Clinical Considerations for Patient Selection for Lutetium-177 PSMA- Gordon Brown
October 6, 2023
In a detailed conversation with Phillip Koo, Gordon Brown delves into the clinical considerations of integrating PLUVICTO into urology practices. Dr. Brown explains the role of Summit Health's navigation team in identifying and monitoring patients for advanced prostate cancer therapies. He discusses the criteria for patient selection, emphasizing the importance of PSMA PET imaging, which is outsourced to local and institutional partners. Dr. Brown also shares his experience with managing adverse events, noting that PLUVICTO has been generally well-tolerated in their patient population. He highlights the importance of strong relationships with medical oncologists for seamless patient care and underscores the value of PLUVICTO in extending survival and improving quality of life.
Biographies:
Gordon Brown, DO, Director of Urologic Oncology, Summit Health, Medical Director of Robotic Surgery Thomas Jefferson University Hospitals, New Jersey Associate Clinical Professor of Urology, Thomas Jefferson University Hospitals, New Jersey
Phillip J. Koo, MD, Division Chief of Diagnostic Imaging at the Banner MD Anderson Cancer Center in Arizona
Biographies:
Gordon Brown, DO, Director of Urologic Oncology, Summit Health, Medical Director of Robotic Surgery Thomas Jefferson University Hospitals, New Jersey Associate Clinical Professor of Urology, Thomas Jefferson University Hospitals, New Jersey
Phillip J. Koo, MD, Division Chief of Diagnostic Imaging at the Banner MD Anderson Cancer Center in Arizona
Read the Full Video Transcript
Phillip Koo: Hi, I'm Phillip Koo and welcome to UroToday. We're continuing our special series on integrating PLUVICTO into a urology practice, and now we're going to move forward and talk about the clinical considerations. We're very fortunate to have with us Dr. Gordon Brown, who's the medical director of urologic oncology at Summit Health, and also an associate professor of clinical urology and the medical director of robotic surgery at Thomas Jefferson University Hospitals, New Jersey. Welcome.
Gordon Brown: Thanks, Phil. Thanks for having me.
Phillip Koo: We've talked a lot about PLUVICTO and radiologic therapies. You have a very large advanced prostate cancer clinic here at Summit Health. How do you best identify those patients that would benefit from this type of treatment?
Gordon Brown: Yeah, I think it's a great question. These patients really are tracked throughout their course. It's really part of our navigation team's responsibility to identify patients prospectively to enter into the Advanced Prostate Cancer Center. And once they're there, they're monitored through a variety of different therapies for progression, to establish the need for scans, establish the need for follow-up laboratory values, etc. They're followed routinely within the clinics, and we have specific trigger points for evaluation for specific therapies based on the progression of disease. These are folks that are seen routinely, usually on a once every one to two month basis interval, and then they're tracked. Both the physicians and the navigators help identify these patients prospectively upon progression of their disease.
Phillip Koo: Great. So for the time being, PLUVICTO is obviously approved post-chemo, post-ARPIs. When you see this type of patient and, let's say they're progressing, what's your strategy with regards to when you obtain PSMA PET imaging, and how do you obtain it given that you don't have a PET, I believe, at your own facility?
Gordon Brown: We do not have a PET on site. We do have a PET within our organization, but it's about 80 miles north of where we are currently. As a general rule, for those folks who have already seen a taxane and are progressing on an androgen receptor inhibitor, when we see those PSAs rise, that triggers us to go on and obtain a PSMA PET. Slower-rising PSAs, we may not initially obtain PSMA PETs for. Those patients who have kind of slow interval PSA changes, the 0.2 to 0.3 kind of PSAs, but those who have more robust suggestions of more aggressive biology, obtain PSMA PETs pretty quickly, pretty readily. They're obtained through our local imaging partners, whether it be a Clarify scan or gallium scan, and also through our institutional partners, either Jefferson and/or some of our Cooper MD Anderson affiliates.
Phillip Koo: So when you obtain these PSMA PET scans, how do you sort of use that together with the clinical information to decide whether or not this patient should move forward with PLUVICTO or not?
Gordon Brown: Well, as you know, these patients have to be PSMA-avid, right? So they have to have evidence of PSMA activity to be eligible for Lu-177 therapy. That's obviously a baseline. So we have to understand what their scans look like and make sure that they're appropriate potential candidates.
Two, we have to make sure that they're in the state of the disease which is currently on label for them as they've progressed through a taxane, that they've progressed through a second-generation ARI, and that clinically they're demonstrating progression, whether it's changes in their performance status or PSA, certainly by scans. Those factors play into our decision to put patients onto additional therapy.
From a urology perspective, it's really nice to see additional therapeutic options for these patients who are really starting to exhaust a lot of the traditional first- and second-line therapies that we have as they progress in their disease process. The goal here really is to maintain quality of life, extend survival, and keep these patients out of the hospital. The data is pretty significant not only for improvements in survival and our PFS, but also for some of the quality-of-life benefits we're seeing here in the VISION trial.
Phillip Koo: Having an advanced prostate cancer clinic and being the primary physician that sees and manages these patients, I sort of create the analogy that you're the conductor of an orchestra. Oftentimes, these patients will need to see, obviously, a medical oncologist for chemo before they would be eligible for PLUVICTO, at least today. How do you navigate that? I imagine you're sending patients outside for medical oncology. How do you stay connected to the patients during that journey and how do you re-enroll them into your APC after that chemo?
Gordon Brown: Yeah, so I think it's an interesting question and one that really revolves around the development of relationships among organizations and, more importantly, among referring doctors and doctors who work in the same space. The idea here is that our main goal is the care of the patient, right? So there are times when there are therapies that we can offer that other places can't and vice versa. Early on when I started our Advanced Prostate Cancer Clinic, I developed important regional relationships with medical oncologists, both academic and private, to understand what the roles were in the continual care of these patients jointly. That allowed us to have open communication. It decreased any issues with cross-referral. It helped us really develop trust between one another, that the care of the patient was our primary concern and we're doing things within that patient's best interest.
That relationship has grown over more than a decade of doing this to really be almost a seamless transition point. When patients are identified as appropriate for a taxane, whether it be in the hormone-sensitive metastatic setting with triple therapy or whether it be downstream after failure of primary ARI therapy, it's a simple text or a phone call or really a kind of collegial interaction at this point, with the understanding that they're going to come back to us. We have some reinforcements there, where we track that patient. We set up a follow-up appointment after the initial medical oncology consultation, and we do have pull-through about halfway through their taxane cycle. So, usually around cycle three, they come back and see us. We assess their tolerability, their toxicity, and kind of make sure we have an additional touchpoint with the patient.
Phillip Koo: You've had a lot of experience treating patients with PLUVICTO and other radiopharmaceuticals like Radium-223. With PLUVICTO specifically, I think a lot of the listeners out there are always concerned about adverse events that they're not used to seeing. Tell us a little bit about your experience and how you've managed some of these patients.
Gordon Brown: Sure. So as a general rule, adverse event management within our advanced prostate cancer patient population is overseen and managed, obviously by the physicians, but also by our navigation team. This is a dynamic, the management of AEs in general, which we've become more familiar with over the last 10 years of managing these patients, as well as our fairly robust clinical trials research program. That allows us familiarity with managing all scales of adverse events, I should say, in both clinical practice as well as in trial patient populations.
Generally speaking, as it relates to PLUVICTO specifically, we've had some mild anemias. We've had some mild bone marrow signals and some mild renal insufficiencies that have come through. However, generally speaking, it's been fairly well-tolerated, even considering the highly pretreated nature of the patient population and the advanced stage of their disease. We have yet to have any patients come off of the trial for AE management reasons, and so from our perspective, they've been tolerating the therapy well.
Phillip Koo: And would you say that most patients have been able to get all six doses?
Gordon Brown: They have been. There have been some supply chain concerns, as you know, which has really hindered patients from starting, but not necessarily completing, therapy. But once they start, they've been able to complete therapy.
Phillip Koo: So in closing, I just wanted to congratulate and thank you for bringing this much-needed service to this community. I think moving forward, it's going to be probably an even bigger part of how we treat our advanced prostate cancer patients, and I just thank you very much for sharing your experiences with the entire UroToday community.
Gordon Brown: Phil, it's all my pleasure to be here. It's truly my honor. Thanks for taking the time.
Phillip Koo: Hi, I'm Phillip Koo and welcome to UroToday. We're continuing our special series on integrating PLUVICTO into a urology practice, and now we're going to move forward and talk about the clinical considerations. We're very fortunate to have with us Dr. Gordon Brown, who's the medical director of urologic oncology at Summit Health, and also an associate professor of clinical urology and the medical director of robotic surgery at Thomas Jefferson University Hospitals, New Jersey. Welcome.
Gordon Brown: Thanks, Phil. Thanks for having me.
Phillip Koo: We've talked a lot about PLUVICTO and radiologic therapies. You have a very large advanced prostate cancer clinic here at Summit Health. How do you best identify those patients that would benefit from this type of treatment?
Gordon Brown: Yeah, I think it's a great question. These patients really are tracked throughout their course. It's really part of our navigation team's responsibility to identify patients prospectively to enter into the Advanced Prostate Cancer Center. And once they're there, they're monitored through a variety of different therapies for progression, to establish the need for scans, establish the need for follow-up laboratory values, etc. They're followed routinely within the clinics, and we have specific trigger points for evaluation for specific therapies based on the progression of disease. These are folks that are seen routinely, usually on a once every one to two month basis interval, and then they're tracked. Both the physicians and the navigators help identify these patients prospectively upon progression of their disease.
Phillip Koo: Great. So for the time being, PLUVICTO is obviously approved post-chemo, post-ARPIs. When you see this type of patient and, let's say they're progressing, what's your strategy with regards to when you obtain PSMA PET imaging, and how do you obtain it given that you don't have a PET, I believe, at your own facility?
Gordon Brown: We do not have a PET on site. We do have a PET within our organization, but it's about 80 miles north of where we are currently. As a general rule, for those folks who have already seen a taxane and are progressing on an androgen receptor inhibitor, when we see those PSAs rise, that triggers us to go on and obtain a PSMA PET. Slower-rising PSAs, we may not initially obtain PSMA PETs for. Those patients who have kind of slow interval PSA changes, the 0.2 to 0.3 kind of PSAs, but those who have more robust suggestions of more aggressive biology, obtain PSMA PETs pretty quickly, pretty readily. They're obtained through our local imaging partners, whether it be a Clarify scan or gallium scan, and also through our institutional partners, either Jefferson and/or some of our Cooper MD Anderson affiliates.
Phillip Koo: So when you obtain these PSMA PET scans, how do you sort of use that together with the clinical information to decide whether or not this patient should move forward with PLUVICTO or not?
Gordon Brown: Well, as you know, these patients have to be PSMA-avid, right? So they have to have evidence of PSMA activity to be eligible for Lu-177 therapy. That's obviously a baseline. So we have to understand what their scans look like and make sure that they're appropriate potential candidates.
Two, we have to make sure that they're in the state of the disease which is currently on label for them as they've progressed through a taxane, that they've progressed through a second-generation ARI, and that clinically they're demonstrating progression, whether it's changes in their performance status or PSA, certainly by scans. Those factors play into our decision to put patients onto additional therapy.
From a urology perspective, it's really nice to see additional therapeutic options for these patients who are really starting to exhaust a lot of the traditional first- and second-line therapies that we have as they progress in their disease process. The goal here really is to maintain quality of life, extend survival, and keep these patients out of the hospital. The data is pretty significant not only for improvements in survival and our PFS, but also for some of the quality-of-life benefits we're seeing here in the VISION trial.
Phillip Koo: Having an advanced prostate cancer clinic and being the primary physician that sees and manages these patients, I sort of create the analogy that you're the conductor of an orchestra. Oftentimes, these patients will need to see, obviously, a medical oncologist for chemo before they would be eligible for PLUVICTO, at least today. How do you navigate that? I imagine you're sending patients outside for medical oncology. How do you stay connected to the patients during that journey and how do you re-enroll them into your APC after that chemo?
Gordon Brown: Yeah, so I think it's an interesting question and one that really revolves around the development of relationships among organizations and, more importantly, among referring doctors and doctors who work in the same space. The idea here is that our main goal is the care of the patient, right? So there are times when there are therapies that we can offer that other places can't and vice versa. Early on when I started our Advanced Prostate Cancer Clinic, I developed important regional relationships with medical oncologists, both academic and private, to understand what the roles were in the continual care of these patients jointly. That allowed us to have open communication. It decreased any issues with cross-referral. It helped us really develop trust between one another, that the care of the patient was our primary concern and we're doing things within that patient's best interest.
That relationship has grown over more than a decade of doing this to really be almost a seamless transition point. When patients are identified as appropriate for a taxane, whether it be in the hormone-sensitive metastatic setting with triple therapy or whether it be downstream after failure of primary ARI therapy, it's a simple text or a phone call or really a kind of collegial interaction at this point, with the understanding that they're going to come back to us. We have some reinforcements there, where we track that patient. We set up a follow-up appointment after the initial medical oncology consultation, and we do have pull-through about halfway through their taxane cycle. So, usually around cycle three, they come back and see us. We assess their tolerability, their toxicity, and kind of make sure we have an additional touchpoint with the patient.
Phillip Koo: You've had a lot of experience treating patients with PLUVICTO and other radiopharmaceuticals like Radium-223. With PLUVICTO specifically, I think a lot of the listeners out there are always concerned about adverse events that they're not used to seeing. Tell us a little bit about your experience and how you've managed some of these patients.
Gordon Brown: Sure. So as a general rule, adverse event management within our advanced prostate cancer patient population is overseen and managed, obviously by the physicians, but also by our navigation team. This is a dynamic, the management of AEs in general, which we've become more familiar with over the last 10 years of managing these patients, as well as our fairly robust clinical trials research program. That allows us familiarity with managing all scales of adverse events, I should say, in both clinical practice as well as in trial patient populations.
Generally speaking, as it relates to PLUVICTO specifically, we've had some mild anemias. We've had some mild bone marrow signals and some mild renal insufficiencies that have come through. However, generally speaking, it's been fairly well-tolerated, even considering the highly pretreated nature of the patient population and the advanced stage of their disease. We have yet to have any patients come off of the trial for AE management reasons, and so from our perspective, they've been tolerating the therapy well.
Phillip Koo: And would you say that most patients have been able to get all six doses?
Gordon Brown: They have been. There have been some supply chain concerns, as you know, which has really hindered patients from starting, but not necessarily completing, therapy. But once they start, they've been able to complete therapy.
Phillip Koo: So in closing, I just wanted to congratulate and thank you for bringing this much-needed service to this community. I think moving forward, it's going to be probably an even bigger part of how we treat our advanced prostate cancer patients, and I just thank you very much for sharing your experiences with the entire UroToday community.
Gordon Brown: Phil, it's all my pleasure to be here. It's truly my honor. Thanks for taking the time.