Nelson Vergel
Founder, ExcelMale.com
Dr. LaBoissiere: Thank you. I have kind of a booming voice so if it gets too loud, let me know and I will adjust the mic. It's certainly a pleasure to be here. I am fairly new in terms of being a physician. I am a fellow and that's always confusing. When I walk in the room, I introduce myself as the fellow and they go, “I know you're a fellow.” I'm like, “No, I'm not referring to my sex, I'm actually a fellow.” What that means is that I'm a urologist. I finished my training. I did four years of undergrad at University of Alberta, four years of med school. I made seven years of residency.
Then instead of going directly into practice, I made the decision that I wanted to get more advanced training. I am a subspecialist or that's what I'm finishing up my training in. The way I word it is I'm a functional urologist. It's a non-official term, but what that means is I don't treat cancer per se. I certainly deal with patients who have cancer. I certainly know the approaches, but I'm not an oncologist. That's not my subspecialty. What I do is I try to restore normal function of the urologic system.
Incontinence is one of my specialties, erectile dysfunction. I'm trying to get you back to normal or as close to normal as you can. Really, I'm a reconstructive urologist. That's what it comes down to, that's what I'm training in. I've had the pleasure to train with some of the world's experts at Sunnybrook and just finishing off with Dr. Herschorn and Dr. Kodama there so it's been a privilege.
Tonight's talk, I wasn't quite sure what they wanted me to focus on. This is the standard physician slide right at the beginning that says that I'm not being paid to be here. I don't have any stock in companies, et cetera. This second part here, I put on, it's important especially if I was talking in the States, but what it means is that I'm going to provide you with information. Certainly it's going to be accurate, but your treatment is an individualized approach so what I don't want is you to go from here and say, “Okay. This is what I need to do now.” All of it should be discussed in context with your physician who understands the intimate details of your treatment, your diagnosis, et cetera. This is to provide information but at the end of the day, it's information to take back to your physician and to discuss.
Now, getting to the talk, I do really appreciate the opportunity to come out and it is truly a privilege to be able to take care of others. I love what I do and I love this opportunity because I think the most important job as a physician is to provide information. Gone are the days where the doctor walked in the room and said, “You need surgery. Sign the form. I'll see you later.” That's not the way it works now. Our job now is to provide you with information so that you can make informed decisions regarding your own health.
That's why I really enjoy these talks because I look forward to the opportunity to provide information. I know there's tons out there on the internet. Some accurate, some inaccurate. I take advantage of these opportunities when presented to hopefully increase your knowledge just a little bit around your own disease, but maybe things you haven't thought about as well.
Men's health screenings. This is a cartoon and it paints a bleak picture. You see the physician and the nurse standing here and obviously they haven't had a patient in some time. This is relating, and I know the women in the room will be able to attest to this, but men don't talk about their problems and that's an issue. When we talk about erectile dysfunction, we're talking about 50% of men over the age of 40 having issues. It's a huge number.
Most people don't know that number because we don't talk about it. Incontinence whether it's in the relationship to prostate cancer treatment or incontinence for other reasons, men don't talk about it. It's a big problem. I see it all the time because I specialize in it, but men just don't talk. We really need to start focusing on men's health and as a urologist … And I'm going to go through some definitions just to clarify. As a urologist, I specialize in the genital-urinary systems so that's looking at the reproductive and the urinary system. I treat men and women, and that's a common misconception. Everyone thinks that a urologist only treats males. In fact, about 50% of my patient population is female.
An andrologist, and I'm going to tie this at the end, is somebody who focuses more on men's health and that can be global. It's not just the urologist. Endocrinologists do it, family doctors do men's health. Andrology is just the study of men's health. What I like to really harp on tonight and hopefully get the point across is that prostate cancer ties in to overall men's health and a lot of the issues that come out of treatment for prostate cancer, so complications of radiation or surgery, incontinence, erectile dysfunction, the effects of being on androgen deprivation therapy or hormone therapy, all of these can tie in to overall male health as well.
A lot of these issues can occur outside of prostate cancer treatment. This gives me an opportunity not only to talk about prostate cancer which I know all these talks really focus on, but globally talk to you a man, about men's health because the reality is that the majority of men in this room even with prostate cancer are going to run into issues with their health not related to the prostate cancer. Number one cause of death in men is cardiovascular disease.
I'm going to take this as an opportunity to broach the subject of overall men's health in the context of prostate cancer. Of course, we're going to discuss the role. Now, when I was being asked to do this talk, I had questioned back to the organizers and said what do they want me to focus on? In my clinic … Is that better? In my clinic, I treat erectile dysfunction and low testosterone. I said, “Do you want me to talk about that?”
Then they sent me back a whole barrage of questions and they said, “Well, most people get up here and they just focus on prostate cancer.” We've had lots of talks about treatment options. We've had lots of talks about counseling groups after for patients and their families, and treatment of erectile dysfunction, and incontinence. What does the prostate do?” I step back and said, “Yeah. I think a lot of people don't know what does the prostate do? Do they truly understand men's health?”
Again, it comes down to that education. If you have prostate cancer, you've been treated for it, a lot of you in the room or some of you in the room may not even have your prostate anymore, but understanding what the prostate does and how this treatment or this diagnosis has affected you, I think, is important. I'm going to go through normal anatomy and physiology or what the prostate actually does and you're going to be disappointed.
Then I'm going to go through the impact of prostate disease. Not just prostate cancer, but prostate disease on overall health because this provides some context to raise some important points. Of course, we're going to focus on prostate cancer. What I wanted to do though is take an opportunity to talk to you about testosterone. Again, it's not going to be the main focus of the talk, but again it's an opportunity because even though you have prostate cancer and some of you in the room don't, but even if you do, you can still be affected by other issues that affect men's health, low testosterone.
Some of you after prostate cancer treatment maybe had normal erections and then you lost them five years down the road. That can be due to a variety of reasons. It's not always related to your treatment. I wanted to take the opportunity to discuss what is testosterone and how does this factor into men's health? It ties in with prostate cancer treatment. It also tries in and hopefully getting you to a healthier well-being.
I'm going to talk about ways to improve overall health in the context of prostate cancer. One of the questions that I got sent back was is there a way to prevent prostate cancer? Is there a way to improve the treatment or the course if I have prostate cancer? Then how can I improve my overall well-being after prostate cancer is treated. I'm going to touch on that. Then after blabbering on for about 40 minutes or so, hopefully at the end, you understand what an andrologist is. I'm going to touch on what the clinic offers at Sunnybrook. Again, I don't have any stock in there. They didn't send me here to try to drum up business. I'm just here for education, but what we actually offer, and there's a lot of clinics that do what we do.
What does the prostate do? If you were to talk to the average male or female and say, “What does the prostate do? What do they tell you?” They tell you the problems that happen with the prostate gland where you get prostate cancer, or I hear men can get prostatitis and that sounds really painful and they run in the bathroom every 20 minutes, or their BPH or that enlarged prostate, and I know somebody who can't pee.
If you actually say, “Okay, but what does the prostate gland do?” A lot of people don't know where it is, what it is, where it is. This is important because when we talk about treatment, you'll understand after I tell you what it does and where it is, why treatment can affect so many different things in terms of normal function. Of course we worry about prostate cancer. A little bit of anatomy, med school 101. Surgeons keep it simple. This isn't going to be a talk using all the Latin terms and everything, this is just a straightforward talk.
Looking at the man, standing at the side, cut him in half. Rectum is back here, intestines, bladder is here. This is obviously the penis. You pee out of this tube going to the bladder, testicles sit here. This little guy right here, that's your prostate gland. Why is this important? Look where this is sitting. I'm going to tell you what it does. As I said you're going to be a little disappointed when I tell you what it does. Look where it sits. It sits right in an important area. You've got bladder sitting here, you've got the rectum back here. This is the external sphincter here. This is what controls continence or allows you to hold the urine in.
You can imagine then the challenge as a surgeon going in to remove this. How do we avoid damaging nerves, blood vessels, bladder, rectum, all this in the area? Unfortunately there's excellent surgeons out there. We've got the robot now and more advanced techniques that we're able to do this surgery better and better and better. The robots still establishing itself, robot versus open. We're able to do this better but you can understand just by a location how difficult it is and why you can run into trouble because taking this out, we damage this or we damage the nerves here and you get incontinence.
You radiate this area, you can damage the bladder, you can damage the rectum, the urethra here where you pee out of can fill up with scar tissue so you get the strictures. It is an important area. The prostate, if you just look at it, you'd say, "That just looks like a blob of tissue," but it's actually broken into four different zones and the transition zone is the zone that is intimately associated with the tube you pee out of. This is where you get enlargement of the prostate, benign disease.
Then we add in the central zone, it doesn't do a whole lot in terms of disease but you can get cancer in any of these locations. The main area for cancer is actually more peripheral. One advantage of that in a sense is that when we go to biopsy, we can stay lateral or away from this drainage tube. 70% of cancers occur here. Then finally, you get this little fibromuscular, just strong connective tissue layer. This right here, these are your seminal vesicles. They're intimately associated. Men sometimes ask, “Well, why do you go remove that?” That's part of the process. It all ties in. You can see they drain directly in where the prostate sits so you have to remove these. This is why [inaudible 00:12:53] fertility, et cetera gets compromised with prostate cancer treatment.
What does it do? I wanted so bad to tell you some profound information that this is a super important gland and that's why it's causing so much trouble when you take it out and there's a risk of complications. An actual fact, it's just an accessory organ. What it's involved in is fertility, essentially. That's as far as we know right now. What it does is it contributes about a sixth of the volume of the ejaculate. It secretes a bunch of different things. Some buffers, citrate, zinc, prostate proteins like PSA, and we'll talk a little bit about PSA because I know that's a big thing for prostate cancer and a bunch of other proteins. What it does is it contributes to the ejaculate which contributes to fertility and that's about it. It doesn't regulate any other hormones, if you lose it, it's not like other parts of the body are affected because of the loss of function and that's a little bit of a letdown because it does cause a lot of issues.
Prostate specific antigen, you hear about it a lot. A misconception with PSA is that cancer produces PSA. That's actually wrong. PSA is normal. PSA is normally produced by the prostate gland. The reason why it goes up or can go up with prostate cancer is the cancer starts to invade those tissues and disrupt the architecture. It leaks out that PSA and it elevates. It's not cancer actually making PSA. That gets a little bit complicated when you start to think about you remove the prostate and PSA comes back and that's because you made some of those prostate cancer cells may have gone somewhere else and they're still making it.
It's a protease so that means it's an enzyme that affects proteins. It breaks down proteins. What does it do? We don't really know. Again, that's a letdown. It's a big thing with prostate cancer but we don't know what it does. One rule we think it does is that it liquefies the ejaculates. When it comes out, it makes it more fluid so it can get where it needs to go. Does this have an impact in fertility? Again we don't know.
We don't know, but again what we do know is that PSA, at least right now is the best test we have for screening for prostate cancer or case detection. What I mean by that is screening is just taking the average man off the street and doing a blood test and seeing if it's elevated. Case detection is somebody coming in with symptoms saying that, “Something is not right. I'm not peeing well. I've got pain, et cetera.” Now we have a suspicion and we're trying to detect if something is there so that's the difference.
I put this up here. This isn't actually my kid. It's just somebody I found on the internet. This is usually the expression I get back when I tell somebody what a prostate does and they say, “That's it?” The problem is, is this. The prostate causes a lot of issues in men so if it doesn't do a whole lot, then what does it do? What causes problems? It causes prostatitis and if anyone in the room has ever had it, it feels like you're peeing fire, it can. You can get pain. That be related to infection or just inflammation of the prostate.
This is a benign enlargement. Most benign tumor in men. This is where the prostate enlarges obstructs the passage way and you can't pee. Then of course we have prostate cancer. It causes a lot of trouble. Again, going back to this, the reason it causes trouble is not because it's a change in function, it's because of its anatomical location in the body. It's associated with the urinary system so bacteria can make its way into the prostate, you can get prostatitis or it can be irritated by prosthesis that causes inflammation or this can enlarge and obstruct the tube and you can't pee or you can get prostate cancer and you can treat that prostate cancer and because of its location, you can run into trouble with incontinence, with erectile dysfunction, with radiation cystitis or inflammation due to radiation damage here and here.
This is just showing you what the BPH looks like or the enlarged prostate. You can see, it just obstructs this area. The impact of health, this is a distinction for prostate cancer versus other cancer is that unlike colon, unlike lung, pancreatic or liver where you're removing an organ that plays an important role in the body in terms of function, the impact on health typically with prostate cancer is not related to the loss of the function of the gland but it's related to where it is.
It's the anatomy or it's the side effect of the medications. We're going to talk a little bit about that. For the men in the room who's been on hormone therapy, the so-called androgen deprivation therapy, you understand the side effects of those medications. You're not running into trouble because you've lost a prostate, it's the treatment itself. We can't avoid that unfortunately. When we talk about alterations of normal anatomy, these are the things that some in the room may have experienced.
Erectile dysfunction very common, unfortunately after surgery or radiation. Urethral stricture disease. Fortunately less common but it does happen. You can get where they join the bladder back to the drainage tube, the urethra. You can get that area narrowing down or you can get it further up into the drainage tube and then you can't pee very well. You can get that leakage, the incontinence. Also very common. Fortunately, and I'm speaking as surgeon who specializes in continence, most men won't need treatment for this.
By about a year or so, most men will have recovered incontinence to the point where they're happy, they don't want to have a surgery. Some will be dry, others will just be content. Only about 5 to 8% of men ultimately will go on to have surgery but that's 5 to 8% of all men treated with surgery or radiation for prostate cancer. It's not low. The obvious one is infertility. As soon as you remove these organs, your fertility fortunately it's usually an age where it isn't an issue but this can be a problem especially for younger men and we do diagnose. The youngest men I've seen with prostate cancer is 32. Obviously, some genetic component.
Then radiation damage to the bladder and the bowel. This is just again harping on the anatomy there. I want to take you in a little bit deeper to understand why the anatomy is a problem and why it's a challenge. Memorize this picture in your mind where we're at. Now, I'm going to show you why incontinence and erectile dysfunction is so common. Now, granted a harder way to look at it but the bladder sitting here, we're basically looking down into the pelvis, if I was to stand here and put a camera down this way. We're looking down. The rectum is sitting back here, prostate is sitting here. Penis is going to be out this way and this is your bladder.
This yellow part right here so you can see the rectum coming down and intestine here, you can see this yellow. This is all the nerves feeding down. This is the nerves of the pelvis. You could see how intimately associated these nerves are with all the structures. These nerves are the nerves that eventually travel to the penis and cause erections. These nerves are the nerves that travel to the pelvic floor and help with continence. We've got to somehow get in here, remove this and if we can preserve this and we can't always.
The problem is from a cancer perspective, the number one goal is to get the cancer out. Its life over limb so to speak. If we have to sacrifice incontinence or if we have to sacrifice erectile dysfunction as a surgeon, as a physician, that's what I'm going to recommend. I don't want to go in and do a surgery that is not going to cure you of your cancer. We want to get you to a cure and we do our best to preserve but we don't compromise cancer care and that's where my job comes in after because once they get you through the cancer, then we're looking at let's get you back to your life again.
I'm going to go a little bit deeper. Now, we're looking from behind. Here's the rectum here, here's your prostate. Now, we're looking as if you're laying down and we cut you in half. This is called the neurovascular bundle. This is the nerves and the blood vessels. Look how close they sit to the prostate? You can imagine trying to get a margin of tissue to make sure we get all the cancer and trying to preserve this. If we go even deeper, rectum, prostate, here's where the nerves sit right here.
Again, this is understanding hopefully for you to understand why it's difficult, why this is common. It's not easy to avoid this with perfect surgery where we try to preserve this layer here even with perfect surgery, we still have a high incidences of erectile dysfunction and incontinence. That's because you've got small nerves. We can't even see them running in this area. Very, very difficult to preserve.
This is what makes it challenging. This is why you run into trouble. This is the challenge and the duty we have as surgeons that do research going forward to try to always advance how we're treating these diseases. We're the one job that's working towards getting rid of our career, our specialty if you think about it. We're striving towards the day that we're not needed and that's what we do with research. We're trying to improve health that way.
I'm going to shift gears a little bit. We're going to talk about how the medications and the treatment can affect you not with the anatomy but with changes to the endocrine system now or the hormone system. This is going to lead into the overall men's health. When I talk about hypogonadism, I'm talking basically about low testosterone and I'm going to talk about why testotesrone is important in your body and I see lots of men in my clinic, in the andrology clinic whether it's been treatment for prostate cancer or as we're going to talk about men, women have their menopause and so do we and we're going to talk about how testosterone decreases with time.
The hypogonadism or low testosterone can be related to a primary cause. We talk about primary, we're talking about the testicles which make 90% of your testosterone aren't making it anymore. In men as we age, this phenomenon now, this late onset hypogonadism, this is the term as of today, it changes probably every week but you may know it as male menopause or andropause or androgen defiance in the aging male are all interchangeable terms.
It's known phenomenon now that as we age, testosterone can get lower and I'm going to talk about the types of things that happen when your testosterone is low. There's many other causes though as well. There's a reason why you've actually get mumps, for instance. Young kids getting mumps, you can get permanent testicular damage. They don't have to testosterone. That can feed into fertility and other issues.
Secondary is when we talk about the signals from the brain coming down and the brain has to signal the testicles to make the testosterone. Is there an issue and this maybe the biggest term of the night but the hypothalamic-pituitary-gonadal axis. Doctors use big terms not because it try to make them sound smart, it just makes it more black and white versus saying, I think it's somewhere here. We give it very specific terms. This is just your hypothalamus part of the brain, pituitary part of the brain and the gonad. When you break it down, smoke and mirrors. We're not so smart. We're just using big words.
The impact. I'm not going to ask people in the room but I know there's men in the room who are on hormone therapy. You may be able to relate to this. What happens when we take testosterone away? You can get bone issues, osteoporosis. You can get hot flashes, not just women, men can get it, erectile dysfunction. That can be related to hormone therapy or the actual surgery or radiation. Cognitive decline. Some of you might feel a little foggy in the brain. You might be getting more forgetful. Not necessarily age. It's not necessarily other causes.
Sometimes if the testosterone is low, you're on androgen deprivation therapy. It can affect the mind. Think about what the body builders are trying to do, pump up the muscles. It doesn't work by the way. It doesn't work well. If you want breasts, you can do that. I'll talk about that in a second. It is important for the male physique, for lack of a better term. The muscle mass, keeping the pounds off, the obesity. When you take testosterone off, there is documented loss of muscle and an increase in fat.
It does feed into diabetes, low testosterone. This is going to factor into overall men's health. Metabolic syndrome. Metabolic syndrome referring to diabetes, elevated cholesterol, triglycerides, abdominal, waist circumference, obesity, gynecomastia. Fancy term for men grow breast. It can happen on hormone therapy. This is a big one, cardiovascular morbidity/mortality. We didn't know this before and we know this has been very strongly established that low testosterone can increase your risk of cardiac morbidity so heart attacks and death related to cardiovascular disease. Probably due to direct effects but also a combination off this. Anemia, low blood counts so a lot of effects.
You can hear me okay in the back? I want to show you this access. This is the brain sitting up here. Hypothalamus, part of the brain, pituitary part of the brain. The brain sends signals down telling the pituitary to send signals, FSH and LH down to the tentacles. FSH says make more sperm. LH says make more testosterone. Then of course the body being brilliantly designed or evolved depending on your beliefs comes back and says, “Stop making it. We have enough.” Then when it runs low, the feedback goes away and starts making it again. Very simple system, on/off switch.
Secondary hypogonadism is a problem up here. This is where the shots come in if you're getting hormone therapy. What's happening is depending on the type of shot, they're either giving you a shot that stimulates this which is counterintuitive, if you stimulate that, why does it cause low testosterone? The reason why is the body needs to secrete these in pulsatile fashion. It doesn't secrete all the time. It comes and goes, comes and goes. When you over stimulate, it burns out. That's why for some shots, you need to go on the other medication that blocks the receptors, the Casodex if anyone has ever been on that or Bicalutamide because initially the shot will actually increase testosterone levels before it decreases it.
There's another form of a shot that directly inhibits there and then you don't get the so-called testosterone flare. When we do hormone therapy, we're essentially inducing a secondary hypogonadism or low testosterone state. Primary of course relates to a problem here. The testicles just aren't making it. One of the issues that I saw more and more coming out to Toronto here and just because the clinic that I was working focuses more on low testosterone is that men that are on hormone therapy, when the hormone therapy stops, generally this recovers, but not always and that's what I'm seeing more of that sometimes with the hormone therapy, for whatever reason this doesn't completely recover and you can have persistently low testosterone after treatment.
I'm older than I look so I know these movies. Testosterone has many great effects on the body. That's obviously the good. It plays a role in some benign disease so some bad disease and then of course it does play a role in prostate cancer as well. Just touching on that. The good, numerous. If you didn't have testosterone when you were developing in your mother's womb, you would be born looking like a female.
Your sexual organs wouldn't develop and in fact, it's a little bit more complicated, you'd have some abnormal anatomy likely coming out. You need it. This is part of the process that makes you male. I mean, I remember back to junior, et cetera. We talked about when does the voice start to drop, when do you start to get hair on the chest, et cetera? That's related to testosterone surges again. You need it for the development of the sperm development and development of secondary sexual characteristics. It gives them the low voice, the beards et cetera.
Now, what happens when you're an adult? This is now starting to focus now on overall men's health. Testosterone has a lot of effects in the body as I alluded to if you take it away. Sex drive, libido is largely dependent on testosterone. Overall general well-being, vitality. Just feeling good about yourself, not being depressed can be related to testosterone. Aids cognition in memory. It does factor into the brain. If you want to grow a beard, you need testosterone. Endurance, energy, muscle mass, trying to get rid of the extra pounds there. Fertility, red blood cells, carrying oxygen to all the parts of the body. Bone density here.
Then what's not shown here though is that cardiovascular health, very important. A lot of important roles in the body. Of course, it can feed into bad situations though. We talk about an enlarge prostate now. Testosterone, and this is the talk that I go through in my clinic, I say, testosterone actually isn't that powerful in the body. Testosterone actually has to be converted generally especially in the prostate into a more potent form of testosterone called DHT.
It's done by an enzyme and in that DHT, affects the prostate. Now, when we have a normal prostate, we know that the prostate cells are growing and dying in a balance and there's numerous things that factor in there. Androgens, testosterone, DHT, being one of them but there's numerous other signaling mechanisms and in fact these ones maybe more important when it comes to enlargement than the actual testosterone but when you do get an enlarged prostate, it's because there's an imbalance now. Too much growth and not enough cell death.
We take advantage of this. I'm bringing up these two medications because I'm going back to these when I talk about ways of preventing prostate cancer potentially or preventing progression of prostate cancer. We're going to talk about a few studies. I know those are boring but I'm just going to highlight the points. We take advantage of this mechanism and say, “If we block this enzyme, then maybe the prostate won't grow,” and in fact, it doesn't. It stops it from growing and it actually can shrink up to 25%.
It can decrease your risk of acquiring surgery if you have a prostate, enlarged prostate by up to 50%. What do you think the side effect of these medications are? A lot of sexual dysfunction. Loss of libido, erectile dysfunction and again all those other testosterone things we talked about. Then of course the androgens testosterone are implicated in prostate cancer. We know that because we treat with hormone therapy occasionally. This could be a talk that could last months if we talk about testosterone, prostate cancer, mechanisms of prostate cancer. I just wanted to raise a few points. Some of them which you probably already know.
Androgens influence the development, the maturation of the prostate gland. We know that. Exposure of the prostate to testosterone or androgens at key times. We don't really know when those key times are. It plays a role in the development of prostate cancer. It definitely does. It's not the only one. Cancer is multi-factorial but it does play a role, we know that and we're learning more about it. They also play a role in the maintenance of established prostate cancers.
We know that they do play some role in prostate cancer staying there and perhaps even progressing. The other thing I wanted to point though is that testosterone replacement, if you come see me in the office, no history of prostate cancer and your testosterone is low, just say from aging and we talked about putting you on testosterone replacement. It doesn't appear to increase your risk of prostate cancer. We can get the testosterone to the normal level. Now that seems a little counterintuitive. If I say prostate cancer can cause it and maintain it, then maybe having a low testosterone prevents it. Again, that speaks to the complexity of the issue. It's not necessarily testosterone all the time, it's testosterone at key points and whether it surges, whether it changes, whether the receptors for the testosterone change in some dramatic way. These are things that are being explored but still being researched.
The reason I bring this up, testosterone as I talk about if we can inhibit this enzyme, maybe we can prevent prostate cancer then. Should we be putting all men on these medications? This leads me into talking about chemo prevention. This is the description of using natural, green teas, blueberries, antioxidants, whatever you pick, synthetic, biological agents to reverse, suppress or event prevent the development of prostate cancer. We're starting to learn more about this.
Does inhibiting these enzyme with this medication, medication that is approved for benign prostate disease, can that prevent prostate cancer? We have extremely good trials done and what I mean by that is they were large, randomized controlled. What that means is, is we had 18,000 men that came in and they said, “We're going to put you in one group or the other. You're not going to know. We're not going to know. You're not going to know whether you're getting placebo or the actual drug.” That's the most accurate way to determine whether there's a cause-effect or difference because it gets rid of confounding variables that way.
The bottom line from this trial is that, “Yeah. It did reduce the risk of prostate cancer.” 30% relative risk reduction. Relative means that it was about 24% of men in the placebo group overtime were found to have prostate cancer and around 18, 17% had prostate cancer in the treatment group. That translates into a 7% overall reduction. Here's the kicker. There is about 14% increase in the risk of high grade cancer in the treatment group. We don't know. It doesn't make sense.
We can't think of a physiologic or a mechanistic reason why Finasteride, this drug would increase your risk of high grade cancers. An actual fact, there's been a lot of debate. A lot of this most urologist don't believe this. There's been a lot of explanations for it however the FDA that approves medications has … And I'll show you their statement, because of these findings has basically said, “We're not going to approve this for prevention.” The other reason why is there was no difference in survival.
When we looked long-term, maybe there wasn't as many prostate cancers but it didn't really affect the long-term outcome. We put all men on a medication that's going to take away their sex drive, their libido, maybe increase their cardiovascular risk, et cetera to decrease the risk but maybe not affect survival and maybe increase the risk of high grade disease.
Continue with Part 2 below.
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