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Old 06-17-2009, 09:08 PM   #1
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Active Surveillance for Prostate Cancer: Age of the Patient

We have a closely related thread now ongoing - "Effectively Preserving Curative Options- Active Surveillance for Prostate Cancer" - in which the role that the patient's age makes has come up in discussing the decision whether to pursue Active Surveillance (AS) for prostate cancer instead of immediate treatment. I hope that discussion continues, but because age is such an important factor in the thinking of the major Active Surveillance programs in the US and world, and because their approaches differ substantially, I thought it deserved a separate thread.

Here's the essence of what I know about it: while most AS programs strongly prefer older patients, at least one is comfortable with patients who are at least 55 years old, and at least one will take truly low-risk patients of any age, and that program is led by a doctor who is arguably the leading guru for AS. He also has a well thought out rationale for his position.

Most of the AS programs prefer that their patients be older, with the later 60s and older considered ideal. On the flip side, for older men and those with significant, likely life-shortening other health conditions, the major AS programs are willing to go with higher-risk case characteristics. This is all kind of logical - the risk of treatment versus benefit of treatment balance is tilted toward higher risk and lower benefit for older patients with low-risk cancer. Obviously, if you are 70 years old and have a prostate cancer that is very unlikely to become a serious threat or burden on your life for at least 30 years, but with a risk of side effects of treatment that can be substantially higher and more intrusive and burdensome for many men as they become elderly, the net likely value of getting treated declines. Similarly, if a man has, for example, diabetes that is difficult to control and serious heart problems, especially if he is elderly, a low-risk case of prostate cancer is not likely to be a significant threat to his life or well-being, and possible complications from prostate cancer surgery (such as blood clots) or other treatment may seriously aggravate other health conditions . There is strong agreement among the AS programs that AS is a highly attractive option for such men.

But the real issue, still controversial and without an abundance of information yet, is what to do about younger men who have case characteristics that all suggest very low risk prostate cancer. Now that many men are being screened with PSA and DRE exams at a fairly young age, it is increasingly likely that men will be diagnosed with cancers that would never have affected them in their lifetimes and would not have been noticed except for the screening. I'm expecting that many more younger men will be screened because the prestigious and influential American Urological Association just revised its guideline to recommend that all men be screened by age 40, with even earlier screening for men at high risk, such as by having a couple or more "first-degree" relatives (like fathers, brothers) who were diagnosed with prostate cancer, especially in their 50s or earlier. I'm expecting that an increasing number of men with very low risk prostate cancer will be diagnosed in their early fifties, forties or even thirties.

I got some insight into this issue when I attended the IMPaCT Conference ("Innovative Minds In Prostate Cancer Today"), held in Atlanta in September 2007. Attendees were invited from among the researchers whose research projects over the past ten years had been supported by funds from the Congressionally Directed Medical Research Program (US tax dollars) managed by the Department of Defense for the Government, from among survivor representatives (like me) who had helped evaluate proposals for at least two years, and from prominent prostate cancer scientists and physicians. One panel discussion included three representatives from major AS programs, Dr. Laurence Klotz from the U. of Toronto (Sunnybrook), Dr. Fritz Schröder from the Erasmus University Medical Center (Netherlands), and Dr. Christopher Warlick, recently from the Johns Hopkins program, but having moved to the University of Minnesota. After each commented on their AS program, I got to ask what minimum age they looked for in their patients, mentioning that I had read that Dr. Schröder's program was comfortable with men as young as age 55. The question stirred a lively discussion among the panelists.

I thought that the Johns Hopkins program under Dr. Carter focused on patients in their mid-60s or older, but Dr. Warlick said that 44% of their program participants were younger than age 65, with the age ranging from 46 to 82, with an average age (median: half older, half younger) of 66. My impression is that most of the major AS programs have preferences for age that are similar to the Johns Hopkins program, targeting men in their 60s, especially latter 60s, and older.

Dr. Schröder confirmed that his program had an age minimum of 55. He also said that about 500 patients were now in his AS program.

However, Dr. Laurence Klotz, from the University of Toronto, Sunnybrook, really caught the audience's attention when he stated that he was comfortable with prostate cancer patients of any age for AS, but adding that the Toronto program takes an even more detailed look at risk factors and does even more observant monitoring for younger men, at least at in the patient's early years in the program.

Of course I cannot speak for Dr. Klotz, but, having heard him on the panel, having listened to and studied one one of his talks, and having read some of his papers, I can give an informed estimate of what his program would do with two young example patients, both 37 years old, who would be considered to have apparently low-risk prostate cancer based on the usual key combination of PSA, stage and Gleason Score. Let's say both got early prostate screening exams because of a mild concern with family history of prostate cancer, and based on some concern because of the DREs, coupled with their PSAs which were elevated compared to norms for their ages, both were given biopsies. Both patients have a PSA of 2, have Gleason Scores of 6 (3+3) confirmed by expert pathologists (with no other concerns in the biopsies), and are Stage 2a (can be felt in the prostate, but only in half a lobe or less). Patient A has a PSA that increased from 1.8 in a baseline test, to 1.9 a year later, and 2.0 the next year. Only one of 12 cores was positive, with cancer in only 5% of the core. His free PSA reading was 20%. Patient B has a PSA that increased from .4 in a baseline test to 1.0 a year later, and to 2.0 a year later; 3 of his 12 cores were positive for cancer, with percentages of cancer of 25%, 40% and 45% in the three cores; his free PSA test value was 16%.

Careful patient selection is key to all AS programs, but especially for younger patients in the Toronto program as described by Dr. Klotz. It's clear to me that Patient A is very low risk in all key case characteristics, but that is not at all true of Patient B. Consider the PSA doubling time PSADT(velocity). Patient A has a favorable encouraging PSADT of 13.17 years - think about it: it's going to take his PSA 13.17 years to double! - (158 months), or .1 ng/mL of PSA per year. Assuming the rate stays constant, as is typical, starting from a PSA of 2.0 at age 37, he will be 50 before his PSA reaches 4.0, about 63 before it reaches 8.0, 76 before it reaches 16.0, and 89 before it reaches 32.0. (Twenty percent of patients in the Toronto program have PSADTs of 100 years or more, as I recall the figure! ) In sharp contrast, Patient B has a rapid doubling time of just 10.34 months! When he is still 37 it could have doubled to 4.0, climbed to 8.0 when he is 38, to 16 when he is still 38, to 32 when he is just 39 (60 years earlier than for Patient A), and so on. And let's not forget the biopsy cores: even though just 3 cores are positive for Patient B, none exceeding 50% cancer in any core, which are numbers that look decent for the average low-risk patient, that is not such a good picture for a very young patient. The free PSA percentages, used in the Johns Hopkins program, might also help project the courses for these patients. Patient A has a free PSA that is close to that for men with healthy prostates; in contrast, while Patient B, at 16%, is above the 15% threshold that triggers concern at Johns Hopkins, he is close to that threshold.

As I understand it, the Toronto program would probably be comfortable with Patient A as an Active Surveillance patient; in accordance with their policies, he would be given extra monitoring in the early years, compared to that given to older AS patients, to make sure his prostate cancer was behaving in a way that lined up with the early favorable clues. In sharp contrast, I believe the Toronto program would strongly recommend treatment in the near future to Patient B. In fact, unless an older patient like Patient B, with his fairly rapid PSADT, had a relatively short life expectancy, I suspect the Toronto program would recommend treatment to him, too.

Dr. Klotz makes the reasonable and generally accepted point that careful screening of men at relatively young ages, followed by efficiently done 12 core (or more biopsies), is going to pick up some small cancers that some of these men would not have noticed for their whole long lifetimes if they had not had screening. However, he also maintains the position that we now have the ability to actively surveil these cancers and provide timely, highly effective treatment if they become aggressive. The Toronto program is finding that the chance that prostate cancer will suddenly become very aggressive for truly low-risk men is extremely remote, as I understand it. The program is also finding that many men are enjoying the benefits of AS for long years. All that makes good sense to me, but I'm sure many of us hope his program will do a special report on how well younger men have fared.

While all the heads of the major AS programs are highly respected, well-known physicians and medical leaders, I've heard several expert doctors say that Dr. Klotz is arguably the leading expert in AS. For me that makes his position regarding the minimum age carry extra weight.

Jim

 
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Old 06-18-2009, 01:53 PM   #2
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

Another excellent body of work, Jim. The way I summarize this into a short sentence, in my own words, is that the individual’s clinical metrics, along with their personal, multi-dimensional circumstances of age, health, etc., all weigh into the entry and exit for AS. Here’s the one thing that gave me pause, however:

Quote:
Originally Posted by IADT3since2000 View Post
Assuming the rate [PSADT] stays constant, as is typical, starting from a PSA of 2.0 at age 37, he will be 50 before his PSA reaches 4.0, about 63 before it reaches 8.0, 76 before it reaches 16.0, and 89 before it reaches 32.0....
In the spirit of advancing the dialogue, I would put forward a comment that the critical assumption that PSADT is constant is only a good approximation within limited bounds—early stage development of PC.

I reference the report “Observations on the doubling time of prostate cancer. The use of serial prostate-specific antigen in patients with untreated disease as a measure of increasing cancer volume.” (PubMed) This report, and others, conclude that the increase of serum PSA over time is exponential (log-linear) in the vast majority of cases.

This passes the common sense test with my own general layman’s understanding of cancer cell growth: one cell divides into two, which divide into four, which divide into eight, which divide into sixteen…after a while, the tumor cell population starts getting significant. I would add for completeness that there is a strong concurrence that the growth rate of PC cells is rapid compared to normal cell lifecycle, but slow compared to other cancers…but it is not linear.

An exponential curve (or one of constant % increase) has an early stage where a simplified linear estimate can be a close approximation, but it is followed by an exponential (geometric) phase of increase. Google the phrase “exponential growth” to easily find an example of linear and exponential growth lines graphed side-by-side. The first (likely) search result, from a widely-used (albeit non-scholarly) site beginning with "W", has a good example...the board rules prohibit me from saying the name of this site. (By the way, for technical completeness it should be noted that an exponential growth curve would appear linear when plotted on log-linear scale.)

A lot of people take two PSA data points, draw a line and extrapolate linearly...especially if they are young and only have one, and then two PSA scores to go by. Again, within a limited range, this can be a reasonable approximation. However, I would also note that lots of factors may impact that data validity, not the least of which is the close proximity of the two points (1 year, for example) when extrapolating out multiple decades. Also, even a relatively small 5% error in either or both data points (due to inter- or intra-assay variation, physiologic variation, or imprecise measurements at low PSA values) could have a big impact when extrapolating over decades.

So, perhaps the assumption that a 37-year old's PSA increase remains approximately linear until he is 89 or beyond might be a stretch.

Pragmatically, with this understanding of PSADT curves, what I would like to see more written about is the exit criteria—when is the AS PC patient advised to exit the AS strategy to pursue more aggressive treatment options—for AS programs that enlist men at any age (such as the program referenced). How well has the body of knowledge progressed to confidently assess when the exponential growth inflection point has passed, before the localized PC has become systemic (spread to lymph nodes, or beyond)? It seems to me that age remains a critical factor (although still only one in the set of multi-dimensional circumstances) at least until this “exit criteria” is more precisely understood and documented. You did mention, Jim, that the Toronto program (the “any age” program) “...does even more observant monitoring for younger men.” So age is a factor, but what does “more observant monitoring” mean?

I’ll conclude with something we can probably all vociferously agree upon…there are no “blanket statements” which apply.

Thanks, again, for your excellent work gathering meaningful information, Jim.

Last edited by kcon; 06-18-2009 at 02:45 PM.

 
Old 06-18-2009, 10:15 PM   #3
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

Thanks to both of you for an erudite summary of the Canadien and other leading A.S. programs from Jim and a very well presented critique of the perils of linear extrapolation for younger men by KCon. The error potential of small deviations between assumptions and experience in any exponential extrapoplation is analagous to the effect of minute differences in the trajectory of a long range missile or the path of a comet.
However both analyses failed to address the more subjective issues which to my mind are being bypassed completely by the advocates for A.S.programs:
1. The Canadian program is being run and funded by a country committed to a single payer government run system where managing health care expenditures is an equal if not paramount objective. The costs of health care practically drive the Canadian economy.
2. Using chronolgical rather than the less objective but more valid physiological age as basis for entry and measuring points, discriminates against older men with longer life expectancies than chronologically younger men in poorer overall health and physical condition.
I question Jim's statement that its possible to predict that a low risk case won't become clinically significant for thirty years. I wonder whether anyone can make that call. As far as I know Dr. Scardino of Sloan-Kettering still uses the rule of thumb that there's a 50% probability of P.C. metastasizing when PSA reaches or exceeds 10 ng/ml.
My fundamental skepticism of scientific advocates has me looking behind the published studies promoting AS for underlying agendas i.e. economic in the Canadian example or in J.H.'s case, consistent with their well known age based patient selection bias.
Deferring treatment is a completely reasonable course for the truly older(physiologically as well as chronologically) and otherwise health compromised patient where the risk obviously outweighs the potential benefit of aggressive treatment. However for the younger healthier population it simply delays the inevitable for a few years and possibly to a time when surgery or other primary treatment will no longer be as effective or uncomplicated.
Utilizing one's curative window is in my opinion too precious an opportunity to gamble on the odds derived from studies whose conclusions could be challenged or overturned tomorrow.

Last edited by shs50; 06-18-2009 at 10:27 PM.

 
Old 06-19-2009, 09:57 AM   #4
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

Quote:
Originally Posted by shs50 View Post
2. Using chronolgical rather than the less objective but more valid physiological age as basis for entry and measuring points, discriminates against older men with longer life expectancies than chronologically younger men in poorer overall health and physical condition.
I think that on this point we are all saying essentially the same thing...
  • shs50 calls it: "physiological age" versus "chronological age" (leaving off the clinical staging, but probably meaning to also include that)
  • I phrased it this way: "the individual’s clinical metrics, along with their personal, multi-dimensional circumstances of age, health, etc"
  • Jim gave multiple hypothetical scenarios of various men, different ages, different health situations and different clinical assessment situations

A lot of this discussion is focused on the entry criteria. If you don't mind, I'd like to redirect the discussion back to my question about the exit criteria.

Restating for clarity: Some men might enter into an AS program, and never have to do anything more aggressive as they might outlive any significant problems that the PC might cause for them. However, others might enter an AS program, and then sometime later in life during the "surveillance" they find things might get worse (the exponential growth phase, perhaps), and then they might have to exit the AS program to pursue a different option, a curative option that they might have "preserved" (and may in fact have improved in it's state-of-the-art from when they first were diagnosed with PC). What is the exit criteria? shs50 alludes to one possible criteria from JH of PSA>10. Anyone with any experience/knowledge in this space?

Again, not an option for me, but simply using this discussion thread to learn more.

 
Old 06-19-2009, 01:35 PM   #5
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

Hi kcon,

One of the great things about this board is that the back-and-forth exchanges improve what each of us knows. I certainly concur in much of what you have in this post, but there is an important point to clarify: that increasing PSA pattern that I use an example, with a constant PSA doubling time (PSADT) of 13 months, actually is exponential. I'll explain below in green.

By the way, I actually ran down the same mental track you did after I had posted after 11 PM and turned in for the night. Before going to sleep, I had one of those "oh shoot, did I get it wrong" moments , as I thought about that constant, linearly increasing PSADT of 13 months, knowing that the pattern of growth for the cancer and associated PSA is exponential instead of linear. Then I realized I had it right and went to sleep. There was a time when I could have figured out the exact equation in a few minutes, but that time was many years ago. Jim


Quote:
Originally Posted by kcon View Post
.... Here’s the one thing that gave me pause, however:

In the spirit of advancing the dialogue, I would put forward a comment that the critical assumption that PSADT is constant is only a good approximation within limited bounds—early stage development of PC.

The way PSADT works is that, for the same amount of time that passes (13 months in the example), the cancer grows and its associated PSA increases at a remarkably steady exponential rate. As a convenient reference point, doctors and researchers use the time it takes the PSA to double. With that understanding - constant time interval but exponentially increasing cancer and PSA between each date, the PSADT is actually helpful throughout our prostate cancer journeys.

I reference the report “Observations on the doubling time of prostate cancer. The use of serial prostate-specific antigen in patients with untreated disease as a measure of increasing cancer volume.” (PubMed) This report, and others, conclude that the increase of serum PSA over time is exponential (log-linear) in the vast majority of cases.

Thanks for citing this interesting report by prostate cancer and PSA pioneer Dr. Stamey and his pathologist McNeal from Stanford U., and the other lead author whom I have not heard of. It's an old report but with some excellent information.

This passes the common sense test with my own general layman’s understanding of cancer cell growth: one cell divides into two, which divide into four, which divide into eight, which divide into sixteen…after a while, the tumor cell population starts getting significant. I would add ... that the growth rate of PC cells is rapid compared to normal cell lifecycle, but slow compared to other cancers…but it is not linear.

If you check the example again, you can see that, while the PSADT is 13 months, the amount of PSA increase in each 13 month time period is growing swiftly. During the first period, it increases by just 1 unit, from a PSA of 1 to a PSA of 2. But in the 13 months between months 39 and 52, for example, the PSA goes from 8 to 16, an increase of 8 of course. The next increase is 16, the one after that 32, and so on - clearly exponential and definitely not linear.

An exponential curve (or one of constant % increase) has an early stage where a simplified linear estimate can be a close approximation, but it is followed by an exponential (geometric) phase of increase....So, perhaps the assumption that a 37-year old's PSA increase remains approximately linear until he is 89 or beyond might be a stretch.

We are in agreement that the PSADT pattern is exponential, and my understanding is that whatever the PSADT time interval is for doubling of the PSA, it stays remarkably constant for each of us - it's individual, sort of like a fingerprint. That is a generalization - a general rule, but my impression is that it applies widely. At the short end, some patients have a PSA that doubles in just two weeks; at the long end, some patients have doubling times of 100 years or longer. It is also clearly true that treatment, including medications, can change the PSADT, as apparently can some of the things we consume. The wonderful, awesome thing about that is that we can use PSADT as a key indicator of whether treatments and other tactics that we try are effective against the cancer. For example, the exciting UCLA team's research with pomegranate juice - their pilot study - resulted in an average increase in PSADT from around 15 months to over 50 months! I also believe that sometimes mutations in the cancer occur that also affect PSADT.


...You did mention, Jim, that the Toronto program (the “any age” program) “...does even more observant monitoring for younger men.” So age is a factor, but what does “more observant monitoring” mean?

I'm not sure, beyond what I indicated in the example. However, I strongly suspect that Dr. Klotz or other doctors managing patients in the program have talked about that; he's an enthusiastic speaker and writer. If anyone knows, please share that knowledge.

Take care,

Jim


...

 
Old 06-19-2009, 02:32 PM   #6
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

I agree with your math. Red-faced smilie: Thanks for clarifying, and I stand corrected. Too much needless babble on my part.

 
Old 06-21-2009, 09:45 PM   #7
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

Hi especially Bob, but also kcon and fellow board members,

Bob, thanks for your thoughts in the third post on this thread, to which I'm replying below. One thing I love about this board is that it helps us exchange views and both fertilize and weed our own personal fields of what we think is true, and I believe these threads will have the key value of helping fellow survivors and their loved ones with their decisions. I've already learned at least a couple of new points from the responses on this thread.

The information in this post will probably not be enough to win you over to the view that AS can be appropriate for younger patients, but it does lay out some of the key considerations and evidence. I'll respond to your points in green.


Quote:
Originally Posted by shs50 View Post
Thanks to both of you for an erudite summary

Thanks, and I hope the thoughts are practical as well. My feeling is that the Active Surveillance (AS) researchers are now giving us a good base of knowledge for our very practical task of making therapy decisions.

of the Canadien and other leading A.S. programs from Jim and a very well presented critique of the perils of linear extrapolation for younger men by KCon.

I have had to become so familiar with the nature of PSA doubling time (PSADT) because of my own case and therapy, that it is now practically second nature. Check out my previous post that responds to kcon's post; the extrapolation in my example is actually exponential instead of linear. (If you are a board reader who is not mathematical, hang on, the rest of the discussion is not so math centered.)

The error potential of small deviations between assumptions and experience in any exponential extrapoplation is analagous to the effect of minute differences in the trajectory of a long range missile or the path of a comet.

I am fully with you in recognizing that it may be somewhat difficult to pin down the PSADT, and that fact double underlines the worth of basing the PSADT on a series of tests from the same lab, using the same brand and kind of PSA test kit, if possible. Actually, like PSA both the missile and the comet follow a trajectory that to me is amazingly predictable. For patients after they choose AS, there is plenty of time to get a very firm grip on that PSADT as the months go by with their semiannual PSA tests.

However both analyses failed to address the more subjective issues which to my mind are being bypassed completely by the advocates for A.S.programs:
1. The Canadian program is being run and funded by a country committed to a single payer government run system where managing health care expenditures is an equal if not paramount objective. The costs of health care practically drive the Canadian economy.

Over the past nine years I've come to appreciate that Canada has an impressive number of highly talented and dedicated physicians working with prostate cancer; they have done some brilliant work, and I am grateful because I am one of the US beneficiaries of at least two of the trails they have blazed. However, I've also come to appreciate the tremendous negative power of bias, and, if the Canadian studies were the only evidence for AS, I would also be somewhat skeptical because of the concern you raise: possible bias due to the influence of wanting to make the Canadian single payer system work. Fortunately, that's not the case: the findings of the Toronto group are strikingly similar to findings from other major programs, mostly directed by surgeons, who you would think would be biased toward doing more surgery rather than encouraging AS. More below.

2. Using chronolgical rather than the less objective but more valid physiological age as basis for entry and measuring points, discriminates against older men with longer life expectancies than chronologically younger men in poorer overall health and physical condition.

I see this as kcon put it - basically we are all agreeing. You yourself are the evidence that a healthy older man, who would not be considered a surgery candidate by many doctors, can do very well with surgery. I suspect that Johns Hopkins would have done the surgery for you if there were no other excellent centers around who had greater belief in the value of surgery for very healthy, older men.

I question Jim's statement that its possible to predict that a low risk case won't become clinically significant for thirty years.

Can't agree with you more! If that's how I came across, I sure did not mean to! I can say for certain that none of the major AS programs take that view either. In fact, their findings are remarkably consistent that, although a clear majority of well-selected and monitored AS patients will do very well with the program and appear to be able to stay in it long term, with the goal of staying until the end of their lives due to death from other causes, a substantial minority - around one third, will turn out to have more aggressive cases and will need timely treatment.

But this is a key point: the major AS programs (and I) are convinced that you can predict a reasonably strong likelihood that a low-risk case will stay low-risk, and also that you can be highly confident that you will be able to identify in time emerging cancer aggressiveness (or under-the-radar aggressiveness that was there from the start) with good monitoring; "in time" means in time to get one of the therapies that intends to cure the patient with likely odds of success in avoiding recurrence that are about the same as for those getting immediate treatment.


I wonder whether anyone can make that call. As far as I know Dr. Scardino of Sloan-Kettering still uses the rule of thumb that there's a 50% probability of P.C. metastasizing when PSA reaches or exceeds 10 ng/ml.

Bob, would you mind rechecking what Dr. Scardino has said about that? I'm thinking you have in mind local spread and invasion beyond the prostate capsule, rather than distant metastasis, where the cancer needs to hitch a ride in the lymph or blood systems. In contrast, I've heard (recollection here - not verifying) that it takes a PSA of around 100 before there is around a 50/50 chance of distant metastasis. The good news here is that external beam radiation, with or without hormonal blockade, can still be curative with prostate cancer that has broken through the prostate capsule.

Of course a concern about exceeding a PSA of 10 makes sense if you are do not want radiation and are highly interested in having surgery or cryo surgery, seeds alone, or any other strictly "local" treatment, since you need to have the cancer contained in the prostate if such local therapy is going to be curative.

That thinking about the importance of not exceeding 10 is based on the very well-known and probably universally used Partin Tables, developed by Dr. Alan Partin of Johns Hopkins. Let's take a look at what the tables say (version as of 2002 in my book (the "Primer"), which used the "new" 2001 version of the tables. For those who don't know, the Partin Tables predict the odds of post-surgery pathology results for OC (cancer that is confined to the prostate - what we hope to have), CP (cancer that penetrates the prostate capsule), SV+ (cancer that is already in the seminal vesicles), and LN+ (cancer that already involves the lymph nodes). The tables base the prediction on three factors: the PSA (broken into ranges of 0 - 2.5, 2.6 - 4, 4.1 - 6, and 6.1 - 10); the Gleason Score (ranging from 2 - 4, 5 - 6, 3+4=7, 4+3=7, and 8 - 10); and the Clinical Stage (based for the tables solely on the Digital Rectal Exam, with separate columns for stages T1c - the tumor cannot be felt, T2a - the tumor can be felt but involves half of a lobe of the prostate or less and does not extend beyond the prostate capsule (none of Stage 2 extend through the capsule), T2b - the tumor can be felt and involves more than half of one lobe but not both lobes, and T2c - the tumor can be felt in both lobes of the prostate; higher stages are not given because for stage T3 the tumor has already penetrated the prostate capsule so surgery alone would not cure the cancer).

I'll just recap here the table numbers for patients with Stages T1c and T2a, because major AS programs will usually recommend against deferring treatment to Stage T2b and T2c patients, and I'll also limit the recap to PSAs up to 10 and Gleason Scores of 5 or 6 basically for the same reason, and for simplicity because Gleason Scores of 2 - 4 are very uncommon these days and such patients have even better odds than Gleason 5 - 6 patients. (This is from the book "A Primer on Prostate Cancer - The Empowered Patient's Guide, Strum and Pogliano, pp. C1-C6.)

For PSAs ranging from 0 - 2.5 ng/ml & Gleason Score 5-6,
here is the percentage of the finding occurring:

Finding.....T1c.....T2a
OC............90......81 (Very high odds cancer is confined)
CP..............9......17 (Fairly low odds of penetration)
SV+...........0........1 (Virtually no chance SV involvement)
LN+...........0........0 (Virtually no chance nodes +)
----------------------------------------------------------------
For PSAs ranging from 2.6 - 4 ng/ml & Gleason Score 5-6

Finding.....T1c.....T2a
OC............84......71 (High odds of organ confinement)
CP............15......27 (Low odds of capsular penetration)
SV+...........1........2 (Virtually no chance SV involvement)
LN+...........0........0 (Virtually no chance nodes +)

----------------------------------------------------------------

For PSAs ranging from 4.1 - 6 ng/ml & Gleason Score 5-6

Finding.....T1c.....T2a
OC............80......66 (High/favorable odds of confinement)
CP.............19......32 (Fairly low odds of penetration)
SV+............1........1 (Virtually no chance SV involvement)
LN+............0........1 (Virtually no chance nodes +)

----------------------------------------------------------------

For PSAs ranging from 6.1 - 10 ng/ml & Gleason Score 5-6

Finding.....T1c.....T2a
OC............75......58 (Strong or better than even odds)
CP.............23.....37 (Fairly low odds of penetration)
SV+............2.......4 (Extremely low chance of SV +)
LN+............0.......1 (Virtually no chance LN involvement)

While these Partin Table odds of the patient's chances of organ confined disease with no spread range in favor from outstanding to substantially better than even, the AS programs actually can see the odds even more clearly. That's because the Partin Tables look at the big three - PSA level, Gleason Score and stage, but not at other factors the AS programs consider, such as PSADT, PSA density, number and percent of cores that are positive, free PSA score, and so on. You can see how the AS programs can greatly refine the odds that a man will be able to do well in an AS program.



My fundamental skepticism of scientific advocates has me looking behind the published studies promoting AS for underlying agendas i.e. economic in the Canadian example or in J.H.'s case, consistent with their well known age based patient selection bias.

I too think we need to keep that grain of salt handy when reviewing scientific reports. However, I have read some of the reports from Canada and they strike me as sound in methodology and diligence, which is more than I can say for many studies. I'm also impressed that they are claiming impressive success rates, but they are not claiming sky-high success rates; that seems realistic based on what is known about the disease in low-risk patients. As for John's Hopkins, an institution that rejected me as a surgery patient (Thank God! - didn't know much then about how challenging cases limit options!), they see their position as not wanting to do surgery unless it will have a good chance of giving the patient a substantially favorable balance of benefits to side effects, and age and other health conditions play in that balance as well as the details of the patient's prostate cancer.

Deferring treatment is a completely reasonable course for the truly older(physiologically as well as chronologically) and otherwise health compromised patient where the risk obviously outweighs the potential benefit of aggressive treatment. However for the younger healthier population it simply delays the inevitable for a few years and possibly to a time when surgery or other primary treatment will no longer be as effective or uncomplicated.

Your "however" sentence is where the AS programs see the prospects for low-risk prostate cancer as bright instead of gloomy, but I suppose it is a "glass half full versus a glass half empty" kind of issue. While the necessity for treatment becomes inevitable for some of us, the major AS programs believe they can make good estimates of who those patients are, and which other patients have an excellent shot at deferring the need for treatment for many years, with a solidly based hope of deferring treatment for the rest of the patient's lifetime. They definitely believe that low-risk prostate cancer does not "inevitably" become a risk to life or welfare for all patients. What do you think of the evidence from the major AS programs that a clear majority of AS patients have been able to stay in the programs since the time when the patients joined the programs? (I've put a table with some key data below.) For some patients in AS programs, that means since 1995, as at least two of them were started in 1995, and one started in 1993; thus, some of the earliest patients have now been in the programs for 14 or more years and their cancers still show no indications of being anything but insignificant.

After a patient has been in an AS program for just one year, most of the AS programs are able to grind down the odds assessment much more finely, as they then have in hand a follow-up biopsy, as well as 6 and 12 month PSA scores and DREs, and they may have other observations and tests as well. Those assessments become even more precise when a patient has his second followup biopsy at the two year point, usually meaning there are three biopsies in the file (baseline, first year, and second year). The AS programs have been able to analyze their multiple biopsy statistics and get this additional combined clue for forecasting long-term success. Based on their AS patient databases of perhaps several hundred patients at each institution, as well as parallel data from other major AS programs, they have an excellent view of whether the patient is likely to be basically stable for the next follow-up period or is approaching the point where the cancer needs treatment soon so that it will not become incurable. In 2008, a number of leaders of AS programs and other researchers published a joint paper that highlighted key methods and findings. One of the tables they presented gave results from five programs. Here is a summary:

..................Patients.........Avera ge........Percent
Program.....Reported.......Followup..... ...Treated

UCSF.............321...............24... ..............21%

Klotz..............299...............64. ................34%
Toronto at Sunnybrook (started 1995)

Hardie...........320...............23... ...............31%
Royal Marsden NHS Trust and Inst. of Cancer
Research, Sutton, Surrey, UK (started 1993)

Warlick...........80................42.. ................14%
Johns Hopkins

Patel..............88................44. .................35%
Scardino, Memorial Sloan-Kettering, files

The arithmetic works out to a weighted (by percent of patients) followup of 37.36 months - more than three years. But what I find most impressive is the average followup of 64 months - close to 5 1/2 years, from the Klotz series at the U. of Toronto, Sunnybrook. Now the "average" in this table is the "median," meaning that half the patients fall below the value, and half above. That means that the Klotz series had, at the time of the study, about 150 men with longer followup than about 5 1/2 years in its series that started in 1995. Just about 1/3 (34%) had needed to be treated or later chose treatment, leaving 2/3 (66%), or about 197 men still in the program.

It does appear that problem cases - those that reveal themselves as more aggressive, can usually be spotted in just two years or so. If a patient makes it past that point - which typically includes the second follow-up biopsy, he has a significantly better shot at staying in the program long term. If he doesn't make it past that point, he is (1) getting treatment only two or so years later than he otherwise would have, (2) he has been monitored carefully and maintained his excellent chance for successful curative therapy, (3) he has maintained his quality of life for two or so additional years without having to bear the potential burdens an side effects of treatment, and he has gained the extra time during which therapies are likely to have continued to improve, giving him better options.

Probably the key issue in AS is, as you put it, whether it delays therapy "to a time when surgery or other primary treatment will no longer be as effective or uncomplicated." As results accumulate for the AS programs, it is looking more and more like a curative option is preserved. The other thread is a better place for those details. But that leaves a couple of questions in my mind for patients, especially younger patients: for those patients in AS programs who are determined to need therapy, for what percentages are the local options still open (surgery, seeds, cryo surgery) compared to the percentage needing radiation therapy that can reach beyond the prostate to achieve cure, and what percentage of these patients needing therapy will be able to have successful nerve sparing surgery compared to surgery that cannot spare the nerves. My recollection is that most of the patients who do have treatment in the AS programs choose surgery. I have seen no figures on nerve sparing success for those patients.



Utilizing one's curative window is in my opinion too precious an opportunity to gamble on the odds derived from studies whose conclusions could be challenged or overturned tomorrow.

I think I would see it the same way if there were only one or two small, short-term studies about AS, or if the success results were marginal or inconsistent among the set of major AS programs. To me, as of 2009, the accumulating evidence looks much too broad-based, long-term and consistent for there to be any risk that it will be overturned tomorrow, let alone in the next decade or ever. Are you aware of any serious challenge to the AS research? The only prominent physician specializing in prostate cancer that I know of who seems to be uncomfortable with the option of deferring therapy is Dr. William Catalona, a great prostate cancer surgeon and researcher. However, I haven't looked into the details of his views, and I'm thinking he may have become a supporter of AS in recent years, because of the accumulating evidence. If you know such details, or of a serious challenge to AS, would you mind telling me about it?

Take care,

Jim

 
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Old 06-22-2009, 12:07 PM   #8
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

I'm learning a lot about AS through this exchange. My eyes are opening wider to importance of PSADT.

(Again, apologies for my misdirected post #2 in this thread regarding PSADT. Use of the word “constant” did give me pause, but I incorrectly equated "constant" to "linear"…which sent me off-base.)

 
Old 06-22-2009, 06:01 PM   #9
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

Jim:
Impressive point by point response. In spite of the growing evidence of the AS programs cited, the data while suggestive is still far from conclusive. Your quite appropiate use of terms such as "points to", "probably" and "most likely" has still a ways to go before AS can be deemed a standard of care along with surgery, external beam radiotherapy, brachytherapy and hormonal therapy. I remain unconvinced of the efficacy of its broad application except for the population where the risk/benefit ratio favors deferred treatment.
Dr. Scardino in his book, Chapter 13 devoted to Watchful Waiting and Active Monitoring cites a large Canadian study which indicated that PSADT "is far from completely reliable".( Ross,P.L.S. Mahmoud,A.J. Stephenson,L.Souhami,S.Tanguay,and A.G. Aprikian."Variations in PSA Doubling Time in Patients with Prostate Cancer on "Watchful Waiting'; Value of Short Term -Term PSADT Determinations". Urology 64, no.2 (2004) :323-8.
He concludes with the following note-" Some tumors will grow,spread, and become incurable despite the most scrupulous state-of the-art monitoring. This is the major risk in deferred treatment: Once the horse is out of the barn, locking the door won't bring it back inside."
That about sums up my feelings on the issue.
Gotta run and visit my wife in the re-hab center.
Bob

Last edited by shs50; 06-22-2009 at 09:22 PM.

 
Old 07-31-2009, 03:00 PM   #10
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

Hi Bob and everyone interested in Active Surveillance (AS).

In the previous post you expressed doubt that AS had been accepted as a standard therapy, and at the time I could not see any evidence that that it had been accepted, though I thought so. But I ran across what looks to me like acceptance of AS as a standard therapy by the American Urological Society and thought you would like to know about it. I'll insert a few quotations in response to your post #9 (of6/22/2009) below, in green.

The source document is the "Prostate-Specific Antigen Best Practice Statement" published by the American Urological Association in April this year. The document was developed by a panel of leading prostate cancer doctors, and the draft was reviewed by 70 "peer reviewers"; it was then reviewed by the AUA's Practice Guidelines Committee, and finally by the AUA's Board of Directors. (This is described on pages 44 - 46, and I'm including the description here because it shows that the AUA views this paper as authoritative. Jim


Quote:
Originally Posted by shs50 View Post
Jim:
Impressive point by point response. In spite of the growing evidence of the AS programs cited, the data while suggestive is still far from conclusive. Your quite appropiate use of terms such as "points to", "probably" and "most likely" has still a ways to go before AS can be deemed a standard of care along with surgery, external beam radiotherapy, brachytherapy and hormonal therapy.

Here are some pertinent statements from the AUA, with pages noted from the "Prostate-Specific Antigen Best Practice Statement" described above.

" ...The AUA recommends that all discussions of treatment options include active surveillance as a consideration, since many screen-detected [meaning, screening programs] prostate cancers may not need immediate treatment." page 8

"A significant proportion of men harbor small foci [meaning, concentrations] of latent prostate cancer, many of which are not destined to become clinically significant. Widespread, repeated PSA testing has raised a concern over the possible overdetection of prostate cancer. Overdetection refers to the ability of a screening test to identify a condition that would have remained silent and caused a patient no morbidity during his lifetime. This is in contrast to overtreatment, although in the United States these two are unfortunately often linked, in some cases to the detriment of patient quality of life. For example, despite a decrease in risk category of disease at the time of diagnosis, approximately 90% of men still elect some type of intervention, including surgery, radiation therapy, or androgen deprivation." about pages 14, 15

On page 33 there is a guideline table that summarizes the staging and decision making for prostate cancer. After the block for discussion, it has a block showing just this: "Treatment or Surveillance".


I remain unconvinced of the efficacy of its broad application except for the population where the risk/benefit ratio favors deferred treatment.

It appears the AUA is moving to the view that that population includes the vast majority of men with low-risk case characteristics.

Dr. Scardino in his book, Chapter 13 devoted to Watchful Waiting and Active Monitoring cites a large Canadian study which indicated that PSADT "is far from completely reliable".( Ross,P.L.S. Mahmoud,A.J. Stephenson,L.Souhami,S.Tanguay,and A.G. Aprikian."Variations in PSA Doubling Time in Patients with Prostate Cancer on "Watchful Waiting'; Value of Short Term -Term PSADT Determinations". Urology 64, no.2 (2004) :323-8.

My impression is that the major AS program leaders would agree that PSADT alone is not enough, though it is a highly important clue. That's probably why the major AS programs do other monitoring, including repeat biopsies for at least the first two years. That paper, dated in 2004, was also almost surely written before the key findings on PSAV were published in 2004 and 2005 by the teams led by Dr. Anthony D'Amico; that's the research that showed the key importance of a PSAV of greater than 2.0 in the year before diagnosis.

He concludes with the following note-" Some tumors will grow,spread, and become incurable despite the most scrupulous state-of the-art monitoring.

I suspect Dr. Scardino's view has now changed, but maybe not. The emerging findings on the impressive effectiveness of diligent monitoring are now being documented as the major programs publish their papers.

This is the major risk in deferred treatment: Once the horse is out of the barn, locking the door won't bring it back inside."

It is clear that surgery would no longer be enough if the capsule has been significantly penetrated, but radiation is still racking up good cure statistics in such cases.

That about sums up my feelings on the issue.
Gotta run and visit my wife in the re-hab center.
Bob
Take care, and hope your wife is better now,

Jim

 
Old 12-02-2009, 03:19 PM   #11
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

Updating Movement Toward Younger Patients' Eligibility for Active Surveillance (AS)

I've recently become aware of two additional leading advocates of active surveillance for younger men: Dr. Charles "Snufffy" Myers and the Prostate Cancer Research Institute (PCRI).

On November 2 our support group was fortunate to have Dr. Myers - long an advocate of AS for low-risk patients - as our speaker, and this highly regarded, expert and insightful doctor told us that he now had more than thirty men in his practice who were younger than age 40 and on active surveillance! Dr. Myers also told us that he does a couple of things in addition to customary staging for potential AS patients in order to further lower the risk of more aggressive disease that is not yet obvious. He told us that he now depends on color Doppler ultrasound (CDU) exams for all his potential AS patients, not just the younger ones. He also stated that TRUS (Trans Rectal Ultrasound) exams are useful for indicating low grade tumors, which tend to be spherical, but poor in revealing possible higher grade tumors that tend to look more like an octopus; CDU is good at spotting the latter, so that covers key ground in confirming that a patient is truly at low risk of stealthy aggressive disease. He also said his go-to CDU expert was Dr. Duke Bahn in Ventura, CA, but that he also referred men to other CDU experts. Dr. Myers also likes to have endo-rectal MRI results for potential AS candidates as that technology excels in determining whether the prostate capsule has been invaded, in addition to providing other staging information.

PCRI, a non-profit organization headquartered on Century Blvd. near LAX airport in LA, recently published a new pamphlet entitled "What's Your Type?" It focuses on assessing the patient's risk level based on six criteria, and for truly low-risk patients - those who do well on all six criteria - it simply recommends "No Immediate Treatment", meaning active surveillance.

Here are the six: a Gleason Score less than 7; less than 34% of biopsy cores with cancer; a PSA level less than 10; a PSA velocity in the previous year that is less than 1; a PSA density (PSA divided by the size of the prostate in cubic centimeters) less than 0.15; and no nodules found in the Digital Rectal Exam. As the pamphlet puts it: "Waiting is not right for every man with prostate cancer, but it's a good option for men with Low-Risk disease."

I can't recommend this pamphlet highly enough. It's not just that the pamphlet emphasizes key information; it also does it with easy-to-understand graphics and a concise presentation. For those who want more detail (me, for instance), PCRI has published associated documents that are highly informative. One is an excellent essay by Dr. Laurence Klotz, MD, probably the consensus choice for the AS leader worldwide.

The other experts I know of who are comfortable with younger men on AS, both mentioned in earlier posts in the thread, are Dr. Fritz Schröder (Netherlands, Erasmus Medical Center), who likes his AS patients to be at least 55 years old, and Dr. Klotz who is comfortable with patients of any age for AS.

Jim

 
Old 12-02-2009, 04:30 PM   #12
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

Jim -

In your post #7 in this thread, you raised the question of Dr. Catalona's views on AS. He has an article in the Winter 2009 "Quest" publication (which I would link here if the board's posting rules permitted me to do so) entitled "Watchful Waiting is Really Wishful Waiting for Many Patients." You can probably guess what his views are from the title. I suppose one could say "he's a surgeon, and makes money doing surgery, so he may be biased." Maybe that is true. I don't know. But there are certainly other surgeons who make money by doing surgery but also support AS -- for example, Dr. Carter at JHU.

Regards,
Medved

 
Old 12-02-2009, 06:55 PM   #13
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

I skimmed through this thread and found the information very interesting. One thing that has not been addressed and unfortunately I do not have the exact statistics is the number of men that begin an AS program and drop out because the tests and biopsies are too stressful and they do not want to continue.

This came up when I was talking to my surgeon (KCON – maybe you had the same discussion) about Watchful Waiting. He said that it was an option, but in his experience about (and this is where my memory is fuzzy) 50% of the men stop “Watching” after 5 years. I also thought he said there was a correlation between length of time “Watching” and a persons age (the younger the person the more likely to drop out).

Has anyone heard of these stats?

MrMike

 
Old 12-02-2009, 09:58 PM   #14
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

Mike,

I did not have this type of discussion with Dr. S, but my approach might have been different than yours. What I did was to first survey treatment methods; then, after I decided on surgery I started searching for surgeons…so my pre-surgery discussions with him were strictly about surgery.

Anyhow, the 50% of men who stop AS which you referenced (recalling here that your memory of that actual number was fuzzy) doesn’t seem too far from the results Jim published in a separate thread tonight. In that report, in one of the best AS programs in the world, the number was reported at around 30% dropped out for radical treatment (or, effectively preserved treatment options until a later date). In other programs that might not be best-in-the-world, the drop out rate might tend to be higher.

Just a general comment on this topic, I think it’s important to remember that an AS program doesn’t particularly mean that you actively survey for the rest of your life. You do that if you can (and that would be the very best possible situation), but if the PC takes a turn for the worse, you are “on top of it” (the “active” part) and can quickly pull the trigger on a treatment mode…thus “preserving treatment” options. The patient benefits by the delay in that over the years while on AS the technologies and successess in radical treatments will have further improved. I have no doubt that 10 years, or even 5 years from now radical treatments will be better.

regards

 
Old 12-03-2009, 06:17 PM   #15
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Re: Active Surveillance for Prostate Cancer: Age of the Patient

KCON:

Thanks for the update - but the 50% I was referring to meant that men dropped out not to have treatment, but dropped due to the stress of constantly checking/looking/testing. I will send an e-mail to my doctor and see if I can get an answer back.

 
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