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Phillip Koo: Hi, this is Phillip Koo and welcome back to UroToday for our special feature discussing the operations and integration of a PLUVICTO program into a large urology group practice. We're going to move on to our final segment, which really focuses on the multidisciplinary aspects of a PLUVICTO program. And we're very fortunate to have with us Doctors Gordon Brown and Glen Gejerman from Summit Health Cancer Treatment Centers to discuss this topic. Clearly, what we've seen in the first four segments is that this is a multidisciplinary program, and it's not just physicians and APPs; it's navigators, nurses, and a lot of team members that really need to come together to make this happen. So let's first start off talking about how it works logistically. So, Dr. Brown, I'll start with you. We've talked about how you identify the patients. How do you work them up and then transfer care or make that referral to your partner for these services?


Gordon Brown: Sure, Phil. As a general rule, these patients are under our care in the APP center. We routinely evaluate these patients and follow up with scans and/or blood work, certain specific clinical triggers such as rapid PSA doubling times, new symptoms. And those patients who have been through appropriate lines of therapy, have seen a taxane, have seen an androgen receptor inhibitor, those folks often go on to receive PSMA scans as part of their evaluation to understand whether this PSA is reflective of disease progression and/or new symptoms might be reflective of disease progression or not.

If that PSMA scan is positive and we have a PSMA-avid tumor and they're appropriate on label as it relates to the FDA indications for Lu-177, then I would normally have a discussion with the patient in the clinic about the next steps in treatment or an option for that therapy for them, the implications of that. And then I would kind of help ask our navigators to start the process of getting them over to see Dr. Gejerman once that data is obtained to have a little bit of additional discussion with them and deem them appropriate for therapy.

Phillip Koo: Great. So once you deem them appropriate for therapy, you sort of make that referral to Dr. Gejerman. Dr. Gejerman, what's your next step that you do with this patient? Do you see them actually in the clinic for a separate visit before you start therapy, or do you do things differently?

Glen Gejerman: Sure. I see them in the clinic. I have the advantage of working with Dr. Brown and the rest of the leaders at the Center for Advanced Therapy. By the time the patient comes to see me, they're really very well-versed on their options and they understand they're at the point of the journey where using a radioligand therapy could be very impactful for their health. So they come with a clear understanding of that. We go over the protocol, we go over some of the radiation safety at least initially. And if they want to sign up, then we have a second meeting with them and their family to really explain how we're going to actually deliver the therapy.


Phillip Koo: So when PLUVICTO was first introduced, I think there were a lot of questions and limited supply, which led many programs to present every single one of these cases at tumor boards. Now that I think the supply is much larger and we're getting more comfortable with this, it probably is maybe not practical to present all these. How do you guys approach the use of tumor boards to best manage these patients?

Gordon Brown: Sure. Initially, we were one of the only suppliers of this therapy in our region. That allowed Dr. Gejerman and me to have a really good understanding of not only patient identification but also how to operationalize this therapy within our individual practices. At that point in time, we would identify these patients and consult on a patient-by-patient basis. We do have a quarterly tumor board that's set up through our organization. Unfortunately, these folks really don't have time to wait often for that quarterly tumor board to occur. So more frequent meetings are really had on an individual basis between Dr. Gejerman and myself, and they occur at all hours of the day, not only during working hours but also after hours if need be. And it's that dynamic and the true collaboration between specialties which really encompasses this as a true multidisciplinary practice for the patient's benefit.

Phillip Koo: I think that really highlights the importance of having that close contact and alignment within specialties under one roof, one umbrella. So these patients, every six weeks, will get a dose up to six doses. That's a long period of time. What other therapies are you putting them on or how are you looking at combinations when they're going through that course of PLUVICTO?

Glen Gejerman: Yeah. That's a great question. Right now, all these patients, based on the VISION trial, have received TAXOTERE. And if they continue to progress, many of them are on Lynparza or other types of drugs that will have to stop before we can give them the therapy, and then we wait for a washout period. So we monitor their PSAs very carefully. We examine the patients midway during that washout period. Many of them can be treated with XTANDI and others. But in terms of chemotherapy, they cannot have that while they're getting PLUVICTO.

Phillip Koo: So we're not using chemotherapy or a PARP inhibitor in combination, but some of the second-generation androgen receptors, is that correct?

Gordon Brown: Correct.

Phillip Koo: Yeah.

Gordon Brown: Yeah. So generally speaking, we want to avoid synergy as it relates to marrow toxicity. So we want to avoid additional anemia risks, specifically with the addition of PARPs or taxane-based chemotherapies. Even if they've already had tax exposure, re-exposure to that or cabazitaxel would be avoided. We don't practice that routinely.

Phillip Koo: Great. So during the course of their PLUVICTO treatments, how often are you seeing them as the primary caretaker for these patients?

Gordon Brown: Yeah, so I see them usually on a fairly regular schedule. We schedule these folks. They're often on concomitant bone agents. They're being seen for blood work. So I would say on a similar four- to six-week cadence at that point in their disease process because these are patients that have been progressing; they have new symptoms. There's a variety of things that may need to be managed. So I tend to tighten up their follow-ups there. So not only seeing them but also with Dr. Gejerman at the time of infusion and therapy.

Phillip Koo: This is a groundbreaking treatment that really has a unique mechanism of action. And I think whenever these things are introduced to the market, there are a lot of questions, especially from patients. So Dr. Brown, I'll start with you. What are some of the questions or concerns that patients bring to you initially when you talk about this treatment?

Gordon Brown: I think they most commonly ask, "Why? Why are we switching gears? What are the implications of this in my disease process?" And then they ask me what the outcomes are associated with and the risks, risk-benefit analysis. These patients really, I think, along their disease continuum, learn to do a risk-benefit analysis and balance that quality-quantity discussion as they go along.

I think the really fortunate thing we have here in being part of that true multidisciplinary team management practice style is that we can, I think, very effectively manage both quality and quantity of life with therapies like this. Extend their survival, decrease or improve their rPFS, and maintain their quality of life consistent with the data we've seen in the VISION trial. So they ask me all of those questions. They ask me, "How is this given? What's my schedule going to look like, and how long is this going to take?" And those discussions honestly are had the moment we introduce this therapy. And if they haven't already seen Dr. Gejerman, which a lot of these folks, by the way, already have, right, they've seen him in some way, shape, or form maybe for focal therapy to a painful bone lesion in the past or some other kind of intervention, then I introduce them to that concept. They're going to have to go from me and transition over to another provider within the organization. That's overseen by our navigator, Chrissy.


Phillip Koo: So I imagine a lot of that investment and time and effort upfront from you and the navigator and the whole team makes your job a lot easier.

Glen Gejerman: Absolutely.


Phillip Koo: Can you talk about how you sort of fill in some of those gaps, or what gaps you're noticing with patients?

Glen Gejerman: Yeah. As I said, patients come to me with a really robust understanding of where they are in their journey and why this is an important treatment modality for them. Very often they'll ask, "Well, what comes next? If this doesn't work, what's next?" And that's something that's on their minds a lot. And we talk about that. There are many agents that can be used. Right now, it's fairly straightforward because of the way the VISION trial was laid out. They have to receive Taxane-based chemotherapy. But some of the really fascinating studies that are being done right now may bring in these types of therapies early on, and that I think would be more of a challenge for us to decide when to employ each modality.

Phillip Koo: So we've had a really enlightening time visiting your practice here and learning more about how you operationalize and work to stand up a PLUVICTO program. To those listeners out there who are thinking about it or perhaps close to opening one, what advice or just final thoughts do you have for them?

Glen Gejerman: When I first read about it, I was intimidated, and we already had an existing radium-223 program. So imagine someone who hasn't done that will be intimidated. My best advice is don't be. Speak to your radiation safety officer. Don't listen to anyone who's going to be overly prescriptive. Work within your geographic area. Find out what you need to do from your RSO. It's a very important program, and your patients will really benefit from it.

Phillip Koo: Gordon, I'll give you the final words.

Gordon Brown: Well, thanks. I think that I would engage key stakeholders in your organization and try to allow them to better understand the patient benefits not only from a quality and quality of life perspective but also allowing us to deliver novel therapeutics and remain at the cutting edge of medicine to improve the lives of our patients and their long-term care.

Phillip Koo: Well, thank you very much, and thank you for allowing us into your practice and to learn and for all of us to learn more. Thank you.

Glen Gejerman: Thank you.

Gordon Brown: My pleasure, Phil. Thanks.