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Alicia Morgans: Hi. I am so excited to be here today with a multidisciplinary team to really talk through and think about patients with newly diagnosed metastatic hormone sensitive prostate cancer and how we share patients across the treatment team to make sure we get the best outcomes for patients. So, let's start. David, would you mind introducing yourself and your role on this team?

David Morris: Sure. I'm a urologist in private practice in Nashville, Tennessee. I am a member of a large group that covers the entire metro area, and so we have a lot of internal initial diagnosis both from me but then also from partners within my practice.

Alicia Morgans: Fantastic. And Ben, please introduce yourself and tell us how you interface with David.

Benjamin Garmezy: Yeah, so I have two roles. So, I'm the Associate Director of General Urinary Research for Sarah Cannon Research Institute's National Network. But I'm a private medical oncologist with a GU focus in Nashville, Tennessee, seeing patients in a private clinic here. And that's why I interface with Dr. Morris here because we share patients with prostate cancer. We share patients with other genitourinary malignancies. And while I have a research role responsibility, I'm a true practicing clinician in the private world, which is a little bit different than our colleagues in academia.

Alicia Morgans: It's very different. And there are some unique hurdles and challenges, and I really hope we can outline them and think through how we overcome those as we have this conversation. So, let's start with thinking about a typical patient case. David, tell me about this patient with newly diagnosed MHSPC.

David Morris: We had a patient earlier this year. He was in his seventies, diagnosed with high-volume Gleason 8 disease, with a very high PSA, in his sixties. At the time of diagnosis, certainly imaging was warranted and it documented multiple bony mets and some nodal disease. So, we had the initial conversations about metastatic hormone sensitive intensification of therapy including the potential for a doublet on top of hormone therapy. But then because he was higher volume, we did at least broach the idea of intensifying beyond that to triplet therapy. And we had that conversation early in the process to kind of at least set the groundwork for a referral to medical oncology so that they're not blindsided and so that they also understand that it's a conversation about options. It's not a you have to go get this therapy. They often hear chemotherapy and they're immediately scared. They have a brand new diagnosis and then we're throwing that on top of it.

So, I think it's nice for us to be able to at least lay the groundwork of chemotherapy is relatively well tolerated in this situation and it is very safe, and we have very qualified medical oncologists in town that can see you and then manage this completely. And so I say, "We're going to set the groundwork for potentially ADT plus something else, and I'm going to send you to have the conversation while this starts. And then you can meet with Dr. Garmezy across the street in a different building, but he's going to take over and at least present things and manage from there." So, I'll turn it over to Ben to kind of see that patient was then sent over having already at least heard about adding things in. And then I kind of send them over to kind of lay the groundwork for the data behind why we might want to give more.

Benjamin Garmezy: And I think the key here is prostate cancer is different than a lot of other malignancies we treat in our clinics, whether you're a urologist that treats oncology, or a medical oncologist, or even a radiation oncologist, because so many men do well. And they all know somebody who had surgery or radiation and they were done. And why is this patient the one that's coming to us not getting that curative intent therapy? So, that in itself brings up a challenge. Now, the nice thing about what we've done here in Nashville is these patients, or almost all of them, come through urology, because that's how they get diagnosed through a prostate biopsy. And then, most of the therapies in the hormone intensive phase of the disease, and even in some of the hormone resistant phases of the disease, can be treated at advanced prostate clinics within urology centers.

These are ever expanding across the country and totally within the scope of keeping and treating patients that you know and have established that relationship with. Now, the one thing that is somewhat divided is cytotoxic chemotherapy. Right now, while some urology groups employ medical oncologists to give those therapies, not all urology groups have them. In Nashville, obviously, the practice Dr. Morris has does not have a practicing medical oncologist. So, they rely on relationships with medical oncology, just like I rely on relationships with urology to take care of urologic interventions for my patients, as well as the referral patterns of urology to medical oncology, just as is traditional within the community. Now, when I first moved to Nashville from Houston, I was at MD Anderson, in these large academic centers, everyone's employed under the same roof. So, everyone has a shared mission, shared financial goals, shared patient care goals, shared billing, shared space, everything. That Makes that a lot easier.

Out in the community, you're in different private practices. That doesn't mean we have to compete with each other, but it means we have challenges in our collaboration and cooperation because we don't share electronic medical records, we're often on different systems, and we don't share any way to easily access information from the other clinic. It involves phone calls, figuring out in real time, being able to be really accessible. And so when Dr. Morris sees a patient, he knows certain patients are at higher risk and need more intensified therapy upfront. And that brings us now to this conversation of this patient that was just described is now being referred to me or any of my medical oncology colleagues for intensification of therapy. And this is based off two large phase three data sets that we have. We have the Pace one data set. We have the MaraSense data set. I don't know that we need to go into all of those details because they're so well covered already on this website.

But we know that when you add a novel hormonal agent, such as darolutamide, or even abiraterone, to six cycles of chemotherapy in the hormone-sensitive phase of the disease, upfront, at the initial diagnosis with an ADT background, that you do better for that patient than ADT and chemotherapy alone. Now, obviously, there's been a lot of discussions about what the comparator ARM, if you did, ADT plus NHA alone, novel hormonal antagonism, would be. We're not going to get into that discussion today. I personally believe that the cytoreductive benefits of the chemotherapy help debulk that tumor burden, perhaps limiting resistant clones. And when you compare hazard ratios across trials, when you have such a good control ARM and you're still beating it by that amount, I do think that that triplet data set is very valuable. This data is valuable to our patients. And we know that we can extend the time our patients are in the hormone-sensitive phase of their disease, where they're going golfing, going to work, enjoying life, not in pain. That is a benefit to our patients.

So, we'll put that topic aside for the sake of today's conversation. We've now identified this patient. They've come to me, and they know that they have a serious problem because they're now in a medical oncology office, and they're not used to that. And a lot of their friends have never seen a medical oncologist with their diagnosis of prostate cancer out in our community. Luckily, as mentioned, chemotherapy is a charged term, just like cancer, the big C, the charged term there, chemotherapy is another one. It scares patients. And now they're looking at me. They're deciding whether or not they need a port. They're deciding whether or not they're going to get chemo, and they're hearing all about neutropenic fever and all these other side effects. So, it's really nice that generally speaking, when Dr. Morris sends his patients, and even with some of his colleagues, and their patients, they know exactly what I'm going to say because I've already said it about 15, 20 different times.

So, they've probably already heard that speech. So, they'll be warned about, well, it's six cycles every three weeks. They'll be warned about what the infusion looks like, what the main side effects are, and how we're going to manage them. And I think that's the key, is hearing that conversation from two different providers at two different times, gives that patient that sense of, "I'm comfortable now. I've gotten my 'second opinion.' I don't need another one. And everyone's on the same page and agrees." And when everyone, they feel that way and they feel comforted that they can get through this, what I call a speed bump in life, to get them back to their old life, they can get through it and move on. I don't know if there are any thoughts about that on your end, Dr. Morris?

David Morris: Well, I think it's great. I mean, I think you're hitting the nail on the head that it's largely a sales pitch for me, to some extent, to the patients that I think that this is valuable to you, and that makes, I imagine, your job a little bit easier to convince somebody that I've already told them it's probably better for them. And so, that's nice from the urology side to send them with the expectation of, "I think this is good for you, and all the reasons you mentioned are great." But it also opens the door to a lot of secondary therapies down the road, if you need them. You're healthier now. I'd rather give you chemo now than potentially discuss chemo later when you're sicker. And so, patients can kind of understand that idea. And I think it probably leads to better acceptance of getting triplet if they've been encouraged that they're going to talk to somebody about a triplet, as opposed to, "Let me send you over here to have a secondary conversation."

Benjamin Garmezy: And I think the key here is, it does seem that patients tolerate the therapy better in the hormone-sensitive phase of the disease than the hormone-resistant phase of the disease. For one, it's a prescriptive six cycles. But the other is, it just goes better. It's easier and patients do well. And I think that's the key is, getting that chemotherapy earlier in the treatment paradigm helps them tolerate it, get it in, and hopefully, it's going to be a while till we actually see in the real world whether or not we're getting the benefit that we saw in the trials, because we've just now started doing this, and these patients are going to have a median PFS that stretches years beyond what we're doing in our clinics today. But we really do believe we're going to see that.

And then it comes to the communication and delineation of roles and responsibilities. So, this is a patient of Dr. Morris's clinic, and he's prescribing the hormone therapy, and he is prescribing that oral agent, such as darolutamide. I'm prescribing the chemotherapy. So, when it comes in, they're seeing me in clinic much more often while they're on chemo than they are seeing their local urologist because I'm giving them an infusion every three weeks. I'm checking their labs. I'm making sure it's safe to go forward with chemo. We're managing the toxicities, whether it's nausea, whether it's edema, whether it's renal issues, whatever comes up, as we provide cytotoxics to our patients. And I am giving Morris big-picture updates. Little things, nausea, I don't need to tell him about that all the time. But all the big-picture stuff, hospitalizations, anything like that, I feed that communication right back to the urology colleague of mine.

And then upon the completion of all six cycles, and so far, all of our patients have gotten to all six cycles, I send that patient back. And most of my patients don't even ask necessarily for a follow-up visit with me. There's a few patients who want to have a check-in six to 12 months later, but then that's the trust where they knew their prostate uro-oncologist. They came to see me. I helped them through that phase of the disease. And then they are most often very willing and happy to get out and graduate from my clinic. They feel like they did something, they accomplished it, and they're ready to move on with their lives.

They know at some point they're going to have to come back. They know that we haven't cured their disease. We're upfront, we're very clear about that, but they feel better. And I think having the ability to get them out of a medical oncology clinic actually almost helps their psyche in the way they interpret their own illness and the way they talk to their friends and their family. So, I think that's another nice thing about being in two separate clinics is unlike when you're at a large academic center in the same kind of building, and you're stuck going to the same room, it might be two different wings of the same floor. Here, they actually get some more time away from me, and I do think that there's some value in that.

David Morris: Ben, I think an elephant in the room is, a lot of urologists are afraid to send patients to their medical oncologist in town because they don't want to lose the patient to that medical oncologist. So, part of your credit is that you've been open with them and realize that we've been doing this for a long time and can still manage a lot of the other stuff. And so you don't sell the patient on this idea of, "I need to now be the captain of the ship forever, and I'm going to take over." It's more the, "I'm the captain for these four months, and then you're going to go back to the urologist who's going to be the captain hopefully for the next five years. And then if down the road, we need other multi-D sorts of assessment, we know you already know us, and it's easier to get back in."

And that has worked better in the community when we found a partner who's been willing to say, "We're going to take our role when it's our time, and then go back to your role when it's your time, and then we'll share them again down the road as it's needed." And that's been more helpful. And I'm not scared that I'm sending these patients out the door and they're never coming back to see me.

Benjamin Garmezy: Yeah, I think this data set has forced us to learn how to work better together. We did it in Nashville with these data sets, with the triplet data set of wanting to add in chemo. We've had to buff up multidisciplinary tumor boards across the entire city, across multiple hospital systems, and actually build out a virtual way of formal communication once a week to discuss some of these edge cases that are on the fence of should they get triplet, should they get a doublet, should they get a clinical trial? Whatever it may be.

And I think that that's a model that needs to be adopted because all too often in the community setting, tumor boards are either not specific to a disease type. Or if they are specific to a disease type, they're hosted at a single hospital. But in large cities, large practices are at multiple sites across multiple hospitals. And we have to be able to focus that expertise across the various practices, the radiation oncology, the medical oncology, the urology, and kind of find a way to make it citywide across practices so that every patient can get access to that kind of multidisciplinary care.

Alicia Morgans: That's so helpful and really interesting to hear how your practice, geographically separate, though semi-colocalized, is able to make all of that happen, and love that you've found this rhythm where you can share patients back and forth and they can graduate from medical oncology, go back to urology, and then at some point, they know that they're coming back to medical oncology. I mean, I think the counseling that you give the patients to help them understand that flow is phenomenal.

As we wrap up because this is a really wonderful discussion. I'd love to hear if you have any tips or tricks on how to enhance communication, given separate EMRs, separate locations. How do you really make this work when the rubber hits the road? We can start with David.

David Morris: Yeah, sure. I think our communication is the ultimate key here. And the easiest, don't overcomplicate it. Email works beautifully. Text messages, as long as it's somewhat patient compliant in terms of what's involved in the text message, works very easily. I probably talk to Ben more than I talk to half of my partners. So, it can happen. It's not a big hurdle, it's just a simple email that, "I've seen so-and-so. We're starting therapy. He's doing well. We're on cycle three." And that's all you need to basically have a touchpoint. And that's been my experience. It's easy going both directions.

Alicia Morgans: Great. And Ben, what do you think?

Benjamin Garmezy: I think that sums it up perfectly. Nothing new to add.

Alicia Morgans: Great. Well, I think it's been very clear from this discussion that there has been a massive evolution in the way that we approach and treat patients with metastatic hormone-sensitive disease, and data like you presented from MaraSense, Pace, and other studies have really solidified the need for this multidisciplinary collaboration for our patients to get the best outcomes, especially when they have, as this patient did, de novo metastatic hormone-sensitive disease. This is high-volume disease. These patients really deserve more. And so, it has been my pleasure to listen to how the two of you make this happen for your patients. Thank you so much for your time and for sharing your techniques and your tips to make this possible.

David Morris: Thank you very much.

Benjamin Garmezy: Thank you.