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Old 01-05-2008, 09:44 PM   #1
IADT3since2000
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Smile Active Surveillance - a sound option for truly low risk men

Men diagnosed with low risk prostate cancer that also have certain other favorable case characteristics may be able to take an "Active Surveillance" approach. This is a much more effective approach than simple "watchful waiting" to see if you will get clobbered by prostate cancer. But what is really impressive to me as a survivor is that major surgical prostate cancer centers are recommending this approach as a reasonable option for truly low risk men. It makes me wish I had had a case that was suitable for this approach.

Most definitions of low risk include a PSA less than 10 (the lower the better), a Gleason of 6 or less (with no Gleason Grade 4 or 5 cancer), stage 1 or 2a, and no more than 50% of a biopsy core positive. Another recent key factor is that the PSA did not rise at a rate of more than 2 in the year before diagnosis; that's an important risk factor even if the other factors are favorable. Another factor is only one or two biopsy cores positive, or a low percentage positive if many cores are taken. One book suggests the PSA density should not exceed .1. Not all the studies use all these factors, and some use additional factors. For low-risk men of 75 and older, or for those with significant other illnesses such as cardiovascular conditions, or especially older men with significant conditions, this approach deserves very serious consideration. But some doctors feel it is a viable option for men of any age.

Repeat biopsies are a key step for monitoring deferred therapy, and a negative biopsy or one like the first are additional favorable indicators. For those wanting extra assurance (that would have been me), a color Doppler ultrasound biopsy, conducted by an expert (there are only a handful in the US) is quite good at locating the tumors in the prostate; if they are near the capsule edge in an area where the capsule is thin, such as the apex, or near openings where the nerves exit, that ups the risk of deferring. Certain markers of aggressiveness can also be checked if desired, such as p53, bcl-2, ploidy, PAP, VEGF, etc.

However, this option, like the others, takes careful thought and follow-up monitoring. It's a tough call however you go. At least with deferring therapy, you have a good shot at a fallback therapy like surgery, radiation or hormonal blockade if the deferred approach comes up short. The great things about deferring therapy are that you give yourself more good years without dealing with side effects that many of us will experience from the various therapies, and you avoid a lot of expense and the burden of a major treatment. Of course the big payoff is when a patient is able to defer therapy for the rest of his life with never a serious threat from his prostate cancer. Moreover, in this fast-developing field of medicine, the treatments, tests, etc., will almost surely have improved while you were deferring therapy. (There have been great improvements in the eight years I have been a prostate cancer survivor.) In fact, a number of leading experts believe a cure is only a few years away.

It used to be thought that men deferring therapy were taking a big gamble. A lot of us in the past (and still now) could not stand the idea of living with cancer; that's changing as many low-risk patients are realizing that an indolent prostate cancer can be like having an appendix -- something you can get comfortable living with. (One leading expert recently compared the range of aggressiveness as going from the risk of a case of dandruff at the low end all the way up to a case of acute leukemia. We don't want to overreact if all we have is the equivalent of dandruff.) Now we have a much better picture of the odds, and the odds are not bad, though there is still some risk. Nothing in this game is risk free, unfortunately. Note that deferring therapy is not the same thing as burying your head in the sand and watchfully waiting until you get clobbered with symptoms of prostate cancer. The idea here is that you watch, put to work a program to hold down the cancer, and make a timely move to a major therapy if advance indicators show signs of trouble. Major Active Surveillance programs are finding that they are having great success in catching any cancers that prove aggressive while they are still in the prostate capsule and potentially curable.

In the past few years, for the first time, we have studies from major surgical centers, involving some of our most expert surgical and pathologist teams, indicating that major therapy can fairly safely be deferred with fairly low risk for low-risk prostate cancer patients and that deferring therapy is a reasonable choice for these patients. The main studies and programs I know of are from the U. of Toronto (leader Dr. Lawrence Klotz) , Johns Hopkins (leader Dr. H. Ballentine Carter with Drs. Patrick Walsh, and Dr. Jonathan Epstein also on the team, and Dr. Christopher Warlick now at the U. Of Minnesota Medical School), Memorial Sloan Kettering (leader Dr. Peter Scardino), and Erasmus University in the Netherlands (leader Dr. Fritz Schroder).

Johns Hopkins and Memorial Sloan Kettering were especially focusing on older men (more or less 70 and older, as I recall), but the Netherlands study speculated that this approach may be reasonable for younger men, say about 55, and Dr. Lawrence Klotz, of the University of Toronto, Sunnybrook, has stated that he is comfortable with this approach for men of any age, provided that younger men are even more carefully pre-screened and monitored.

Major cancer centers at MD Anderson and the University of California at San Francisco (leader Dr. Peter Carroll) have more recently contributed their studies favorable to active surveillance. Dr. Stephen Freedland from the Duke University Medical School was on an active surveillance panel moderated by Dr. Christopher Logothetis of MD Anderson with Drs. Klotz, Schroder, and Warlick at the IMPaCT Conference in Atlanta sponsored by the Prostate Cancer Research Program of the Congressionally Directed Medical Research Program. There are many more active surveillance programs, but the foregoing list gives an idea how seriously this option is taken by major centers and leading doctors. Abstracts of papers in the body of published research on active surveillance (also known as “deferred therapy,” “expectant management,” “medical management,” and other names) can be found on [url]www.pubmed.gov[/url], the free US Government public medicine website.

AND, I don't believe any of these studies tracked whether patients were implementing a program to try to hold the PC at bay or to knock it down, though Dr. Freedland spoke about that at the IMPaCT Conference. There is now a growing body of evidence that a diet, nutrition, supplements, exercise and stress reduction program, perhaps with low-key medications, is effective for many low-risk men and helpful to others at higher risk. Some fairly well established key elements are lycopene (from cooked and processed tomatoes), selenium, vitamin E with gamma tocopherol instead of just alpha, omega 3 fatty acids from fish or good quality fish oil, vitamin D3, and soy. (Vitamin D3 has gotten a lot of attention in just the past two or three years.) Certain supportive low-key medications like Proscar and Avodart and Celebrex also seem to help. Some doctors suggests oral bone density medications like Fosamax and Actonel as well.

It is also worth mentioning that active surveillance has been a major emphasis in some of the key medical association conferences in 2007. The conference for the medical oncologists association had three presentations/papers on active surveillance of just twelve total papers in the section of their Education Book on genitourinary cancers in 2007 for their annual meeting. The Education Book is the key information that medical associations want to communicate to their members. Vu-graphs and audio recordings of the talks are available on the web for the public.

I've become educated in prostate cancer through the School of Hard Knocks and have not been enrolled in medical education. I feel I'm able to help provide leads, but patients interested in this need to do enough research to choose their own course.

Jim
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Old 01-06-2008, 10:16 AM   #2
able5
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Re: Active Surveillance - a sound option for truly low risk men

Quote:
Originally Posted by IADT3since2000 View Post
It makes me wish I had had a case that was suitable for this approach.
Jim...

Great job!

That must have taken hours of web research...

In spite of not having any first hand personal experience in Active Surveillance (AS), nevertheless, I appreciate your hard research work which helps all of us better understand AS as a treatment!

Thanks!

Personally, I do not consider today's prostate cancer staging methods as perfectly accurate and completely reliable science. According to their personal discussions with me and my case, neither does my GP, my urologist or my surgeon. My pre-op staging and my post-op pathology were very different. In my opinion, today's staging methods, at best, merely get you into the ballpark. I was much more at risk in spite of what my staging tests indicated. The whole premise, in my view, of the validity of AS as a treatment is based on a firm reliance upon a 100 percent guarantee that the recently diagnosed prostate cancer patient is "truly low risk".

QUESTION: As a newbie pre-treatment prostate cancer patient, how do you know for sure that you are "truly low risk" based upon today's less than 100 percent accurate staging results?
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Last edited by able5; 01-06-2008 at 06:48 PM.
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Old 01-06-2008, 09:01 PM   #3
IADT3since2000
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Re: Active Surveillance - a sound option for truly low risk men

Quote:
Originally Posted by able5 View Post
Jim...

... Personally, I do not consider today's prostate cancer staging methods as perfectly accurate and completely reliable science. According to their personal discussions with me and my case, neither does my GP, my urologist or my surgeon. My pre-op staging and my post-op pathology were very different. In my opinion, today's staging methods, at best, merely get you into the ballpark. I was much more at risk in spite of what my staging tests indicated. The whole premise, in my view, of the validity of AS as a treatment is based on a firm reliance upon a 100 percent guarantee that the recently diagnosed prostate cancer patient is "truly low risk".

QUESTION: As a newbie pre-treatment prostate cancer patient, how do you know for sure that you are "truly low risk" based upon today's less than 100 percent accurate staging results?
I believe the leading doctors advocating Active Surveillance would basically agree with you: "today's prostate cancer staging methods [are not] perfectly accurate and completely reliable science." That's why they emphasize both screening of patients before admitting them to their AS programs and monitoring diligently to catch any cancers that prove aggressive.

However, they would fully disagree with your statement that "AS as a treatment is based on a firm reliance upon a 100 percent guarantee that the recently diagnosed prostate cancer patient is 'truly low risk'." They are quite aware that a substantial proportion of their patients are going to have cancer aggressive enough to warrant timely treatment. In fact, Dr. Carter of Johns Hopkins and his team recently updated the statistics from their AS program (which they refer to as "expectant management") and demonstrated both substantial success in keeping men free of both aggressive cancer and treatment as well as a substantial proportion who needed treatment. Their report in the December 2007 issue of the Journal of Urology stated that there were 407 men in their program, and that 239 (59%) "remained on active surveillance at a median [average] followup of 3.4 years" (followup ranging from .43 years to 12.5 years. But "103 (25%) underwent curative intervention at a median of 2.2 years after diagnosis (range 0.96 to 7.39)," with others lost to followup, withdrawing from the program, or dying from other causes. While that 59% is quite impressive, it's obvious that a minimum of 25% needed active therapy.

The leading programs believe that they can select patients using a combination of low risk features, including expert pathology assessments. They believe they have forumulas that provide good odds of success to the patient, even if it just means putting off therapy for a few years while maintaining a high potential for curative intervention if needed.

Moreover, the programs are steadily improving their patient selection and monitoring techniques. Some patients are now using color Doppler ultrasound guided biopsies, which give a superior indication of the shape and size of the cancer, indicating whether it might be near an easy exit point from the capsule, as well as other information. The new information from the D'Amico team about a PSA that rises by more than 2.0 in the year before diagnosis is now being addressed by at least the Toronto program.

You can see from this that AS is a far superior approach to watchful waiting.

As for your being sorry for beginning another post, you should not be. You put a key objection that many of us feel to AS in a nutshell, even though it is not based on what AS is really about. It is vital to get these thoughts and feelings out in the open if we are going to help address the "overtreatment" problem while still ensuring appropriate treatment when needed. To paraphrase the colonial Revolutionary War general Israel Putnam, "Don't fire til you see the whites of their eyes, but when you see the whites, you better fire!"

Jim

Last edited by IADT3since2000; 01-06-2008 at 10:16 PM. Reason: Changed "as" to "[are not]" in first sentence of reply, which makes quite a difference. 259 to 239Also added final paragraph.
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Old 01-07-2008, 09:11 AM   #4
able5
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Re: Active Surveillance - a sound option for truly low risk men

Quote:
Originally Posted by IADT3since2000 View Post
I believe the leading doctors advocating Active Surveillance would basically agree with you: "today's prostate cancer staging methods [are not] perfectly accurate and completely reliable science." That's why they emphasize both screening of patients before admitting them to their AS programs and monitoring diligently to catch any cancers that prove aggressive
From what I've been reading, Active Surveillance has been a much favored treatment in the UK for a few years.

Also, the American Cancer Society has an article (06/14/2007) about this subject. If you do a web search "ACS Expectant Management" you'll find it. Mentions that this approach includes a PSA blood test and digital rectal examination (DRE) every 3 to 6 months or so, possibly with yearly transrectal ultrasound-guided biopsy of the prostate. Also says it's less likely to be a good option if you are young, healthy, and/or have a fast-growing cancer (for example, a high Gleason score).

My Gleason score was a 6 (pre-op) but my post-op pathology showed a much more aggressive tumor.

Regardless, I never hesitated for a moment about surgery. That's just me. My thinking was, if it's possible to completely remove it, let's remove it! Again, that was "my" personal decision.

AS (Expectant Management) would not have worked for me since my tumor was fast-growing. However, AS may be the right treatment for certain people. It depends on age and the nature of the tumor.
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Last edited by able5; 01-07-2008 at 09:15 PM.
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Old 01-07-2008, 05:34 PM   #5
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Re: Active Surveillance - a sound option for truly low risk men

The problem with AS as I see it and as born out anecdotally by my brother-in-law is that its impossible to know exactly when the tumor progresses and/or becomes more aggressuve. My brother-in-law progressed from Gleason 6 to Gleason 7 and the formerly low risk "indolent" ( indolent doesn't mean inert)tumor pushed out to touch the rectom requiring more extensive robotic surgery including partial resection of the rectom. This occurred under Active Surveillance with PSA testing every 3 months and annual biopsies. He was under AS for 3 years. The surgeon said he could have spared both nerves and the tumor would have been organ confined if the surgery had been completed when diagnosed as confirmed by endo-rectal spectroscopic MRI.
Prostate Cancer doesn't go away by itself and rarely if ever lays dormant without treatment.
A.S. may be reasonable for older men past 75 with other health issues which would either complicate local treatment or who are more likely to die from other causes before the cancer metastasizes. Even H. Ballentine Carter of Johns Hopkins admitted Expectant Management isn't for the risk averse althogh he advocates it as a reasonable option for low risk cases in men over 65.
Its one thing to publish statistics supporting deferred therapy in the majority of closely watched cases, however 1/4-1/3 may still progress within 3years without treatment and require more extensive surgery and possibly follow up[ radiation when they could have been more easily cured at the outset.
Its easy to understand why England and other socialised medicine nations advocate it as a cost effective method of rationing scarce and expensive resources. A case can be made for it statistically but I wonder how many Drs defer their own treatment when diagnosed with prostate cancer. I know of none although my sample is very limited to about 10.
How many men want to hear after deferring treatment that they waited a bit too long and it spread?
While many will maintain that A.S. is a reasonable option if monitored scrupulously, I continue to believe that its an irresponsible recommendation
for an otherwise healthy man with a 15 + year life expectancy.
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