How long should we wait for results?

Dr. Chen: The great difficulty about this from a general “big-picture” viewpoint is that we’re in the midst of a very large controversy about whether we should even be looking for or treating prostate cancer, because very good data say that many men with the disease are going to be alive in five years even if we do nothing for them. So it becomes very difficult to know how long a period of time is adequate to determine if this HIFU treatment is useful and safe and effective, if men do very well anyway when nothing is done.

But in this restricted, select group of men who are at higher risk of treatment failure because they’ve already had a treatment before, and they don’t really have a lot of other options, if HIFU works, it works and you find out pretty quickly; if it doesn’t work, you find that out pretty quickly.

A lot of resources are dedicated to prostate cancer. And part of the question is, is it useful to dedicate even more resources to investigate a treatment when the existing treatments are already quite, quite good? I’m not going to say we should or shouldn’t be investigating HIFU, but from a health-care policy standpoint, if there are limited resources for medical care, should there be an investment in these other approaches that are marginally better or conceptually could be better, but they aren’t going to be huge leaps and bounds better than what we have already?

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It’s not that prostate cancer is not well-treated, but people can have a very dramatic change in their quality of life from these treatments. As the saying goes, is the medicine worse than the disease? HIFU is not going to be avoiding that.

But for some urologists, this HIFU approach becomes a means of keeping a patient by offering something that maybe nobody else does.

Is there any specific reason why the FDA has not approved HIFU therapy for prostate cancer yet?

Dr. Chen: I don’t think the FDA has a specific position for or against this. The agency is just very, very careful about what it approves, and it has a stringent approval process.

My take as an FDA outsider is that because most men today don’t die of prostate cancer, it is going to be politically very, very difficult for the FDA to approve something that ends up being more harmful than the cancer might be. If there’s a new treatment for pancreatic cancer, where 95% of patients die, the FDA might be more supportive of trying to move along the treatment approval process. But when it’s a development for a disease that is already established to be well-treated with existing approaches, there’s much less pressure to say, “Well, we really have to get this through.”

Can you share anything about results in your study patients to date?

Dr. Chen: It is really premature to say much about this at all, because no one has gone a full year from their treatment. I certainly would say HIFU is not a magic bullet. There’s definitely a lot of impact to the body, and perhaps that’s because we are treating a specific category of men—men who have already been treated once and so may have a higher risk of issues related to a salvage treatment.

How do you think the men you’ve treated to date are doing at this point compared with other men undergoing other forms of salvage therapy?

Dr. Chen: The outlook with HIFU is, comparatively, perhaps a little more optimistic than other salvage therapies, and that might be the role for this technology: Maybe it’s not useful to treat in the beginning for primary therapy, but maybe as the options for salvage therapy are limited, that would be where HIFU might be best applied.

Generally speaking, it is a very problematic situation of what is the appropriate and best way to treat men who have been previously treated. Secondary therapy—whether it’s salvage HIFU therapy, or salvage freezing  by cryosurgery, or salvage removal and prostatectomy—is recognized to be fraught with a lot of potential risks and challenges. I think HIFU patients on average probably do better, because it is noninvasive in its approach, but it’s also very early to make any conclusions.

Where is HIFU cost-wise in relation to other treatments?

Dr. Chen: The impression I have is that the rough health care costs for this procedure are probably about the same as for traditional surgical removal and prostatectomy. Like prostatectomy, HIFU will have the costs associated with anesthesia, certain equipment, operating-room fees, and surgeon fees.

But you are unconvinced at this point that HIFU brings anything better to the table?

Dr. Chen: This machinery has to be approved not only for safety, but for effectiveness. There’s not going to be a one-treatment-fits-all for prostate cancer, and there may certainly be a role for HIFU in prostate cancer.

But my general bias as someone who does surgery—prostate removal, using robotic surgery—I don’t personally believe HIFU adds anything to that. In my experience with my patients who have had their prostate removed, I think they do exceedingly well with some unavoidable change in their quality of life, but not much. And I do not foresee HIFU being able to be better, because there are inherent technical limitations to this treatment.

Do you see any urologic problem for which HIFU could be a valuable addition?

Dr. Chen: It was originally developed for benign prostate enlargement, and so it might be interesting to see whether it could still have a role there.