- Ongoing, recruitingTherapeutic confirmatory (Phase III)
(21140 ARANOTE) A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC).
This study looks at a new drug, darolutamide, for men with prostate cancer that has spread and still responds to hormone therapy. It compares darolutamide plus standard hormone therapy to a dummy pill plus standard hormone therapy, to see if darolutamide helps patients live longer without their cancer getting worse.
For: Metastatic hormone-sensitive prostate cancer (mHSPC)Spain · Latvia · Lithuania - AuthorisedTherapeutic confirmatory (Phase III)
ALADDIN: evaluation of dAroLutamide Addition to anDrogen Deprivation therapy and radIatioN therapy in newly diagnosed prostate cancer with pelvic lymph nodes metastases
This study, called ALADDIN, looks at a new drug (darolutamide - BAY 1841788) alongside standard hormones and radiotherapy for men with newly diagnosed prostate cancer that has spread to nearby lymph nodes. It aims to see if adding this drug helps them live longer without their cancer getting worse.
For: Newly diagnosed prostate cancer with pelvic lymph nodes metastasesFrance - Ongoing, recruitingTherapeutic exploratory (Phase II)
Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial (DART).
This study looks at a new way to treat prostate cancer that has come back in a few spots. Doctors are testing if adding a drug called Darolutamide to a special type of radiation (SBRT) can help stop the cancer from spreading further, compared to radiation alone.
For: OligoRecurrent prostate cancerBelgium