Well I’m Doomed Prostate: Trial Finds 58% Drop in Relapse
An Australian-led phase 3 trial found that adding darolutamide to standard treatment reduced the risk of prostate cancer relapse and spread among very…
An Australian-led prostate cancer trial has found that adding darolutamide to standard treatment reduced the risk of relapse and spread among very high-risk men. The finding could change care for patients with aggressive disease, although regulators still need to assess what the results mean for treatment access.
The global phase 3 trial reported a 58 per cent drop in cancer relapse and spread to other organs and tissue four years later. Researchers said the results support calls to change the standard of care for these patients.
That is the central finding.
All 1106 participants had very aggressive cancer, or scans showed the disease had spread to lymph nodes in their pelvis. They had received radical prostatectomy or primary radiation therapy, and all participants also received androgen deprivation therapy (ADT) and radiation. Half took darolutamide; the other half received a placebo.
After four years, 95 per cent of participants who received darolutamide had not developed metastatic prostate cancer, compared with 88 per cent in the placebo group. Fewer people in the darolutamide group died of prostate cancer: 5 per cent, compared with 14 per cent among those given a placebo. Deaths from other causes were no different between the groups, and both reported similar side effects.
“We’ve seen a very strong treatment effect with decreasing relapses substantially,” said Professor Christopher Sweeney, co-chair of the DASL-HiCaP trial.
What the prostate trial could change
Darolutamide, sold as Nubeqa, blocks androgen receptors in prostate cancer cells. The drug prevents testosterone or similar hormones from attaching to the receptors and fuelling cancer growth. Sweeney described its action as “like a broken key, which blocks any residual hormones from activating the receptors.”
The medicine is currently available and subsidised through the Pharmaceutical Benefits Scheme for metastatic prostate cancer or disease that no longer responds to testosterone suppression. The trial’s first analysis suggests more men could benefit if treatment guidance changes.
The scale of the potential effect is significant for Australia’s patients. More than 28,800 cases were diagnosed in 2025, and an estimated 38 per cent were high-risk, very-high-risk or advanced disease each year nationally, according to the source report. The trial’s findings focus on a defined group with very aggressive cancer, rather than all people with prostate cancer.
“Adding testosterone suppression to radiation decreases the number of men who relapse, but there are men who still break through and relapse,” Sweeney said. He is also director of the South Australian immunoGENomics Cancer Institute at the University of Adelaide.
Professor Henry Woo, director of uro-oncology at Chris O’Brien Lifehouse, called the results “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.
The trial included Howard Smith, who recalled thinking, “Well, I’m doomed,” after learning his cancer had spread to nearby glands. In his late 60s, his PSA level rose from 23 to 35 in five months, and a biopsy confirmed aggressive prostate cancer. His urologist told him: “This is not the one that you’re going to die with. This is the one that’s going to kill you.”
Smith chose radiation therapy rather than prostatectomy first. His radiation oncologist considered him an ideal candidate for the trial because of his very high-risk disease. Since it was double-blind, Smith does not know whether he received darolutamide or placebo; investigators are still tracking participants to assess long-term survival.
“From my end, it’s turned out exceptionally well,” Smith said. Now 71, he has been cancer-free for two years and has a PSA of 0.01. Sweeney said the open question is what further data Australian and international medicines regulators will require.
Source: theage.com.au
