Darolutamide + ADT for Prostate Cancer
(ARANOTE Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a drug called darolutamide combined with a common hormone-lowering therapy in patients whose prostate cancer has spread but still responds to hormones. The goal is to see if this combination can effectively and safely slow down the cancer's growth. Darolutamide was approved in 2019 for a specific type of prostate cancer.
Eligibility Criteria
Men with confirmed metastatic hormone-sensitive prostate cancer, who have started ADT within the last 12 weeks and are in good physical condition (ECOG PS of 0-2) can join. They must not have had certain heart conditions or other cancer treatments like chemotherapy for prostate cancer in the past 6 months.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Androgen Deprivation Therapy (ADT) (Hormone Therapy)
- Darolutamide (Antiandrogen)
Androgen Deprivation Therapy (ADT) is already approved in Canada for the following indications:
- Prostate cancer
- Metastatic prostate cancer
- Non-metastatic high-risk prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
Orion Corporation, Orion Pharma
Industry Sponsor
Liisa Hurme
Orion Corporation, Orion Pharma
Chief Executive Officer since 2022
PhD in Biochemistry, University of Helsinki
Hilpi Rautelin
Orion Corporation, Orion Pharma
Chief Medical Officer since 2023
MD, University of Turku