Radical removal or radiation of the prostate is still considered the gold standard for aggressive tumors. However, for medium-risk tumors, focal therapy—the targeted treatment of only the tumor site—has established itself as a serious alternative. Various technical options are available for this therapy. However, there is a discrepancy in the reimbursement system: while the heat-based HIFU (high-intensity focused ultrasound) procedure is already covered by basic insurance, patients must pay for the innovative irreversible electroporation (IRE) themselves.
New data from the large-scale PRESERVE clinical trial is drawing attention to this non-thermal procedure (NanoKnife). It uses electrical pulses instead of heat to eliminate cancer cells – a decisive advantage in anatomically critical areas near the sphincter and nerve bundles, where heat would be too risky.
Prof. Dr. med. Gernot Bonkat, who was the first to use IRE in Switzerland, explains why the current data suggest that the service catalog should be adjusted for both medical and economic reasons.
Prof. Bonkat, is prostate cancer still too often treated too aggressively today?
I would take a more nuanced view of the term “aggressive.” In the past, the diagnosis often meant immediate surgery. Today, we weigh up the options very carefully. For less risky findings, “active surveillance” is an established and safe strategy. However, if we decide on therapy, the standard treatment is still usually radical treatment – i.e., complete surgical removal of the prostate or radiation of the entire organ. Despite state-of-the-art radiation or robot technology, this remains a significant intervention in the body that can affect quality of life, especially continence and potency. This is precisely where a rethink is taking place: Is it always necessary to treat the entire organ in order to control a locally confined focus? The future lies in precision: effectively eliminating the tumor while preserving the man’s functional integrity as much as possible.
Viele Männer glauben: Krebs gleich Operation. Ist das medizinisch überholt
This is not a matter of “belief,” but rather the logical consequence in the case of aggressive tumors. Radical removal is the absolute gold standard here—as is radiation—and is currently still indispensable from a medical perspective. However, thanks to modern imaging, we now see that there is a growing group of patients for whom this major procedure may be “too much of a good thing.” The aim here is not to replace established surgery, but to intelligently expand the spectrum of options. If we can preserve the organ in these specific patients without compromising safety, we will be closing a gap in care. Focal therapy is therefore not an attack on the standard, but the missing piece of the puzzle for complete, tailor-made urology. And this is where I see great potential for IRE.
The new PRESERVE study shows good results for targeted tumor treatment with irreversible electroporation (IRE). What does this mean for the current standard?
The PRESERVE study is a real milestone, as it meets the highest scientific standards as an FDA approval study. It prospectively shows that we can effectively eliminate cancer with the Nanoknife system (IRE) without risking the typical collateral damage associated with thermal procedures. The most important result for quality of life: continence was completely preserved in 96 percent of men. Erectile function was also preserved in the vast majority of cases. For the current standard of care, this means that we now have a validated, safe option that precisely fills the gap between “active surveillance” and radical surgery.
Could it be said that we often treat the whole organ even though only part of it is diseased?
The comparison is absolutely apt. Organ-preserving therapy has long been established for breast cancer. We are now implementing this paradigm shift for prostate cancer as well. Thanks to high-resolution MRI and fusion biopsies, we can now precisely locate the tumor and target it specifically, instead of removing the entire prostate as standard practice. But—and this is crucial for safety—we are very selective. Not every case is suitable for this approach. There are clear criteria that call for radical therapy, and we adhere to them consistently. The trick is to identify precisely who will benefit most from which procedure.
Why has this logic persisted in medicine for so long?
This was mainly due to visibility. For a long time, the prostate was a kind of “black box” for us. We knew there was a tumor there, but we couldn’t locate it reliably enough using imaging techniques. Radical therapy was therefore not a mistake, but a necessary safety measure. It was modern technology that finally shed light on the situation. Today, we have the precision we need to treat the specific area rather than the entire organ “blindly.”
Guidelines react slowly to innovation. Is this justifiably cautious or structurally conservative?
As I myself chair a guidelines committee of the European Association of Urology (EAU), I am very familiar with this balancing act. Guidelines are the safety net for broad-based care; they must be conservative and await a high level of evidence. Innovation, on the other hand, often takes place before the guideline is issued. The reason we used IRE early on was because of its convincing physical logic and the obvious need of my patients who did not want radical surgery. We did not promote it as a new standard for everyone, but as an option for well-informed patients in specialized hands. The PRESERVE study now closes the scientific gap. It provides the objective data that confirms our clinical approach. With this, IRE leaves its experimental status behind and becomes a valid component of modern uro-oncology.
What role does the fear of liability or under-treatment play in this?
This is a very human reflex. Radical removal is often perceived as the “safest” option because the organ is gone. However, even surgery does not offer a 100 percent guarantee against recurrence. Consistent follow-up care is therefore mandatory for both procedures. In terms of liability, the PRESERVE study now gives us exactly the data we need. It defines the safety standard. It is important to me to emphasize that focal therapy is not an “easier” option or a “light version.” On the contrary, it requires excellent diagnostics and the highest level of expertise in selection. It is the precise approach for the right patient, and this individualization is the future of urology.
If patients had a choice and understood all the information, would fewer opt for radical therapy?
I am convinced of that. Patients today place a very high value on quality of life—that is, maintaining continence and potency. When men understand that IRE can achieve this in suitable cases without compromising tumor control, their preference naturally shifts. However, it remains important to be honest: we cannot promise anything that biology cannot deliver. Not every tumor is suitable for IRE or another form of focal therapy. But studies such as PRESERVE have finally put an end to the days when focal therapy was dismissed as a medical novelty.
Health insurance companies do not usually pay for the IRE method. Is this about evidence or economics?
Until now, there has been a lack of hard data. Health insurance companies act as trustees of premium payments and rightly demanded evidence. However, this argument no longer holds water. The PRESERVE study and FDA approval provide the required safety data. We also need to think in terms of health economics: a precise therapy that prevents incontinence and impotence can save the system expensive follow-up costs in the long term. Adding the method to the list of covered services is therefore not only medically necessary, but also commercially sensible, and should be discussed accordingly.
Could the system paradoxically favor more expensive therapies because they are established?
The system does not necessarily favor expensive treatments, but rather standardization and predictability. Established procedures are highly routine and clearly reflected in the tariff structures. Individualized, focused therapy breaks with this routine: it initially requires a higher investment in diagnostics and planning. Our healthcare system is still designed to reimburse standardized procedures and finds it difficult to adequately reflect this individual precision—which initially appears to be “additional expense” but saves follow-up costs in the long term.
How is focal therapy changing the way urology sees itself: from “removal” to “preservation”?
It is indeed an evolution of the medical mission. We are transforming ourselves from mere “surgeons” to “function preservers.” This step is logical: organ preservation has long been standard practice for kidney tumors. Now we are taking this step for prostate cancer as well. It’s about honest, personalized medicine. Patients today no longer unconditionally subordinate quality of life to survival, but demand both. Our task is to use sensitivity and technical excellence to enable this individual path – away from “one size fits all” and toward customized care.
Will prostate cancer in future be a disease that is controlled rather than eliminated?
That depends largely on the risk profile. Prostate cancer is an extremely heterogeneous disease: it ranges from harmless “kittens” to aggressive “saber-toothed tigers.” Today, we no longer treat the harmless variants, but actively monitor them. We are actually seeing a shift toward managing a chronic disease, similar to diabetes or high blood pressure. What is new, however, is the next step: if biology requires intervention, we no longer necessarily have to remove the organ. Today, we can make targeted “corrections” with focal therapy. The goal is long-term control of the disease with maximum quality of life.
When do you think the discussion will change and how?
The discussion no longer needs to be overturned—change is already a reality. The strongest drivers are the men affected and their families. Men today are extremely well informed and specifically ask about the possibilities of focal therapy. While I cannot recommend it to everyone, I must inform everyone about it. Providing “comprehensive information” about all options – both radical and focal – is not only a legal obligation, but also an ethical standard. Because only those who know the whole picture can make an informed decision.
Prof. Bonkat, you are a pioneer of IRE in Switzerland and established the “NanoKnife” in Switzerland back in 2017. As I recall, there were not only positive reactions back then?
That’s right. We at alta uro were the first in Switzerland to use the NanoKnife in 2017 for the treatment of prostate cancer. However, I wouldn’t call it “established,” as we later strategically paused the program. To my knowledge, we are still the only ones in Switzerland with this expertise. As a pioneer, you often encounter headwinds; innovation challenges the status quo. The criticism at the time—including on Swiss television—primarily related to our communication strategy, not the medical substance of the method. We accepted this criticism, corrected our communication, and learned from it.
Despite this initial criticism, you have stuck with the method. Do you feel vindicated by the current studies?
Absolutely. From a purely scientific point of view, our colleagues’ skepticism was understandable at the time, as there were no large-scale studies available. But there was already sufficient data to convince us of the potential of this technique, and our own clinical results were almost entirely consistent with the current data from the PRESERVE study. Those who lead the way are bound to attract criticism. The fact that we are now being confirmed by the new evidence shows that our vision was correct. I tend to agree with William James: “Every new idea in science goes through three stages. First, people say it isn’t true. Then they say it is true but unimportant. And finally, they say it is true and important, but not new.” We are currently on our way to the third phase, and suddenly it seems that many people have always known this.
The questions were asked by Binci Heeb.
Read also: Prostate cancer: Health insurers do not yet pay for focal therapy
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