So, Dr. Scholz, we've received a lot of questions regarding HI-FU and also
Tulsa-Pro on our YouTube channel and I know we covered it lightly in the conference,
but we kind of wanted to ask some more individual questions. So, first of all,
can you explain— let's start with Tulsa-Pro, what this is, and how the procedure works.
So, it's the same technology. HI-FU and Tulsa-Pro are the same technology, but
with what's called HI-FU, "high-intensity focused ultrasound," that's what Tulsa-Pro is as well,
but what's different when they talk about doing HI-FU and Tulsa-Pro is that the
HI-FU technology uses a device that's put in the rectum and they fire through the rectal
wall into the prostate to destroy prostate tissue or prostate cancer in the prostate.
Tulsa-Pro uses a device that's put in the urethra, which goes down the middle of the prostate,
and it fires outwardly to destroy prostate tissue or prostate cancer.
So, it's the same idea of focused high ultrasound beams that when they cross it creates so much
energy that it actually burns the tissue and that— it destroys the tissue, burns it, and the
kind of cool thing is that if the transducer is right here, firing this way—because it's crossing
beams—that you can fire past something like the rectal wall and not damage it, or you can fire
past the urethral wall and not damage it, and so the destructive force is a distance from the
from where the device is, and this does have some limitations because if there's heavy
calcifications, the sound won't go past it, and there's only a certain maximum depth that you can
go to. So, really big prostates are not going to be very amenable to this type of technology
because you can only go so far. So, it's the same exact thing—high-intensity focused ultrasound—it's
just a matter whether they call it HI-FU, if it's delivered through the rectum past the rectal wall,
whereas it's called Tulsa-Pro if it's in the urethra firing outward from the urethra.
Well, on either side—HI-FU or Tulsa-Pro—what are the side effects related to that? You know,
we're damaging tissue, so is there any sort of urinary issues, incontinence issues?
Like any powerful tool, it's mostly determined by the skill of the operator and how ambitious
the doctor is to how much tissue do they want to destroy? You can treat the whole prostate
and you can also do focal therapy, which means a section of the prostate where the tumor is.
The side effects and the risks are much less when they treat a smaller area and they're much—
they're greater if you try and treat the whole prostate. Side effects of, you know, after you
have a lot of destroyed prostate tissue— they put a catheter in for a week or two afterward while
this all heals up so that the urinary passage doesn't block off, but most of the problems are
related to therapeutic misadventures where they fire the gun into the wrong area. So, if they
hit you know hit some other sensitive structure then you can have problems. They try and stay
away from the neurovascular bundles and thus the hope of reducing the risk of erectile dysfunction,
which has its pros and cons. If you do stay away from the neurovascular bundles there's
going to be a lower risk of erectile dysfunction compared to surgery or radiation that cover those,
but many times prostate cancers tend to lurk near the neurovascular bundles. There's also
a possibility of leaving cancer behind if you avoid the neurovascular bundles. So,
my experience with it is that it is pretty well-tolerated, that ED rates are less than
surgery and men do seem to recover well. This is in the limited experience that I've seen from
a relatively small number of practitioners that I've seen the results from. Probably the biggest
problem I've seen is when they are not aggressive enough or don't cover enough tissue and then they
have relapses. So, anytime some doctor is aiming to do a focal therapy, they have to
not only hit the target but they have to hit it at a margin around the target and make sure
that they get adequate coverage, and and if it is properly administered, it's effective.
So, you know, you mentioned that it may not be great for larger prostates, so
what size prostate would that be under in order for it to be effective?
Well, partly, prostates are not necessarily spherical, so it's not an absolute number,
but they start saying that if the prostate's over 60cc, 60 cubic centimeters,
which is about 50 percent larger than the average prostate, you're starting to get into an area
of— if you're trying to treat the whole prostate, you're not going to be able to cover the whole
prostate. If someone has a big prostate but the tumor is located near the rectal wall and they
want to do focal therapy, then it would still be feasible, or if it's a transition zone tumor
that's not too far away from the urethra, even though it's a big prostate, you could cover the
tumor with the Tulsa-Pro. So, it's not every big prostate's going to be a problem; it's whether
or not you want to treat the whole gland—which is sometimes administered in that fashion—or
whether you're planning to do a focal therapy, and if the targets within range of the HIFU beam.
So, a couple questions from our audience:
somebody was wondering if there's HI-FU would be better for localized prostate cancer, but
you know, if it's better for like Gleason 7 versus Gleason 9? Does it matter the grade of the tumor?
Well, you look at the literature and a lot of the
protocols have talked about using this for intermediate-risk cancer, and I'm not sure exactly
why. The destructive force is more than capable of destroying higher-grade tumors. I think that
when there's new technology coming out—and HI-FU is not brand new, but it's relatively new compared
to surgery, for example—the people doing the research try and set their new technology up
for success, and so they go after the tumors that are less likely to have metastases,
which makes sense, but if people can confirm that the higher grade tumors—the Gleason 9s and
8s 9s and 10s are localized, now that we have PSMA PET scans—I don't see any reason that you can't do
HI-FU with higher Gleason scores. If you do HI-FU with a higher Gleason score, would a short course
hormone therapy also be part of the protocol, or do you think we could go without that?
Well, no one knows. If you have a PSMA PET scan in a high-risk patient that doesn't show
any metastases, the studies that i've seen suggest that the scan will be accurate in about 80 percent
of patients. So, men that are can live with the 20% relapse rate because the PSMA PET scan
missed something could consider skipping hormone therapy. How much value is there in taking, say,
an 18-month course of hormone therapy? Well, at most it's going to cut the risk of relapse by 10%.
So, if you're going from an 80% to a 90% cure rate and you're willing to pay with 18 to 24 months of
hormone therapy, then I guess that's the patient's choice. I don't think that the
hormone therapy is going to improve the cure rates in the prostate if someone's having HI-FU,
but it could have some benefit if there were micrometastatic disease,
and if the PSMA PET scan shows that there's no micromets, there's an 80% chance there's
nothing out there. That's pretty good—without hormone therapy—so you can probably improve it
somewhat with hormone therapy, but it comes at a significant price of side effects and
different people will probably have different attitudes, particularly if someone's
more elderly—75 or 80—I would really hesitate to give them hormone therapy.
So, you mentioned the possibility of you know curing it within the prostate,
so you consider HI-FU and Tulsa-Pro a possible curative therapy?
Yes, the the high energy beam is more than able to destroy prostate tissue, prostate cancer tissue,
so it's all about the skill of the operator and whether or not there are any small specs
somewhere else in the body that, of course, don't get addressed with Tulsa-Pro or with HI-FU.
So, what about Tulsa-Pro and HI-FU versus
other forms of focal therapy? How do you measure those out?
I think all forms of focal therapy— they don't lack horsepower to kill tissue;
it's just a matter of the skill of the operator who's
using these tools. I'd rather have a you know very skillful doctor who's good at targeting
with electroporation or cryo or laser than I would have someone use Tulsa-Pro or HI-FU if
they don't have the practice and the skills. Doing focal therapy is a real tour to force proposition,
figuring out where the tumor is, and how much margin needs to be around it, and how to make sure
that the the treatment you're giving accurately treats the section that you're proposing to treat.
It's more than just one doctor; you have a team of people that are working on this, radiologists, and
that is the the the tricky part is that focal treatment probably still needs to be considered
semi-investigational; they're still in the learning process in terms of how to ensure
the best outcomes. Now we have PSMA PET scans, we have even a better handle on assuring ourselves
that there's not something on the other side of the gland that we're missing, you know,
in the past we've done biopsy, saturation biopsies, MRIs, color dopplers, and that is the—
finding the extent of the tumor within the prostate has always been a big challenge
and then accurately delivering treatment with a margin is also another challenge.
So, as far as insurance coverage goes, have you seen this across the board be covered by medicare?
Well, I'm glad you bring that up because the costs of Tulsa-Pro and HI-FU are quite a bit
more. Most of the other options, the traditional options, like surgery and radiation are covered by
standard insurance, but the laser treatments, Tulsa-Pro, HI-FU, many times there's a large
out-of-pocket expense. The insurance companies will pay maybe a portion of it or not any of it.
So, I know that, you know, Tulsa-Pro and HI-FU, obviously as you explained, works similarly,
but if you had to choose between one or the other, would it purely be based off
of the experience of the doctor or is there another factor you would take into play?
Yeah, if I have some personal knowledge that a specific individual has real talent and skills,
I'm much less concerned about which tool he wants to use. I want him to use a tool he's familiar
with using. The Tulsa-Pro technology is kind of intriguing because they're doing it in an MRI,
so they're able to visualize with one of the better tools that we have for seeing cancer,
MRI, while they're doing the treatment. So, it does suggest that the technology
is going to aid the physicians in doing a better job, but if a doctor already
has experience with his own methodology and is getting good results, I just stick with that.
So, let's talk about that for a minute. Oftentimes we get asked on our channel
how do we find a doctor? So, we've talked about reading reviews online from patients,
how many papers has this doctor [written], have they done any research work in this,
and then also how many procedures? So, how many procedures for Tulsa-Pro and
HI-FU would you suggest a patient look for, like how many has this doctor done?
Oh, I'd say at least 25 to 50 minimum.
Probably the most important thing, I think, is to try and find if a family doctor or a urologist or
a radiation therapist who's got familiarity with the physician doing these focal therapies and has
seen how their patients have turned out over time. I think that is the most reliable way because,
you know, I have patients come in and say, "Well you know my gardener went to so and so and he had
a good result." Well that's just one patient. We really want doctors that can consistently
get great results time after time, and the only people that have that type of exposure
are referring physicians, family doctors and whatnot, where they've sent a sequence of
patients to a specific physician and they've been consistently pleased with the results.
I know another form that patients have been using is like online facebook groups and support
groups to try to find consistent testimonies of those physicians. That's been really helpful.
So, my last question is regarding follow-up and PSA declines. So, what should the PSA
look like maybe two weeks out versus two months out versus two years out,
and then what would the follow-up scanning look like as well?
Well, it's certainly going to depend on whether they did a focal treatment or a whole prostate
treatment. The focal treatments, you can calculate with scans how much prostate normal prostate
tissue is left behind, and then you can divide that by 10 and that's the average PSA that you
would expect. In our patients that have had focal treatment, we treat their untreated prostates
the same way we treat men who are on active surveillance. So, we get a
MRI once a year or a color doppler once a year, check their PSA twice a year,
and that's because they can have new cancers that show up in the untreated
prostate, or they if the doctor missed some of the cancer, we want to detect it at an early stage.
Men that have had their whole prostate treated with HI-FU should have very low PSAs less than 0.5
and it should remain steady in that range and how long does it take to get there? It goes pretty
quick. I would say—with radiation sometimes it'll take a year or more for the PSA to drift down to
the really low levels—but with HI-FU, the PSA should be very low within three to six months.
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