Expert opinion on criteria for application of focal therapy

The  statements that you will find below represent the “expert opinion” of a multinational group of specialists who have been using focal therapy investigationally in the treatment of men with certain types of prostate cancer in recent years.

As the participants/authors state very clearly in the abstract to their recently published report, this is “only” expert opinion (which comes with a low grade for validity of the evidence, i.e., evidence level 5, compared to the evidence level of large, well-conducted, randomized clinical trials, which is evidence level 1). The recommendations being made by the group therefore need to be interpreted with caution. It should also be noted that this set of statements may already be out of date, since the meeting at which the various statements were evaluated and discussed was held more than a year ago in London.

For what it is worth, here are just a few of the most important things that the panelists all agreed on after discussion at that time:

  • Patients with intermediate-risk disease and patients with unifocal and multifocal prostate cancer are eligible for focal treatment.
  • MRI-targeted or template-mapping biopsy should be used to plan treatment.
  • Planned treatment margins should be 5 mm from the known tumor.
  • Prostate volume or age should not be a primary determinant of eligibility.
  • Foci of indolent cancer can be left untreated when treating the dominant index lesion.
  • Histologic outcomes should be defined by targeted biopsy at 1 year.
  • Residual disease in the treated area of ≤ 3 mm of Gleason 3 + 3 = 6 does not necessarily need further treatment.
  • Focal retreatment rates of ≤ 20 percent should be considered clinically acceptable but subsequent whole-gland therapy is deemed a failure of focal therapy.

There were, in fact, a total of 246 statements considered by the 15 panelists, and they were able to reach consensus on 154 of those statements (63 percent).

The best way to think about all this is not that they are recommendations about how to evaluate and treat men who want to have focal therapy. Rather, they are key factors to be taken into consideration in the evaluation and treatment of men in current and ongoing studies designed to evaluate the risks and benefits of focal therapy.

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