosterone suppression to radiation decreases the number of men who relapse, but there are men who still break through and relapse,” said Sweeney, who is also director of the South Australian immunoGENomics Cancer Institute at the University of Adelaide.
asserted
who → add → Adelaide
All 1106 trial participants had very aggressive cancer, or their CT scans showed cancer had spread to lymph nodes in their pelvis, and had undergone radical prostatectomy or primary radiation therapy.
asserted
cancer → have → prostatectomy
All participants received ADT and radiation therapies.
asserted
participants → receive → therapies
Half also took darolutamide, the other half a placebo.
asserted
half → take → darolutamide
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.
asserted
cent → develop → group
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.
asserted
deaths → die → arms
Both trial groups reported similar side effects.
asserted
groups → report → effects
Howard Smith recalled thinking, “Well, I’m doomed,” the moment he learned that his prostate cancer had spread to nearby glands.
asserted
cancer → recall → glands
Smith was in his late 60s when his PSA level jumped from a significantly elevated 23 to 35 in five months.
asserted
level → jump → months
A biopsy confirmed his prostate cancer was aggressive.
asserted
cancer → confirm → ?
“My urologist said to me: “This is not the one that you’re going to die with.
asserted
you → say → that
This is the one that’s going to kill you.”
asserted
that → go → you
Smith chose radiation therapy rather than undergoing a prostatectomy first.
asserted
Smith → choose → prostatectomy
Considering Smith’s very high-risk level, his radiation oncologist said he was the ideal candidate for the trial.
asserted
he → consider → trial
Smith does not know whether he received darolutamide or a placebo in the double-blind trial, as investigators continue to track participants to assess their long-term survival.
asserted
investigators → know → survival
“From my end, it’s turned out exceptionally well,” he said.
asserted
he → turn → end
“I’m very lucky,” he said.
asserted
he → ’m → ?
“By the sound of it, I got in for treatment just in time.”
asserted
I → get → time
Darolutamide is a type of drug known as an androgen receptor pathway inhibitor.
asserted
Darolutamide → know → inhibitor
It binds to antigen receptors in prostate cancer cells, preventing testosterone or testosterone-like hormones from attaching and fuelling their growth.
asserted
It → bind → growth
“It acts like a broken key, which blocks any residual hormones from activating the receptors,” Sweeney said.
asserted
Sweeney → act → receptors
Professor Henry Woo, director of uro-oncology at Chris O’Brien Lifehouse said the results were “quite profound”.
asserted
results → say → Lifehouse
“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.
asserted
Woo → talk → care
Sweeney said the open question was what more data would Australian and international medicines regulators need to approve darolutamide for men at very high risk of relapse.
asserted
regulators → say → relapse
“Our job with this study is to get this drug available to patients and treating physicians … to increase the cure rate of men with high-risk prostate cancer,” he said.
asserted
he → get → cancer
Bayer Australia, the pharmaceutical company that supplies darolutamide, would need to apply for the drug’s PBS listing to be expanded to include the treatment of patients at very high risk of relapse.
asserted
listing → supply → relapse
Professor Ian Davis, chairman of the Australian and New Zealand Urogenital and Prostate Cancer Trials Group, the trial’s lead sponsor, said a diagnosis of very high-risk prostate cancer can be confronting for patients and their families, and the encouraging findings contributed to our understanding of how outcomes for these patients may be improved.
uncertain
outcomes → say → patients
Common side effects of darolutamide include fatigue, skin rash, diarrhoea, high blood pressure, and elevated liver enzymes.
asserted
effects → include → fatigue
The trial results – not yet been peer-reviewed – will be announced on Saturday at the European Society of Medical Oncology Congress in Madrid, Spain.
asserted
results → review → Madrid
The Aporia
