Fairwind said...
As far as I know, NONE of the 47 has suffered a negative outcome..but a few have noticed no improvement..Doctors in England claim that one lucky man was actually cured
Unfortunately, that's not the case. The 47 is based on two separate pilot studies, one for mHSPC (n=29), the other for
asymptomatic mCRPC (n=16). Neither of these small pilot studies were among men who "only had a few months to live." It is also unclear whether or not the increased testosterone accelerated progression in many of the men in each trial. In the HSPC trial, 6 of the 29 had detectable metastatic progression after 18 months on BAT. How do we evaluate that without a control group? In the CRPC trial, half had no discernable PSA or radiographic response to BAT. Was that worse than expected? Impossible to know without a control. Their new clinical trials for which they are currently recruiting are still Phase 2 - testing efficacy in various settings.
Pilot tests like this are great for eliminating non-starters and for generating hypotheses. Tony can tell you war stories of all the Phase 2 clinical trials that washed out when expanded to Phase 3. Importantly, can we identify patients in whom it is likely to be beneficial, and those in whom it is likely to be detrimental? And, perhaps most importantly, will the observed PSA/radiographic response in some translate to a survival benefit?
This is definitely not ready for prime time and will not be for several years at least.
BTW - the doctors were at Johns Hopkins rather than England.