In our research project, we want to find out whether the combination of darolutamide (experimental treatment) with ADT (androgen deprivation therapy) works well or just as well or better than ADT alone.
Aim of the study
Before a drug is used to treat a disease, it must be scientifically tested on study participants. We therefore want to investigate whether and how effective, tolerable and safe the drug darolutamide is in the treatment of metastatic prostate cancer. The drug is a new treatment developed by Orion Corporation Orion Pharma and Bayer Healthcare. It works by blocking a hormone receptor called androgen, which plays an important role in the development of prostate cancer. The primary endpoint of this research is therefore whether the administration of ADT is more effective than ADT treatment alone.
Who can take part?
Patients who have recently been diagnosed with metastatic prostate cancer but have not yet started treatment and are not eligible for ADT treatment in combination with a standard treatment called docetaxel or other agents that target androgen receptors.
Procedure
To answer the study objectives, patients are divided into two groups: one group that receives ADT and darolutamide, and another group that receives ADT and a placebo treatment (tablets that look exactly like darolutamide but contain no active ingredient). Darolutamide is available as white film-coated tablets (300 mg) in vials containing 140 tablets each. The starting dose of darolutamide is 4 tablets per day, 2 in the morning and 2 in the evening. During the treatment phase, we will ask you to return to the hospital at regular intervals for various tests and examinations so that we can assess how you are responding to the treatment.
Compensation
Original study name
A double-blind, randomized, phase III study to evaluate the efficacy of ADT +/- darolutamide in patients with newly metastatic prostate cancer with compromised functional capacity who are not eligible for doxetaxel or another androgen receptor.
BASEC number
2022-01593
Sponsors