To treat or not to treat (appropriately selected, low-risk patients)


In the most recent of his regular video commentaries on the management of prostate cancer on the Medscape Oncology web site, Dr. Gerald Chodak discusses the recently published, final results of the PIVOT study, and argues that, “It is absolutely critical that we [i.e., the urology community and other physicians who treat prostate cancer] make sure that every man diagnosed with prostate cancer is aware of these results.”

The “New” Prostate Cancer InfoLink is in complete agreement with Dr. Chodak. Not only do physicians need to be advising their patients about the results of this trial. They also need to be doing so in a neutral and unbiased manner so as to help their patients make good decisions about how each individual patient wishes to be treated.

We now have data from the two largest trials completed to date (the PIVOT trial and the Scandinavian trial), both of which have clearly shown that, for men > 65 years of age with low- and very-low risk localized disease, there is no evidence of overall or prostate cancer-specific survival benefit from radical prostatectomy compared to observation.

We are quite sure that — despite these data — there will still be men with low-risk disease in this age group who are going to insist on surgery as a treatment for their prostate cancer. This is their right — but they now need to understand that there are no data to support such a decision in men > 65 years of age. In addition, those men who are already concerned about the benefits of surgery need to be able to hear that there are data from two good clinical trials that would support active surveillance or some other form of observation as opposed to surgery.

We do wish to emphasize, however, that there are also no data to suggest either of the following conclusions from the PIVOT study or the Scandinavian trial:

  • Since surgery is no better than observation as a first-line treatment for low-risk, localized prostate cancer in men > 65 years of age, then no other form of treatment is effective either.
  • Observation is a better management strategy than any form of treatment for low-risk, localized prostate cancer in men > 65 years of age.

What we actually now know is that we have no evidence that treatment is better or worse that observation for this category of men (a very high percentage of all those diagnosed each year with low-risk prostate cancer). Some may still prefer to “bite the bullet” and hope that treatment will still extend their personal life with limited side effects. Others are going to say, “Let’s simply avoid any risk for the side effects” and hope that not getting treated doesn’t lead to aggressive, metastatic disease. These are both valid, personal choices.

There is no “right” or “wrong” here in terms of the individual patient’s decision. “Right” and “wrong” are going to be confined to the will of the treating community to ensure that their patients receive a neutral explanation of the risks and benefits associated with the very available and very different approaches to patient care.

7 Responses

  1. Well; I don’t know what to think now. I am set for surgery on October 19 this year. My tumour is 20% of my prostate, which is three times the size (127 cc) of a normal prostate. Logic would say that if you wack the cancer in one confined area, that would be the most appropriate way to go. I have a sneeky feeling that there are bean counters involved in these decisions and that they want to save the health care system the added expense.

    Joseph Mac Isaac

  2. “OBSERVATION” AS ACTIVE SURVEILLANCE (AS)

    Thanks for highlighting Dr. Chodak’s comments on the PIVOT trial.

    It is important for newly diagnosed patients to understand that for the vast majority of them “observation” should be “ACTIVE surveillance,” rather than passive waiting to observe whether or not symptoms will appear.

  3. We are quite sure that — despite these data — there will still be men with low-risk disease in this age group who are going to insist on surgery as a treatment for their prostate cancer.

    No doubt there will be. A surgeon urologist commenting on local (Australian) TV last night echoed the point made again and again by Dr Catalona and others of his ilk – this from Catalona’s site:

    Q: Do you feel that a radical prostatectomy offers the best chance for a “cure” of prostate cancer?
    A: Yes, I do. That belief is based upon my own published results, the research literature, my own prostate cancer screening studies, and my professional experience.

    As my dear old Dad used to say, this seems to be a case of “Don’t confuse me with the facts, I’ve made up my mind.”

    But at least there are now informed voices like Dr. Chodak’s spreading the word that has seemed so bleeding obvious to many of us non-scientists for so long and, to be fair, to fine people like Dr. Stamey.

    Of course each man must make up his own mind as to what risk he is prepared to take and our aim, when setting up the YANA — You Are Not Alone Now at http://www.yananow.org in 1999 was always:

    “To provide comfort to any man diagnosed with prostate cancer, to offer thoughtful support to him and his family and to help them to decide how best to deal with the diagnosis by providing them with and guiding them to suitable information, being mindful at all times that it is the individual’s ultimate choice that the path he decides to follow is his own and that of his family, based on his particular circumstances.”

    If only the majority of medical advisors had the same kind of aim.

  4. As a follow-up to Jim Waldenfels’ comment above … There is (as yet) no well-defined protocol for active surveillance … Thus, “active monitoring” may be a more appropriate term to describe a spectrum of active management strategies that include more and less aggressive forms of patient oversight short of invasive treatment.

  5. Dear Joseph:

    While it is true that increased application of active monitoring strategies would reduce the short-term revenue of urologists (from surgical intervention) and others (e.g., radiation oncologists, from radiation therapy), it has actually been shown that in the long term the total costs associated with active monitoring actually seem to be about the same as the costs associated with immediate intervention, and may even be somewhat higher.

    Since, for nearly 20 years, people like Terry Herbert and I have been pointing out that active monitoring (as opposed to immediate invasive treatment) is an entirely appropriate form of management for carefully selected patients diagnosed with prostate cancer, I think that many of us would argue that this has nothing to do with the money from our point of view and everything to do with quality of life over time.

    If you personally have some 25 cc of tumor in a 127 cc prostate, are under 65, and have any amount of Gleason 7 cancer in your prostate, then surgery may be an entirely appropriate option for you. On the other hand, if you are over 70 and have only Gleason 6 disease, then the value of surgery may be limited. All that The “New” Prostate Cancer InfoLink (and people like Dr. Chodak) are trying to do is to make sure that you are fully aware of all your options.

  6. The options really lie at the disposal of men suffering from low-risk prostate cancer. While some may want to opt for surgery, some would want to wait to see if any there is evidence of disease progression. However, the active surveillance is no easy task. Most of us would want to try some treatment option when suffering from illness like cancer and not be comfortable with just observation. Recently, I came across some university studies done on mice with prostate cancer which proved that use of certain mushroom extracts and African tree bark extract resulted in reduction in prostate tumor size and cell proliferation. The results are exciting and the study concludes that these ingredients (mushroom and African tree bark extracts) may serve as useful supplements for men with prostate cancer. Since men with low-risk prostate cancer have an option with regard treatment (whether invasive or observation), they may benefit from these supplements.

  7. Please note that the preceding comment was posted by an individual or organization seeking to promote and sell the products referred to in the message. We have left the message but deleted the reference to the web site promoting the products. The “New” Prostate Cancer InfoLink does not permit product advertising on this site.

    It should also be noted that biological activity of specific products in mice (or in vitro, or in other animals) is a very long way from being a clear indication of effectiveness or safety of these products when used in man (or woman either).

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