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Phillip Koo: Hello, my name is Phillip Koo, and welcome to UroToday. One thing that we've noticed over the years is a significant growth in the number of clinical trials that have used nuclear medicine imaging, specifically PET imaging, and also theranostics and therapies in the prostate cancer space. And with that comes a greater need to scrutinize these studies, especially when it comes to diversity and equity. And to speak about equity in prostate cancer clinical trials from a Nuclear Medicine perspective, we have Dr. Joe Osborne, who's Chief of Molecular Imaging and Therapeutics at the Weill Cornell School of Medicine, to really give us his perspective on how this field is shaping up, and what we can do in the future to make sure our trials are more robust and have the greatest impact over the greatest number of patients. So thank you very much, Dr. Osborne, for joining us.

Joe Osborne: And thank you so much for having me. I really appreciate bringing my perspective to this audience. So I guess to start off with, I have been in practice for about 15 years and over this period of time, I've been at Cornell with Neil Bander, who has been one of your guests in another segment talking about the growth of radionuclide. And so this process of radionuclide therapy in trial has been really the process of my career. And it's incredibly exciting, but with all advances in GU oncology, with every advance, you have to bring everybody along, or else you could have a wonderful, valuable advance that doesn't have equity. And that is also the other half of my Nuclear Medicine perspective, which is how do we, when we're growing these trials, grow it's such that it grows with the science, but also grows with the population.

I'm Joe Osborne. I'm the Chief of Molecular Imaging and Therapeutics, Department of Radiology at Weill Cornell Medicine, New York-Presbyterian Hospital. And today I'd like to talk about my perspective of equity in prostate cancer clinical trials or nuclear radiologist perspective. So first I would like to disclose that, well, I have nothing to disclose in this presentation except to say, this is the wonderful part of my group who is focused on the GU component of Nuclear Medicine. And without them, I wouldn't be able to talk about a lot of the interesting things that we're doing in the department today. So I'd like to focus on three different aspects of clinical trial equity for prostate cancer. And first is a little bit of the progress, but just a small part of it because as we all know, there's a tremendous amount of progress in the field at the moment.

Second, an evolution in thinking about some of the issues of equity that I've had personally, and also I've seen in the field and also a set of goals. Some of the goals that we have specifically in my practice and some things that I believe are aspirational for the field. So one of the really just incredible parts of what we're talking about today, it's just the progress, which is the fusing of imaging of the cellular molecular phenotypes in vivo and primarily now with PET imaging and [inaudible] medicine and patient selection by genotype. And these are absolutely converging technologies. And I'd like to acknowledge specifically Neil Bander, who's given another one of these, URO Hope Today, lectures, wonderful development radiopharmaceuticals in Nuclear Medicine and in prostate cancer and has really been the evolution of my time in Nuclear Medicine from the beginning to the end for about the last 15 to 20 years where Neil started with the injection of Lutetium PSMA in the antibody, J591 form in clinical trial, about 20 years ago and the culmination, the arc that we've seen through the OSPREY and CONDOR trials.

And now with the landmark VISION trial that has really culminated in all of these technologies that we're seeing today. That being the case, there's also the double edge of progress, which is that when you have progress finding cancer, if you're not extremely careful about the tools that are being used or the patient, the patient populations that this is being rolled out on, you end up with even greater disparities. And so as Martin Luther King said, all progress is precarious. And one solution to one problem brings us face to face with another problem. And in this case with colorectal cancer, as colonoscopy was being rolled out more broadly, it wasn't seen in every population over these years and decades. So initially there was a gap in treatment that was seen between white and black patients. And this could be seen as unequal treatment. And part of this was the uneven colonoscopies being done across the population.

So there has been an evolution and we are actually seeing many of these things before we even start. So, we have an amazing opportunity to look at this and look at the disparities that we've seen that are extremely significant. When looking at men of African ancestry who have had these disparities in incidents about twofold treatment, access, death, and all these all along the continuum. At every step, you see this disparity, but they exist in the context, not only of race but also socioeconomic level, education, and zip code. And therefore, when you really start digging down, these are very recent trials, a lot of work seen in radiation oncology recently, even despite presenting with more advanced disease, self-reported African American patients demonstrate favorable outcomes into clinical trial context. And that's seen even more broadly in a larger meta-analysis done to show that men of African descent tend to have favorable outcomes in clinical trials.

With those things in mind though, personalized imaging and genomics are still likely to contribute to achieving equity. And this was shown very elegantly in Stopsack's piece, that there's still a lot that we can and should learn in order to achieve equity in this traditional, personalized image and genomics. So what about the evolution in imaging? This has happened at the same time where we started decades ago, decades with theranostics, but with radioiodine and thyroid cancer. So this is really weird. Nuclear Medicine was born before it became Nuclear Medicine, looking in a lot of different compartments and then moving on to molecular imaging, looking at specific targets. And now we're back again in theranostics. So this is really something that is a full circle event for people who have been in the field for some time. And, for me personally, I would say, one of the reasons I was really attracted to Nuclear Medicine and imaging was that it was a blind edition, the molecular imaging, you don't actually see the patient.

A lot of the time with diagnostic imaging, you can make some guesses based on the names and sometimes the common ethnicity seen in the catchment, but you don't really know, right? So you're actually in a place where you could just look at the images and make some judgments of the disease and not necessarily patients. And now molecular imaging and theranostics have brought in it back all into one place. Where there's a component at a time where we're not going to see the patients except through the images at the EMR, but then the therapies where we're very much in the middle of how the patients come into the process and continue. As imaging is seen and is going to be part of every step of their journey. Right?

So this evolution that we've seen where race is now seen as a social construct. This is something that potentially or at least, I would say for me personally, is something that I've thought about quite a bit over the years with prostate cancer or imaging in general, which is that there are many things that bring race into the picture, but the social construct is so important that much of the social construct really may be the driver of what we see with race.

And this is something that we all have to understand at a basic level. So what I see at equity is as population health, over systemic bias. When one is looking to improve equity, this is the very basic equation that we're looking at, right? So, we have to optimize care, which adheres to the patient's values, their environment, and their location, right? So prioritizing access to quality of care also means promoting greater inclusion in clinical trials and clinical care just in general. And one based on the trials that we have done thus far, what we know is that we need to make room for greater genomic diversity and inclusion past self-reported race, right? We need to get past that and past what, not only what we see, but what patients report, and the genomes, particularly of African ancestry must be included in trials going forward.

And this has to be all pulled together with a patient in its center, but through multidisciplinary teams, including Urology, Radiology, Medical Oncology, Radiation Oncology, and Pathology, all of us have to be at the table trying to get at each individual patient through their prostate cancer journey. So we've created at Cornell, the Rad Health Equity Lab, and this is in prostate cancer, but also across other cancers and disease continuum, to look at the access to affordable and validated technology and improved communication is really part of it because if you have a valuable technology, but it's not communicated and access isn't provided to the patients, then you'll never get from value to equity. So you have to improve communication. And that means patient navigation and share decision making, which is a model that we're looking at very closely. And so for prostate cancer trials in general, I would say some of these things need to be looked at, but specifically with trials, one needs to address site selection and the catchment.

Without the patients, one is trying to enrich our target in the catchment or be the patients that actively accruing physicians are seeing, one will never really truly get equity. And one has to then address the access to care issues. How close they are to clinical trials, navigate them in, deal with financial toxicity, if their components in the clinical trial where the patients are going to pay, that is a problem. And that is something that is going to skew one's clinical trial. So you to have assessed enrollment with all these things in mind to enrich for genomes of African Ancestry and really stop and focus because without this, we're never going to get there and promoting early access to affordable molecular imaging. And this is very much a personal belief, but I think what we're seeing with a lot of the trials is extremely important.

So as a take-home, just looking at those three points again, progress has just been incredible, but there's a caveat. With all progress, we have to make sure it's well distributed. In terms of the evolution that we've seen, theranostics are back and they are really back for Nuclear Medicine, nuclear radiology, and I would expect my field to embrace it, and to really be a part of these larger multidisciplinary teams that are really going to move the needle. And then of course, they're the goals which will change over time. But I will say some of the bedrock components of Rad Health Equity, at least for us as a site. And, I have to say, I'm very lucky with our site because we have a prostate score and we have Neil Bander where it started, but there's also Scott Tagawa, Max Loda, and Chris Barbieri who are the heads of core; and Doug Scherr and Himanshu Nagar.

There're so many names who have been a part of this multidisciplinary team, which I think will really push things forward just with Rad Health Equity. But I think in terms of our global needs, we need to address how patients are getting into trials. So, thank you very much. And I would be happy to talk more and answer any questions.

Phillip Koo: Thank you, Joe, for that wonderful perspective on equity in Nuclear Medicine and the prostate cancer trials. We have a lot of listeners out there who are in the process of designing or participating in these clinical trials for prostate cancer. What practical advice do you have for them to make sure they can capitalize, maybe not capitalize, but make sure that they create the best trials possible to have the greatest impact?

Joe Osborne:  Well, I think access to our trial trials is extremely important and really getting a sense of wherever the practice exists. Really what is the catchment? Who are the possible people who one can enroll in this trial and how could you really look at the depth of the community and bring in the patients such that if there's imaging a part of it or there's genomics or chemotherapy, how everyone can possibly benefit because as you look at all the details, there's so many details that when you look at prior trials, even successful trials, they can be done better. And so what we do is really just try and learn from the past, a very obvious message, but that's something that we very much have to do.

Phillip Koo: Great. So it seems like at Cornell you've created this institute or this model with Rad Health Equity. Can you explain to us what Rad Health Equity is and how other institutions might go down that path as well?

Joe Osborne:  Well, there's one side of radiology and I talked about this a little bit in another segment with you. It's amazing. It's bringing people in for the blind medical audition, right? You don't actually see the patients who are on the scanner much of the time, right? You're looking at their disease without looking at anything until you go into the electronic medical record and get more detail. That being said, what we've been trying to do with Rad Health Equity is acknowledge the other part of diagnosis, which is the therapeutic part of radiology, which is, if we are going to have greater acts inclusion, we have to actually talk to the patients and figure out what are the things that may have them not joining clinical trials, where we know that there is the greatest potential benefit for the patients.

And also the benefit for us to learn from our mistakes and how to make our medicines and therapeutics better. So we tried to do at least three things, look at what the access to validated technologies were. Second, talking to the patients what was going to improve the communications; and third and this is the trickiest part, right? Navigating the patient and looking at shared decision-making. One of the things that I had found when I was at a neighboring institution when I was at Sloan Kettering, is that when we went to the catchment of York, and Queens and Brooklyn, two of the most diverse counties in the United States. Sometimes the barrier was language and sometimes it was even self-reported race. Sometimes it was socioeconomic and there was a financial toxicity associated with the clinical trial and a reason why a patient might not be a part, maybe they needed their family to be brought in.

And that's where shared decision-making came in. And it really became important to us in the next iteration of Rad Health Equity over at Cornell to bring in the patients into the conversation, bring in the families because frequently it was the family members and the community that would help convince the patients to be a part of the trial. When you have greater inclusion, we simply get better at what we do, right? And, we can look towards the next set of solutions for these patients.

Phillip Koo: So to that point, how have you worked closely with the other stakeholders like the Medical Oncology teams or whoever the Rad-Onc teams or whoever you're working with to help improve that access?

Joe Osborne:  Well, so part of it is good luck, right? We have a terrific team and a prostate cancer school. So just naturally we're getting together within a spore with surgery, with Chris Barbieri and Max Loda, but also with Med Onc and Scott Tagawa, and Rad-Onc and Himanshu, and Ari. Everybody's really getting together around building clinical trials. And I would say in our group, everybody has a different perspective. So people are really coming from a different place and it speaks to how one is successful. Everybody brings in something a little bit different into the mix and that grows the pot, right? Because I don't feel in that group, we're really competitive with one another. We're all trying to bring our own perspective and bring more patients and bring more people in.

And people have been very welcoming to the idea of, okay, if New York-Presbyterian Weill Cornell, also has New York-Presbyterian Queens, New York-Presbyterian Brooklyn, and all of these other parts of our enterprise that really tap into different communities. Let's use those parts of the community to really improve access to these clinical trials, improve access to different kinds of communities, and really start thinking about. I mean, for me personally moving past things that we thought about in the prior iteration, self-reported rates, maybe we want to look at enriching the genomes of African Americans. Maybe we want to figure out ways to get early access to advanced molecular images. Maybe we want to bring in the pathologist because they are going to tell us something about the molecular diagnosis and really that's how it's been put together. So I've seen that it can work. I think it works quite well. And from that, I think we, by example, hopefully, other people will adopt the same approach.

Phillip Koo: Wonderful. So it's clearly you're highlighting the importance of diversity on the patient level from your collaborators and medical specialties, ideas, really diversity, really being an important part of everything that you do as a group, as a team, and as a program. So we just want to thank you very much, Dr. Osborne, for your time and your expertise. We look forward to supporting this and bringing more awareness around equity in prostate cancer clinical trials. So thank you very much.

Joe Osborne:  And I really appreciate the time to bring this to your audience and hopefully we can expand Rad Health Equity. I think it really is something that everybody can have a piece of.