ICECAP collaboration was the largest study looking at the prognostic value of PSA nadir in localized prostate cancer, finding a PSA level of less than 0.1 could provide an early prognosis signal.
So in this study, we looked at data available within the ice cap database. Icecap stands for intermediate clinical end points in cancer of the prostate. And it's collected individual patient data from more than 40 randomized trials conducted over the last 30 odd years for localized prostate cancer. What we looked at was patients were treated with radiation with or without hormone therapy. Be that short term or long term hormone therapy for localized prostate cancer. And we specifically sought out to see the prognostic implication or prognostic value of PS A na deer at six months after completion of radiation. So that's the lowest PSA A patient gets to at six months after completion of radiation, there were about 16 trials that provided this data totaling 10,400 patients. The median fall up was 10 years, 60% received radiation and short term hormone therapy. 20% received radiation alone and the remainder received radiation and long term hormone therapy. The proportion of patients achieving the favorable PSN idea which we defined as less than 0.1 was fairly low, just 2% in the radiation alone group. It was 16% in the radiation and short term hormone therapy group and 23% in the radiation and long term hormone therapy group. The key results were that patients who achieved this favorable ps A of less than 0.1 at six months after completion of radiation or without hormone therapy did much better in the long run. This achievement of this Nadia was strongly associated with better metastasis, free survival, overall survival and prostate cancer death. And this held true regardless of whether the patients just had radiation alone or radiation and either short or long term hormone therapy. And this is really the largest study looking at the prognostic value of PS A Nadia and localized prostate cancer and the implications are twofold. Number one, it provides data that we can use in routine clinical practice to counsel our patients. And number two, we could take forward this PSN idea as an intermediate endpoint to aid in the conduct of clinical trials going forward. For example, we could use it as a way to escalate or deescalate treatment based on the whether you get that PSN idea or not. And number two, we could use it as an intermediate endpoint in itself in sort of smaller studies, assessing different treatments along with radiation and hormone therapy to see which might have a good signal to take forward into a larger, bigger randomized trial.
