Intense discussion of the future of focal therapy in prostate cancer

At a 4-hour meeting yesterday afternoon here in New Orleans there was intense discussion of issues related to the future of focal therapy and (potentially) to the approval of new types of device and technologies that might be able to deliver focal therapy.

This is a topic that raises all sorts of issues that still need to be resolved — from who is a good candidate for focal therapy in the first place (and how accurately such patients can be defined) to what endpoints could be used in trials designed to assess whether particular types of focal therapy actually produce therapeutically beneficial results.

It is impossible here to give even a quick summary of all of the issues that were discussed by something like 25 presenters and discussants (not to mention the dozens of comments from members of the audience). However, what was clear to your sitemaster was the following:

  • Multi-parametric MRIs and MRI-based biopsy techniques are now probably “good enough” to help to accurately define the types of patients who are most likely to be good candidates for focal therapy … but these techniques could still be better.
  • There is likely a role for some of the newer genetic/genomic markers in helping to define appropriate patients for focal therapy too.
  • There is little consensus across the urology community as a whole about the appropriateness and potential value of focal therapy.
  • There was strong advocacy from experienced patient representatives on several panels in favor of high quality trials designed to bring focal therapies into the mainstream in the treatment of lower-risk forms of prostate cancer.
  • There was considerable concern that the widespread availability of focal therapies would lead to many men who were excellent candidates for active surveillance being given unnecessary focal therapy.
  • Quality of life endpoints and data capture would be an essential component of the evaluation of any focal therapy technique as compared to whole-gland therapies.
  • The primary endpoint which the most experienced clinicians seemed to favor as a means to measure the effectiveness of focal therapy was time to the need for second-line treatment (as opposed to one repeat of a specific form of focal therapy).

To this last point, what the discussants were implying that a repeat of focal HIFU or FLA to the same original lesion in men who had not fully responded to a first use of such a focal therapy would not be considered a second-line treatment, but anything like the necessity for subsequent whole-gland treatment of any type would be, and so would the need for focal therapy to a different area of the prostate in a man who had already had focal therapy to one specific lesion. Whether such an endpoint would be acceptable to the U.S. Food and Drug Administration (FDA) — at least for a medical device as opposed to any form of drug therapy —  is still to be determined.

Perhaps what was of greatest interest to your sitemaster, however, was the fact that a research group in the UK has already started to recruit patients to a large randomized trial of focal therapy vs. radical, whole-gland prostatectomy for men who meet specific criteria as candidates for focal therapy that include either a large but highly defined volume of Gleason 6 disease or any focal amount of Gleason 7 disease. This so-called PART trial was described by Dr. Freddie Hamdy. It has been designed to enroll a total of between 600 and 800 patients subject to the successful enrollment of the first 100 patients in a pilot phase which is already under way.

As was learned by the UK investigators in conducting the ProtecT trial, the PART trial is again using clinical trial nurses as opposed to physicians to discuss the opportunity to enroll in this trial with patients, and Dr. Hamdy stated that, at his institution, the first seven patients asked whether they would consider participation in the trial all agreed to do so. Dr. Hamdy did not state exactly what form or forms of focal therapy were being used in the PART study.

One Response

  1. “There was considerable concern that the widespread availability of focal therapies would lead to many men who were excellent candidates for active surveillance being given unnecessary focal therapy.”

    As opposed to the current concern about unnecessary radical, whole-gland prostatectomy?

    I know what you mean, but my guess is that the largest group of converts would be in the “I have to do something, anything group ” now getting radical surgery, followed by the radiation group with the AS group coming in third.

    All of which, as you point out, is secondary to “Does it work?”

    Go Brits.

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