Heres someone who may be participating in the FGN-1 clinical trial!
rattler.cameron.edu
We are just initiating our clinical trials as a participating member in
FGN-1 per Cell Pathways, Inc (CPI). FGN-1 is essentially an agent that
promotes programmed cell death or apoptosis. It is a sulfone metabolite of
Sulindac. Sulindac is an anti-arthritis medication. FGN-1 appears to affect
the rate of apoptosis selectively in precancerous and cancerous cells. No
one knows yet has this occurs. It is felt to be beyond the interaction of
bcl-2 (an anti-apoptosis oncogene) and beyond p53 (a tumor suppressing gene
when dealing with wild-type p53). Interestingly, FGN-1 seems to be work on
cells independent of where they are in the phase of cell growth. FGN-1
works on resting cells and actively dividing cells equally.
Enough said, for now on FGN-1. My initial take on this and other new agents
of unknown efficacy is to take a hard look at the patient and make sure
they know that we have no idea on the short-term or long-term value of
these new treatments. I love to explore so honestly I want to be involved
in areas of breakthrough. Yet we must be honest and above board with people
we treat and let them know the full scope of what options they have and the
real pros and cons of each one. With this said, let me review your PCD and
see what I can suggest.
<<David Domizi, father (2 sons), wife- Susan; ex-race car driver,
engineer, design/manuf. industrial laser cutting systems,
fisherman, bridge player, Conn. & E. Shore, MD.
DxPC age 57, 4/94
bPSA 9.5, 9.7,(& 11.2?)
Staging: bone scan/CT neg, PAP 1.9 (nl to ?);ploidy ?>>
That PAP is normal with virtually every lab I have used.
I am missing the original GS, clinical stage, number of cores biopsied and
number involved. You can always add this on later.
<<RP July'94; Gleason 3+3=6, PNI+, Capsule +, SV + R&L;
nodes neg = T3c;ploidy?>>
Ploidy is a test on the DNA. If you don't ask for it, you don't get it. SV
positivity is a high risk finding for biochemical relapse being seen in
about 80% of the men in the Stanford series within 5 years of the RP. The
capsule and SV involvement are expressions of greater biologic activity and
of course metastatic potential of this disease.
<<Post-RP PSA's: 10/94 0.1; 1/95 0.2; 6/95 0.36; 9/95 0.46,
1/96 0.7; 4/25/96 0.7, 8/16/96 1.0 (current PSA pending)
I find it impossible to believe that there are no PSA readings from 1997 or
from 1998. These are very important issues. The PSA velocity or PSAV is 0.5
ng/ml/year (add this to the PCD).
WITH A GS OF 6 AT RP AND A PSAV OF 0.5, IF THERE WAS NO SEMINAL VESICLE
INVOLVEMENT, THE CHANCE FOR LOCAL RELAPSE WOULD BE 60%. There is no
database for a PSAV of 0.5, AND SV involvement with a GS of 6. The lowest
GS seen in this setting was 7. In such patients (that is GS of 7 at RP,
PSAV of 0.5 post RP, and SV positive at RP) the chance for local disease
was only 6% with the chance for systemic disease being 94%. Sorry to relate
this to you.
Our suggestions:
baseline tumor markers such as PAP, PSA (current), CEA, NSE, CGA, chem
panel
baseline hormone levels such as T, DHT, DHEA-S, Prolactin, Androstenedione
Staging studies such as bone scan and if normal then ProstaScint scan and
go from there.
Of course we would expect the usual detailed physical exam with DRE
I would feel medically obligated to workup a patient such as your husband
and to determine if we are dealing with local vs systemic disease as best
as we can in 1998. In the near future, such men will also have RT PCR PSA
or PSMA done on bone marrow aspirate samples.
My opinion re: FGN-1 in this setting. I would want the workup to assess
disease activity and get a sense of disease bulk before going on such a
trial. If there was no flagrant disease, I would consider this. I would
also be on low fat diet supplemented with selenium and vitamin E. I would
defer on the flax seed oil until this controversial area is clarified. I
have great respect for Snuffy Myers and his lab apparently is finding that
flax seed oil makes prostate cancer grow, not vice versa. If you want to do
something good, try Baker's Chocolate. This is high in Stearic Acid that is
supposed to be effective in killing PC (again per Myer's lab).
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