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ARANOTE showed that darolutamide added to hormone therapy alone, without chemotherapy, delayed the progression of newly metastatic prostate cancer on scans, extending the drug's use to men who cannot or do not want to have docetaxel.
ARASENS had established darolutamide with docetaxel and androgen deprivation for metastatic hormone-sensitive prostate cancer. ARANOTE randomised 669 men with metastatic hormone-sensitive disease two to one to androgen deprivation therapy with darolutamide or with placebo, without docetaxel. The primary endpoint was radiographic progression-free survival.
Darolutamide lengthened radiographic progression-free survival with a tolerability profile again close to placebo, and the result led to approval of darolutamide with androgen deprivation alone for metastatic hormone-sensitive disease in 2025. It gave darolutamide the same two-drug indication that apalutamide (TITAN) and enzalutamide (ARCHES, ENZAMET) already held.
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.
669 enrolled.
Median not reached · 95% CI 19.0 to not reached
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiological progression-free survival by central review (registry results)primary | Darolutamide + androgen deprivation therapy | - | Median not reached | 0.541 (0.413 to 0.707) | <0.0001 | link |
| Placebo + androgen deprivation therapy | - | 25 months |
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 A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Metastatic hormone-sensitive prostate cancer, 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 ARASENS, Darolutamide, Metastatic hormone-sensitive prostate cancer.