Risk stratification in diagnosis and management of prostate cancer

A new article by Vickers, Roobol, and Lilja, scheduled for publication in the January 2012 issue of the Annual Review of Medicine is likely to raise some eyebrows in the urology community.

Vickers et al.  clearly state that:

A sophisticated reading of the randomized trial evidence suggests that, although screening for prostate cancer with prostate-specific antigen (PSA) can reduce cancer-specific mortality, it does so at considerable cost in terms of the number of men who need to be screened, biopsied, and treated to prevent one death.

They go on to argue that we need to rethink our whole approach to prostate cancer “screening” programs, by emphasizing the need to minimize prostate cancer-specific mortality and to minimize unnecessary over-treatment of low-risk, clinically insignificant forms of prostate cancer.

The authors believe that this can be done by the application of risk stratification processes in screening and biopsy; increasing reliance on active surveillance for low-risk cancer; restricting the use of radical prostatectomy to high-volume surgeons; and the use of appropriate, high-dose radiotherapy.

Now it should be noted that this proposal is not being put forward by people with limited research knowledge in the field of prostate cancer. Dr. Roobol was one of the key personnel associated with the development and implementation of the ERSPC trial; Dr. Lilja is one of the true developers of the PSA and the free PSA tests; and Dr. Vickers is a highly experienced statistician and research methodologist who has spent the last few years of his career working on prostate cancer-related issues specifically at Memorial Sloan-Kettering Cancer Center.

The “New” Prostate Cancer InfoLink concurs with Vickers et al. that a risk-based stratification process for patient evaluation and a much greater focus on the application of expectant forms of management (active surveillance included) is absolutely the direction to take as we move forward. We also believe that it may be helpful to find a new form of nomenclature for early forms of prostatic neoplasia that are of questionable clinical significance at the time of initial identification so that we can stop referring to these neoplasia as “cancer” when they may very well not be cancerous.

7 Responses

  1. Finally, a sliver of hope for low-risk disease men.

  2. Unfortunately, even if their suggestion is adopted, the dilemma is unlikely to improve significantly for two reasons. First, once a diagnosis is made, all the advice of experts to embark on active surveillance for a low-risk tumor is unlikely to dissipate the anxiety and fear of the patient or his family, especially for men under 65, and, second, the prostate cancer industry will not thrive nor will it be paid for by encouraging a large percentage of active surveillance to take a conservative approach. The intervention must start before screening ever occurs with better education about the risks and benefits in ways the public can understand.

  3. The key to getting these changes implemented is to truly shift the health care paradigm to patient centeredness. As stated, this means providing all the necessary information at every step of care. Second, actually letting the patient share in the decisions on their treatment.

    Truly empowering patients will change the economics of prostate cancer.

  4. You say, “restricting the use of radical prostatectomy to high-volume surgeons; and the use of appropriate, high-dose radiotherapy.” Is there a definition of “appropriate high dose radiotherapy”?

    Is it accessible to the entire population? How is a high-volume surgeon defined? I asked the AUA to consider a subspecialty in prostate cancer with a minimum number of surgeries performed each year and CME’s after a fellowship for training. Easier to ask for than accomplish.

    Then how do you deal with rural areas? Where I live we have one urologist who comes here 2 days per week from Richmond to handle all urology issues. People travel 60 miles roundtrip just to see him. It is an additional 120 mile roundtrip to go to Richmond. A free-standing radiation facility opened 2 years ago so people can access care without the long trip. What about Medicaid patients?

    Click here to get a snapshot of the prostate cancer situation in Virginia. We have large pockets of uninsured or Medicaid populations or men in rural areas with very low population density.

    Could this potentially make access to care a problem for some men?

  5. Dear Kathy:

    (1) It would be extremely easy for high volume surgeons (e.g., surgeons who do 200+ RPs per year) to travel to decent hospitals in rural areas and do (say) 3 RPs on a single day (or 6 over 2 days) using laparoscopic technology. Of course our current medical reimbusement system doesn’t encourage this.

    (2) High dose radiation therapy with image guidance and intensity modulation can be used to give doses of up to 80 Gy and higher, but most people would consider 75 to 80 Gy to be “high dose” external beam radiation today.

    (3) I hate to tell you this but by comparison with most of America, Virginia is barely a “rural” state at all. Think Montana. Think Alaska. Think large parts of New Mexico. I would estimate that everyone in Virginia is within a 3-hour drive of a major academic medical center! Again, it is our social mindset that is the problem, not the ability to actually get people to appropriate care. Many people think nothing of making a 100 mile roundtrip by car just to go to work each and every day … Others think that everything should be available to them at their local hospital. We will never resolve this issue with our current health care system. This has nothing to do with prostate cancer or any other specific disorder; it has to do with equality of access to health care.

  6. Mike, I agree on number 1. Also on number 3, but until I moved here and faced the reality of the area I did not understand what it means to live in a rural environment. It is not just about distance. My county in the most recent census had a little over 11,000 people. It takes approximately 2.5 hours to drive from one end of our health district to the other. Virginia has two NCI-designated cancer centers. One in Charlottesville and one in Richmond. VCU does very little prostate cancer work. http://www.massey.vcu.edu/prostate-genitourinary-cancers-team.htm Most of the work is done by a large private practice. http://www.uro.com/. People do go to Duke or to Georgetown. In the southwest part of Virginia the closest cancer centers are in Nashville or Charlottesville. In the northwest part of the state the closest NCI cancer center is Pittsburgh or Georgetown. There is a system to have oncology nurses to travel the circuit. Then there is follow-up care. Dr Schelhammer found that his patients from Delmarva were not coming in for follow-ups. The toll on the bridge/tunnel went up to $20.00. He set up an office where they were so they would get the necessary followup.

    I recently gave a mattress to a family whose kids were sleeping on the floor. There are people here who do not have indoor plumbing. I recently spoke to a woman who lives across the river and has never been to Tappahannock.

    Personally I am in favor of the recommendation but there are cultural, financial and access issue that need to be addressed.

    I do not have the personal knowledge of other states but yes Alaska, etc have access issues that are worse than ours.

  7. The socioeconomic problems you describe aren’t limited to rural America, Kathy. Spend a day in Camden or parts of northern and western Philadelphia or almost any other major American city. Poverty in America is worse than what one would find in most of Europe, but we are in total denial as a society. Prostate cancer is not the problem that worries me (in relative terms) when you start down that path.

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