Why 1.5 is the New 4.0 for the PCP?

Why 1.5 is the New 4.0 for the PCP?

I was asked to talk about family practice and prostate cancer screening. We’ve done this for a couple of years, and I’ve evolved. When I first came up here a couple of years ago I was asked to take a critical look at the United States Preventative Service Task Force, which I did. Whether we agree or disagree with the Task Force recommendations, they can’t be implemented; that’s the reality.

The other reality is there’s a lot of cancer out there that unfortunately we’re going to miss unless we do something about it. I want to start by giving my conclusion. You see in the title, why is 1.5 the new 4.0? What I hope today is at the end of this lecture that you think about this and you realize that you should be telling your colleagues in primary care 1.5. When they have a question to you about prostate disease, say 1.5. When they ask what to do, say 1.5, because we need to make it simple, and 1.5 is simple. I’m going to explain why now.

We just heard a nice lecture on the recommendations and the guidelines; I don’t need to go over this. Some guidelines say to talk about it, some say don’t. Some say don’t do it; they all talk about shared decision-making. So, what is shared decision-making’s three tenets? Provision of information, elicitation of patients’ perspective, and guiding final decision making. If you do a good job it takes 23 minutes. 23 minutes per patient, per adequate conversation.

Now, the bad news, and Dave harassed me about this yesterday at the meeting – you probably thought I was going to forget about this – he said I said PSA was a horrible test. I actually used worse words than that, and I was corrected. Gerald said, Matt, it’s not that, it’s we use it improperly, which makes it bad, and that’s true. So, I’m going to change that. I’m going to yield that point to them. It is not a great test; it’s used poorly.

The reason for that is PSA’s prostate-specific, I don’t need to tell you that. It goes up, it goes down, with various disease states. Depending on your lab it can change within lab or other labs. What happens when we have a limited test is we end up with a dilemma.

We end up with a lot of false positive numbers. We end up biopsying people who don’t need it; it’s not going to have any end–it’s not going to give them a benefit in their life, in fact, if anything, it’s going to make their life worse. It’s going to be inconvenient. It’s going to be painful. It’s going to give them an infection.

The problem is if we give up on it like the Task Force recommendations are telling us, then we miss the opportunity to get people who we could otherwise help. Dave already mentioned this–I’ve shown this at every meeting for the last three years–this is a problem for primary care. You are the leaders in the field. You need to help us. But primary care are doing the overwhelming majority of PSAs.

Now, the reality of it is I do a lot during the day, and you guys need to know that. When I see a patient–this is my annual check-up, this is every day–we go through their medical history, their physical, we have a myriad of problems. They’re coming in not only for their prostate, which I’m loving it if that’s what they come in for, and that’s all they come in for.

They’re here for their hypertension, their diabetes, their hypolipidemia, their ingrown toenail, their dog died and they’re grieving, their mother needs to go to a nursing home and they have a hemorrhoid. And oh, by the way, they have ED. That’s my day. That is my day, and I have to deal with a lot of issues.

I look at PSA and me, as a specialty, as primary care, we look at the PSA and say, what are you guys talking about? It’s word soup out there. What do you mean by velocity or prostate density, or what is 4.0? Why was that okay once upon a time a few years ago, but now it’s not okay? What happens with age-related changes? I get confused. As a result of that, as a result of the confusion, I don’t relay this information to my patients very well.

This is an article that just came out this year. There was another article that just came out last night that a friend of mine, Jed Folk, shared with me. It’s showing that shared decision-making is failing. I told you that three years ago when we were here. I told you that shared decision-making doesn’t work, because I don’t have that kind of time.

But, when we look at that, only 10% of patients received all the tenets of shared decision-making. 55% got a PSA, which meant 45% didn’t. 22% understood that some doctors recommend and some don’t–this is patients, by the way–and 14% were informed that we’re not sure about PSA. So, we can put a big F on this. This is a failure of shared decision-making.

Now, I tried to understand this a little better, and I did a survey this year at the American Academy of Family Practice, which is just down the way in Denver, and actually I just had this accepted, so I’m presenting this at the AUA in San Diego. What I did was, I looked at 153 doctors that came by and I gave them a survey. You can see the split there, a few more males than females, and they were split between employed and not-employed. I asked them a bunch of questions.

What describes your practice in terms of prostate cancer screening? 23% said they don’t do it at all. 39% start at 45, 31% start at 55. But, then I asked them what guideline do you follow, and if you look at the numbers and add them up, 72% follow the United States Preventive Service Task Force; either that or the AFP guidelines, which go along with that, or a combination of them, which they don’t screen.

When you look at this slide, the prior slide and this one right here, what it shows is confusion. They don’t know what’s going on. I asked them, for those of you who don’t recommend PSA testing, what guideline do you follow? 77% knew the right answer. When I asked them, for those of you who said you started screening at 55-69 years of age, what was the guideline? Only 10% knew that those were the AUA guidelines.

So, what are we seeing? Massive confusion. I asked them what age they start screening; 48. I said, what’s a suspicious PSA? And this really got me nervous. Under the age of 59 or younger, the range was 1.5 to 10, and it was a pretty even bell curve with an average of 4.99. I had one guy who said to me, well, at 8 or 9, I repeated a couple of times, and then when it’s above 10 I refer.

You guys cringe at this. I know you cringe at this. You look at the data for the guy who’s over 60, 1.5 to 12. I’m like, ugh, that’s not right. But, where are they getting the education? The bottom line is, they’re not. We’ve made this too complex.

With regard to velocity, forget it. 52 people answered that question; 10 said 0.5, which obviously not correct, and then five said maybe one a year, and the rest of them were all over the place. No consistency at all with those answers.

Now, they did note that some cancers are more aggressive than others, and they also said if we had a way of defining or differentiating an aggressive cancer from a non-aggressive cancer, I’d take it. I’d use it. They understand that aggressive cancers are bad. They understand that we want to take care of those patients; what they don’t want to do is make unnecessary patients.

So, when you look at the problem with shared decision-making and you look at the problem with these doctors, how is this panning out? Well, this is from Jemal’s article in JAMA just came out a few months ago. It shows the data here, that we peaked in 2008 in regards to the incidence of prostate cancer. Then a precipitous drop in 2012. We see a peak in the incidence of 540 in 2008; in 2012 it was 416 per 100,000 patients. If we do the math, what we see here is a drop in the absolute number of prostate cancers that are diagnosed.

In 2011, 213,000, and in 2012, 180,000. So, you get the people, the proponents of not screening, saying, yes, we did the right thing. We get you in the audience who deal with prostate cancer saying, wait a minute, there’s 33,000 guys out there with prostate cancer and we’re not taking care of them. Yes, the reality is, a couple of those patients will have indolent, low-grade tumors; it won’t matter, but not all of them, not all of them.

He mentioned in the summary, authors noted the incidence change in the drop, noted the rate drop, and they said further follow-up, longer follow-up is needed, but what if we’re wrong? We can’t afford to be wrong, so we have these people saying–making all these recommendations, but the reality is we cannot afford to be wrong. I’m going to take a line from Lenny Gomella’s article years ago. He saw this happening, and he said, dare we go back to the pre-PSA era where all we do is diagnose men with their metastatic.

Now, you’ve seen this slide three times; this is the thrid. What it shows here is that by using PSA we drop the incidence of metastatic disease. We drop the incidence–we drop mortality. You see there, mortality dropped 20%, and they looked at that, and they said in the article, well, it’s not such a big deal; 20%, a tumor that’s not going to kill you; is it worth all the effort? That was his argument. He put a value on life. Now, I disagree with that, but I disagree with the metastatic issue, too, because we reduced metastatic disease 50%.

Now, part of the problem is what you guys do. Over the next couple days, you’re going to hear some tremendous lectures on what we can do to keep the patient with metastatic prostate cancer alive. You guys have a done a phenomenal job, so much that when I’m in my office and a patient says I have metastatic prostate cancer, I put my arm on their shoulder, I say, you know what? The likelihood of this killing you is not very high. We’ve got great stuff to you keep you alive. You guys have done fabulous with that.

But, I’m going to ask you a question, and I’d love to ask Welch this thing; I would rather be alive and healthy than alive with metastatic disease and having to deal with all the side effects. So, we have to point that out. The drugs, and the meds, and the chemos, and the radiation we have are phenomenal, but they all come with side effects.

So, we end up with this issue. What do we do? We’re not doing shared decision-making well. We’re confused about this. The incidence is going down, which means that we’re going to be seeing metastatic disease up the road, so how do we do this? Can we simplify this? If we simplify this in primary care for your primary care colleagues, this is what you need to do. You need to decrease the needless evaluations, because that’s what they want to hear.

They don’t want to make unnecessary patients. They don’t want to do 23 minutes of shared decision-making in a disease that they’re not comfortable with. It’s like asking you guys to read an EKG; you don’t do that. I don’t deal with prostate cancer in a primary care setting, other than the fact that I screen. So, the question is, is it possible to just have one value, and why is 1.5 the only value I need to know? What is my case there?

Well, it’s easy, let’s go back to the data. You’ve already seen a little bit of this. Prostate cancer doesn’t happen at low levels of PSA, it happens at higher levels, at 1.5. First there’s a paper on the curve, there’s a paper from Aus, the second is from Vickers, which pointed out a single PSA measurement of greater than 1.6 in men aged 45-49 is associated with a greater risk of dying of prostate cancer. So, there’s something about 1.5.

This is a paper from Europe, an old paper, that basically shows your pre-test probability of prostate cancer and what happens after you have a PSA. What do you see here? At a PSA of 0.5 and 0.1, your chance of cancer is low. It doesn’t go up until we get past 1.0. So, there’s something resonating here. There’s a number that’s making sense. Dave already pointed out in his paper at the Henry Ford System, a PSA of 1.5 or less than 1.5, you’re pretty safe. It goes up after 1.5, and even higher in African-American males.

So, what you’re thinking right now is wait a minute–and this is what my primary care colleagues say–wait a minute; 1.5 is really common. It’s really common, Matt; that means we’re going to be screening everybody. That’s not the case. I asked my friends about a reference lab to look at data, to look at the all the PSAs that were done in the last 12 months in men aged 40-75, and we found 217,000 patients who had a PSA of 1.0.

I kept it to 1.0 PSA because if it was 2.0 or 3.0 we were probably looking for something. 1.0 was screening. Then I had them take out the extreme levels, which only dropped 1,400 patients off, so we had over 215,000 patients, and this is the curve. What do we see? 27%–only 27%–of men aged 40-75 had a PSA above 1.5, which meant 73% didn’t.

73% of men were safe, in terms of we didn’t need to do anymore. So, really we can look at an algorithm that Dave and I have published this year which looks at–the male comes to the office, gets screened, if the PSA is less than 1.5 we’re done; if the PSA is greater than 1.5, maybe we consider doing something. It’s not even maybe, we do consider doing something.

We get a further investigation by the PCP or by the urologist. We use biomarkers, we make a decision. We use this intelligently, which means, just as Dave said, we use the PSA as a vital sign. I don’t need to go have a discussion on your cholesterol level until I get your cholesterol level. I don’t talk to you about your blood pressure until I get this.

I shouldn’t have to talk to you about your prostate level until I have an abnormal level, and the reality is, I’m only going to have to talk to 26, 27-30% of the men. Then we can evaluate them with a bio marker. This allows us to make these intelligent and personalized decisions that have been so recommended with shared decision-making. I can focus on things that are smart; age, health, quality measures. I use the PSA wisely.

I take a test that’s not so good, but I make it good by using it wisely, which means I have satisfied what is happening. Instead of criticizing the PSA, I’m just saying, let’s have thoughtful evaluation before we do intervention, and primary care love this. We have analogies in primary care for this. My guess is you all have gone to a doctor at some point. Guess what, we check a blood sugar, and if your blood sugar is high I get an A1C. I don’t put you on insulin. I evaluate it.

If you come in and get an EKG, I don’t set up cardiac surgery for you. I evaluate the normal EKG. So, why should prostate, and prostate cancer, and prostate surgery be any different? So, rounding the horn here, I want to help you make your colleagues in primary care happy. We’re dealing with so much. We need basic information. We want to do what’s best for the patient. Is the information about prostate screening based on evidence and beyond dispute? Because that’s what I need.

Can the patient be presented with a clear framework? Because that’s what I need; is the process appropriate for primary care, because that’s what I need. Don’t assume I have a lot of time to do this, and don’t assume I have the education that allows me to do this in a good fashion. Unfortunately, the reality is, we don’t have that information. We don’t have that clear framework, but we have 1.5, and 1.5 is simple and appropriate.

This is my call to arms. You guys are the specialists in the field; I’m looking to you for leadership. You have to take the lead in this. You can sit and argue the guidelines, and argue everything else, but I’m in this abyss of not knowing what to do. 1.5 may not be how you do it, because you’re going to look at different factors. You may look at age, you may look at risk factors, you may do a lot of things. But, from a primary care standpoint, I need something simple.

Because as we talk about patients taking care of their disease, we’re going to end up taking care of these patients with metastatic disease because we’re not going to be able to get the patients early on. That’s the key thing. I heard a very wise statement last night at dinner, which is the death of PSA is actually the death of active surveillance, because we’re not going to have active surveillance anymore. We’re going to find these patients with metastatic disease. It really hit home for me; it was a brilliant, brilliant comment.

You have to help us with this. You have to make it simple for us. We obviously know screening is important, it has to be done correctly. The PSA is a first-line test. Bio markers, we’re going to hear a lot about that at the meeting, are very, very good. I think given the information we have, given the successes and failures we’ve had up to this point, the reality is we can start that conversation at 1.5.