In this study, we are investigating how the combination of the selected standard therapy with the drug darolutamide affects the progression of the disease and whether darolutamide is well tolerated.
Aim of the study
With this study, we want to find out whether the drug darolutamide can extend the time to possible disease progression when taken together with standard treatment and then as maintenance therapy.
Who can take part?
Patients with metastatic hormone-refractory prostate cancer
Procedure
There are various possible standard therapies for this disease. These include:
- Chemotherapy with a taxane
- Radionuclide therapy with lutetium-PSMA or radium 223
- targeted oral therapy with the PARP inhibitor olaparib if a mutation is found in the BRCA 1 / 2 gene.
The choice of standard therapy will be determined individually by your investigator, depending on various characteristics of your disease.
If you would like to take part in the study, you must fulfill certain criteria. These are clarified first. If you fulfill the criteria and decide to participate in the study, you will be randomly assigned to one of 2 groups. They belong to either the test group or the control group.
- In the trial group, you will take darolutamide in addition to standard therapy and as maintenance therapy after discontinuing standard therapy. The intake of darolutamide is stopped if it is no longer effective or if an intolerance occurs.
- In the control group, you will receive one of the above-mentioned standard therapies (without darolutamide).
Your participation in this study will last a maximum of 5 years. The treatment phase can last from 3 to 24 months, depending on the group allocation and the standard therapy selected.
Compensation
If you take part in this study, you will not receive any compensation.
Original study name
SAKK 08/23 - Addition of Darolutamide to first line treatment of mCRPC: a randomized open label phase II trial
BASEC number
2024-01287
Sponsors