Men with very high-risk prostate cancer who added a daily pill called darolutamide to standard hormone therapy and radiation had a 58% lower risk of the cancer spreading or of dying than men who took a placebo (a dummy pill)1. The early results come from a large trial called DASL-HiCaP and were presented on October 24 at the ESMO Congress 2026, a major cancer meeting in Madrid1.
The finding matters for men whose cancer has not spread beyond the prostate area but carries a high chance of coming back1. But it comes with two clear limits: darolutamide, sold as Nubeqa, is not approved for this use, and the trial has not yet shown that the drug helps men live longer1.
What happened
DASL-HiCaP is a Phase 3 trial, the last big stage of testing before a drug can be approved for a new use. The results shared in Madrid are “interim,” meaning the researchers looked at the data partway through, before the trial is finished1.
The trial enrolled 1,106 men in Australia, New Zealand, Canada, the United States, Ireland and the United Kingdom between 2020 and 20231. Every man received 96 weeks of hormone therapy, which lowers the male hormones that feed prostate cancer, plus radiation to the prostate or the area where the prostate had been, and to the nearby lymph nodes in the pelvis1. Trade coverage described the radiation as either the first treatment or “salvage” radiation, given after earlier treatment2.
Half of the men also took darolutamide twice a day for 96 weeks. The other half took a dummy pill1.
The evidence so far
The main measure was how long men stayed alive without the cancer spreading to other parts of the body, which doctors call metastasis1. After men had been followed for a median of 3.8 years (half for longer, half for less), the darolutamide group had a 58% lower risk of spread or death13.
Put another way, at four years 95% of men taking darolutamide were alive with no detectable spread, compared with 88% of men on the dummy pill, according to figures reported by OncLive and cited by Medical Daily1.
The two groups also differed in what kind of setbacks they had. In the darolutamide group, spread of the cancer accounted for 9 of 27 events (an event being either spread or death). In the placebo group, spread accounted for 46 of 63 events1. That means there were fewer events overall in the darolutamide group, and fewer of them were the cancer spreading.
What it does not show yet
The most important open question is survival. The analysis is early, and the trial has not yet shown that darolutamide helps men live longer1. Delaying spread is a meaningful goal for patients and doctors, but it is not the same as adding years of life, and that answer will need more follow-up.
Other limits:
- Not yet a full paper. The results were presented at a conference1. The sources reviewed for this article do not describe a peer-reviewed publication, so outside experts have not yet been able to examine the full data.
- Side effects in this trial. The coverage available for this article did not give detailed side-effect numbers from DASL-HiCaP. Earlier trials of the same drug in other stages of prostate cancer are described below.
- Not approved for this group. The drug is not approved for this use1, so the results do not change what is officially on its label.
- “Detectable” spread. The four-year figures count men with no detectable spread1. Spread too small to see on scans would not be counted.
Who is behind the drug
Darolutamide is a pill that blocks the androgen receptor, the docking point on cells that male hormones use to drive prostate cancer growth3. It was developed by the drugmaker Bayer3. The sources reviewed for this article do not say who funded or ran the DASL-HiCaP trial, so Biohack cannot report on its funding or any company ties of its researchers.
Bayer did sponsor the earlier trial that led to the drug’s first approval. That trial, called ARAMIS, is registered as a Bayer-sponsored, placebo-controlled Phase 3 study that enrolled 1,509 men4.
How it fits with earlier darolutamide results
This is not the first time darolutamide has been tested against a dummy pill. In the US, it was approved in 2019 for men whose cancer had not spread but kept growing despite hormone therapy, based on the ARAMIS trial5. In that trial, men on darolutamide went a median of 40.4 months before the cancer spread or they died, compared with 18.4 months on placebo, a 59% lower risk3.
That earlier trial later did show a survival difference. At its final analysis, darolutamide lowered the risk of death by 31% compared with placebo53. Three years in, 83% of men in the darolutamide group were alive versus 77% in the placebo group3. The drug’s US label was later updated to include those survival data3. In a separate trial called ARASENS, adding darolutamide to chemotherapy and hormone therapy improved survival in 1,306 men whose cancer had already spread3.
On safety, in ARAMIS a similar small share of men stopped treatment because of side effects in both groups: 8.9% on darolutamide and 8.7% on placebo25. Longer follow-up of that trial reported a slight increase in tiredness and no significant heart or nerve-related safety problems2. About 30% of men who started the drug in ARAMIS had taken it for at least four years by early 2023, and researchers reported no new safety concerns in that longer use5. Those results come from a different group of patients, so they may not apply directly to the men in DASL-HiCaP, who also had radiation.
The broader idea, adding a stronger hormone-blocking pill earlier in the disease, is being tested in other trials too. At the same meeting, researchers presented results on apalutamide, a similar drug, given around surgery in high-risk prostate cancer that had not spread3. Biohack has also covered a pill given around surgery that delayed prostate cancer spread.
What to watch next
- Survival data. Whether longer follow-up shows that men on darolutamide live longer, as happened in the earlier ARAMIS trial5.
- A full publication. A peer-reviewed paper with complete results, including side effects and how men felt during treatment.
- Regulators. Whether Bayer or the trial’s researchers seek approval for this new use, since the drug is not currently approved for it1.
For now, the trial shows that in this group of men, adding darolutamide to hormone therapy and radiation delayed detectable spread of the cancer over a few years of follow-up. Whether it helps them live longer is still unknown1.
