Latest / Intellectual Medicine / Focal Therapy for Prostate Cancer: Does It Actually Work?
Transcript
- 0:00Focal therapies do not come without risk.
- 0:04They all come with inevitability that will be a significant
- 0:08failure rate with progression of disease.
- 0:10They don't have as much negative consequence, but do they really
- 0:15make a difference or are we simply cashing in on men who
- 0:20have very early stage indolent prostate cancer that is best
- 0:24left not disturbed and treated with lifestyle nutraceutical
- 0:31repurposed drug therapy with non invasive monitoring treating
- 0:37prostate cancer. What a dilemma.
- 0:40There's been a rise lately in focal therapies.
- 0:44We're going to discuss those today.
- 0:46What is a focal therapy? Does it have merit?
- 0:49Let's start out with why the focal therapies are on the
- 0:52ascension. There's several variables.
- 0:54One of them, the conventional treatments, are God awful and
- 0:58have not been shown to be substantially better than doing
- 1:01nothing with regard to dying from prostate cancer.
- 1:05That is, after all, the objective, isn't it?
- 1:08We all got to die of something. We do not want to die of
- 1:10prostate cancer, and we want to do things to diminish the
- 1:13likelihood. Unfortunately, prostate gland
- 1:17removal and radiation have not been shown to have that value,
- 1:22and they're awful. Side effects are abominable, so
- 1:25there's an opening for new treatments.
- 1:29Now there's also a capitalistic Dr. I'm not against capitalism,
- 1:35but we have to be have to be a little bit skeptical when new
- 1:39equipment comes to the medical marketplace.
- 1:42Now here's how it works, folks. Medical equipment is not FDA
- 1:47approved. The equipment is FDA cleared.
- 1:51That means that it's been shown to be reasonably safe,
- 1:55reasonably effective for a specific purpose.
- 2:00Now, once a device has been cleared and it can be sold to
- 2:03doctors, they can use it for whatever they choose.
- 2:07That's off label use. That's cool.
- 2:10That's what I do in my repurposed drug therapy, off
- 2:13label use. It's a it's using the doctor's
- 2:16experience, skill, knowledge to apply the technology toward a
- 2:22space in which it's not previously been approved.
- 2:24So that's ethical, legitimate, but the problem lies in the
- 2:28motivational dynamics. What do I mean?
- 2:32Device gets approved, it gets cleared, FDA cleared.
- 2:36There's often millions of dollars in investigative studies
- 2:41to get it to that level. They need ROI, they need return
- 2:45on investment. And to get that, they've got to
- 2:49promote this as advantageous. Now, this is replete in the
- 2:53world of prostate cancer treatment.
- 2:56Men do not want to have, they don't want to suffer at the
- 2:59hands of ablative therapies. Many of you are reading about
- 3:05this, you're hearing about it from me, from other credible
- 3:08sources, and you are rightfully hesitant.
- 3:13Problem with these focal therapies?
- 3:15None, not one. There's not a focal therapy yet
- 3:19that has been shown to diminish your risk of dying from prostate
- 3:22cancer. Those studies can take 20 years.
- 3:25It doesn't mean that they may not ultimately show that value,
- 3:30but so far, the early returns are a little disappointing.
- 3:34Now, what they have in common. We'll discuss individual focal
- 3:38therapies in a moment. What they have in common is the
- 3:41concept that you can identify where the prostate cancer is by
- 3:47virtue of an imaging study, an MRI in particular, maybe an
- 3:51ultrasound, and go in there and ZAP it.
- 3:54That is, kill the cancer cells and spare everything else.
- 3:57All right, that's just foolhardy.
- 4:00Cancer of the prostate, and for for that matter, elsewhere, is a
- 4:04cellular disease. It metastasizes without leaving
- 4:09a trace, without visible evidence.
- 4:12Cellular escape. So no matter what you do to
- 4:17address your prostate cancer, this does become a lifelong
- 4:22endeavor. You can never be certain if
- 4:25those cells have escaped the target if they're going to plant
- 4:29in the bone, in the liver and come back 5-10 years later.
- 4:33So the point is not to be pessimistic and say, oh, it's
- 4:37hopeless. After all, the cells will
- 4:39escape. No, we want to combine things if
- 4:43if, if needed, we want to combine things to go after the
- 4:46cells. Even if you're doing a focal
- 4:49ablation because a focal ablations may have an itch.
- 4:54My concern about them in addition to the fact that
- 4:57they've not been proven at the back end.
- 4:59We don't need absolute proof to advocate for a treatment, by the
- 5:02way, right? What we need is evidence of
- 5:05benefit and safety. We don't want to cause harm.
- 5:09The ablative therapies don't measure up to that standard, in
- 5:13my view. So let's start with focal laser
- 5:16ablation. The focal laser ablation is
- 5:19based on equipment that has not been FDA cleared to treat
- 5:23prostate cancer. It is cleared for the
- 5:26destruction of tissue, and doctors have applied it toward
- 5:29the prostate because, after all, they're trying to destroy cancer
- 5:33tissue. It's a rational extension, but
- 5:36it doesn't work out so great. It involves A surgical procedure
- 5:41with anesthesia, inserting a probe through the perineum into
- 5:46the prostate gland. And right away we got problems,
- 5:49right? We're piercing the capsule,
- 5:52We're introducing trauma with the potential of metastatic
- 5:56disruption that can happen. And piercing the capsule has a
- 6:02risk of metastatic spread even if it's followed by an ablation.
- 6:07So the laser goes in through the capsule and zaps the area of
- 6:12concern. Still some incidence of erectile
- 6:17difficulty, still some incidence of urinary difficulties,
- 6:21although much less than conventional treatment.
- 6:24So I guess it's got that going for it.
- 6:27The other problem in two different studies, one study
- 6:30showed one year later, 29% of the men had recurrence of
- 6:34prostate cancer cells in the gland.
- 6:36That tells me a couple of things.
- 6:38Number one, they had a high incidence of treatment failure.
- 6:41Number 2, they had to get biopsies to get that
- 6:44information. So you're still stuck in the
- 6:46conventional, you know, Whirlpool of biopsy assessed
- 6:51biopsy. You know, which I don't
- 6:54advocate. I do not advocate biopsies.
- 6:56If you've had them in the past, you can't undo the past.
- 7:00But think twice, go back. Look at my podcast.
- 7:03Another study on focal laser ablation found a 15 to 56% rate
- 7:11of cancer cells being present 12 months later.
- 7:15That's not so good. You're going through the
- 7:17ablation and in many times you're paying for this out of
- 7:20pocket, folks. You go through that ablation,
- 7:22right? You expect cancer to be gone,
- 7:25but it's cellular, it's tenacious, and it's going to
- 7:28linger. It's hard to know for sure if
- 7:31those cancer cells are gone. The other problem with focal
- 7:36laser and other focal therapies, they are specifically utilized
- 7:42for men with low risk prostate cancer.
- 7:46Now you know I do not advocate a biopsy, which means I do not
- 7:50advocate getting a Gleason score.
- 7:53Go back and look at my podcast on that topic.
- 7:55Gleason scores are not needed to guide thoughtful treatment
- 7:59decisions, nor are they needed to determine how aggressive
- 8:03cancer is. You can do that with sequential
- 8:05assessments, but the biopsy becomes fundamental to this.
- 8:10In the case of laser therapy or focal ablation therapy, they're
- 8:15treating men with the most indolent form of the disease.
- 8:19In other words, men who never needed to have surgical
- 8:23intervention and all likelihood and have a high likelihood of
- 8:27thriving with something like the repurposed drug therapy that I
- 8:32advocate. So should you consider focal
- 8:36therapy? It's reasonable to contemplate,
- 8:40but go in there with your eyes wide open.
- 8:43Make sure you shop before you buy.
- 8:46So focal laser ablation, it's got some liabilities.
- 8:50How about high intensity focal ultrasound or high food?
- 8:55It's been around for quite a while, since at least 2010.
- 8:59With this one is a little different.
- 9:01The probe goes in the rectum and the high intensity focal
- 9:04ultrasound happens externally going through without piercing
- 9:10the capsule. So it does have that advantage,
- 9:12non capsule disruption. It just doesn't work that great
- 9:18to prevent cancer from progressing.
- 9:21In one review article looking at 10 years of HAIFU results, they
- 9:25found 50% of the cases had progression of cancer.
- 9:30So if you do HAIFU, you've got to be diligent.
- 9:34It's not going to be a circumstance where the treatment
- 9:37cures you and you don't have to sweat.
- 9:39You want to continue monitoring the other treatment approach,
- 9:44cryotherapy. Now, cryotherapy involves once
- 9:48again going through the perineum, inserting a probe into
- 9:53the prostate and freezing it, usually with argon gas, making
- 9:57an ice ball out of the prostate. Now, what I like about that
- 10:01conceptually is we're not trying to pretend that we can target
- 10:06specific spots where cancer is likely to be.
- 10:09We're freezing the whole damn prostate, a big ice ball, and
- 10:13that kills cancer cells, and it kills prostate cells as well.
- 10:17It affects both, and as you might expect because of its
- 10:23global impact, is a higher incidence of erectile
- 10:27dysfunction with this treatment than with other focal therapies.
- 10:32But in studies looking at its long term outcome, it was shown
- 10:37to be no better than active surveillance.
- 10:41Now, active surveillance, as you probably know by now, is simply
- 10:45medspeak for doing nothing. Well, we're going to do active
- 10:50surveillance. It sounds nice.
- 10:52I like being surveyed. I like it to be active as
- 10:55opposed to passive. But it is a fallacy.
- 11:00We're going to simply watch your cancer by doing periodic
- 11:04biopsies to tell what it's how silly when you know cancer is
- 11:10present, why would you stick a needle in it?
- 11:12So anyhow, the cryotherapy no better than effectively doing
- 11:17nothing with regard to long term outcome.
- 11:19A more recent procedure called the Tulsa All Capitals Tulsa
- 11:24stands for transerethal laser therapy.
- 11:29It involves going through the urethra.
- 11:31So this does have an advantage of not piercing the capsule,
- 11:35right, going through the urethra, that's better.
- 11:38And then it uses the energy of the laser extending outward in
- 11:44order to heat and and then destroy the prostate cancer
- 11:48cells. So conceptually it has some
- 11:53advantages goes through the urethra rather than through the
- 11:57the capsule. It extends outward from the
- 12:00urethra destroying the cells. So hopefully there'd be less
- 12:05incidence of metastatic spread. To date, it's a relatively new
- 12:09procedure and that that statement can't be verified
- 12:14right. So the potential for spread does
- 12:16exist. In one study looking at this, 10
- 12:21out of the 23 individuals who had Tulsa done had cancer
- 12:25present 12 months later, 10 out of the 23.
- 12:29It's a high incidence of failure in a treatment that is intended
- 12:33to be definitive or at least therapeutically effective.
- 12:36It's a problem because it's not obliterating the cancer.
- 12:40The good news, at least it's not as traumatic as prostatectomy or
- 12:45radiation. I don't advocate for either
- 12:48other big study. There was a study that looked at
- 12:51150 men. This was a study that helped it
- 12:54to get FDA cleared for treating prostate cancer. 35% of the men
- 13:01a year later in the study still had prostate cancer.
- 13:05Which I suppose if you flip it around, 65% did not.
- 13:10One year later? What about three 5-10 years?
- 13:15The nature of prostate cancer is such that we could expect the
- 13:18failure rate to increase over time.
- 13:21Is it worth getting? Well, it's better than having
- 13:25the gland removed. It's better than radiation.
- 13:28It doesn't have as many side effects.
- 13:31I like it conceptually better than piercing the capsule like
- 13:37laser therapy, like cryotherapy, but it's pretty brand new and
- 13:43it's currently being utilized in men with very early stage
- 13:47disease. And it's an out of pocket cost.
- 13:5110s of thousands could be up to 30,000.
- 13:55That'd be sweet if it were one and done and you had a high
- 13:58degree of confidence it's going to take care of the problem.
- 14:02There is an incidence of erectile dysfunction with this.
- 14:07In one study of 13 men who had no problem with erection before
- 14:11the procedure, seven of them, 7 out of 13, developed erectile
- 14:16difficulty afterward. It's not exactly as it was
- 14:21promoted. So as you can see, focal
- 14:25therapies do not come without risk.
- 14:29They all come with and that inevitability that will be a
- 14:33significant failure rate with progression of disease.
- 14:38They're better than focal. They're better than having the
- 14:41gland removed. They're better than radiation
- 14:43therapy. With regard to the negative
- 14:47consequence, they don't have as much negative consequence, but
- 14:51do they really make a difference or are we simply cashing in on
- 14:57men who have very early stage indolent prostate cancer that is
- 15:02best left not disturbed and treated with lifestyle
- 15:07nutraceutical repurposed drug therapy with non invasive
- 15:12monitoring. That's the real comparative
- 15:14assessment that we care about. That'll never happen in an
- 15:18organized study, but it is happening in real life, in real
- 15:22time as we speak. Men are choosing to pursue the
- 15:27protocols that I've advocated, and by virtue of their choice,
- 15:33we are now gathering experience data over years.
- 15:38Well, we'll be sharing that with you as it continues to unfold.
- 15:40But today, today was about focal therapy.
- 15:44Do your homework, take time. Remember, there's never an
- 15:48emergency when you're looking at localized disease and
- 15:52contemplating what to do. Take your time.
- 15:56Make a decision that prioritizes your vitality and values what
- 16:02you value. Feeling strong, staying vital.
- 16:06Do not compromise your masculine health out of a false promise of
- 16:11disease cure. All right gang, that's all I got
- 16:14for today. We'll be talking again soon.
- 16:16Thanks for tuning in, Talk to you next time.