COMMENTARY

Should Focal Therapy Be Used in Localized Prostate Cancer?

Gerald Chodak, MD

Disclosures

August 21, 2018

Hello. I'm Dr Gerald Chodak from Medscape. Today's topic is focal therapy of localized prostate cancer using high-intensity focused ultrasound (HIFU). It's based on a recent report in European Urology that was conducted in Europe and is based on 625 men treated at multiple centers.[1] They have a median follow-up now of 56 months.

They're reporting a high overall survival, a high metastasis-free survival, and a high [failure-free] survival. The strengths of this study are that it's prospective, it's multicentered, and it includes reasonable follow-up. I believe that there are a number of weaknesses in this study.

The authors have made a conclusion that, based on these findings, focal HIFU is effective in the intermediate-term or median-term follow-up period, as a way of managing men with localized prostate cancer. There are several questions that I can raise about the findings so far.

First, 28% of the men had low-risk disease and 55% of the men had Gleason 3 + 4 disease. Many [men in] these two groups would be reasonable candidates for active surveillance with a low risk for recurrence. Reporting data on the majority of men having those characteristics may not be very good proof of the effectiveness of this approach.

Second, they did not report results on erectile dysfunction, even though they did measure it using validated surveys. The results from those validated surveys show a high continence rate, with 20% having some amount of leakage, but it is relatively small.

The follow-up period is also troubling. They had a requirement that men have at least 6 months of follow-up, and although the median is 56 months, it would seem that a high percentage of the men have been treated for less than 2 years. Reporting anything on men with that short follow-up [time] does not help provide strong support for the effectiveness of that treatment.

The third [question is related to] biopsy results. Thus far, 25% of the men who had a biopsy had recurrent disease and were eligible to be retreated. It is a concern that [this] many men did not have their cancer eradicated effectively. At 5 years, the freedom from not having a repeat HIFU treatment was 78% for men with low-risk disease, 79% for men with intermediate-risk disease, and only 69% for men with high-risk disease. These findings do not provide great strength for the value of this approach.

Going forward, where does this leave us? A position paper published in European Urology from the European Association of Urology argues that, based on what we know so far, focal therapy must be considered an experimental treatment.[2] There's just not enough good data showing that this is an effective way to eradicate or control the disease.

The authors have argued that conducting a prospective randomized trial will be quite difficult, as it has been for some of the other treatments currently used for treating localized disease. However, this is not an argument for why we should accept these results and make it a reasonable alternative therapy. For now, the argument in favor of focal therapy needs much more support. Showing [results from these immature] data does not provide great confidence that focal therapy is going to prove to be a valuable way to manage these men.

Is it going to be a good treatment for men who don't need to be treated at all? Is that an argument in favor of doing focal therapy, so that men avoid some of the psychological trauma of watching their disease without active therapy? I do not believe that that's how we should back into a treatment for managing men who don't need treatment at all.

I look forward to your comments. Thank you.

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