DARO-LIPID

This study is taking a novel approach to using predictive biomarkers to select people for lipid (fat) targeted treatments, to attempt to overcome hormone resistance in people with metastatic hormone resistant prostate cancer.
There is increasing evidence that abnormal lipid (fat) metabolism promotes the growth of prostate cancer cells. We have previously shown that abnormal patterns of blood-borne lipids (called ceramides) can identify a group of people with metastatic hormone resistant prostate cancer who are likely to be resistant to the usual hormone treatments: abiraterone and enzalutamide. In the DARO-LIPID study, we will first identify which participants with metastatic hormone resistant prostate cancer have the high ceramide lipid signature through a blood test. Participants who do not have this lipid signature will receive usual care by their oncologist. Participants with this lipid signature who consent to the study will all receive darolutamide as standard of care. Participants will then be randomly split into two groups with one group also receiving the lipid drug called Opaganib to target the abnormal lipid changes and the second group receiving a placebo.
The study is designed to see if Opaganib can increase the number of people who respond to darolutamide, and increase the time that they get benefit from the treatment. We will also look at how the Opaganib is affecting lipid/fat metabolism in the body/tumour.