John Fortin: Welcome to today's discussion, Focal Therapy Society and the 12th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer. I have the pleasure of introducing Dr. Tom Polascik. He is a urologic oncologist with considerable experience in both kidney and prostate. The symposium was jointly sponsored by the Endourological Society and The Focal Therapy Society. As its founder, could you tell us a little bit about The Focal Therapy Society?

Tom Polascik: Well, this was a concept that we've had for the last several years, but it wasn't until I had a conversation with the FDA about a year and a half ago and they said, "Gee, wouldn't it be nice if you started a society and perhaps we can use that as a format and a means to work together to gather data on outcomes and really push the field forward?"

Since that time we've written the bylaws and started forming our board of directors and really getting everything up and running, that needs to be done when starting a society.

John Fortin: Critics of focal therapy, for prostate cancer at least, have said for years that the disease is heterogeneous and after prostatectomy, pathology is often upgraded. How do you respond?

Tom Polascik: Well, much of that is true, but let me break that down into different parts of a question. First, we know that prostate cancer is multifocal. About 80% of prostate cancers are multifocal and this has been shown by numerous studies across the medical literature.

That's not to say that we can't target and characterize each of the different foci of cancer. In other words, traditionally we've had whole-gland treatments, be it radical prostatectomy, in which case we would remove the entire prostate. Be it whole-gland radiation or brachytherapy, or perhaps some of the ablative technologies such as cryotherapy or HIFU et cetera. In each of these cases, we would target and destroy the whole gland.

Now, if you wind back about 20, 30 years, most of our nomograms and predictors would look at such entities as well, what's the likelihood that the cancers contained? What's the likelihood that it's penetrated a capsule, invaded the seminal vesicle, or perhaps spread to the lymph nodes. That was pretty much the state of the art for many years. Whole-gland does a reasonable job at addressing those concerns, but technology and times change. Certainly, we've gotten into an area of more personalized medicine.

Our imaging technologies have improved and we're able to since around the early 2000s focus on the different tumors that are in the prostate. Now, I would beg that it's important to understand each of the tumors and their potential biology. For example, we now have active surveillance and we make those decisions based on a relatively indolent biology that the patient may have, but again, that's trying to understand and characterize that cancer that resides within that man's prostate.

Just think if we understood each of those cancers in the prostate, and we're not even talking about focal therapy, we're talking about biology. For example, if a man had three cancers, why not try to characterize each of those cancers? I mean there's likely one that's going to drive the national history of the disease. We tend to turn this the index lesion because we know that some of the other tumors that may be apparent are essentially passengers or satellite tumors that really don't affect the longevity of the patient nor the disease natural history.

I would submit that we're in a time now where we're able to image many of those tumors. We're able to put a needle into those tumors. In other words, targeted biopsy. We're able to do genomic analysis of those tumors and we're able to similarly target and destroy those individual tumors.

For the critics, I would only say, you have a choice. You can do what you've done for the last 10, 20, 30, 50 years and treat in a whole-gland fashion and then accept the quality of life issues that the patients have to face. Such as incontinence and impotence. Or you can get with the times, try to understand the biology of the individual tumors, target the ones that are aggressive, place the other ones on active surveillance, and monitor.

I think in the end what's driving this is the patient and their desires. If I were a patient, I would want to control the cancer with the least amount of toxicity possible. I think we have as a mantra in focal therapy to first do no harm.

The way I see things, we should do our best to characterize the tumor, understand the biology, and then recommend an appropriate treatment. We should give active surveillance the first opportunity for patients because that's the least invasive. Of course, if the patient doesn't qualify or has select tumors that need ablation, you should consider targeted focal therapy as the next echelon of options. If the patient really has multifocal aggressive disease, then that's the proper situation for whole-gland therapy.

John Fortin: Tom, that was a great summary of the evolution and care. When you think about The International Symposium itself, this was the first one that I've gone to, but this is in fact the 12th International Symposium. How has this event evolved over the years?

Tom Polascik: Well, I started this in 2008 at a time where it was essentially considered heresy. Matter of fact, I was a little bit timid on setting up the first meeting because as you know, when you go against the establishment or the grain of teaching at that time, you're thought to be on the fringes of medical therapy. That was back in 2008.

I got by with a little help from my friends. There were a number of supporters that shared this vision and we launched the first meeting as a prostate only meeting held at Duke in 2008, which was aimed at trying to figure out ways to image and target prostate cancer. It was more of a developmental meeting for research purposes.

There's this old saying that, "It takes a village to raise a child," and for sure it took a community to enact this first step, the first focal therapy meeting in 2008. Since that time, we've alternated the meetings predominantly between North America and Europe. We wanted to make sure that we got everyone involved.

We understand that it's difficult to take time away from one's practice and travel, especially out of one's continent. We did that alternating between North America and Europe for several years. Then last year we extended to Asia and held our first meeting in Japan. Dr. Osamu Ukimura hosted that and it was a great success. We have a lot of Asian communities on board with this concept. Next year it's going to go to Turkey towards the Middle East.

John Fortin: Thank you. By the way, a friend of mine was diagnosed with Gleason 3+4 prostate in 2008. It was a new laser ablation treatment that had just been designed. I believe the first patient in the US was actually a medical doctor. My friend, who is still doing well, had a mapping biopsy. There was no real imaging, but he had the mapping biopsy and he was treated with laser focally, and he's doing well today. It's a remarkable parallel in terms of what you've been doing in his personal progress.

Tom Polascik: Yeah. I was going to mention that one of the tipping points that we've seen over the years was the advent and institution and widespread use of high-quality multiparametric MRI. Now, to make a comment on the three-dimensional mapping biopsy, I've done that for a number of patients too and there were several indications. One of which is we suspect that a patient has cancer and we just cannot find it with traditional biopsies, but it's also known that the mapping biopsy is about as near as you can get to whole amount pathology with a surgical extra patient. It's a very good technique to put into a three-dimensional construct, the location, size, and volume of the individual tumors in the prostate. Of course, with the advent of some of these real crystal clear multiparametric MRIs, we've supplanted the mapping biopsy by a less invasive approach nowadays.

John Fortin: Now the symposium covered both kidney and prostate. In terms of imaging, how would you compare imaging used on both organs?

Tom Polascik: Well, that's a great question and it's a little bit different. Kidney tumors tend to grow as a single mass and they expand into a specific volume. Essentially, a CAT scan can begin to detect these when they're over usually a critical size of one centimeter. CAT scan is very good at characterizing them especially as they grow larger.

Most kidney tumors tend to be solitary and there's little concern about multifocality. Even if there is multifocality, we tend to wait until again, another tumor crops up that we can detect on imaging.

In contrast, it's been very difficult to image prostate cancer and I think that that's why prostate cancer diagnostics and treatment really lags behind out of breast cancer. Prostate cancer, as you mentioned, tends to be multifocal and it tends to be slow-growing. Imaging modalities like CAT scan are just not very good at detecting prostate cancers.

Matter of fact, when MRI first came out, it was studied quite intensively and that was also considered useless at the time until such time in the early 2000s when multiparametric MRI using different functional parameters was worked out and improved. Now we can actually see these tumors, the vast majority of them on multiparametric MRI.

John Fortin: In a similar fashion, at a high level, could you compare therapies that are being evaluated today for kidney and for prostate?

Tom Polascik: Yes. Many of the therapies are similar, if not the same. For example, cryoablation can target both prostate and kidney tumors. Radiofrequency ablation is used quite often on kidney tumors and it's starting to trickle into the prostate scene. I think they're trying to figure out how to best utilize it.

HIFU, which is perhaps ideally suited as an endocavitary approach, in other words, transrectal, can be used on the kidney, but again the kidney doesn't have the benefit of having a way to insert it right next to the kidney without the laparoscopy or something like that. Then you have modalities like irreversible electroporation that can be used as well.

Some of the techniques that we use for the prostate are a little more dainty, such as laser, because the prostate tumors tend to be smaller than the kidney tumors. I think one of the big differences with kidney cancers, not only can you see them, but they tend to be larger. When you look at the volume of tissue that needs to be ablated, you need a bigger brush stroke. For kidney tumors than you would ordinarily with prostate tumors.

John Fortin: Thank you. Well, Tom, before we wrap up, do you have any additional comments?

Tom Polascik: Well, I just wanted to make a few comments about The Focal Therapy Society and why it was formed and what we can do going forward. I think that we have a very strong mission. Looking at it, we aim to advance and position minimally invasive treatments and image targeted cancer therapies in a safe and effective gland-preserving manner to extend and maintain one's quality of life. We have a lot of work to do. We have formed a number of subcommittees.

I think we all recognize that the concept of whole-gland therapy is antiquated. It often requires less sophisticated tools and that partial-gland treatment is very common for most organ systems. I also think that we strongly believe that the successful application of focal therapy is going to require a multidisciplinary approach. It's going to be personalized medicine. Again, it's not just going to be about the device, it's going to be about proper patient selection, the use of adjuvant therapy. We can all envision a time when imaging is going to get much better. It's not going to stay the way it is right now. It's going to continue to evolve and improve.

The therapies are going to evolve and improve. We're going to have adjuvants and systemic means to also add on to the ablative measures. I think the goal was to maintain functional status in a man for prostate cancer. That's very important to the patient and I think we need to embrace that because essentially that's what patients want.

Going forward we need more Level I evidence. I think this will put the critics to rest. We have one Level I study right now that was used in low-grade tumors, but it showed that the use of focal therapy actually helped to stab off progression. This was a nice study that was recently done. I think looking forward again we want to be international. We want to put up consensus statements, we need to work with industry and partner with them for different therapies. That includes targeting, imaging, adjuncts. We want to work with the FDA and other regulatory bodies to give them the data that they need to make decisions. There's really a lot that needs to be done going forward.

We're going to be launching multisite trials. We'll have a focal therapy registry that will be housed in a Focal Therapy Society and we're hoping to provide good training and education for physicians who want to embark on this new technology for men's health.

John Fortin: Well, that's quite an ambitious agenda and I really can't emphasize enough as a patient, how patients are really trying to balance oncologic outcomes with ongoing quality of life.

Also, I really appreciate the work you're doing and trying to get the very best evidence. I know that's a particular talent for devices. It's hard to design a randomized control trial for devices and it's hard to have blinding in those situations. I understand and appreciate what you're trying to do. 

Tom Polascik: If I would have to make one comment about devices that you asked before. If you look at the data for many of these devices because you mentioned there's a lot of devices out there. It's pretty similar. The cancer control, the preservation of continence and potency is not so much device-specific, but what we're finding now, it has more to do with patient selection, the ability to image the cancer, to understand the boundaries of the cancer needs to be treated.

Really one of the main issues that we're faced with going forward is how do you identify radiographically the MRI invisible tumor. This is one of the main challenges that we have when we talk about multifocality is the tumor that we can't see on imaging at least yet. I'm very hopeful in the future that we will have the technologies to be able to address that very important question for patients.

The Focal Therapy Society is one of collaboration because ultimately it's not about me, or you, or this technology, or that. It's about developing better tools for patient care.

John Fortin: In closing, I very much enjoyed The 12th International Symposium, the presentations, the faculty, the enthusiasm, and I was surprised. There was a very collaborative tone. It wasn't a battle between therapies, it was really a collaborative discussion of as you said, Tom, which type of modality may be better in a particular client situation. Where the patient has a certain location or aggressiveness, and it was really a discussion of which focal may make sense for a given patient. Again, congratulations on bringing together experts from around the globe and thanks for sharing.

Tom Polascik: Thank you.