January 11, 2001:
I Start a Clinical Trial
[Introduction: On the prompting of some friends on a private list, I wrote this on 3/30/01. I decided to repost it here with a few clarifications to reassure some who might also be wondering what has been happening.]
I've been promising to update you guys as to what I've been doing and the
longer I wait, it will seem I'm hiding something. I'm not. It's actually
fun news but I was trying to get it all together to post to the p5 site but
it is going to take me even longer I'll explain so I thought I would give
it to y'all in the short version WITH the explanation why I wanted to do it
on the site.
Anyway, I've been on a clinical trial since January 11 and to explain it
all and what I'm getting is sooooooo much work that I wanted to just do it
once, along with URLs (of course) as to what it is, some scans of the
little forms I fill out, some essays about the whole procedure from the
selection process on because while every clinical trial is different, I
wanted to really make a record of this one so people had SOME idea what
they are like.
It is in Cincinnati and it is a double-blind trial, which means neither I
nor the doctor I work with on this knows if I am getting ''the stuff.'' It is
a Phase III clinical trial, using Quadramet, a radioactive substance that is already
on the market for the treatment of bone pain, and has been for years. So,
the question is, if it is already on the market, why a clinical trial?
Quadramet has been approved to treat bone pain. This particular trial is to see if it
can be used to prevent or delay the onset of bone pain from mets.
Qualifications for admission are (roughly and this is one of the reasons
why I wanted to get it all together, so I get it right the first time)
hormone refractory (which I am, my PSA has been slowly climbing since June
and I figure it started in April), no other treatment on-going and
relatively free of pain. The latter is important as they didn't want guys
on it who are taking serious painkillers as that would screw up the study,
wouldn't it? (laugh)
Anyway, the procedure is that you get the shot and it would be either a
placebo (they use the light stuff that is injected for a bone scan) or the
Quadramet with the difference being one is a double-dose of the other,
sort of the way I take my Scotch. Then there are the follow-ups, which I'll
I started the application for admission somewhere back in November and went through several screenings and was finally approved. I got my shot January 11, at the
University of Cincinnati hospital, Dept of Radiation/Nuclear Medicine,
which was quite a procedure! (laugh) After that, all I had to do was go in for blood tests and
checkups each week. For the last couple of weeks, I didn't have to go in
and won't until next Thursday. After that, I'm off again for a couple of weeks. And so it goes.
After 16 weeks, the trial is done with a host of tests and I get the option of signing up to do
it again and to get another shot. In other words, it runs in 16-week sections.
The last time I asked, there are only two of us in the trial here in Cincy.
Most men who apply don't qualify and I was told at least a dozen have
applied. The study needs something like 200-300 nationwide. I'm starting to
understand why these trials take time and are so expensive.
Okay, over to Quadramet for the moment. It is a radioactive substance
injected via syringe. I've read lots about it but it is way too technical
to try to repeat off my head. Basically, it attaches itself to bone mets
and thus is able to deliver radiation directly. It then washes out of the
system pretty fast and it has a fast half-life, so it doesn't linger in the
Only side effect of any note is a dropping of white blood cell count for
the first 5 weeks and then it recovers. That was one of the reasons why I
didn't want to enter into some ''experiment,'' because of unknown side
effects. That is what Phase I is about. Basically, IMHO, if you live
through Phase I, the drug is safe. If you don't, they don't go to Phase II.
That's a harsh view but it was why I avoided them. I wasn't interested in upsetting my QOL which was just fine. So when I read up on Quadramet and saw it already was on the
market, I felt better. Additionally, I do know bone mets pain and I didn't
like the prospect of it returning, so me and the trial were made for each
[A note added later: A week after I wrote this, I learned that this ia a Phase III trial, not Phase I. What I find interesting is that I went in thinking it was Phase I, meaning only that I overcame even more resistence, than I would have had if I had known it was Phase III.]
Now, onto results. While I don't know if I am getting it or not (either dosage), I
do know that I have been feeling better. Plus there is one other little
fact: my PSA has begun to drop. It was 16.1 in December and climbed to 41.4 but the test of 3/15 showed it had dropped to 33. So even if I'm not getting it, I'm doing
There is one other part of this procedure that I really like: they watch me
like a hawk. One week I got a call from the nurse that I see each time who
said one of my blood counts (not white blood that is the only
figure withheld from me and the attending doctor as it would be the tale)
had dropped too far and could I come in immediately for another test and bring a stool
sample. (As it turned out, they thought I was losing blood.) I did and it all turned out to be probably a lab error but it showed how closely they monitor me.
What it means is that I am getting constant checkups and if anything at all
is awry, they would take action and, at the very least, get the data over
to my primary care physician, so I am getting checked more than I would
EVER get checked in ANY system, and there is a certain comfort in that.
There's a lot more to write about, such as the whole approval procedure with tests,
ceremony of the injection, and some not-so funny things, but I'll save those for the write-ups for the site.
So that's what the ''news'' is that I've been holding onto for the last few months. I don't like to
just announce I'm on a clinical until I have some sense of it. And why
bother saying I had applied if I don't know if accepted? I don't like giving
halfway pieces of news when it comes to these parts of my life. I also
wanted to get it all together to avoid questions from people about
Quadramet and the like. Maybe this will prompt me to get it all on line.
Anyway, I'm happy with the trial for more than one reason. When it comes
time, I'll sign up for shot #2.
For information on
Quadramet, go to the FAQ at their site, or
The Quadramet page or
Berlex, which makes Quadramet.
For more informaiton about Samarium 153: