Now these are the stages. Prostate cancer
Now these are the stages, the staging distribution that you will find by and large. I think this is slightly out of date by this time in the sense that the A-lesions, because of the A-3 increase in PSA determinations are going be higher, but you can see that about 60% of patients who localized, about a quarter of the patients are going to have metastatic disease. And this is a fairly representative distribution of a series of patients with this. Except, as I said, for probably an increase in the A’s and a decrease in the B’s.
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I already alluded to this and that is the problem of early diagnosis. There are several problems posed by early diagnosis which really basically equates with someone who has a PSA level that’s elevated, gets worked up and is found to have the disease. The issues of early diagnosis are: first of all, does it really improve survival? This has been argued about. As I said, the data presented at this year suggests that there is a mortality reduction with PSA screening, but not surprisingly that study was jumped on as soon as it was out of the box and attacked by many statisticians as being seriously flawed. I think that usually until you have a second study that reproduces positive data it’s hard to be certain that a single trial is definitive. So I think there are still issues about whether these lesions that are found in PSA elevation only will translate into improved survival with treatment. Therefore we have still this year one of the most accurate measurements for early detection, given the specificity issues with PSA. Can we distinguish clinically significant disease from that which is not significant? And finally, what is the most effective form of therapy for these early stage patients? Particularly those found by PSA? One of the things that turns out to be very useful in assessing what you are dealing with is the use of tumor grading. And there are multiple ways you can grade these tumors. You can look at flow psychometry, you can get flow levels, you can look at nuclear morphology but the architectural formation, the so-called Gleason system I think has been the most useful to date in establishing the grade of the tumors. This cartoon shows you what the Gleason system is all about. Basically what we have in the Gleason system. You can see this is a Gleason grade 1, this is a Gleason grade 5. These are well differentiated that look much like normal prostatic tissue. You can see various degrees of un-differentiation. So what they do is they look at two areas of the tumor and they grade the dominant area and the less dominant area because there are often discordances and they give each of those two areas of Gleason scores. So you can have as low as a 2 or as high as a 10, in terms of grade. We know that patients who have a low Gleason score – and I’m talking particularly about these PSA level determination patients, or patients with very small amounts of tumor involving prostatic chips – if you’ve got a low PSA level under 10, a low Gleason score and a small volume tumor, the rate of progression over the next ten years is very very low. It is in the low single digits. So if you are looking at a 75-year-old man with those characteristics you might proceed one way, whereas if you are looking at a 50-year-old man with a Gleason grade of 6 and A-2 tumor, that patient clearly is at risk before a normal life span passes needs therapy. So the Gleason grade is a very useful thing in assessing when to walk or when to run to the nearest exit. I think that if you combine the Gleason score with the PSA levels over or under 10 and measure tumor volume, gives you a fairly useful construct for thinking about management.
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Again, before we had the Gleason score and the PSA level, we just looked at volume of disease. You can see that these are the patients detected by TURP chips, small amounts of tumor involved. Much better prognosis than more extensive disease. These are all people with no palpable disease. This is multiple chips involved. Much higher rate of progression.
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So if you have prostate cancer, these are the choices that you have available to you. You have observations, surgical radical prostatectomy, external radiation, radiation implants, androgen depletion, some combinations of the above. As I’ve already said, patients who have favorable characteristics might be good candidates for observation only. With regard to the other therapies, we have some data, although it tends not to be randomized and prospected. This is pooled data from series that have either done prostatectomy or radiation therapy. You can see these are from B-1, that is nodules that are palpable under 1.5 cm, for survival up to 10 years looks the same with either radiation or a radical prostatectomy. Again, this is some surgical data looking at B-1’s B-2’s and you can see that with surgery, you are going to have about half of the patients living and cancer free 10 years after therapy. And again, the radiation data looks pretty similar to this. You are talking about an 80-90% five year, and about 50% ten years. That is significant because it means there is going to be some drop off in survival even after the fifth year from this disease. Some of it is due to co-morbidities as these are often older patients but there is some continuing mortality from the disease as time goes by.
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