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I Finally Find Out
May 31, 2001
Well, this has been an interesting month.
I sign up again for another 16 weeks and then on the next visit am told the trial is closing for lack of volunteers. But they want me to come in almost each week (there is a calendar as to which ones) for a blood draw so they can monitor whatever they are monitoring. Today was one of them.
After the blood draw, I decided to ask that since the trial is over, when can I find out what I was getting? Quadramet or the placebo?
Gayle smiled and said, "You want to know?"
Sure, I said.
Well, it turned out I was getting the Quadramet and a full dose.
Back when I started, I heard some were to get a "double-dose" but I misunderstood. What I was getting was the regular dosage and the other group (beside placebo) were getting HALF of that. So the "double" was double the other group.
For what it is worth, the dosage is 1.0 mCi/Kg, which means 1 milliCurie per kilogram.
So it wasn't just a flat dose but proportional to one's weight. (I kept wondering why they were weighing me on a kilogram scale, thinking, oh well, the metric system.)
So what is a milliCurie? Well, it is one-thousandths of a Curie.
Curie, as you might remember, is Marie Curie who made so many discoveries in radiation (and won two Nobels for it) so she gets a measurement named after her.
Actually, it an incredibly complex formula, as to what a Curie of radiation is. I looked it up and gave up. ("A unit of radioactivity, equal to the amount of a radioactive isotope that decays at the rate of 3.7 x 1010 disintegrations per second." See what I mean?)
Back to the world of pints and pounds...I was getting the full dose, which definitely ends the double-blind.
Then she said something even more interesting. She said that she found that I am eligible to get it two more times. I was to get it for up to four times in the trial and even though the trial is over, since I have gotten it twice, I am still able to get it two more times.
I was at first a bit perplexed, before I could be pleased. Why, I asked.
She said she had no idea why they will do it but they will.
Well, I said, leaning back with a smile, now I am really glad I decided to stay with the blood draws. Since the news that the trial had ended, I had been giving thought to the dreariness of coming in almost each week for a blood draw but now that I know I am getting the actual Quadramet and that I will be able to continue (and since the dosage is good for 16 weeks, that means 32 more weeks after 12 weeks from now, because I am in Week 4 of the second dose), I was definitely interested in the blood draws. She smiled and said, yes, I was going to urge you to continue with them. The decision to continue is up to me.
She asked me if I had been getting some "flare" (meaning an onset of pain after shot) and I said, yes, I was but after a few weeks it was gone, such as this last week when I didn't even need my sometimes-dosage of a couple of Advil in the week when some aches and pains come in. (They aren't bad and seem to be as old age as anything.)
I also decided to confide in her a feeling that I had developed about the trial after a few months. I could not figure how they could truly measure preventing the onset of bone pain. And even if they could with a large enough group of men and the PSA tests and the imaging that we went through, it seemed to me that they were testing something else.
Now you have to realize that in clinical trials, everything has to be above board. Except for what I was getting, I would have been able to get access to every document they had filed to get the trial, as to purpose etc.
But it seemed to me that there was something else that they could have been testing without disclosing it AND without violating the law. (And I certainly don't know the law on this.)
I had a theory that since bone pain comes from the spread of the cancer, if Quadramet could prevent the onset of the pain, that would seem to imply that it was actually therapeutic, rather than palliative. Like hormone therapy, it would be seeking to control the cancer but it would do so by delivering radiation directly to the cells, providing the benefit of radiation without the side-effects of beam radiation, or even seeding.
She said that was interesting because there is one cancer where that is done: thyroid cancer. With that, a radioactive substance is injected that (when the thyroid collects it) will attack the cancer. But whether or not Quadramet could be used in that way, we simply don't know.
And let me interject here. Quadramet is usually used in end stage cancer. It is a pain killer. But as Dr. Silberstein mentioned, the problem with judging any therapeutic value is that men who take it are truly in their end stage.
Now backing up, what is interesting in this trial was that they were seeking men who had refractory prostate cancer that had metastasized to the bones but below a certain pain level. In other words, they seemed to want men whose cancer had not advanced as far as those that usually take Quadramet.
I may be completely out to lunch on this. As I said, it was just a feeling. But it is an interesting theory: can radiation delivered at a cellular level be effective at combating the cancer? And was that what the trial was testing without violating the law as to the purpose of the trial? In other words, if they had seen a positive result, they could have presented the results to the FDA and proposed a new trial, starting again at Phase I with an increased dosage. (Testing with a dosage that had already been approved for safety certainly has to cut corners on Phase I.)
I don't know but it is a pleasure to now offer my speculations. It may also be why they will allow the full four doses. Maybe it can give them some raw data to restructure another clinical trial.
Regardless, I left feeling pretty good. Knowing I was getting the Quadramet explained why I had been feeling so good physically these past months. There WAS a difference and it is so easy for improvement to come from a variety of areas when you are 63 and have Stage M1c prostate cancer, not to mention feeling worse. But I think the Quadramet played a definite role.
What will be interesting will be my PSA. It dropped once before the trial started and then climbed and then dropped again in the trial and then climbed. There is no pattern yet. But I'm due to get another one next week, I think it is. So we'll see.
Meanwhile, the Big-Q and I are going to be very good friends for another 44 weeks.
I can manage that. (smile)
RVY
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