Yet another new type of HIFU is now in Phase II clinical trials


Another breathless media release has announced enrollment of the first patient into a Phase II clinical trial of yet another new form of high-intensity, focused ultrasound (HIFU) in men with low-risk and favorable, intermediate-risk, localized prostate cancer. However, once again, everyone seems to be going out of their way not to say that this is HIFU.

In the case of this new trial, the technology is described in the media release as “TULSA-PRO … an emerging therapy that uses MRI guidance and robotically driven therapeutic ultrasound to obtain precise prostate cancer tissue ablation”. In the trial description on the ClinicalTrials.gov web site, it states that TULSA-PRO is “intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.” TULSA seems to stand for “transurethral ultrasound therapy system”; quite what the PRO stands for is less clear; it may just be an abbreviation for the name of the developer (see below). Whatever people want to call this, it is actually just a form of HIFU.

So the trial is scheduled to enroll 110 patients at centers in the USA, Germany, the Netherlands, Spain, and Canada. It is an open, single-arm, non-comparative trial — which means that when the sponsoring company gets the trial results, neither they nor we will have any real idea whether it is better or worse than any other form of HIFU (or even active surveillance) for the eligible patient population.

For those who are interested, the company developing this technology is called Profound Medical Corp. On the company’s web site they define this technology as “A profoundly different approach to ablate the prostate”. It may well be profoundly different to surgery or radiation therapy, but not to the three other forms of HIFU that are already on the market, all of which can already be combined with MRI-based targeting techniques!

The “New” Prostate Cancer InfoLink sincerely hopes that the trial protocol requires all low-risk patients to be very clearly advised that treatment with this or any other technique may have short-, medium-, and long-term outcomes that are no better than active surveillance.

Of course for any patient who wants to have treatment by HIFU and who meets the trial enrollment criteria, this is a chance to get treated with what is probably a high-quality HIFU technology for free. On the other hand, we have no idea whether those using the equipment have any significant experience at all of actually treating men using any form of HIFU, which is well understood to have a significant learning curve.

We would note that this technology us already approved for commercial sale in Europe and in other CE Mark jurisdictions (which does not include the USA). According to the company, this approval “was based on a 30-patient phase I study conducted in the US, Canada, and Europe that demonstrated that TULSA-PRO precisely ablates prostate tissue, with low toxicity and a well-tolerated safety profile.”

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