Question about availability of Lu-177 therapy

[mandrake248]

Good news that Lu-177 Infusion treatment is now available to certain PCa patients. Commercial name is PLUVICTO. ..For “adult patients with PSMA-positive metastatic castration resistant prostate cancer who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.”

My question is: what will be required for FDA approval for earlier stage patients, namely, those who have failed first line treatment (surgery, radiation), but are still castration-sensitive. Will there have to be phase I, phase II and phase III trials?

It’s crazy that this treatment is available in a number of other countries, and has been for a number of years.

[Tall_Allen]

No trials for it for recurrent patients who are still castration sensitive that I'm aware of.

[spencoid2 in reply to Tall_Allen]

There is one in Santa Barbara CA but I do not qualify because I have been on ADT too long. As with most studies the requirements are very specific. clinicaltrials.gov/ct2/show... To me it is nuts that you have to wait until your cancer is so advanced thatthe treatment is likely to fail instead of treating earlier.

[Tall_Allen in reply to spencoid2]

That is only for newly diagnosed patients. There are none for recurrent patients that I know of.

[spencoid2 in reply to Tall_Allen]

I do not know exactly what recurrent means. You can not have been on ADT for more than something like three months but I don't know if that applies to recurrent? You can call and they will guide you through figuring out if you qualify.

[Tall_Allen in reply to spencoid2]

Recurrent is your situation. It means you have received some therapy that attempted to cure you, but didn't.

[spencoid2 in reply to Tall_Allen]

they only asked about my current ADT did not ask about previous treatments but maybe would have if my case had been different. anyway i did not qualify because i have been on ADT/orchiectomy for over 6 months.

[swwags]

clinicaltrials.gov/ct2/show...

clinicaltrials.gov/ct2/show...

[mrscruffy]

The FDA in this country is a slow grind, wife and I have a war chest and contingency plan for treatment in Europe should the need arise. Month in Europe doesn't sound too bad

[Echotango51]

Mandrake248, I agree with you. Why wait for other treatments to fail. I have been on lupron for over 5 years. I asked my MO about these treatments, why put a patient through chem and all the ADT drugs, by that time the PC has advanced more. Skip bases 1-3 and go to home plate.

[Hidden]

I ran across this: shebaonline.org/treatment/l...

[Brysonal]

I was told I would qualify for PSMAddition when I was systemic therapy/ hormone naive and my HIFU had failed. However it didn't start early enough in the UK and too urgent for me me to get on hormones. I was told 45 days prior to randomisation was all that was allowed.

clinicaltrials.gov/ct2/show...

So hormone sensitive was not enough but hormone/ systemic treatment naive was.

I went overseas for a private option 10 days after starting hormones therefore.

[lewicki in reply to Brysonal]

University of Heidelberg. AC-225 and LU-177.

[j-o-h-n]

The rabbit in your hat has all the answers....

Good Luck, Good Health and Good Humor.

j-o-h-n Monday 03/28/2022 6:16 PM DST