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Neal Shore: Hi everybody. Welcome to UroToday in our online medical education program entitled Beyond Androgen Blockade to New Pathways and Novel Treatments in mHSPC and mCRPC. I'm Neal Shore. It's a great pleasure and honor for me to moderate today's discussion following a presentation by an internationally renowned medical oncologist, Dr. Mark Fleming, who's pioneer's cutting edge research, as well as super busy clinical community advancement. His topic today is real world evidence on the under-utilization of treatments of mCRPC. Mark, it's a great pleasure to have you here.

Mark Fleming: Thanks. Thank you for having me, Neal, and the whole UroToday team to having me here, so it's an honor. I have the pleasure of talking to you about the real world evidence on the under-utilization of prostate cancer treatments for metastatic prostate cancer. I always begin my talks talking about the prostate cancer clinical states model, and we'll talk about the current shortcomings that exist today despite these great treatments that we have, the shortcomings that exist of the under-utilization..

I believe the real key step that we need to do in prostate cancer is emphasizing multidisciplinary management. It's needed of urologists, medical oncologists, which I am, radiation oncologists and interestingly genetic counselors, for the use of the optimal treatment for castrate-resistant metastatic prostate cancer. I want to update one of my sayings. I'm a mnemonic kind of a person. PM SAGAS to have people, clinicians can think of how I approach and a simple way to remember making sure you're utilizing all the proper treatments.

This is the initial prostate cancer clinical states model from my mentor, Dr. Howard Scher, that we have clinical and localized disease and the disease can progress if it returns from a non-castrate rising clinical state to a metastatic state and metastatic castrate resistant prostate cancer. How we really think of things is first line therapy, second line therapy as we work our way through.

But today we have, how I think of the disease, is this is a listing of all the multiple treatments that you have and how can you remember which one to use and what's the right sequence. How I approach it as I think of a mnemonic PM SAGAS that makes you think of the prior therapies, the metastatic sites of disease because the metastatic sites of disease might change how you might do things. The symptoms, is this an androgen indifferent cancer, looking at germline mutations, AR signaling defects, as well as somatic mutations.

I was asked to focus on castrate-resistant metastatic prostate cancer, and why are we under-utilizing these awesome therapies that we now have? Well, if we look at the poor adaptation of treatment, we can start with metastatic hormone-sensitive prostate cancer. Despite the level one evidence that exists that definitively showed there's an improvement of overall survival, we're not using these intensifying therapies as much as we should.

There's a population-based study that showed only 12% of men were receiving intensified treatment. While these are kind of old data from 2014, 2019, we still have a way to go. When we look at Veterans Health Administration claims data, we're still not utilizing all the effective strategies that we have, including second generation androgen deprivation therapy and chemotherapy, and many patients are just getting androgen deprivation therapy alone, which in my opinion as many would say, is under-utilization of therapy.

If we focus in on metastatic castrate resistant prostate cancer, almost one quarter of patients do not receive first-line therapy and you wonder how can that exist in 2023. More than half of patients do not receive subsequent therapy, despite life prolonging strategies that exist. Among patients who do receive therapy, novel hormonal therapies are still under-utilized, and our treatment durations are still too short in how we offer these therapies, and some men getting six months less of therapy per line of therapy.

It's very clear racial disparities exist and we need to do a better job of educating providers, patients, and caregivers to optimize these treatments, and I have some thoughts that I'll get into the end why I think that might exist.

How do we approach treatment options? Well, there's cancer-related factors, there's patient-related factors, there's clinician-related factors and there's treatment-related factors, cost and toxicity being all criteria that we ultimately want to arrive at a treatment decision to optimize for a patient.

In my opinion, we now need to have a multidisciplinary management of metastatic prostate cancer. We need to utilize urologists, radiation oncologists when we look at all the treatment strategies that we have, medical oncologists, and even geneticists to help our patients walk through the journey of prostate cancer. There's multifactorial issues of patient preference and clinician expertise and availability, and I think that's one of the factors that is driving some of the under-utilization, the clinician expertise and the availability.

Primary care providers play a vital role as we expand our treatment options. We have treatments that we need to have multidisciplinary management, including using some type of, if a patient is on anticoagulation therapy, we need to know those type of issues in order to optimize their treatment.

I think one of the key issues, and me being a community provider, I need a referral from a provider to get me involved in their care and I think it's essential as a community to optimize these treatments. We should have some type of thought behind the timing of transitions between clinical teams, which would include urology to medical oncology, radiation oncology or nuclear medicine, and also geneticists. I think the timing of this varies dramatically depending upon where one might practice. Let's talk about that a little bit more. That timing of transition is essential to optimize the optimal treatment.

When I look at how can this happen in this real world, I think that we have to start having a broader lens of how we look at prostate cancer. It is very different during my training, when I trained in an academic environment at a tertiary care center, Memorial Sloan Kettering, how those referral patterns to medical oncology was very different. Oftentimes in that setting, once the PSA begins to rise or once someone has metastatic disease, it oftentimes will refer to medical oncology. Well, that doesn't necessarily happen in the community. I think there's a big difference between a small group urology practice and a LUGPA or large urology group practice association.

In my community here in Hampton Roads in Virginia, I have a large urology group practice who does an excellent job of managing and utilize the treatments appropriately for early stage metastatic disease. But small group urologists tend to refer often to me earlier on in the case once the PSA begins to rise. I'm not trying to say there's a right or a wrong, but I do think there's a role for cross-collaboration, and I think as a community we need to decide what is the right timing, when to do that.
I've noticed differences in my own practice of if someone is at the urologist is in a private practice or they come from a hospital-based group who might want to "hold onto these patients" to keep them within that hospital-based group, but however, they're not utilizing all the treatments because such treatments, there's newer treatments like Lutetium or Pluvicto is still not widely available across the board. We should optimize in making sure men get the optimal treatment.

Finally, rural versus urban. These are issues that we need to come to grips with in order to find the right ways to treat our patients. I can tell you personally, my father was, I actually lost my father to prostate cancer, and so I'm very passionate about making sure that we are doing the right things for a patient to optimize all the levels of treatments that one might receive.
To find the solution we're going to need to come up with strategies to guide, especially the small group urologists, how do we educate them? The large urology group practice associations are doing a great job of educating their practices on how to appropriately utilize these strategies, and it really will take a multi-pronged approach to answer these questions.

Now looking at the PM SAGAS, looking at the clinical states model, I believe I felt obligated now to update this slide, and to insert that, we really need to do multidisciplinary management for the treatment of metastatic prostate cancer, because we're seeing an under-utilization and I've touched upon some of the reasons why it might be underutilized. We must work together and collaborate, putting the patient first, putting the patient in the center, to optimize all of these wonderful treatment options that we now have.

These treatment options can involve chemotherapy, which is historically given by medical oncology, involving genetic counselors to give information regarding gene alterations that might exist, as well as nuclear medicine and radiation oncologists, involving the use of Lutetium or even radiation to oligometastatic sites of disease. The key now is PM SAGAS is a way to approach this disease to making sure that we're optimizing all the treatment options for patients to optimize their care.
Thank you for allowing me to have some brief time to talk about this subject and I'll be happy to answer any questions you might have.

Neal Shore: Well, thank you Mark. That was fantastic. I love the acronym PM SAGAS. That was really a great presentation, Mark. Thank you. You've obviously given so much thought to putting this type of depth into this. We do regularly talk about the multidisciplinary team and also why it's so important to avoid this under-utilization with level one evidence of both insensitive and resistant disease. I really appreciate how you're saying it's not a one size fits all. There's nuance, you got to tailor it.

One of the things that's always been sort of fascinating to me, in the arc of your career, I'm not going to ask you what's the best way to perform education to the busy healthcare providers out there in the community. But what are some of the different strategies you've seen evolve over time from when you came out of practice to where you are today? Because what I frequently hear is I'm too busy to go to a meeting or I'm overwhelmed by things and invitations that I get invited to. Do you have any recommendations to our colleagues?

Mark Fleming: I think the tried and true tumor boards in helping community. I think if there's one good thing that came out of COVID is the use of platforms like this to educate. I think people can do them on their time and I think a case-based approach is very, very helpful.

In addition, multidisciplinary clinics. We have tried in the community, which is a little bit more challenging because to be quite frank, there's multiple tax IDs in order to get different doctors involved, and that's very challenging. But it can be done with cooperative motivated groups. But I think essential to that is radiation oncology, medical oncology and urology, and we're starting to utilize our geneticists to also contribute to that as well. I think the dinner meetings are a way. I think that does a real good job of getting mid-levels and nurses educated, but I think to get clinicians, physicians, I think one of the ways is the tumor boards is probably the way to go.

Neal Shore: That was really good, and I love the fact that the overarching theme of everything you're saying is put the patient first, do what's in the best interest to patients. Make sure all of our patients have accessibility. Let's overcome some of our historical disparities. Let's think about how we can do better. No more of this specialty rivalry. No more of rural, urban, suburban, community versus tertiary academic. Let's just make sure that people are getting optimal care. It's all gotten so much more complicated from the time you and I got out of training, looking at the vast marker and therapeutic selection. It really does take a really well-honed communicating multidisciplinary team.

Mark Fleming: I agree.

Neal Shore: With that, Dr. Mark Fleming, thank you so much. Great presentation. Thanks for being part of the masterclass.

Mark Fleming: Thank you. Thanks for having me.