In Switzerland, every year around 6000 men are diagnosed with prostate cancer. This makes it the most common malignant tumour in men. Medicine has made significant advances in treatment over the last few decades. However, metastasised castration-resistant prostate cancer, which no longer responds to anti-hormonal therapy, unfortunately remains incurable. Researchers are therefore looking for new treatment options.

Darolutamide is a pharmaceutical compound that strongly binds to the androgen receptor on prostate cancer cells and thus blocks the growth-promoting effect of testosterone. The compound has a favourable side-effect profile and is approved in Switzerland and Europe for the treatment of earlier stages of prostate cancer.

The predecessor study SAKK 08/16 showed that darolutamide is effective in patients with metastatic hormone-refractory prostate cancer when taken as maintenance therapy after chemotherapy. The new SAKK 08/23 study is investigating whether this effect can be confirmed or even enhanced if darolutamide is used from the outset in addition to standard therapy and then as maintenance therapy.

The study compares the treatment results of 81 patients in the test group with the results of 81 patients in the control group who receive standard therapy without darolutamide. The participants in the trial will be randomly assigned to each group. A total of 162 patients will be taking part in the study.