The Emperor’s New Clothes: Active Surveillance’s Discipline vs. Focal Therapy’s Drift

(Editor’s note. Join ASPI for a look at what researchers actually know about the microbiome in the gut and the prostate— and what remains speculation — with urologic oncologist Dr. Michael Liss of UC San Diego, a leading voice in microbiome research and prostate cancer innovation. The program is Saturday, August 22, 2026 • 12 PM Eastern. Register here: https://aspatients.org/event/gut-microbiome-prostate-cancer/ If you can’t make it, that’s OK. Sign up and those nice people at ASPI will send you a link of the program. Why not sign up and help out your Gnarly Old Uncle Howard, the moderator?)

By Howard Wolinsky, Editor, The Active Surveillor

Hans Christian Andersen’s The Emperor’s New Clothes is an odd but perfect parable for modern prostate cancer care.

In a JAMA editorial by Daniel Spratt, MD, chair of the Department of Radiation Oncology and Urology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio, and colleagues, the fable becomes a warning: prestige, novelty, and social pressure can make clinicians praise what they cannot see — evidence. And in prostate cancer, Spratt argues, too many are admiring invisible cloth.

The editorial opens with the line: “The fable warns that when prestige, novelty, and social pressure line up together, the absence of evidence can be mistaken for evidence of excellence.” Spratt and colleagues argue that prostate cancer care is especially vulnerable to this mistake.

New technologies arrive “dressed in the language of precision, personalization, and reduced morbidity,” and clinicians — influenced by key opinion leaders, professional societies, reimbursement incentives, and market competition — can be swept along.

But the editorial also highlights a counterexample: Active Surveillance, which has quietly become one of the most evidence‑based disciplines in prostate cancer.

Spratt points to the Veterans Affairs (VA) health system, where Active Surveillance adoption has soared. Between 2005 and 2024, surveillance for low‑risk disease rose from 27% to 93%, and for favorable intermediate‑risk disease from 14% to 61%. These are not incremental changes; they represent a wholesale redefinition of guideline‑concordant care.

For more, go to: here.

Spratt writes: “Randomized trials, mature prospective cohorts with long-term follow-up, unified guideline support, and patient advocacy all converged to reverse a pattern of overtreatment.”

The VA’s integrated system helped clinicians resist the financial incentives that often push intervention. Surveillance adoption in the VA reached 87% to 90% for low‑risk disease in 2020–2021 — far above the ~60% national rate reported in the AUA Quality Registry.

Spratt emphasizes that clinicians learned to treat patient anxiety directly rather than using it as a justification for unnecessary treatment. Active Surveillance became disciplined care, not therapeutic inaction.

Even so, Spratt cautions that surveillance must be done well. Gleason grade group 2 (GG2) disease requires careful selection and follow‑up. He notes that “not all GG2 are the same,” citing ProtecT trial data showing that men with invasive cribriform morphology had significantly reduced metastasis risk with radiotherapy. Surveillance is powerful — but only when applied with rigor.

By Howard Wolinsky, Editor, The Active Surveillor

If the VA surveillance study represents progress, a second JAMA paper (see more below) represents the opposite. It is a warning siren.

Using the National Cancer Database (NCDB), the authors identified 15,672 men who received focal therapy between 2010 and 2023. Of those, 51% had low‑, high‑, or very‑high‑risk disease — categories where focal therapy is inappropriate and not supported by any guideline.

The research letter states: “Current guidelines recommend focal therapy only for intermediate-risk disease within clinical trials or prospective registries. No guideline panel recommends routine use outside of these settings.”

Even intermediate‑risk use cannot be assumed appropriate, because the NCDB cannot capture trial enrollment, lesion characteristics, or multifocality. As Spratt writes, “That restraint should not be mistaken for endorsement.”

Spratt dismantles the conceptual problem with clarity. If whole‑gland therapy does not improve outcomes in low‑risk disease, then partial ablation simply turns a surveillance‑appropriate condition into a procedure — with toxicity, cost, follow‑up burden, and retreatment risk — and with no evidence that destroying tissue improves how a patient lives.

He writes: “The prospective trial evidence for focal therapy is still mostly 1- and 2-year outcomes in small single-group cohorts of patients who were, in many cases, surveillance candidates themselves.”

And then the devastating comparison: “There is greater randomized evidence comparing 19 vs 20 fractions of external beam radiotherapy for localized prostate cancer than all focal therapy trial evidence combined globally.”

In other words: focal therapy’s evidence base is not just thin — it is almost nonexistent.

Spratt and colleagues note that focal therapy is more common among older and sicker patients, at community programs, and at higher‑volume centers. These patterns reflect diffusion, not benefit. Once a technique is available, reimbursable, and marketed as cutting‑edge, repeated use creates an aura of legitimacy the data have not earned.

Spratt et al. write: “Once a technique is available, reimbursable, and useful as a point of competitive difference, repeated use builds an aura of legitimacy the data have not earned.”

In Andersen’s fable, every approving courtier made the invisible cloth look more real. In prostate cancer, every off‑trial focal therapy procedure makes investigational care look routine.

Spratt and colleagues make this point: “Focal therapy should not be sold as an interchangeable middle option between radical prostatectomy and active surveillance.”

He contrasts the two approaches:

• Active Surveillance defers treatment while reassessing disease and keeping every curative path open.

• Focal Therapy destroys tissue irreversibly and leaves open questions about residual cancer, follow‑up, retreatment, salvage, and increased morbidity from salvage.

Spratt writes: “One is a mature strategy whose apparent simplicity hides real rigor. The other is an intervention whose technical sophistication can obscure real uncertainty.”

Spratt ends with a plea for honesty. Medicine needs the child in Andersen’s story — the one who simply says what everyone can already see: the emperor is naked.

He warns: “It is troubling when social and financial pressure bends clinical judgment toward experimental therapy given outside a trial.”

And the researchers remind readers that the field has made similar mistakes before — overtreating low‑risk disease, overselling proton therapy, assuming surgery was superior to radiotherapy — and each belief was corrected only by randomized trials, often after many patients were harmed.

Their final message is a challenge to academic leaders and professional societies: pause and ask whether promoting unproven treatments outside trials truly serves patients.

Taken together, these two JAMA papers show both sides of prostate cancer care today:

• Real progress — Active Surveillance is finally recognized as disciplined, evidence‑based care.

• Real concern — focal therapy is being adopted ahead of evidence, driven by marketing, reimbursement, and the allure of technology.

For men on Active Surveillance, the message is reassuring: your path is grounded in decades of randomized trials, long‑term cohorts, and guideline consensus. Focal therapy, by contrast, is still an emperor wearing invisible clothes.

By Howard Wolinsky, Editor, The Active Surveillor

Focal therapy has always lived in a strange space — part promise, part marketing, part hope, and part hype.

Two recent studies, one from the University of Pittsburgh and one from the UK, show just how far apart the promise and the practice have drifted. Together, they tell a story that matters deeply to men on Active Surveillance: focal therapy may look elegant, but the evidence supporting it remains very limited.

The Pittsburgh study led by Andrea Cosenza, MD, published in JAMA, examined more than 1.1 million men diagnosed with nonmetastatic prostate cancer between 2010 and 2023.

Only a small fraction — 1.3 percent — received focal therapy.

But the shock came in the details: 51 percent of those procedures were performed in men with low‑, high‑, or very‑high‑risk disease, categories where focal therapy is not recommended by any guideline.

The authors stated: “Current guidelines recommend focal therapy only for intermediate-risk disease within clinical trials or prospective registries. No guideline panel recommends routine use outside of these settings.”

In other words, focal therapy is being used where it shouldn’t be used.

Low‑risk men — ideal candidates for Active Surveillance — are being treated unnecessarily. High‑risk men — who need durable oncologic control — are being undertreated. And intermediate‑risk men are being treated outside trials, without the safeguards that make investigational therapy responsible. The Pittsburgh study shows focal therapy drifting into routine practice, pulled by availability, reimbursement, and the allure of technology rather than evidence.

The UK study, led by Dr. Alexander Light, of Imperial Prostate, Department of Surgery and Cancer, Imperial College London, London, UK, by contrast, tells a very different story — not about where focal therapy is used, but about how it performs.

Following more than 3,400 men treated with HIFU or cryotherapy, the UK team reported extremely low rates of metastasis and prostate‑cancer‑specific death over ten years. At first glance, it looked like a triumph for focal therapy.

More here and here.

But the fine print revealed why: the cohort was overwhelmingly composed of Grade Group 1 and 2 patients, men who already do well with Active Surveillance.

AS experts note low rates of metastases or prostate‑cancer‑specific death at 10 years would have been anticipated regardless of treatment.

The UK study did not prove that focal therapy cures high‑risk disease. It did not prove that focal therapy should replace Active Surveillance for low‑risk men. It simply showed that favorable‑risk prostate cancer behaves well — something Active Surveillance has demonstrated for decades. The outcomes reflected the biology of the disease, not the magic of the treatment.

The contrast between the two studies is stark. The UK study shows focal therapy performing well in men who were already expected to do well. The Pittsburgh study shows focal therapy being used in men who should not be receiving it at all. One study reflects careful selection; the other reflects clinical drift.

The UK team did not claim focal therapy is a middle option between surveillance and surgery. But in the U.S., that is exactly how focal therapy is often marketed — as a compromise that preserves quality of life while “treating the cancer.” The Pittsburgh study exposes what happens when that marketing spills into practice: overtreatment of low‑risk men, undertreatment of high‑risk men, and widespread use outside trials.

The two studies together form a cautionary tale. Focal therapy may have a role, but only in carefully selected intermediate‑risk patients, and only within clinical trials. When used outside those boundaries, it becomes either a solution in search of a problem or a compromise that leaves aggressive cancer behind.

For men on Active Surveillance, the UK study reinforces that favorable‑risk prostate cancer behaves well — exactly why surveillance works. The Pittsburgh study reinforces that focal therapy is drifting into territory where evidence cannot support it. Surveillance remains the disciplined, evidence‑based path. Focal therapy remains investigational, no matter how elegant the technology or how enthusiastic the marketing.

Join Dr. Jacob Tallman of UChicago Medicine for a conversation about life after prostate cancer. He’ll discuss survivorship, long-term health, and ways to support your quality of life after treatment.

This four-part series offers research-based information and practical strategies to help individuals diagnosed with prostate cancer and their caregivers navigate life during and after treatment. Participants are welcome to attend whichever sessions are most relevant to them and do not need to attend the entire series.

Registration is through an online portal called Mindbody (scroll down to view the Mindbody registration links). If you do not have a Mindbody account, you will be asked to create one. It’s easy and free. If you would like additional information about this event before signing up, please call 630.323.5150.

To Register: Click the “Register” button. You will be prompted to create an account or log in with our registration site, Mindbody Online.

The program is available at Wellness House, 31 N. County Line Road Hinsdale, Illinois. You can attend remotely.

Beyond Dr. Tallman’s presentation, topics include:

• Monday, September 14 | 6:00 – 7:30 pm: Safe Exercise After Prostate Cancer. Discover how physical activity can improve strength, reduce side effects, and support overall well-being.

• Monday, September 21 | 6:00 – 7:30 pm: Healthy Eating After Prostate Cancer. Explore nutrition strategies that promote health, recovery, and long-term wellness.

• Monday, September 28 | 6:00 – 7:30 pm: Coping with Prostate Cancer: Emotional Support, Caregiving and Reducing Isolation. Learn ways to manage the emotional impact of cancer, strengthen caregiving relationships, reduce isolation, and connect with support.

• Most Developed Countries: MRI First, Needles Later — But Not in U.S. Workflow: Ass‑Backwards and Out of Step.

(Editor’s note: For years, The Active Surveillor has been warning that the U.S. dramatically underuses pre‑biopsy MRI, even as the rest of the world has embraced MRI‑first diagnosis as the modern standard. Journalist Annalisa Merelli published an article on the topic Aug. 5 in STAT— tucked behind a paywall — lays out the case with striking clarity: America is still stuck in a biopsy‑first mindset that drives overdiagnosis, overtreatment, and patient anxiety. Yet another example where the US lags in prostate cancer care.)

By Howard Wolinsky, Editor, The Active Surveillor

The Active Surveillor has long argued that MRI’s supposed “blind spot”—missing lame small, non-threatening Gleason 6 so-called low-risk cancers— isn’t a flaw — it’s a feature.

Missing these these low-risk cancers doesn’t hurt patients and may help them avoid an unnecessary diagnosis.

Meanwhile, the prebiopsy MRI is largely ignored in the Land of the Brave, Home of the Free.

As UCLA urology chair Scott Eggener, my original AS urologist, told STAT, many of these microscopic findings “shouldn’t even be called a cancer.”

Yet half or more of these men still end up being treated. It’s the paradox The Surveillor has highlighted for years: the U.S. finds too much cancer that doesn’t matter — and then acts on it.

Meanwhile, Europe, Canada, Australia, and the U.K. have flipped the script. There, MRI comes first. It spares 30–50% of men from biopsy entirely and sharply reduces the discovery of clinically insignificant disease.

As STAT recently reported, MRI‑first means “between 30% and 50% of patients can avoid a biopsy… significantly reducing the risk of finding clinically insignificant cancer.” They also miss potential risks of biopsies, such as potentially deadly sepsis.

University College London’s Mark Emberton told STAT: “It’s one of the world’s worst global scandals that the richest country in the world denies most of its men access to something proven at level-one evidence.”

When I told Emberton the low uptake of MRI in the States, he was shocked.

He told The Active Surveillor earlier this year that roughly 35% of American men get an MRI before biopsy — itself a sobering figure — and a recent Medicare study found that only 1 in 20 received a pre-biopsy MRI. Rural men fared even worse.

Emberton’s view is simple and provocative: “The MRI is twice as good — and no needles.”

So why does the U.S. cling to biopsies?

STAT’ reports a mix of habit, training gaps, uneven MRI quality, limited access in rural and underserved communities, and the financial incentives baked into biopsy-heavy practices.

Michael Ahdoot, MD, Medical Director of Academic Urology and Director of the Minimally Invasive Urology Institute at Cedars-Sinai in LA, described a “knowledge deficit,” noting that “the vast majority of urologists don’t know how to read a prostate MRI reliably.”

Eggener added that MRI quality “can be all over the map,” especially outside major centers.

Radiologists should have expertise in reading the images.

Emberton argues that visible lesions alone should guide treatment. He told The Surveillor about “MRI invisible lesions” that are seen in biopsies but not MRIs.

Check out, this:

Eggener pushes back, telling STAT that “every study that’s out there shows that there can be meaningful cancers that aren’t seen by MRIs.”

Radiation oncologist Tyler Seibert, MD, PhD, Section Chief for Genitourinary Cancers at University of California, San Diego: “If I’m an oncologist treating a patient, I want the information from the systematic biopsy.” Ahdoot’s own research found that adding systematic biopsy detects 8% more clinically significant cancers — a number that keeps many clinicians from abandoning the needle entirely.

Yet despite the disagreements, one point is universal. As Seibert put it, “The right thing to do is to get an MRI every time.”

Share that with your urologists, Surveillors.

STAT’s reporting reinforces what The Active Surveillor has been arguing for years: MRI‑first isn’t just better medicine — it’s overdue. Until training improves, access expands, and incentives shift, most American men will continue to get biopsies first, and many will continue to be diagnosed with cancers that may never matter.

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