New NCCN guidelines on prostate cancer are not an all-around success!

Alas, the latest revisions to the National Comprehensive Cancer Network (NCCN) guidelines on early detection of prostate cancer seem to have instigated more furore than they have clarity (although the original premise behind them may have been well intentioned).

The new guidance was unveiled at the 19th Annual Conference of the NCCN, being held in Hollywood, Florida, and includes two recommendations that critics already argue are not supported by high quality evidence:

  • Establishment of a baseline PSA level in men aged 45 to 49 years of age
  • Routine PSA testing in appropriately selected men up to and including those of 70 years of age and older (in carefully selected individuals)

The key revision of the guidelines can be found on page PROSD-2 of the NCCN guideline for early detection of prostate cancer (version 2014.1). This is accessible to any interested reader, but you do need to register to gain access. For a detailed discussion of the furore, see this article on the Medscape Oncology web site.

The “New” Prostate Cancer InfoLink has a degree of sympathy with the critics. There is no Level 1 evidence supporting the validity of either of these two recommendations, and they are indeed based on opinion — which is based on retrospective data analysis in the first case and pragmatism in the second.

Having said that, The “New” Prostate Cancer InfoLink is also of the view that the NCCN is trying hard to find a middle ground that will be acceptable to many and that will

  • Increase the likelihood of appropriate, early diagnosis in those men who need such a diagnosis
  • Minimize risk for over-treatment by emphasizing that early diagnosis is not an absolute indicator of the need for immediate interventional therapy (because active surveillance may be a more appropriate first-line management strategy, even in some of the relatively young)

The problem is that there are those on either side of this debate that want black/white absolutes and who are unwilling to consider that there are some very real shades of grey in between.

The “New” Prostate Cancer InfoLink is increasingly convinced that this debate has become stale to the point of futility. There is no common ground that people are willing to stand on together, so as to give really sound guidance that is of value to the majority of doctors and their patients. That, in and of itself, is simply sad. Some men really do, justifiably, need and seek early diagnosis. And we cannot always tell easily who those men might be. Equally, some men really do not need early diagnosis. These are men who have low- or very low-risk, indolent forms of prostate cancer that will never need treatment at all. Again, it is impossible to identify and categorize these men with accuracy, even once they have been diagnosed.

As we have stated many times in the past, for all its purported value as an assay for risk of prostate cancer, the PSA test has almost no value when it comes to understanding what to do about the results it provides. We need a better, non-invasive test, and to have real value that test must be able to give us some clear insight into who does need early intervention and who may be able to defer any treatment for years. Without such a test, the current futile debate is going to play out for another 20+ years, with no real chance of any resolution.

What do we do in the interim? There seems to be little doubt that we have to just muddle along in much the same way as we have for the past 20 years, since the PSA test first became widely available. This seems like a very poor way for an informed society to be addressing a very complex problem.

2 Responses

  1. First, thank you for maintaining this extraordinarily thoughtful site. The first step in better care is for physicians and patients is to recognize the enormous uncertainties in the field with respect to screening, diagnosis, and treatment. All decisions are fraught with risks as well as potential benefits, and few medical center web sites or brochures convey this challenging reality. Your site is one of the very few on the Web where the complexity of the medical and psychological issues associated with prostate cancer are addressed. It’s so refreshing to see data discussed, rather than impressions, opinions, and anecdotes.

    Unfortunately, the lack of any regulatory requirements to demonstrate the efficacy of new diagnostic procedures (such as imaging) and introduction of new therapies has been a disaster from the patient’s standpoint. I’m not sure how this can be remedied at this point. The dearth of well-controlled clinical trials for the spectrum of surgical, radiological, ultrasound, active surveillance, and other therapeutic strategies is an intractable barrier to evidence-based decision-making. Retrospective comparisons are far too easy to bias, or simply too vulnerable to unappreciated confounds to interpret.

  2. Dear Francis:

    (1) Thank you for your kind remarks.

    (2) The FDA has started to require actual data related to the approval of some new forms of treatment and diagnostic tests, but this is a challenging area for the regulatory community, for many reasons. One of the reasons that high-intensity focused ultrasound (HIFU) is not approved as a form of treatment for prostate cancer in the USA is because the FDA did, in fact, require the equipment manufacturers (SonoCare and Ablatherm) to provide clinical evidence of efficacy and safety related to the use of HIFU in the management of prostate cancer. This did not sit well with many of the advocates for this technology. However, The “New” Prostate Cancer InfoLink sees it as a positive step in the right direction, and we await the outcome with great interest.

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