There is nothing more frustration that the current methods used by the FDA to approve drugs. The theory is great, but how it gets translated into our real world is killer, I mean a literal killer of men. The FDA wants assurances that before they approve a drug that it really works, or shows efficacy. This certainly sounds reasonable, but the method of evaluating efficacy is survival.

So, all the prostate cancer clinical trials require men to die. Fortunately, (but one could also argue unfortunately) men with prostate cancer often take many years to die, so we are forced to wait around year after year to count our brothers as they die. It is only after many years do we achieve enough deaths to be able to say that this drug gives a longer survival time over another drug or a placebo. In the mean time, we wait and not only do the men in the trial die, but all the rest of us not in the trial also die without access to this potential new treatment.

We are in desperate need to find alternative endpoints to death (or survivability). We need to find surrogate endpoints that reliably allow us to assume the survivability numbers without having to wait years and years of men dying.

There was just a paper published in Lancet Oncology, which is assessing the possibility of using circulating tumor cell (CTC) counts as a prognostic factor for survival (or as a surrogate endpoint). Dr. Scher from Sloane Kettering Hospital and his colleagues are currently involved in a trial with men who have progressive, metastatic, castration-resistant prostate cancer. They have been isolating CTC from blood samples at baseline and after chemotherapy treatment. Baseline variables, including CTC count, PSA level, concentration of lactate d