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Focal Treatments TULSA & HIFU: Breakthrough Or False Promise? · Intellectual Medicine

• 0:00
  The problem is that the biopsy is often a requirement to prove
• 0:05
  you have prostate cancer. When you have an MRI, you have
• 0:08
  APSA, you have abundant clinical evidence that the cancer is
• 0:12
  there. Sticking a needle in there does
• 0:15
  nothing except for risk metastatic spread.
• 0:18
  What stops that from happening? It's your own immune system,
• 0:21
  guys. It's your immune system.
• 0:23
  So you got to keep it strong. You have to be proactive.
• 0:26
  You can't let yourself corrode. Wouldn't it be nice if you could
• 0:33
  target the spot where cancer occurs and just ZAP it out?
• 0:39
  Kind of like a skin cancer? But there is an analogy here,
• 0:43
  folks. I'm talking now about focal
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  therapy for prostate cancer. That means targeting a section
• 0:53
  or the gland itself, without surgery, without radiation.
• 0:58
  Is it worth considering? Does it work?
• 1:02
  Does it live up to the billing? Here's the problem.
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  There's not a single focal therapy that has been proven to
• 1:10
  prevent you from dying of prostate cancer.
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  Now, that seems like a pretty fundamental question to be
• 1:15
  answered, but it's not easy. It takes 10 years, maybe longer.
• 1:20
  Prostate cancer moves slowly. Therefore any study that
• 1:25
  proclaims success by virtue of saying hey in five years we had
• 1:29
  a great survival rate is very useless in my view because so
• 1:34
  many men are going to survive five years.
• 1:36
  In addition, most of these studies are done with early
• 1:40
  stage prostate cancer, which is often times a misinterpretation.
• 1:47
  Early stage prostate cancer is often simply atypical dormant
• 1:52
  cells. Now they need to be respected
• 1:55
  because they can be dormant, meaning they're asleep like
• 1:59
  Godzilla. But we all know what happens
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  when he wakes up. Godzilla wakes up and Tokyo goes
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  downhill. We're Tokyo.
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  Godzilla's the cancer cells keep it sleeping.
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  How do you keep it sleeping? Well, you all remember Godzilla.
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  I think it would set up bombs and woke them up.
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  The equivalent of the bomb that wakes up your doorman cells is
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  the biopsy. Well, let's talk about some
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  specific focal therapies. Now, all these focal therapies
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  are based upon what is called the index lesion theory of
• 2:33
  prostate cancer, which means there's a spot where the cancer
• 2:38
  begins and then it grows. Simplistic and simply not true.
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  The theory supports the propagation of this
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  psychologically comfortable but an effective treatment in my
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  view, that we could target the lesion in quotes and get rid of
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  it. Look, even in skin cancer, every
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  nodule of cancer has tentacles that can't be seen with the
• 3:04
  naked eye. They extend out and that's why
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  they cut out large areas. And that's why if you've ever
• 3:12
  had surgery for skin cancer, there's a procedure called the
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  Mohs procedure, MOH Apostrophe S, where they carve it out like
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  peeling an onion, looking at the layers to make sure they got all
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  the cancer. You can't tell that by the naked
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  eye. So let's go back to this focal
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  theory, this identifiable lesion.
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  They will convince you that an MRI can identify the exact spot
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  to be targeted. That's just silly.
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  We know that prostate cancer is a cellular phenomenon, and it
• 3:45
  spreads throughout the gland through these little fibrils and
• 3:51
  cells, and you can't target it. It's everywhere.
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  And it's undeniably either in that gland or outside of it.
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  We have evidence that can help support.
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  Is it inside or outside? So are focal therapies worth
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  doing? There's a relatively new one FDA
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  cleared in 2019, and when you hear that term FDA cleared, it
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  means a piece of medical equipment has been determined by
• 4:19
  the Food and Drug Administration to be safe and effective for its
• 4:24
  intended purpose. The intended purpose of the
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  Tulsa equipment, Transurethral Ultrasound Ablation Tulsa,
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  somehow they got that acronym out of it, is a procedure where
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  they use ultrasound to heat the prostate and destroy the cells.
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  The device is placed through the urethra.
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  The heat via the ultrasound emanates outward.
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  They can control it with an MRI, trying to make sure that they're
• 4:53
  not burning stuff that shouldn't be burned.
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  It sounds good, and one of the reasons that these focal
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  therapies sound so good is because conventional therapy is
• 5:05
  awful and it doesn't work. It does not prevent you from
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  dying of prostate cancer. When they talk about curing the
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  disease, that's a bold faced exaggeration.
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  They really shouldn't be able to say that any more than I can say
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  that about my protocol. And my protocol has not been
• 5:23
  proven to cure the disease. But it's not going to hurt you.
• 5:26
  And there's evidence of benefit behind the drugs and the
• 5:29
  supplements that are used. So in my view, if you have
• 5:34
  prostate cancer or a high risk thereof, it number one, do not
• 5:38
  get a biopsy. And if you have, don't shed a
• 5:41
  tear, just don't get any more right.
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  You can go back to my earlier podcast on that, but the essence
• 5:47
  of it is that a biopsy isn't going to help us make decisions
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  when we've already ruled out prostatectomy.
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  We've ruled out radiation because they're awful.
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  At least you should rule them out.
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  That leaves you with what? A biopsy to prove what you can
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  otherwise discover through an MRI and monitoring the PSA over
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  time. That's what we want to know.
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  Are things changing? Is this getting worse?
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  Is the risk increasing? So these focal therapies have
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  the comfort of not being as destructive.
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  OK, that's a good thing. So in that sense, I can't be
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  completely dismissive. I understand why they have an
• 6:31
  appeal, and they may turn out to be worth considering.
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  But here's some problems. The Tulsa procedure, the trial,
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  one of the primary studies that helped get it through FDA
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  clearance, looked at 115 men for 12 months.
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  So right away I have a problem. 115 men is not enough, and 12
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  months is not long enough. So all right, let's go with it.
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  See what information they gathered.
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  What they discovered was that it was effective at diminishing the
• 7:04
  prostate size and lowering the PSA.
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  All right, I suppose those are good things.
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  But far too much emphasis is placed upon chasing a number the
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  PSA, and way too little emphasis is placed upon preventing the
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  disease from spreading. And those are two separate
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  phenomenon. They roughly correlate, but it's
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  not inevitable. High PSA does not mean that you
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  have prostate cancer. We'll talk about more than in a
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  moment. Let's go back to the study.
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  What happened? So the tonsil procedure was
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  done. The men had an ablative therapy
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  performed. By the way, all the men had
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  either mild or moderate risk disease.
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  These are not men with really ominous looking disease.
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  And the prostate glands were relatively small.
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  Well, that makes sense. If you're going through the
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  urethra and you're heating it with ultrasound, you can't have
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  a gigantic prostate. The heat would reach the outer
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  perimeter of it as effectively. So in this study, 12 months
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  later, 35% of the Med still had cancer.
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  At least 65% didn't have evidence of it, but 35% did.
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  That's not really a high level of success if you're going
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  through an expensive, potentially hazardous procedure.
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  Yes. Often times this is not
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  insurance covered. 25% of the Med had erectile difficulty
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  after the procedure, so it's not benign.
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  Is it less traumatic than a prostatectomy?
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  Yes. Is it less traumatic than
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  radiation? It is, but is it worth doing?
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  Those are separate questions. In this study, they did not
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  compare to a placebo. Well, that's unethical.
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  I don't think it's right to take a man, tell him he has prostate
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  cancer or a high likelihood of it, and just say good luck with
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  this. We're just going to kind of sit
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  around and do nothing. That's what they call active
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  monitoring or watchful waiting. It sounds comforting, but in
• 9:02
  essence, no treatment is rendered your left throne
• 9:06
  devices. And that's why so many of you
• 9:08
  guys get stuck on the Internet sucking on ivermectin at toxic
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  doses. I like it in its place, but it's
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  simplistic when you start to go down that path.
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  And I can't blame you because there are a few other
• 9:22
  alternatives. So here we are.
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  The ablative therapy looks good. Well, here was their conclusion.
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  I'm going to quote from the conclusion now.
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  Listen carefully to what is not said.
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  Quote effective tissue ablation and low rates of toxicity and
• 9:37
  residual disease. That's how they summarize the
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  treatment. Effective tissue ablation.
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  Big deal. I don't want to just ablate
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  tissue. I want to not have cancer spread
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  and low rates of toxicity and residual disease.
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  I don't consider a 35% residual to be a low rate.
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  I want something better than that.
• 9:57
  If you're going to stick a wand up my urethra and heat my
• 10:01
  prostate with a 25% chance of losing erectile vitality, I want
• 10:07
  a better outcome. Now that's my perspective.
• 10:12
  Should you consider this? I'm still open minded toward it.
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  I will say this, and I'm looking for a urologist that would be
• 10:20
  willing to do this. If they would be willing to do
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  it without a biopsy. It may have a niche.
• 10:27
  The problem is that the biopsy is often a requirement to prove,
• 10:32
  Yeah, prostate cancer. When you have an MRI, you have
• 10:36
  APSA, you have abundant clinical evidence that the cancer is
• 10:40
  there. Sticking a needle in there does
• 10:43
  nothing except for risk metastatic spread.
• 10:47
  So if that could be done, maybe a consideration in conjunction
• 10:51
  with addressing it systemically. The problem, you can't tell when
• 10:58
  that cancer leaves the gland because it does so at a cellular
• 11:02
  level, like dandelion seeds spreading over the lawn, right?
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  One day you look out and there's the lawn covered in dandelions
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  and you go, what happened yesterday?
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  They weren't there because those little cells can spread and they
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  can seed themselves in the skeleton, in the liver, in
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  places where they all bloom at once.
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  What stops that from happening? It's your own immune system,
• 11:26
  guys. It's your immune system so you
• 11:29
  got to keep it strong. You have to be proactive.
• 11:32
  You can't let yourself corrode, right?
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  So should you get a Tulsa procedure to consideration?
• 11:39
  But would they do without a biopsy?
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  And does it complement the protocol I developed?
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  It may it may, but I like the protocol as a stand alone.
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  I want to see future studies done with my protocol as the
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  control group and I want to see what the difference would be.
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  We're in the process of gathering that data from our
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  group, but how cool would it be if they would compare them?
• 12:03
  Well, how about another blade if I've got time for another one?
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  Haifu high intensity ultrasound therapy done usually
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  transparentineal in order to try to ablate the prostate.
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  It's another one of these heating mechanisms problem one
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  year after a procedure. This is a study published in
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  2000 and 2329 patients. You'll notice once again,
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  relatively small numbers. One year later, 44.8% still had
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  cancer and 30% had erectile difficulty.
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  Only 3%, however, were leaking urine.
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  So it's got that going for it. Less urinary leakage.
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  Should you get a high food? Should you get these local
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  therapies? I'm not an advocate of them.
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  They're expensive, not proven to work.
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  I think that they're a consideration of the right time
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  and place, but that right time in place may well be only after
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  you've tried other things like the protocol that I've
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  developed. So be careful about being lured
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  into that. Which sounds comforting.
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  A sense of false comfort can happen.
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  They're expensive. If you're going to get this
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  done, take your time, get multiple opinions.
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  I wouldn't say never. Ultimately, man, this is your
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  choice. You all have to decide, but do
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  not do some of these procedures until you've had comparative
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  assessments from other urologist.
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  Consider all your options side by side.
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  One of the problems with these procedures is once they're
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  released by the FDA, they can disseminate widely and they tend
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  to be utilized a lot more aggressively, in part because of
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  the reimbursement dynamics. Simply put, dude, invest a lot
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  of money in this equipment, wants to then put it to work.
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  So those nicely refined protocols, yeah, they kind of
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  get blown up. Well, the index lesion theory, I
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  think is a comfortable myth that I don't believe is actually at
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  play. What we have is a cellular
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  theory. So what we need systemic
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  treatments. Well, that's all I got for
• 14:18
  today, gang. Thanks for spending some time
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  with me. Consider your options.
• 14:23
  Take your time, be thoughtful, continue to watch the podcast,
• 14:27
  and I invite you into the community as well.
• 14:30
  That's the Prostate Protocol community where you can get more
• 14:33
  expanded information and contact.
• 14:36
  All right, we'll talk to you next time.
• 14:37
  Bye.