I just tried to put a patient on the Cabo survival trial and learned that according to clinical trials.gov very few centers in NY are actively recruiting and the one center I contacted said they were having trouble recruiting because half the patients on the trial get a useless treatment. I understand the FDA and the company but personally unless there is a crossover after progression the trial will take a long time to accrue. On the other hand it is difficult if not impossible to show a benefit in survival if crossover is allowed. The trial should have been done on earlier patients against something like Jevtana. We are going to have to be super patient to see results in the survival trial
It's hard for trial design. Patients want to be in the drug branch, and statistics/FDA like double blind. At least COMET-1 is against prednisone, and COMET-2 mitoxantrone + prednisone. They are much better than some trials against starch pills.
Survival trial. Neither mitoxantrone nor prednisone by themselves have any real activity in advanced prostate cancer. The studies might as well have been against starch.
the right study would have been against jevtana. Sorry.