Yesterday was my husband's quarterly doctor's appointment. He's been in a clinical trial for the last 5 1/2 year. As we near the end of the EMBARK Trial, I have been worried about how we will manage to get Xtandi after the trial concludes. He's not old enough for Medicare, and the co-pay with our employer-provided insurance is $2,000 per month. I've checked into several different programs, but cannot get an answer to anything as long as he's actively in a trial. I've worried myself sick about how to manage the cost. Each time we go, we ask for any information about the end-date. As of now, we still don't know.
When we asked yesterday, the oncologists pointed out that Xtandi isn't FDA approved for Randy's situation (thus the clinical trial). In order for her to prescribe, she'd have to prescribe off label and the insurance company would then deny the claim. She said that sometimes the drug company would continue to provide the drug after the trial...sometimes they don't. There's no way to know. She said she'd certainly 'go to bat' for Randy, but is not sure what will happen when the trial ends. The clinical trial coordinator also seems to be without a clue as to what happens after.
I've read everything I could find about clinical trials, what to expect, questions to ask, and it never occurred to me that ending the trial would be the issue. It's apparently uncommon for someone to continue on a trial for such a long period of time. Has anybody here participated in a trial until its end-date? Were you able to continue with your treatment after the trial concluded?
Written by
COG1
To view profiles and participate in discussions please or .
I've been on several clinical trials with fixed end dates. The medications were not available to me afterwards. But I don't know if I got the medication or the placebo.
Was he in the open-label Xtandi-only arm? If not, how do you know that:(1) He got Xtandi rather than the placebo?
(2) Xtandi+Lupron was more effective than Lupron alone? (the primary endpoint)
He is in the blinded Enzalutamide/Placebo + Lupron arm. We don't know for sure that he's taking Enzalutamide. Post-surgical pathology showed positive margins, and lymph node and bladder neck involvement. He has Gleason 9 disease and his PSA doubling time before starting the trial was <5 weeks. He's been on this trial for 5 1/2 years with no progression. At one point during the trial, he was taken off all meds and his PSA started rapidly increasing. I know that trying to guess whether he's on the actual drug or a placebo is a useless game. What ever he's doing has been effective, since he's had no radiographic progression and is still castrate sensitive. The end dates on the NIH website have changed (now showing August of 2022).
You weren't told whether you got placebo or the actual medication when the trial was over? My understanding was that we would be 'unblinded' when the trial was over. Did your doctors not need that information in order to proceed with treatment? Thanks for your insight.
I was told after the trial was over, and I was also told that there was no difference between the medication and the placebo (in two trials), and that there was a small difference but there were safety concerns (in one trial). But I didn't learn about efficacy and safety for several months after they'd had a chance to analyze the data.
This is a great question ! I’m ve been on the tak-700 trial seven years . I have no idea if or when it ends. For me it kept me clear. Although the trial was said to fail in promoting life. There are a very few like me still on it ..I don’t think that they can cut me off of the drug since it’s working? Is it not enough that you’re worried about his survival that you also
Must stress about paying for the drug? This is complete BS in My book. I’m hoping you’ll find a way and not pay out of pocket . Thats brutal. Thanks spent my $ my first two years with bcbs. I spent $40 k out of pocket . Then I went broke on Medicaid Medicare and ssdi .. but bcbs spent $858, 000 those first two years on me. . Thanks bcbs. Now it’s free so far to me due to the test???? In America all cancer treatments should be free to all! If not , it’s inhumane.. I’m sorry that you going though this. I pray that you can find a fix and heal him! 💔🙏
Must stress about paying for the drug? This is complete BS in My book. In America all cancer treatments should be free to all! If not , it’s inhumane..
I cant comprehend it. Mind boggling for a "civilized country".
Japan and probably other countries you get free care and a living pay allowance when diagnosed with cancer, multiple sclerosis, lupus. The list goes on.
What the hell went wrong with the U.S.
The dictionary pages defining compassion and humanity have been ripped out from the dictionaries in our government/society/corporations.
What didn’t go wrong? It’s the entire planet gone mad right now . Buckle up baby ! A storm is here! 2022 yrs later and not one inch of improvement in mankind in thinking! The world will regenerate after we are gone . Something else will climb out of the soup and maybe get it right next time? 😳✌️
In titan trial i was able to continue getting erleada after it went to open label...still on it...and was onit since entering the double blind trial..lucky me....i think they would continue to give it to him...since he was a frontline warrior.....
Thank you for your post. I am so sorry for your worries but hopefully it will make you feel momentarily better knowing you helped others with your post.
Go Canada! I’m sorry Sir, but just that you even have to think about the cost of this is a fn American tragedy . No respect ! Somehow my test drug is available to me as long as I want it? I don’t know why? Except maybe they’re liable if they cut me off it while it’s still working? Who knows . I remember as a kid in the 60 ‘s ,there weren’t these problems then .. so the modern med has advanced for us some ,but the cost are prohibited and out of sight !
Content on HealthUnlocked does not replace the relationship between you and doctors or other healthcare professionals nor the advice you receive from them.
Never delay seeking advice or dialling emergency services because of something that you have read on HealthUnlocked.
Looks like I've gone castrate resistant. How much trouble am I in?
My husband's experience with Xtandi
The Journey continues 
Hormone therapy with the lutamides and keepin your testosterone intact
PLEASE READ THIS REQUEST
