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Post by cspivak on Oct 22, 2014 3:43:02 GMT -8
Hi!
My husband is in the control arm of S1216, the TAK-700 trial. He had his first monthly blood work specifically for the trial this week.
The consent form says (which we forgot about and were surprised, our bad) no results will be shared with patient.
is this normal? The protocol person let slip that some testing for genetic markers was being done and I would love to see that.
Also, PSA testing is part of it - should we expect to see those results or will he have to have duplicate testing done?
The whole thing seems kind of un- American. I understand about burdens on the research team, investigational tests, and privacy, but geez.
your thoughts? Thanks.
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Post by KC on Oct 22, 2014 9:56:32 GMT -8
Here’s KC’s “short answer:” You should expect to be informed promptly of the results of “standard” monthly tests such as PSA and liver enzymes, but you should not expect to be informed promptly of the “big-picture” direction the clinical trial’s overall results, unless there is a dramatic and unexpected interim data assessment which indicates that significant harm, futility or benefit is brought to either the control or experimental arms. That seems "fair" to me.
I’ll comment a little more on what I understand to be the case with this trial…but please do fill-in gaps or correct errors as you observe them, cspivak…
The purpose of this Phase III study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy (experimental arm) which is used to treat prostate cancer as compared to the standard of hormone therapy alone (control arm). The primary objective is to compare overall survival results, but there are other important secondary objectives and interim measurements. It is not a blind study because the TAK700 requires taking two pills per day spaced 12-hours apart.
The control arm (Lupron/Casodex) is the “standard of care,” so your husband is receiving the best known treatment available. This arm is the baseline against which possible improvement (via the study's experimental arm) will be measured. Because outcomes do vary, the study needs a large number of participants in both the control and experimental arms. We already know that not everybody responds favorable to the “standard of care;” and the same is true of the experimental arm. The big-picture question to be examined is whether large numbers of people when taken in aggregate have a different outcome which is statistically significant between the two groups.
This trial (and every trial) will have pre-defined criteria for removal from protocol treatment. Rising PSA, or other indications of significantly progressive disease would warrant removal…either arm. In both cases, time to try something else.
Maybe we'll also hear from Tony. S1216 is a SWOG-administered trial, and Tony's a SWOG member...but I hope at least my "short answer" helps a little.
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Post by Tony Crispino on Oct 22, 2014 11:17:22 GMT -8
Short answer is right. All information is blind right now as that is customary while the trial is ongoing. Once we hit the 56% mark a preliminary analysis will ensue. I will be co-author of that paper but even right now I do not have that data. The only physician with access is Neeraj Agarwal out of Huntsman in Salt Lake City. He sees the data and the results and oversees the trial. KC is correct, the control arm is standard of care in this trial so any data pertaining to that was from previous completed trials in the 90's. Lupron and Biacalutamide have been proven safe and effective at extending lives and controlling disease.
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Post by cspivak on Oct 24, 2014 17:56:12 GMT -8
Thanks for your explanations, makes sense. I knew this was the right forum to ask this question...
I actually had the impression (from the protocol coordinator, maybe I just misinterpreted) that the researchers were going to do some kind of genetic or bio marker testing with the blood samples. So if (for example) they happened to test for AR-V7, which evidently predicts response to some important drugs, we would really like to know.
So it's that kind of thing I was wondering about...not so much the results of the study. Maybe that kind of additional testing is very unlikely; I don't know a thing about how medical research gets done.
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Post by Allen on Oct 25, 2014 9:37:14 GMT -8
The AR-V7 study was a separate clinical trial done at Johns Hopkins. You generally can't be enrolled in multiple clinical trials, although it may be possible if, for example, one is for a treatment and the other is diagnostic. Especially when studies are blinded and controlled, they probably will not want you learning additional info about possible treatment effects because it may bias the results. But check with your study administrator first - there are strict rules about such things, and you wouldn't want to invalidate the results.
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