Loading
ARAMIS showed that darolutamide, an androgen receptor blocker that barely enters the brain, delayed metastases and lengthened life in men whose prostate cancer was rising on hormone therapy but not yet visible on scans, with side effects close to placebo.
ARAMIS randomised 1509 men with non-metastatic castration-resistant prostate cancer and a PSA doubling time of ten months or less two to one to darolutamide or placebo alongside androgen deprivation. The primary endpoint was metastasis-free survival.
Darolutamide lengthened metastasis-free survival substantially and improved overall survival in the final analysis, with rates of fatigue, falls, fractures, seizures and cognitive effects that were close to placebo, a tolerability profile attributed to its low penetration of the blood-brain barrier. It was approved in the United States in July 2019 and is often preferred among the three androgen receptor inhibitors for this setting in older men.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,509 enrolled.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Darolutamide, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Bayer, Androgen deprivation & AR pathway inhibitors and the tag subtype-trials.
Shares Prostate cancer drugs in England: what NICE recommends, and what it refuses, Androgen deprivation & AR pathway inhibitors, Prostate cancer and the tag subtype-trials.
Shares Bayer and the tag subtype-trials.
Shares Bayer and the tag subtype-trials.
Shares Darolutamide, Bayer, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares Darolutamide, Bayer, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares Darolutamide, Bayer, Androgen deprivation & AR pathway inhibitors.
Shares Metastasis-free survival (MFS), Non-metastatic castration-resistant prostate cancer, Prostate cancer.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/