Focal therapy: time to step up to the plate (or not)!


An opinion piece in the May 4 issue of the Journal of Clinical Oncology has outlined serious (and not unreasonable)  questions about the long-term viability of focal therapy (of any type) as a method for the treatment of small foci of localized prostate cancer.

This article by Giannarini et al. states that — at least for the time being — any form of focal therapy for the treatment of localized prostate cancer should be considered to be an “experimental” or at best an “investigational” form of treatment for localized disease. And regrettably the authors use both of these terms in their opening statement, which will help insurance companies in the USA to justify not covering the costs of such procedures.

The article by Giannarini et al. is also discussed in a commentary on the Medscape Oncology web site, under the heading “Prostate lumpectomy: will it remain an attractive illusion?

Although differing types of focal therapy have been used in the management of small foci of prostate cancer for several years now — dating back to about 2005, the fact is that we still have no well-documented, long-term outcomes data from any significant series of patients, all treated according to a single, well-defined protocol. Without such data, it is impossible to know whether focal therapy does or doesn’t have good and reliable 5- and 10-year outcomes data in an appropriately selected subset of patients.

The situation is further complicated by the fact that most of the patients who do undergo focal therapy are (arguably), and certainly have been in the past, the patients who are probably most appropriately managed with some form of expectant management, i.e., careful monitoring with deferral of any therapy until such therapy clearly becomes necessary because of upstaging or upgrading or a rapidly rising PSA level.

If we are going to be able justify the theoretical value of focal therapy, we need real, long-term, prospective data from a carefully selected series of patients, and ideally from a carefully selected series of patients who

  • Have been on or at least told they are appropriate candidates for active surveillance
  • Are either not appropriate candidates to stay on active surveillance or are unwilling to start or remain on active surveillance, and
  • Who still meet a set of very specific criteria suggesting that focal therapy would be a viable form of care

What would be the most appropriate type of focal therapy for such men, if we were to pursue this objective with rigor? Nobody really knows, which is the other half of this very problematic equation.

Focal use of high-intensity focused ultrasound (HIFU) is certainly a possibility — but no form of has been approved for the treatment of prostate cancer here in America (to date). Focal laser ablation of the prostate may also be a possibility (although there are very few surgeons with experience of this technique as yet). Focal cryotherapy has been more widely used, but there is little consensus about the methodology, the efficacy, or the safety of this technique. Other candidates include the focal use of stereotactic body radiation therapy (SBRT), of radioactive seed implantation (“brachytherapy”), of proton beam radiation therapy (PBRT), and of a whole spectrum of other lesser known therapies.

What is clear to The “New” Prostate Cancer InfoLink is that it is time for us to make some serious decisions about focal therapy:

  • Are we going to really pursue this objective seriously or not?
  • How could one construct and fund an appropriate clinical study protocol (given that any type of randomized clinical trial is certainly out of the question)?
  • What types of focal therapy really should be pursued in th short term, and which ones not?
  • How are we going to make sure that such a form of treatment is really being explored in the most appropriate patients?
  • And, last but not least, who will be willing to take this on and manage a process over 10-15 years that collects sufficient, high-quality data that will really be able to give us some meaningful guidance about the viability of the technique(s) that get tested?

It’s time for us all to stop talking and deal with the issue!

Supplementary editorial comment (dated May 7, 2014): Apparently others have also had this issue on their minds. An article published just a few days ago by Ahmed et ea. in Nature Reviews: Clinical Oncology is entitled “Can we deliver randomized trials of focal therapy in prostate cancer?” This link will take you to the abstract, but Dr. Ahmed has just sent us a copy of the full text of the paper, and so we will probably have more to say on this topic.

2 Responses

  1. This article is interesting. I had this treatment over 2 years ago and my PSA at the end was 0.03 from 4.7 in the beginning. I recently had a check of my PSA and, although it had risen slightly, I believe this procedure is the best available to an extent. My doctor performed a TRUS approach taking 12 samples, but now I think that a 3D mapping procedure would be better and, according to a doctor in Orlando, FL, would cover the entire prostate. My thoughts are that the TRUS approach missed some of the cancerous tissue is the reason it has returned. My doctor feels that my PSA rose because it fluctuates as in the past. My next appointment is October. These are my personal thoughts on the subject and I will be seeking the improved procedure soon, if PSA continues to rise.

    Ed

  2. Dear Ed:

    Exactly what type of focal therapy did you have? It would actually be most unusual for any patient to have his PSA level drop down to 0.03 ng/ml, let alone stay there, after focal therapy of any type. Focal therapy should leave the patient with at least half of his normal prostate after treatment. That normal remaining prostate tissue would produce normal PSA levels, which might very reasonably have levels up to 2.0 ng/ml or thereabouts, and they would most certainly fluctuate a little from test to test, just as PSA levels do in men with normal prostates.

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