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Proved 'triplet therapy': adding darolutamide to hormone therapy plus chemotherapy reduces death by a third.
ARASENS, trial NCT02799602 sponsored by Bayer and Orion and reported in 2022, proved triplet therapy in metastatic hormone-sensitive prostate cancer: adding darolutamide to androgen deprivation plus docetaxel reduces the risk of death by about a third compared with hormone therapy and docetaxel alone. It randomised 1,306 men and met its primary overall survival endpoint, with benefit in both high-volume and low-volume subgroups. OnCo links it to prostate cancer, darolutamide, docetaxel and Matthew R. Smith, and its result is consistent with PEACE-1, which tested an abiraterone triplet in de novo metastatic disease. Because every patient received docetaxel, the trial cannot say whether the chemotherapy was needed on top of darolutamide, which is the main open question. Darolutamide has its own page.
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.
1,306 enrolled.
Step lines join published landmark estimates; the true curve between them is not shown.
Curves show the trial population; they are not a prediction for any one person.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Darolutamide + ADT + docetaxel | 651 | Median not reached | 0.68 (0.57 to 0.8) | <0.001 | link |
| Placebo + ADT + docetaxel | 655 | 48.9 months |
Shares Darolutamide, Bayer, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares Darolutamide, Bayer, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares Darolutamide, Metastatic hormone-sensitive prostate cancer, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares CHAARTED (E3805), Metastatic hormone-sensitive prostate cancer, Androgen deprivation & AR pathway inhibitors, Docetaxel.
Shares Darolutamide, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Bayer, Androgen deprivation & AR pathway inhibitors.
Shares Darolutamide, Bayer, Androgen deprivation & AR pathway inhibitors.
Shares ARANOTE, Metastatic hormone-sensitive prostate cancer, Prostate cancer.
Shares Prostate cancer drugs in England: what NICE recommends, and what it refuses, Metastatic hormone-sensitive prostate cancer, Androgen deprivation & AR pathway inhibitors, Docetaxel.