ARASENS
Proved 'triplet therapy': adding darolutamide to hormone therapy plus chemotherapy reduces death by a third.
1,306 men; OS HR 0.68 (4-year OS 62.7% vs 50.4%); benefit in high- and low-volume subgroups.
Setting
Metastatic hormone-sensitive prostate cancer: ADT + docetaxel + darolutamide vs ADT + docetaxel
Phase
Phase 3
Sponsor
Bayer / Orion
Registry
Headline result
OS HR 0.68.
Reported
2022
Enrolled
1306
Replication
Consistent with PEACE-1 (abiraterone triplet) in de novo metastatic disease.
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 48.9 months with Placebo + ADT + docetaxel.
- Darolutamide + ADT + docetaxel: Median not reached.
- "Not reached" means that, when the data were analysed, more than half of that group had not yet had the event, which is good news for that group.
- A median is a midpoint: half the people did better than this and half did worse.
- Put another way, the treated group had about 32 percent lower chance of the event at any given time (hazard ratio 0.68, likely range 0.57 to 0.8).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Metastatic hormone-sensitive prostate cancer: ADT + docetaxel + darolutamide vs ADT + docetaxel. People in a different situation may not see the same effect.
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 participants enrolled.
Overall survivalprimary
HR 0.68 (0.57–0.8) · p <0.001
Darolutamide + ADT + docetaxel
Median not reached
Placebo + ADT + docetaxel
48.9 mo
Median not reached
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Darolutamide + ADT + docetaxel | 651 | Median not reached | 0.68 (0.57–0.8) | <0.001 | link |
| Placebo + ADT + docetaxel | 655 | 48.9 months |
Replication
Consistent with PEACE-1 (abiraterone triplet) in de novo metastatic disease.Pages like this
not linked directly; found by shared links- TrialCHAARTED (E3805)
Shares Docetaxel, Prostate cancer.
- TrialPEACE-1
Shares Docetaxel, Prostate cancer.
- PersonNicholas James
Shares Docetaxel, Prostate cancer.
- TrialSTAMPEDE
Shares Docetaxel, Prostate cancer.
- CompanyBayer
Shares Darolutamide, Prostate cancer.
- PathwayAndrogen receptor signalling
Shares Darolutamide, Prostate cancer.
- TechnologyAndrogen deprivation & AR pathway inhibitors
Shares Darolutamide, Prostate cancer.