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BackTable / Urology / Article
Evolving Guidelines on Focal Therapy for Prostate Cancer
Kaitlin Sheppard • Updated Nov 8, 2024 • 67 hits
As focal therapy becomes more prominent as a treatment option for prostate cancer, clinicians are grappling with inconsistent terminology and limited guideline support. Discussions with urological experts such as Dr. Matt Cooperberg and Dr. Arvin George reveal the challenges posed by a regulatory system that more readily approves devices than drugs, often without requiring robust efficacy data. While the field is shifting toward more structured studies and better data collection, focal therapy's past as a poorly defined, under-regulated, and variable practice underscores the necessity for clearer guidelines and definitions to enhance patient care and research outcomes.
This article features excerpts from the BackTable Urology Podcast. We’ve provided the highlight reel in this article, but you can listen to the full podcast below.
The BackTable Brief
• The term "focal therapy" is used inconsistently across clinical discussions and research literature, leading to confusion. The definitions can vary widely, with some using it strictly for treatments with minimal tissue impact, while others may label more extensive ablation procedures as "focal."
• The methods employed under the umbrella of focal therapy can vary significantly. These include hemi-ablation, which treats half of the prostate, and hemi plus ablation, which extends to most of one side while sparing select tissue near neurovascular bundles.
• The diverse use of terminology and the broad range of techniques encompassed under focal therapy create substantial challenges for clinicians trying to compare treatment outcomes and efficacy. Inconsistent use of definitions across studies makes it difficult to conduct meta-analyses or draw meaningful conclusions from different data sets. This lack of standardization highlights the need for uniform guidelines and clearly defined terms to enhance research quality and clinical application.
• In the United States, focal therapy for prostate cancer is acknowledged but does not yet have comprehensive support in national guidelines. This limited endorsement stems from the relatively recent development of focal therapy as a standard treatment option and the absence of long-term data comparable to traditional treatments such as surgery and radiation.
• Although focal therapy is not classified as first-in-human research, it retains a status that advises its practice within controlled settings, such as clinical trials or registries. This ensures that patient outcomes are meticulously tracked and data is collected to build a stronger evidence base. The intent is to refine the technique, gather efficacy data, and monitor for potential long-term side effects.
• There is a growing movement toward more structured research and academic involvement in focal therapy. Prospective studies and controlled trials are being conducted to provide the robust data needed to refine treatment protocols and address longstanding questions about safety, efficacy, and optimal patient selection.
Table of Contents
(1) What is Focal Therapy for Prostate Cancer? The Need for Consistent Terminology
(2) Guideline & Regulatory Challenges in Prostate Focal Therapy
What is Focal Therapy for Prostate Cancer? The Need for Consistent Terminology
True "focal therapy" involves targeting the index prostate cancer lesion along with a safety margin, typically around one centimeter or more. However, some practitioners may also incorrectly use the term focal therapy when describing any form of partial gland ablation.
Inconsistent terminology often causes confusion when discussing ablative procedures in prostate cancer and complicates the clinical literature, as various modalities—ranging from true focal therapy to hemi-ablation or even more extensive approaches sparing specific tissue structures—are used interchangeably. Standardizing terms is an important step in ensuring consistent communication and accurate comparisons within clinical practice.
[Dr. Arvin George]:
There's some semantics that surround [focal therapy] and there have been some attempts at trying to clarify the terms but there's partial gland ablation, which is the overarching umbrella term, which is anything that's a subtotal ablation. Then focal therapy, in my mind, is really treatment of the index lesion plus a safety margin that I typically employ about 1 centimeter or more.
[Dr. Aditya Bagrodia]:
Matt, does that sound about right?
[Dr. Matt Cooperberg]:
Yes, I would totally agree, but to emphasize Arvin's point, the terminology is used highly variable across the literature. Samaritan Asia had a nice classification, which I'm sure many others have used as well, which is, truly focal being exactly what Arvin just described, a visible lesion with some margin around it. It could be hemi ablation. Others will do hemi plus, the other side. I've seen somewhere they do hemi plus almost the entire side, just sparing a little bit of tissue around the NVB and still call that focal.
You can see the term used and abused in lots of ways. It's one of the things that has made the literature a little bit difficult to track.
[Dr. Aditya Bagrodia]:
Yes, whole gland ablation, hockey stick ablation, hemi gland ablation.
[Dr. Arvin George]:
It's a spectrum. It's just a spectrum from A to Z. We feel compelled to call it different names to help clarify for comparing apples to apples, I guess.
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Guideline & Regulatory Challenges in Prostate Focal Therapy
The current state of focal therapy for prostate cancer reflects an evolving landscape marked by sparse and cautious guidelines. Dr. Matt Cooperberg highlights the guarded approach of US guidelines, noting that while focal therapy is no longer considered purely experimental, it lacks the extensive follow-up and validation seen with standard treatments like surgery and radiation.
National organizations have yet to adopt explicit guidelines, emphasizing that patient tracking through trials or registries remains essential. However, guidance from major bodies such as the AUA and EAU, recommend performing focal therapy within well-structured prospective studies. Regulatory hurdles add complexity, with a stark contrast between the rigorous approval process for injectables and the comparatively lenient path for devices. This environment has historically led to inconsistent practices and outcomes, further illustrating a need for more standardized oversight and data-driven approaches.
[Dr. Aditya Bagrodia]:
For much of my training career, focal therapy was this gimmicky deal that people in Florida were doing for cash pay. Then they'd wind up at a normal center where everybody, high grade, low grade, surveillance candidates, high risk for getting ablation. I guess we just saw these catastrophes.
The state of the art seems to be improving imaging, all that. Of course, we'll talk about that. What about just guidelines? What do our US guidelines say? Is this experimental? Is this ready for prime time?
[Dr. Matt Cooperberg]:
The guidelines are, I think, appropriately pretty sparse in terms of what they say about focal. It is still experimental to an extent. The guidelines are pretty guarded in their endorsement of focal as an option. There are no explicit focal therapy guidelines that have been adopted by any national organizations. There are a variety of society guidelines and statements that have been put out.
We just had one out from the five University of California sites, which, of course, you were a part of, which does emphasize the point that patients should be told this is not a treatment with nearly the same duration of follow-up, with nearly the same validation data that the standard treatments, surgery, radiation therapy, active surveillance have. We don't call it experimental in the sense that this is first in human research, and it can be done outside of the setting of an academic institution.
That's I think a big part of the problem in the field is the way it's being done across the community practices. The guidelines do state we should be tracking these patients in a trial or a registry to collect better data about outcomes. It's a rapidly evolving space without a lot of hard guidance reflecting the state of the literature.
[Dr. Aditya Bagrodia]:
What do you think, Arvin? Do you think the guidelines are–
[Dr. Arvin George]:
Your two key guidelines are going to be the AUA and EAU guidelines, and either they say that it should be done within a well-designed prospective cohort or within a comparative study or clinical trial. In the salvage space, NCCN does include HIFU and cryo as a salvage treatment option, but I agree it should be exercised with caution. I'm not sure it's necessarily a community urology problem, it's just a lack of urology knowledge problem. Like you said, this is a field that we're taking a bite out of now and we're really starting to study it and understand it.
Things that may seem obvious to us maybe as academics 10 years from now, we're going to look back at it and say, what were we thinking at that time? I think it's a period of learning for all of us, and I think we have to accept that and be very brutally honest about it to ourselves and to our patients.
[Dr. Matt Cooperberg]:
One part of the problem, if we take a step back even from the guidelines, is that we're still in the regulatory environment here and it just reflects the fact that it continues to boggle my mind how difficult it is to get through the FDA with an injectable. To get a targeted fluorophore into the operating room, it's completely safe, not even a theoretical risk of harm, is this years-long process.
Whereas to get a device like an ablation machine or OR, you just have to show a lack of harm. It amazes me how difficult it is for drugs and how easy it is for devices. You just have to show that this will not cause direct harm to the patient. You don't have to show a single thing about efficacy. That's just the nature of our regulatory environment, which is different in other countries.
Once it is out there, well, it can be used for lots of different things without IRBs, without protocols, without being in a trial. If you look at how focal and ablation modalities have been rolled out over the last 20 years in the States and I should say across North America, if you look at the experience of folks taking their patients ex-US to Canada and Mexico to do HIFU in the 2000s, it's a history now that doesn't look great for us in terms of the way we have rolled this out.
I think there's a lot of horror stories out there, as you were just talking about. We're now getting just to the point where we actually have prospective studies. Some trials, and academics that are starting to take this seriously, but in a way, we're playing catch up with a field that really has been Wild West for quite some time.
Podcast Contributors
Dr. Matthew Cooperberg
Dr. Matthew Cooperberg is a professor at UCSF in San Francisco, California.
Dr. Arvin George
Dr. Arvin George is an associate professor of urology at the University of Michigan in Ann Arbor.
Dr. Aditya Bagrodia
Dr. Aditya Bagrodia is an associate professor of urology and genitourinary oncology team leader at UC San Diego Health in California and adjunct professor of urology at UT Southwestern.
Cite This Podcast
BackTable, LLC (Producer). (2024, May 28). Ep. 169 – Prostate Cancer: Navigating Focal Therapy Options [Audio podcast]. Retrieved from https://www.backtable.com
Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.
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