Summary
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, researchers 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 be randomly split into two groups with one group also receiving the lipid drug called Opagnib 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. Researchers will also look at how the Opaganib is affecting lipid/fat metabolism in the body/tumour.
Potential participants who meet all of the inclusion criteria and none of the exclusion criteria listed will be presented with a pre-screening consent. If they consent to pre-screening, a sample will be collected for PCPro biomarker testing. If the pre-screening assessment shows that the trial is suitable for the participants who have undergone pre-screening, then they will be presented with the main study consent and will be given the opportunity to decide if they want to enrol in this trial or not.