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Zach Klaassen: Hi, I'm Dr. Zach Klaassen, a urologic oncologist at the Georgia Cancer Center in Augusta, Georgia, and I'm pleased to be joined today for a UroToday discussion with Dr. Chris Pieczonka, who is a urologist and clinical trial director of United States Urology Partners, as well as CEO of Associated Medical Professionals of New York.

Dr. Pieczonka, thanks so much for joining us today.

Christopher Pieczonka: Gee, thanks so much, Zach. I really appreciate you taking the time to go through some things and collaborate.

Zach Klaassen: Yeah, absolutely. We're going to be talking about the continuum of care for metastatic hormone-sensitive prostate cancer. So just off the top, we're going to focus on triple therapy today. How are you selecting the ideal patient for triple therapy in 2024?

Christopher Pieczonka: Yeah, it's kind of a new thing for all of us, because I think that for the urology community out there, we've all gotten pretty comfortable with the thought that androgen deprivation therapy as monotherapy is not what needs to be done for metastatic disease. And then this study was published and it was pretty groundbreaking, based on the ARASENS protocol, that showed that there was a benefit in overall survival comparing the patients on ADT with docetaxel and Nubeqa, compared to the patients on ADT and docetaxel alone. So I think the thing that's interesting about that is it's another historical thing that has now been taken aside. So not only is it, I think, an inappropriate thing to do ADT as monotherapy, but the old CHAARTED type of data that would be ADT plus docetaxel for newly diagnosed metastatic patients seems like it's off the radar as well.

I think based on what you asked me specifically, one could make an argument that this type of therapy should be done on all comers who have metastatic disease, but I think being practical, you know who needs it. So I think in my mind, somebody that has... Not all metastatic disease is created equal. So I think somebody that has visceral disease, high-volume disease, perhaps a younger patient that you want to throw everything plus the kitchen sink at them, you're going to go ahead and do that. I think somebody that might segue into oligometastatic disease, maybe poor performance status, maybe some contraindication for, maybe they have preexisting neuropathy or something, you may not want to go the route of 'triple therapy'. But I think by and large, it should be thought about for everybody, and that you should be looking for a reason why you may not want to do that, particularly because the triple therapy, in and of itself, is not to be docetaxel forever.

So I think that's an important thing, that it's really meant to have perhaps a dual mechanism of action of dealing with the hormonal axis and then having a direct cytotoxic chemotherapy effect right upfront, with the thought that the chemo then stops. And I think that that may be something that we should do better in communicating to our colleagues, that it's not chemotherapy forever, like you would in the mCRPC setting where you would just keep going and going and going and then the toxicity keeps going up and up and up. So at least for me, I consider it for everybody, and then look for reasons why you either wouldn't want to do it medically, or you talk to the patient and ask them.

Zach Klaassen: Sure. And I think you brought up a good point at the beginning there. I think when we look at the control arm of that trial, this was standard of care and groundbreaking in 2014, 2015. Right now we have triple therapy against a very good control, and this is what I explain to patients too, that now has completely basically taken out of the NCCN guidelines. If you're a chemo candidate, it's no longer preferred to get ADT plus docetaxel, you should be getting triple therapy. And I think when people think about chemo, you say, well, the data's fantastic, it's a great control arm, and I think that's important for communication. Would you agree?

Christopher Pieczonka: Yeah, I totally agree. Now I think part of that is, as somebody that does a lot of clinical trials, part of the thing that happens is that the idea and the framework for clinical trials often envision years prior when you're looking at things like overall survival, it takes a while to get that, and sometimes the landscape changes. So the landscape has now changed with the advent of PSMA scanning because that was not part of the study, and we can talk during the next little bit about what the implications of that are. But I think you hit it right on the head, it's really all about education and communication.

Zach Klaassen: Absolutely. So you've got a patient you've identified for triple therapy. How is your practice and how are you collaborating with medical oncology? How does that work for being delineated?

Christopher Pieczonka: Yeah, so we do not do cytotoxic chemotherapy in the office. I think we have the capability for that logistically if we wanted to. I think it's a business decision not to, just in terms of the volume of patients, and really, we are a private equity-based group so our shareholders get compensation based on how successful the company is. So administration of these medicines that, by and large, the docetaxel at least, is going to be generic and really not going to be very lucrative in a non-Article 28, non-hospital setting, so some of the business stuff plays into that. So we have within our community, actually went from two to now three different oncology choices, one is to work with the university, the second is to work with a private entity, and then the third is to work with a hospital that has recently partnered with Roswell Park, which is one of the NCI Cancer Institutes in our state.

All the medical oncologists I work with are great. Some of it becomes logistics, so the logistics may be, where is the patient originating from? So if they were from the Catholic system, the Catholic system has a medical oncology team there, then that patient probably needs to go back to the Catholic system. So that issue aside, I also am very... Tell my patients that the role for the medical oncologist is going to be a long-term role, going to give you the chemotherapy, you have metastatic disease, you may come back and may keep you on, if it's an ARASENS-type patient, on the darolutamide as well, but then you might not need their services for a while. So it's meant to almost be like tag team wrestling, is what I say to my patients, kind of like, okay, you're in, doing their thing, okay, now we're back. And the length of time that I might be in the ring, so to speak, may be years, if we play our cards the right way.

Zach Klaassen: No, that's great. And I think, from a logistical standpoint, you're absolutely right. They're meeting the medical oncologist, they're getting their six cycles of docetaxel, and in ARASENS, I think it was 41.6 months of ADT plus Nubeqa after the docetaxel was done. So at that point, if they progress, they already have a contact with the medical oncologist, correct?

Christopher Pieczonka: Absolutely. And I think that they have these touchpoints, not occasionally with them, but what we try to do is to try to keep it convenient for patients. So for example, maybe somebody has bony metastatic disease, let's say, and they might need to be on bone-tropic support. We don't play a game with our patients to have them get injections in the urology office and see the medical team; it's really like, what's best for the patient? The other thing in my neck of the woods, we don't have a very population-dense area, and so patients may travel far, so to make them have a visit where they're just seeing what I'm doing, whether on chemo, for example, might be a waste of their time. Unless there's some sort of plumbing issue, of course. So if there's some sort of urinary issue, of course, we jump right back in.

So generally speaking, what I would do is I would see the patient, counsel the patient. Now you didn't ask this, but if I can put a patient on a clinical trial, they will be put on a clinical trial in our organization. But assuming they can't, if they do standard of care, then we will often obtain the prior authorization for whatever the medicines may be, even though if we may hand that off for the administration to the other team.

Zach Klaassen: So it sounds like if you're identifying a patient, you're going to start them on ADT plus Nubeqa, then send the consult to med onc, they'll get their six cycles. Is that how it works for you guys?

Christopher Pieczonka: Yeah, and I think that, now the thing with Nubeqa which is a little bit tricky is, depending on the insurance, they might actually need to have an authorization for docetaxel. Sometimes there's some practical stuff that gets in the way of that and obviously, I can't... If I'm not writing for it, I don't think I should get the authorization. But that practical issue aside, exactly as you propose, we will do the ADT du jour, and get them started on the ARI, and if it's a triplet patient then it would be darolutamide, and then suggest that this needs to be done in component with the docetaxel. And I think that the study wasn't done... Yet, to really look at what you get with ADT versus darolutamide alone. So I think in my mind, if you're going to do docetaxel, you should use darolutamide and ADT. I kind of think it goes in the other direction too, but there are ongoing studies that are going to really answer the question, as to whether or not the secret sauce is really on the darolutamide component versus the docetaxel component.

Zach Klaassen: Yeah, great points. I'm going to have you put your CEO hat on for a minute; you're the new CEO of Associated Medical Professionals. And when we think about triplet therapy, in terms of cost, healthcare utilization, etc., how are you thinking about that from a CEO of the company?

Christopher Pieczonka: So a couple of things. One, from a healthcare resource utilization standpoint, where we currently are, we are not in a capitated payment model. So we will try, and we are in a Medicare model where most of these patients are Medicare eligible. We're 50/50 between Medicare, I would say, disadvantage, and versus secondary insurance. So you didn't ask this, but one of the things that we have when we make a referral to our clinic is we actually have an education piece, and we believe that the provider should be up to speed on the real cost to the patient. So the docetaxel component and the ADT component often go through Part B of Medicare, and generally speaking, for the patient, it is usually more affordable. The thing with darolutamide is that it goes through Part D coverage, and so there could be more out-of-pocket cost to the patient.

Now, there have been some positive changes that have helped with something called the Inflation Reduction Act, that have started to limp in into 2024, but really become a better thing for the patient in 2025. But I think the issue becomes, is the patient going to be able to afford their therapy? And how can we help them best afford the therapy? I can tell you that in my mind, because I have the luxury of not being in a capitated risk share model, I like it because I'm allowed to be as aggressive as I want to be for my cancer patients. I would feel like my practice might be looked at differently if I had to really look and say, "Okay, doc, why are you using something like darolutamide? It's expensive. Why do it?" And I think the answer is because there's a benefit in triple therapy versus double therapy. That's not quite what you asked, but I think the social determination of care is important for patients. Putting my CEO hat on, we have had conversations also with our local healthcare organizations because they want our business, and they want the infusional oncology part of our business, and they want our prescription business as well. So we have a medically integrated dispensary. We want to try and have that medically integrated dispensary and the income come into our organization, but the hospitals want that too. And at the end of the day, these cancer patients are expensive long-term players, no matter how you look at it. So I think that it's hard because when the patient's sitting in front of you, I think that my job is to deal with them sitting in front of me and not try and figure out how to save the world or balance the federal budget over what the cost may be for them.

Zach Klaassen: No, that's a great answer. I appreciate that. I want to go back a little bit just quickly about the collaboration between medical oncology, and it certainly is for triple therapy. But as we look into the next five years of radioligand therapy, those relationships, it's going to be really important, this is such a multidisciplinary disease right now. How would you say to the listeners, if there are barriers between urologists and oncologists sharing patients, maybe a little territorial, certainly this is going to become more collaborative, already is, and especially with RLT, it's going to be even more important?

Christopher Pieczonka: Yeah, such a tricky thing. So I think it's all about having team members and maybe you go from tag team wrestling to three people wrestling, using that analogy, and I think it's important to know who's in the ring captaining the ship at that point in time. So I think each individual practice is going to try and identify where that referral pattern is and how to not piss off your referring providers. And that may be that you might get into a strange bedfellow situation in terms of where that additional care and therapy needs to be done to make the hospital whole, for a lot of these hospitals are purchasing or owning primary care groups.

The radioligand thing, I think, is something that... There was something in the New York Times about this, I think, last week, maybe it was in The Wall Street Journal, I forget, that said nuclear medicine is just the whole... Cancer conundrum is going nuclear, I think it said. So this is going to be an ever-evolving thing that, quite honestly, urologists, by legislation, are not going to be able to administer. We can't administer radium-223. We're not going to be able to administer the different radioligand therapy. So we're going to need to get creative about how that might be done with a collaborating radiation oncologist. In our clinic, we do have an attached radiation oncology suite, and we're doing external brain radiation therapy. We have looked to try and implement that next step on the radioligand front. In particular, the lutetiums of the world, as that might move earlier on, and there's a litany of other companies that are working on that.

So I think it'll be the same approach. I still see the urologist as being the captain of the ship on that because, even in the radioligand space, it's not going to be a forever thing, so it'll be a time-limited thing. They're going to get their dosing for what they are. They're still going to need their ADT. And what I think is important, we didn't get to that, is that the whole component, as far as I'm concerned, on the urology standpoint, is really the role for advanced practice providers in this. And setting, maybe the doctors set the vision, but the APPs are going to come in and make sure that they do bone health better than I do. They're going to look at the metabolic syndrome that might evolve, perhaps the social things that might develop in terms of fatigue and some of those other things. So I still think that the urology team is going to be the home for that patient, the cancer home, as they go off to do some radiation stuff, off to get a little chemo stuff, and come back.

Zach Klaassen: Yep. That's fantastic. Anything we haven't hit on you want to talk about? Maybe a couple of take-home messages for our UroToday listeners? It's been a great discussion.

Christopher Pieczonka: Yeah. Well, first of all, thank you for asking me to participate. I like talking about this stuff. The thing that I think is really interesting for all of us who are practicing urology is, first of all, how do we do this in a way that keeps our business savvy and keeps us in business? Unfortunately, it's hard to make money being a doctor nowadays and getting paid for professional services, so I think that one thing that I would encourage all of the viewers to really think about is, they're, good or bad, this is a for-profit medical system in this country until it changes, and so I think leveraging whatever that might be, either in your own clinic or in a friendly hospital that maybe, as you send them patients back, maybe they're paying you money for call or something.

So I think there's a tendency to undertreat all of these patients. At the end of the day, I think historically that's been the problem. It's not overtreatment, it's undertreatment. And the data out there suggests, at least on triple therapy, that you ought to consider that, and I don't think it's been taken up as much as we want to. So I think maybe you're not ready to do that if you're in a certain clinic, but that might be a call to the friendly hospital administrator and say, "Okay, how can we make this happen?" So I guess that would be my point, is don't undertreat your patients.

Zach Klaassen: Fantastic. Chris, we thank you so much for your time and expertise and sharing your insights on UroToday.

Christopher Pieczonka: Yeah, thanks so much, Zach. I appreciate it.

Zach Klaassen: Thank you.