177Lu-PSMA-617

[spencoid2]

I am getting a bit tired of the side effects of ADT. I am still castrate sensitive. I have a phone appointment (have had two before) with Dr Agerwald next Monday. Previously I did not qualify for the previous 177Lu-PSMA-617 trial because i am not castrate resistant yet.

There is a suggestion (forget where) that early treatment with 177Lu-PSMA-617 while castrate sensitive might be more effective and might be the subject of a future study.

I do not understand why the FDA is taking so long to approve it. The reviews are very positive and it has been approved (?) in Europe for years?

If there is some way of getting a treatment here that would be best although it might be very expensive if not approved and paid for? For trials it seems that (in SF) you have treatment covered by insurance but the nuc medicine has to be paid for. That would be about $2000 for the scan not sure how much for the treatments. I can afford $2,000 treatments but not $50,000 treatments.

So where could I get the treatment? France would be best because my father lives there and it would be a great excuse to visit him every 6 months.

Once my prednisone level is back (ran out for two days) I may feel differently but the way i have felt for the last two days is hopefully not going to be repeated. Life is not worth living like this. Dizzy, can't think well, can barely make it 1000 feet without a major rest. I am not 120 years old and do not want to feel like i am.

[Tall_Allen]

You are in luck. A trial of Lu-177-PSMA-617 for men who are still hormone sensitive begins in Nantes, France this week:

clinicaltrials.gov/ct2/show...

It is randomized, so you may not start by getting the radiopharmaceutical, but you will have the option of getting the drug later anyway.

There are no trials in the US yet for men who are hormone-sensitive. When the FDA approves the drug, hopefully by the end of the year, your doctor will be able to prescribe it off-label. But I'm sure it will cost a lot out of pocket.

[spencoid2 in reply to Tall_Allen]

i am going to see if Dr Aggarwal has any ideas. then will check out the Nantes study but that is a bit soon? Have to figure out how many injections and if they need to begin right away or if it can be delayed? There are 6 treatments 6 weeks apart which is a bit of a challenge, lots of trips (do not enjoy traveling) or 9 months away. Maybe Agerwal will have some idea on the cost once it is approved and how much "off label" treatment might cost here. Maybe I can finish treatments here after it becomes legal.

[Tall_Allen in reply to spencoid2]

The study is starting next week but will be running for 3 years, so you have plenty of time. I doubt that Novartis has priced it for consumers yet. That is usually not done until FDA approval, which is still several months away. They charge $54,047 for 1 injection of Lutathera, a similar drug, so I expect each shot would cost about that if off-label. It's much less expensive to go to France for it.

[spencoid2 in reply to Tall_Allen]

Insurance "is billed" $2000 plus for my generic Firmagon In France without using my insurance it was a little over $100 and it was the brand name

[Cooolone]

So how do you handle something like this?... Do you get a special Visa to remain in country for the 6x infusions (once every 6 weeks). Or do you go back and forth? Is interesting... And I'm just curious! Does France have Compassionate Care rules like Germany? What validation does the host then require, does carrying your own medical records in hand qualify or does your at home care team get involved as well?

And yes, for Hormone Sensitive patients, it's very frustrating to know, that you need to sit and wait for disease progression to a more aggressive variant in order to "qualify" for more aggressive therapy!

[spencoid2 in reply to Cooolone]

some good questions. i don't think i can take 9 months off to "vacation" in locked down France. what would be ideal is to be able to start the treatment there and finish here once it is approved although that might cost a fortune. maybe Aggerwal has some ideas about timing and if this would be possible etc etc.

[Cooolone in reply to spencoid2]

Hahaha, no doubt. Not sure I could handle France that long, but certainly would enjoy Bavarian Food between cycles

Could commute from Germany to France every 6 weeks lol.

Just making light of what may be a complicated set up to get this... Because it looks promising!

[TeleGuy in reply to spencoid2]

Many people on this forum (including me) have reported going to/from Germany every six weeks. A letter of medical necessity from the German docs gets you into the country, and the German compassionate use laws let you get the treatment without it being the last resort as in the US. You'll have to search for the posts that have summarized the various places that will treat Americans. But still, it is still a big cost.

[spencoid2 in reply to TeleGuy]

not sure if i can handle the traveling but might overcome that. any estimate on cost for the six treatments in Germany?

[Cooolone in reply to TeleGuy]

Appreciate the reply, I understand and have seen the Germany references, my post was about doing this in France. If they have the same as you mention in Germany. Especially with their Covid lockdown... Personally as noted, I would prefer Germany and my wife complains that too much any more is just "all about the food" hahaha