I'm still not quite sure what to think about "enrollment" vs. "randomization", personally (which I'm perfectly aware doesn't count for anything anywhere) I would consider a patient enrolled if he met the entrance criteria for getting the Lupron-shots in the first place. He would then be eligible for randomization to either Provenge or Placebo only if he reached the "undetectable" level, but even if not meeting these requirements, he would still be counted as enrolled. Assuming that I'm right, this would explain the low number of Provenge treated patients (104 patients) in Dr. Provost's presentation and it would also explain why Dr. Kylstra mentions 160 patients as treated (Iwfal: I didn't quite get your comment to my post #749 about design n... please have a look at Dr. Kylstras presentation once again and check if that is what was meant).
I believe I came across a paper describing that patients that reached the undectable level from ADT had a tremendously better chance of surviving (on continued ADT) than patients who did not. I can't quite remember, but I think median survival was about 12 years(?). I therefore think that it is likely that the patient group in this study may not progress as fast as one could have expected from other studies.
Anyway, I still think my points in post #749 are pretty valid (irrespective of IR responses telling the opposite) and I also think the treated population - i.e. those who achieved the undectable PSA level - represents a special group that may progress slower. Then again, a single shot of Lupron shouln't keep the testosteron at bay for much longer than about 4-5 months, and as such, the patients might progress rapidly no matter their PSA being very responsive to ADT.
I don't know what to think, but I get kind of worried when reading Iwfal's latest guestimates on the chances of stat sig of P11, I would certainly have expected these numbers (chances of stat sig) to be more favourable for a long position...
Best regards,
Bengt
