Anyone here enroll in the Vision Trial and get standard of care? Well I had the unfortunate luck of not getting the Lu177 treatment arm. Did you stay in the trial or go on to other treatment? I have tried and ultimately failed everything including Xtandi and Taxotere. Out of options except possibly to Europe. A bit worried about physically making the trip. I have bone pain from fractures and cancer.
LU 177 Vision Trial: Anyone here enroll... - Advanced Prostate...
LU 177 Vision Trial
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IMHO, the Vision trial's big weakness is the "Standard of Care" part. Most of us are already getting the "Best Standard Of Care" and then some, provided by our existing providers..To switch to the trials providers makes little or no sense unless, after a few months, they allow you to switch to the active treatment arm, which they don't...Also, the trials 'Best Standard of Care definition excludes any chemo agents and any radio-nuclide treatments like Radium 223. So basically they will provide treatments most of us have already failed..I think Novaris needs to adjust the trials procedures or most of the men randomized into the "Best Standard Of Care" arm will drop out of the trial..I should also add YOU get to pay for any treatment provided that falls under the "Best Standard of Care" definition, including the LU-177 infusion itself should you be lucky enough to get it..! (They pay for the drug but YOU pay to administer it !)
in reply to Fairwind
You are right. I get to pay for Zytiga which is likely to fail since Xtandi stopped working for me. I will see what the Dr has to say next week and may just drop out of the trial.
GeorgeGlass in reply to
Why would zytiga fail it's a different drug than xtandi.
in reply to GeorgeGlass
They have a cross resistance. Very few people get a positive response with the second drug no matter which you try 1st.
Caring7 in reply to
My husband did get about 6 mos on zytiga/abiraterone after failing Xtandi (2 great years in that).
The vision trial is really flawed. They won’t even let my husband be eligible because SOC is chemo for him.
Note that you can try Jevtana if taxotere failed.
Best wishes and better luck.
Also - there’s a stage 1 dosing trial of Lu-177 that we’re hoping for.
Doesn’t the LU177 Vision trial allow some previous chemo? Is your husband on chemo as a standard of care treatment every 3 weeks because it is working for him? My husband had 8 cycles (1 course), got his PSA down to 1 then quit. Within 2 months his PSA was 15. He just had another chemo cycle but we don’t know if it’s working as they won’t test his PSA for 3 weeks right before his next scheduled cycle. I wonder if that will disqualify him from the trial?
The Vision trial actually requires prior chemo.
"Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane."
Thank you!
Patience seems to be the #1 criteria for dealing with this thing!
Waiting for 3 weeks is normal, and even so, sometimes the first 2-3 cycles of chemo don't show improvement in PSA - just FYI. This second time on chemo (4 years after first time) - my husband's PSA went up after #1, stabilized after #2, and we'll see after #3.
Being on chemo does not disqualify you from trial. I think Taxotere is OK but not Jevtana. However, once you are *in* the trial, if you do not get in the treatment arm (like the guy who started this post) - you cannot resume chemo and stay on the trial.
Of course most guys who are wanting the trial, have few options other than more chemo (as post below notes -- some chemo treatment is required) - and it's not allowed during the trial. If chemo has failed, then that doesn't matter, but so far it seems to be working for my husband because his symptoms are down (other than PSA - which is only one marker).
You don't say if your husband has also run through Zytiga, Xtandi, RA223, Provenge -- and if not, those are all options to try, and they are treatments, not trials.
Good luck with the patience!
in reply to Caring7
Jevtana is okay to have in order to particpate in the Vision Trial. I did both. Taxotere worked for a very short while Jevtana not at all. This was the end of the line for me. Need to consider Ac225 or Europe.
Thank you! We met with an oncologist today about the ProStar trial and he told us that if the chemo was working they could not enter him into the trial because you do not stop a treatment that is working. He has had Zytiga and chemo (Docetaxel) but PSA began to rise again after 2 months so he did chemo again last week. We will not know if the chemo is working for another two weeks when he has another PSA test done. The trial oncologist said he would need either three increases in PSA, scan which shows new tumor growth or chemo toxicity to begin the ProStar trial. We are also looking into the Vision Trial.
Do you know how much LU-177 treatment in Germany or Australia costs?
I paid between 12K and 16.5K depending upon what they were doing and how many scans I had done. They take 13K initial payment upon arrival and then refund or bill more after the hospital stay.
Heidelberg was 9800 euros which comes to about $11,000 with the exchange rate. Of course, in addition you have the cost of the PSMA PET scan which can cost anywhere between $2700-5000 here in the States and all the travel costs to Germany. And the treatments and trips are multiple so you can count on the treatment and travel costs at least four times. On the good side, my husband had the dual Lu-177/AC-225 treatment on May 16 and he seems to be benefiting really well.
Thank you - great to hear your husband is doing well!
in reply to Mohopes
Great news.
Cost of Lu-177 in OZ is about A$10000 / cycle.
Is Oz in Australia or Germany? Thanks!
Sorry for the slang. OZ = Australia : )
Thanks!
Are you in the US? You may qualify for one of these radiopharmaceutical trials:
clinicaltrials.gov/ct2/show...
clinicaltrials.gov/ct2/show...
clinicaltrials.gov/ct2/show...
clinicaltrials.gov/ct2/show...
in reply to Tall_Allen
Thanks. I am actually looking at the first one of them since the Vision Trial I am in is at Weill Cornell also plus the same Dr. Just don’t know if they will let me bail to switch trials. Meeting with them on a Thursday. The second one I do not qualify due to chemo. I appreciate all the research you have done.
Tall_Allen in reply to
The Th-227-PSMA trial at MSK allows up to two cycles of taxane therapy:
Mike, I tried to look at your profile, but can’t find any info there regarding your PC, age and/or treatment(s) you have had. There many in this group spend lots of time studying our disease and potential treatments to help us (TA, Nal etc.) from scholarly articles with words that we non-medical patients can understand. Knowing your stats and data will help us understand more what works and what doesn’t. See this link: cancernetwork.com/prostate-...
There are many other options and trials that I think benefit all of us if we share these kind of info, especially trial participation results. You said you are becoming resistant to newer AR drugs Xtandi and Zytiga. There are Erleada, and new AR drugs being tested such as darolutamide. There are also other immuno as well as targeted drugs in pipeline. Don’t give up and keep looking. I have been on one trial (SBRT in 2007), and would not hesitate into entering others when the beast began to adapt to my current treatment (Zytiga). I believe that doctors that only do SoC are not interested in helping us find a “cure” or long term remission, WITH QoL.
in reply to Cmdrdata
Thanks for your response. I filled in some data. Feel like I am pretty much at the end of the line between rapidly rising PSA (137 now ), bone pain in my rib from fracture and fatigue.
Rexwaterbury in reply to
Hang in there Mike. Let us know what Dr. Drake has to say.
Longterm101 in reply to
How old are u and where do u live?
in reply to Longterm101
I am 74 and I live in Rochester NY.
Longterm101 in reply to
Praying for you. Perhaps you should see dr Kwon at mayo or Michael Morris at Sloan to find a clinical trial
in reply to Longterm101
Seeing Dr Tagawa at Weill Cornell and like him very much. Will see what he has to say on Thursday my 1st meeting after the randomization. Went to Sloan for the Vision trial about 6 months ago and they just blew us off and said our best option was cabazitaxel. Very unimpressed with the Dr and their prognosis. Felt like he indicated go home and die. Of course chemo did not work. We did not see Dr Morris.
Longterm101 in reply to
Dr Morris is excellent at MSK
Keep as an alternative
Keep us posted on how things go on Thursday !!
Best of luck
Good morning. Sorry to hear how thins have gone for you. I’m on your same path—zytiga just failed for me—so I’m looking at Germany. I’m also worried about the trip
I’m working with these people to arrange the hospital. bookinghealth.com/
Best wishes
I am in the Vision Trial out of Houston Last Friday one of the employees told me everyone who did not receive LU177 has dropped out.
This is a really problematic trial -- because of above. That's what we found in our research. So - because of the dropping out - they are being really strict about who they let in (and provide free PSMA PET scans to!) -- they are trying to identify people who won't drop out if they don't get treatment arm. Good luck. We talked to several centers offering the trial in the western US and there's been a lot of starts and stops of accepting patients, etc. There seem to be more LU-177 trials coming down the pike, so . . .
We are leaving for Germany June 21. We booked it through Booking Health.com, which was recommended on here. It was surprisingly affordable and they made it very easy. Will let you know how it goes but maybe you shouldn’t wait! Best wishes, J
in reply to
What hospital in Germany are you going to? Please keep me posted. I will be VERY interested to hear about your experience . You can private message me if you would like. I read they also are doing it in a private hospital in the UK. Not sure the difference in cost.
Foster007 in reply to
yes, please which hospital and how much did they charge you? I did it on my own and am very curious. thanks
in reply to
Good luck!
Hi, Mike. Sounds like you're getting good advice. The "Standards of Care" theory is "you'd be getting that anyway so why should we pay for it?"
The Portland Oregon VA and OHSU, where my VISION trial is, are pretty incestuous so my "Standards of Care" - in my case Zytiga - comes through my regular VA doctor so I pay zero. If I had to get this damn disease at least it's service connected so Uncle Sugar picks up all of the tab.
Hi Fellow Veteran Can you help me understand how Uncle Sam sees PC as service connected? D
If you were "boots on the ground" in Vietnam - and can prove it - your prostate cancer is Agent Orange presumptive. You don't have to show any more than an honorable discharge, proof of "boots on the ground" (I used a copy of my OER from Phu Cat) and the diagnosis of prostate cancer. I did it myself, although the VFW has an excellent program, and I've found the VA to be very responsive.
Good luck.
Thanks I was in the MC stationed off of Vietnam No boots on the ground Have you seen or heard of anyone getting help with PC medication cost that was not service related ? D
I think the "blue water Navy" cases have been been resolved in favor of the "blue water Navy". Check with your Veterans Service Officer (if you have one) or the VFW.
Will do Thanks so much
If you are an honorably discharged veteran your level of care depends on your annual income. If you are married, about $38,000. Just annual income counts, not other assets like homes, cars, stock, real estate...Just income. $38 K gets you a CAT-5 position which means the VA pays for just about everything with very modest co-pays..When my journey took me to Zytiga, I would have been bankrupted were it not for the VA.. Check it out...
Thanks this is very helpful I have an appointment with the VA. Next week
I am currently failing LU177 at UCLA. Worked great for 3 cycles. Starting to fail on 4th. Dont know if they will give me 5 until I get my scans next month. I also have pelvic mets and a rib. Everybody in standard of care drops out. Most who fail drop out as well. UCLA Oncologist there there suggested Germany if I drop out and do a combo of LU177 + Actinium-225, but it depends on how bad I fail LU177. Also I dont think I can afford 100 grand. For you, you might be able to get into a US clinical trials testing Actinium-225 as a single drug because you never did LU177.
He said the combo is more effective, but may knock out your saliva glands. His experience is late stage patients got at least a 2 years life extension on the combo. Per Dr Myers (retired), combos are many times better than single drug therapies. I was also his patient for a while.
I made a copy of TALL Allens post. Good post of various trials.
True about the AC-225 and the saliva glands. My husband has had only one combo treatment and he already has dry mouth and throat. He has trouble swallowing meat, in particular, and must take a drink with every bite he swallows. The dry saliva glands could last up to a year according to the German drs. or might be permanent. Actinium is way stronger than the Lutetium.
Hey Mike, I’ll let you know how it goes for sure. We are going to a University hospital in Homburg, Germany, about 11/2 hours southwest of Frankfurt, right on the border of France. We could’ve chosen a bigger one (Heidelberg) but the cost and wait times are higher/longer. So far, everyone speaks fluent, perfect English and you get an interpreter to meet with the doctors and translate your records as part of the package. They have been doing these treatments for a long time over there and are definitely leading the charge. This small hospital alone treated over 600 patients with LU177/Ac-225 last year. Once you get there, they determine if you need the combo LU177/Ac-225 or would be better off with just the LU177. If they do the PAMA Pet scan and determine that you are not a good candidate, they refund the unused portion of your payment. The people that you correspond with over the phone are very knowledgeable and efficient and could readily answer all of my questions, medical or otherwise. The cost was less than $20,000, which you pay in advance, all inclusive. We may have to go back for a second treatment which I assume would be at similar cost. This price included everything except airfare from US to Frankfurt. They did include transport from Frankfurt to the hospital which we chose to forego. Pat wants to drive an Audi on the Audubon! Hahaha so we rented a car, which I’ll then have for the week to take a few day trips. It’s still a leap of faith in many regards but it gave us an option and for that we are grateful. We are also spending 8 days in Italy before we check into the hospital in Germany. Might as well blow it out while we’re there and make the most of it. I’ll check in from time to time and let everyone know how it’s going. I would’ve PM’d but I think others may want to know too. Hope you’re having a great day! J
in reply to
Sounds like you have everything under control. After reading your post it may actually be something we will consider. We will see what we decide after our meeting with the Dr on Thursday. Already had the PSMA scan so hopefully he should be able to tell us how successful the treatment may be. Have a wonderful visit in spite of the reason for traveling. Thanks for sharing !!!!
MeliaQuinn in reply to
Best of luck and please keep us posted. I wonder how they make the decision to do the combo versus just LU-177? Will be very interested to hear about your experience and hope you have a wonderful time in Italy!
Diane
in reply to
Thinking about your travels and wondering how the treatment went in Germany. Hope all went well and you also enjoyed your side trip to Italy.
PSMA sorry
I too have problems getting the LU-177 trial. Seems like they always find a way to turn me down. 6/14/10 I am going to University of Heildelberg for the PSMA scan and LU -177 treatment. Was talked into the trial ESK981 with verbal agreement that if it failed I would be able to do the lu-177 trial. Yep ESK891 failed and was turned down . no lu-177 .
Besides the Lu 177 PSMA or Ac 225 PSMA treatment in the clinical trials in the USA or abroad, you could consider the clinical trials with niclosamide at UC Davis.
Niclosamie could make the cancer to respond again to enza or abiraterone.
clinicaltrials.gov/ct2/resu...
I had Lu 177 PSMA treatment at the Technical university of Munich in 2016. It is a good place. They have good equipment and experience with this treatment
A member (can't remember who) documented (crossed T's and dotted I's) his trip to Europe (Germany?) regarding his LU 177 experience/treatment. See if you can locate it via a search it's very detailed.
Good Luck, Good Health and Good Humor.
j-o-h-n Sunday 06/09/2019 9:54 PM DST
I didn’t know I will register tomorrow Many thanks D
The categories the VA uses are on your ability to pay. If they determine you could pay through the private sector they will not pay for non service related.
Close enough for government work. Yes there are a lot of other things that go in the hopper (POW, Purple Heart) but the biggie for most veterans is ability to pay. Except for Agent Orange presumptive prostate cancer, I'm Category 8. Which means all my cancer-related costs are covered but absolutely nothing else. Which is basically what I said.
This trial "Vision" NCT03511664, could be in danger of collapsing and being canceled..If NOBODY stays in the "Best Standard Of Care" group for whatever reason, (cost, travel inconvenience) and the willing participants are only those who get the LU-177 and it's working for them, then the trials goals from the sponsors standpoint will not be met..In order to get the coveted FDA approval, they (Novartis) may have to redesign the trial..
I'm in the SoC arm of the Vision trial now. I've been taking Xtandi for it for a week and a half now. I'm willing to stay in if the Xtandi is doing anything. We'll decide based on a PSA test after 4 weeks. I don't think I'm "dropping out" if the SoC treatment has failed.
With all of the preconditions and the limited SoC options available, they have set the bar pretty low. I hope it gets approved before time runs out.
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