So, the next topic I wanted to cover is on Lutetium-177. So, I've heard a lot of activity
in Germany and in Australia. Can you speak to what Lutetium-177 is? Is it an imaging,
is it a treatment, and how does it work? And then we'll get into access...
So, Lutetium-177 is another brand new treatment that is almost certainly going to be life-prolonging.
Almost certainly will be FDA-approved. The phase-III trials, I believe, are completed
and they're waiting for them to mature and I predict that they will show that Lutetium-177
is life-prolonging for men with advanced prostate cancer—men that have had taxotere, that
have had Xtandi/Zytiga, those types of medicines, and those stops working and then they went
on Lutetium or a placebo and the group that got treated I predict will have lived longer.
Why do I predict that? Well, this medicine has been available overseas now for a while
in Australia and Germany and we've had patients that have flown to those countries that needed
this treatment, that had advanced disease that wasn't responding to standard therapy
and we've observed good responses with relatively minimal side effects. So they've taken this
antibody and modified it putting a high-energy lutetium-177 molecule attached to it that
emits such powerful radiation that it will kill whatever cells it draws near. So, antibodies
float around in the blood and then they stick on the surface of the prostate cancer cells
very specifically, radiating them and killing them. This is a targeted type of smart therapy
that has been in development for 20 years and now is coming to fruition. So, the treatments
are given every six weeks or so as an intravenous injection. The most common side effects, because
there are some of the same prostate-specific markers in the salivary glands that cross
your activity with the salivary glands, can cause some dry mouth in some patients. People
can get low blood counts if there is too much exposure to the bone marrow. Anemia, low platelet
counts, low white counts, but thankfully that's not very common. Patients do tolerate it extremely
well. It's effective and we're keeping our fingers crossed that FDA approval will be
coming up in the next year or so maybe.
So, when you say dry mouth, is that just during the treatment or would that be a permanent
side effect?
Could be a permanent side effect.
Okay, is there anything to mitigate that?
Nothing specifically. I mean, there is some attempt–as we do with chemotherapy to preserve
the tastebuds–we'll put ice on the tongue to shunt blood flow away during the infusion
and I believe there have been some attempts to put ice over the salivary glands. Not really
sure how effective that is.
You know, you had said that you had good responses so can you talk about a case study from your
practice regarding this?
Sure, I mean responses are easy to judge. These men all have PSMA/PET scans prior to
initiating therapy so you can see where the cancers are and make sure there is a PSMA
antibody on their cancer cells. 90% of men have it, but 10% don't. And then the patients
then would go and let's say their PSA is 100 when they go in or they may have some bone
pain or theymay have 14 spots of cancer and then they'll get rescanned after a couple
of cycles and their PSA is down to 20 and some of the spots on the bones have disappeared,
so that's the kind of results you're hoping to get.
So how many cycles? Is there a minimum? Is there a maximum?
So, patients are usually reevaluated after two cycles like with any therapy to make sure
it's working for that individual and then they can go on and receive an additional 2-4
cycles. There is a potential for cumulative bone marrow toxicity if you get too much radiation
in your body, so you can't go on forever, but it has typically been set at around four
cycles. They're given six weeks apart so you're looking at, you know, four or five months
of treatment.
So, regarding access, I mean, is there anyone doing this in the US that you could send patients
to, or is it only happening in in Germany and Australia at this moment?
Well, I believe there are still some small PSMA lutetium-177 trials still in the United
States. I don't know if they're sill accruing. You can go to ClinicalTrials.gov and see where
any trials, you know, they're very selective in terms of the people they take, but if a
person has the right profile they could get it. And then, I believe it is indeed still
available in Australia and Germany. It's out of pocket cost.
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