Isn't amazing that you have to go outside of the US To get LU-177 and AC-225 and spend your wallet. For something tried and works.
What really is the reason this stuff not available here.
Forget right to try.
Treatments outside of the US - Advanced Prostate...
Treatments outside of the US
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lewicki
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Yes you are correct. But the Germans, Indians, Israel , Australia been doing these treatments for years. Is their a money reason to not provide this for Americans . Is it like it took 20 plus years for the proton radiation to be approved . Loma Linda in California had it a long time. ago.
The Vision trial may report results in the near future. This should get the Lu177 therapy approved by the FDA.
It is difficult to make trials with Lu177 because everyone thinks it works well now and wants to get the treatment. So patients randomized to standard of care will drop out from the study.
Also, many hospitals can generate Lu177 on their own and thus do not need big pharma to treat the patients. So why should big pharma pay for trials?
Yes sir agree. Hospitals and especially research medical hospitals make mix there own Nuclear chemical composition radioactive doses.
Like my 68Ga-PSMA-11 i had Aug 2019 @ IU Neurosciences Research Center facility. I even asked and talked to there Pharmacologist Radiologist Chemist Scientist doctor, not sure if that was his official med title.(Dr Green).
He did tell me face to face that LU-177 was coming to USA. Well that was about 19 months ago.
Time to back research LU-177 more maybe @ IU School of medicine and Research.
It hasn't been proven until there is a randomized clinical trial comparing it to standard of care. Germany has a more liberal right to try law.
Do you have any experience with the Sheba Hospital in Tel Aviv? I am working with them to see if I can get over there to have the LU-177.
Sorry, no.
I started the process but switched to India. The Covid restrictions were much tighter and I had a friend who had stepped up to go to India..the cost is much less in India albeit but the infusion drug (lu-177) is produced in Germany. Let me know if you go...Blue Skies. Oh Sheba will send you a cost sheet hard to understand . Once approved have them break out what their cost estimate is and number of sessions for your condition. That way you have a better feel for what it will cost and number of tx. I was chemo naive and required only 3 visits and was given a higher dose in India ....good luck
I got a break down from the clinic in London(Windsor) and it looked like close to 100K for 4 treatments after conversions (including testing)...the cost he "quoted me" would be somewhere between 20K and 40K (for between 2 to 4 injections) in Israel. That kinda sounded like a good value to me overall. Plus they want me to come with someone and stay for whole treatment. I asked about payments and I won't pay anything until I pay for the first PSMA test which will be about 3K ...after that it's pay as you go so he said. It's a state hospital in Israel and it's the biggest in the Middle East...and also in the top 10 hospital in the world...so it sounds good on that account...plus I haven't been there...and I've been to India.
I traveled business class on United, stayed in a suite at the Westin , and had a private driver to Fortis health. Had 3 rounds and total was just under 38k. You should enjoy Isreal a bit more money but that is relative is it not? Blue Skies...I made three one week trips with a six week break in between....
Interesting stuff about getting Lu177.I live in small city of Canberra, 300km south west of Sydney where I got 6 doses of Lu177 for cost of usd $7,200 per dose, and I was able to stay at my sister's apartment for 2 nights, and transport was by slow train at very low cost because Govt funds retired ppl so the only major costs I had were for treatment.Lu177 is made in reactor in Australia most of time but when the reactor here had a problem, Theranostics Australia imported Lu177 from Germany. This has to be carefully arranged because Lu177 has a short half life, and it needs to be flown from reactor to where it has to go without ant delay.
The Ra223 is also usd $7,200 per dose.
Cost for PsMa Ga68 scans here are usd $525.00 I've had 10 PsMa scans so far since 2016.
University of Michigan wanted $5000 US for the PSMA scan then turned me down because FDA said I did not qualify as I still have a prostate.
What’s the process Patrick, do they give you 3 doses then wait, and for how long, do you get PSA tests done and PET PSMA scans before continuing? I notice in the TheraP trial TA quoted:-
“At 12 months, progression-free survival was 19% for Lu-177-PSMA-617 “
Is it 12mths before continuing and only for the 19%?
Interesting how it’s made!
If you google Theranostics Australia, you can read about what happens before, during and after the Lu177 doses. PsMa Ga68 scans are done before to see if PsMa avidity is high enough. If it is not, then a man cannot expect a good result. After 2 doses, I had another PsMa scan and it justified me continuing, even though Psa only dropped from 25 to 17.
After 4 doses, Psa went down a lot, and another scan showed I was doing well, and 12 months after I began, Psa was 0.32, but a lot of that Psa drop was due to me taking Xtandi since just after 3rd dose. But once Psa got to 0.32, it stopped falling, and began rising, and I believe that was when Ztandi failed after taking it for 8 months.
I had more PMa scans and 2 more Lu177 doses. At 2 years after I began Lu177 the follow-up scan showed all soft tissue mets all gone, but overall reduced level of bone mets, but there were new mets which didn't make enough PsMa to justify having more Lu177. Psa was 7, but then Psa really took off, and I now have Psa > 260.
It seems all my mets are in my bones and I began Ra223 to try to kill whatever is there, because Ra223 does not rely on PsMa expression.
I still don't have any Pca symptoms.
Its possible my Pca grows faster than Ra33 can kill it. Its the worst future outcome I can imagine, and going back to chemo looks fruitless, because my Pca didn't die when I had 5 doses in 2018. In the month before starting Ra223, Psa went up 2.7 times.
Its enough to really terrify anyone, but I am aware that a sudden very big fast rise of Psa can indicate the Pca has suddenly become much more aggressive, and able to grow despite whatever any doctor can give me.
I've had Pca since maybe 2004,when Psa was probably 3.0, and when I should have had an RP, before any spread occurred, but the stupid docs and medical system here in 2004 didn't get men to be fully examined unto Psa got over 5. By then, I had an inoperable Gleason 9, and when I read the chat groups at that time, a Gleason 9 was a ticket to an early death. But a few men were getting annual biopsies when Psa went to 2.5, and some got quite good outcomes.
But I knew I was going to have the Long Fight since diagnosis that was 5 years too late in 2009.
If I am real lucky, Pca in bones will slowly and surely die, and despite the high Psa.
I may need 6 Ra223 doses.
If Psa goes low, I'll be quite happy, but maybe Pca could spread back to soft tissues, and there's a limit to how much nuclear radiation and chemo that I could tolerate.
Patrick Turner.
Thanks Patrick and good luck with the Ra223.
RIP Patrick. 😧💔😪 You helped many of us and you will be missed.
Can you please provide contact information, thanks
I will send tomorrow morning.
Hi Monkey, if you follow some of Patrick’s posts, he has had his treatment, I think, from Thernostics at the Peter Mac in Sydney. I’m on the Gold Coast and it’s done through Genesis Cancer Care also in Brisbane.
Do they call it less litigious in Germany?
It has nothing to do with litigious. The laws are different.
Are you saying that none of these countries in the world that offer that treatment have done their own randomized clinical trials yet to prove the efficacy?
Schwah
That's right. If efficacy is defined as extending life.
There has been one randomized trial, The TheraP trial in Australia- randomized to Jevtana (85 patients) vs Lu-177-PSMA-617 (98 patients) with 13 months of f/u used reduction of PSA by more than half as its endpoint. All other trials have not been randomized vs standard of care and have only used PSA reduction as an endpoint.
When I did PSMA at the university of Heidelberg Dr Haberkorn Head of department said I tested very high. " we will melt your cancer like butter in the hot sun". Were all those in this trial tested very high , average or ?
Here are the results of the TheraP trial:
Wow. People running all over the world spending tens of thousands of dollars on a treatment with no proof of extending life. I’ve actually read a number of individual experiences where it reduces PSA initially and then the non PSA avid cancer comes roaring back. Hope it turns out to do more good than harm. What are the top MOs you talk to saying they anticipate the results of the FDA clinical trials to be?
Schwah
My OC and Urologist both suggested I stop ADT and live the rest of my next 10 years. I am 80. Who knows ?
I haven't asked for their guesses, but the results are expected soon. All I can tell you is that Xofigo increased survival in symptomatic, docetaxel-treated patients by 3 months in the ALSYMPCA trial. In the VISION trial, patients were pretreated with either Zytiga or Xtandi too.
I don't think there are special laws in Germany. Several EU countries do this treatment. It must me because of difference is the compassionate-use laws in EU vs. the right-to-try laws in US. Are there good reasons for the US less liberal position?
The EU usually follows the US FDA approval. None of these drugs have been FDA or EU approved. The FDA demands proof of efficacy and safety. But if it is the only drug possible for a patient, the patient may ask the manufacturer to use the drug. In Germany (perhaps throughout the EU - I don't really know), an institution can provide any experimental drug under compassionate use. Because Heidelberg holds the patent for PSMA-617, and have made it freely available, they are able to provide it.
Is there a patent for AC-225?
Shameful .
Liability, unfortunately, us real patients have to be underwritten with real evidence it's the human race, for every one real PCa patient, like me and you, there's many more imposters, the insurance companies need to know who are real, not easy. The problem, individual healthcare record cannot be validated for truth.
With lives and suffering at stake seems there should be a faster means for application in the US
Most people believe that NIH stands for National Institute of Health. But, it really stands for Not Invented Here. America does not like any competition with its own home grown products. As someone said, follow the money, always. A simple treatment of LU 177 will knock out most men's problems, especially when caught early. No fuss, minimal side effects, and it usually is good for 5 years. It costs around 10 grand. Now, imagine what chemo, radiation, and surgery costs. Who is going to give up that kind of income? That, my friends, is why cancer will not be cured for a long time. Too much money involved. I remember Dr. Ronald Levy at Stanford was on morning TV show years ago announcing a two injection treatment directly into the prostate tumor that completely destroyed the primary and mets. Ever hear of it again??? Just keep you passport up to date. Even if the FDA approves, there's still the battle with the insurance companies. By the time they're done, it may still be cheaper to go to Europe or India.
Or all the carburators that would get 100mpg🤔......oops im in wrong chat room.....
I want one
PSMA Lutetium treatment was developed by researchers at clinics and hospitals, not by a pharma company. So even though clinical data for thousands of treatment results have been published, this has not previously had the aim of obtaining a formal health authority approval.
The problem is the approval process takes MUCSH longer in the US vs say the EU. Those who favor this point to the Thalidomide disaster which affected Europe WAY more than the US as US approval was late. The reality is, delayed treatments (FDA delayed approval) have had, overall, a much detriment to patient welfare than what only fortuitously happened to the US with Thalidomide. The speed of the COVID vaccine approvals shows it does not have to be this way. PSMA scanning & PSMA related treatments are just another example which proves the idea of "American Exceptionalism" (the US is the best at everything) is a myth. As in many things American, I suspect the ultimate reason traces back to money .... it is certainly NOT patient care.
Just an opinion.
As I posted a few days ago, my doc (who is a leading MD in this fight) said "There is going to be a new procedure (think 177 Lutetium) this year and it will be a 'game changer' ". And he is not one for superlatives.
Sounds right
Went to University of Heidelberg. PSA >0.1.
My results without US clinical trial results
In the 1950s, thalidomide was approved and used in the UK, West Germany, and Canada. Dr Frances Kelsey, a Canadian working for the FDA, refused to allow thalidomide into the USA because she did not think there was enough testing done. As a result, the USA did not have the thousands of deformed babies that other countries experienced. This may help explain why the USA is reluctant to rapidly approve drug therapies that other countries use.
Here's a good article if this story interests you.
I can agree with you whole-heartedly if this were a new procedure, and, if this were intended for the general masses. But this precision oncology has been around since 2015 with clinical trials and available clinical data from countries like Israel, Germany, Australia, and the UK, just to name a few. I should imagine they could be trusted. And, those that did not have stellar results appear to have waited too long and their disease progressed beyond any intervention. I am very pleased that it is being considered for approval in the States but still hold to my theory of protectionism.
My results.
I had AC-225 in combination with LU-177.
Simple: It is called private, fee-for-service medicine. Those other countries got smart and established a single-payer system. As they say: follow the money.
Its probable that US FDA won't approve Lu177 or AC225 any time soon because it was invented in Europe, and maybe patents are owned by Europeans, plus the fact that if men get to have Lu177, it means many medical providers in USA for chemo and other treatments will suffer financial loss. If Lu177 can be given to men in US without reliance on using a ligand chemical binding to PsMa and instead relying on some other chemistry of Pca invented in USA, then you may see approval given.
I found the reliance on PsMa is flawed, because after 6 doses Lu177, the follow-up PsMa Ga68 scan showed I had new bone mets which made very little PsMa so I could not have more Lu177 to "finish the job".
That led to very rapid Psa increase, and having to turn to Ra223 which I think may not kill Pca in my bones at a faster rate than new bone mets are growing.
Research is continuing in Melbourne to find out why Lu177 does not work as well as anyone wants.
Patrick Turner.
U of H at first would not let me come unless I had the PSMA scan to see if it would work for me. 10 percent of men it does not work at all. Fortunately I tested very high and could be why it worked for me.
Totally agree. So how great is it that many countries have socialized medicine but most likely will not work well in the US
No cure but long time remission. As I am 80 years old all is good.
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