ARANOTE
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.
Overview
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.
Similar pages
not linked directly; found by shared links- TrialARAMIS
Shares Darolutamide, Bayer, Prostate cancer and the tag subtype-trials.
- TrialENZAMET
Shares Metastatic hormone-sensitive prostate cancer, Prostate cancer and the tag subtype-trials.
- TrialGRID
Shares Bayer and the tag subtype-trials.
- TrialREGOBONE
Shares Bayer and the tag subtype-trials.
- TrialA Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have Hi
Shares Darolutamide, Bayer, Prostate cancer.
- TrialPROSPER
Shares Prostate cancer and the tag subtype-trials.
- TrialA Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer
Shares Darolutamide, Bayer, Prostate cancer.
- TrialTulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in
Shares Darolutamide, Metastatic hormone-sensitive prostate cancer, Prostate cancer.