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Luke Nordquist: --private medical oncology practices and their role in PSMA radioligand therapies. I have to say that there is no science with this talk, so I want you to take off your scientist-physician hat and put on your business manager and CEO hat. These are my disclaimers.

So what I’d like to get across today is not only can community medical oncology practices be involved, but they really need to be. More than 50% of cancer patients are treated by medical oncologists in the community. I don’t know any other commercial product where you can leave over half of your potential customers on the table. So definitely need to be involved.

Benefits include expanding access, closer to home for patients, and really allowing them to maintain family relationships, support groups, and patient–physician relationships. But the struggles—they often lack experience with this—resources, reputation, lack of ability to start a research program. These are small businesses. And they're facing really large financial strains, which limit their ability to start new programs. And I’ll go through that in a minute here.

But you have to think much like what Denise was saying—talk about fighting denials. We do that on a daily basis. If we get burned on a PROVENGE or one dose of Pluvicto, it’s not always the first one. It’s not nice to say, “They denied it, let’s fight it.” We might have given four doses by then. And they paid for the first one, denied the second and third, and now we’re at $100,000. That’s a bad day, and the bank comes knocking. Because again, we’re small business owners.

So this is real data. We work—so my center XCancer is my center. I do prostate cancer there. But we also help other community cancer centers do research. We’ve helped up to 45 now. This is a group in Dothan, Alabama, real-time. They’d never touched research until about three years ago. They came to us. And now they’ve been doing breast cancer and lung cancer research trials, drug studies.

And now, they jumped in with both feet. A couple of months ago, they broke ground on a theranostic center. It’s going to have SPECT/CT, PET/CT, uptake rooms, hot lab—the whole bit. AUs, RSO. But these are real numbers that it took to do this. And that’s about $1.5 to $1.7 million for the first year. And most of that is recurring, except for your hot lab expenses. So again, take a small business owner that’s already struggling and say, “Let’s put out $1.7 million.”

On top of that, we’re used to chemotherapy hoods and infusion centers. But now we’ve got to deal with regulatory licensures, RAM licensing, compliance with the regulatory, new infrastructure, hot labs, waste storage, new employees. We need RSOs, contracts with authorized users, nuclear technologists, new collaborations. We have waste pickup, radio pharmacies, couriers that are coming in the middle of the night, complex scheduling of patients.

A lot of these are because of production—can only be given on certain days. Sometimes we have to have staff come in on Saturdays because of how these are given. The reimbursement complexities—we just heard Denise give a talk about that. So they’re going to do all of this for a couple of Lutathera and a couple Pluvicto doses per year. Remember, most medical oncologists—they’re not seeing a ton of prostate cancer. They’re seeing lymphomas and lung cancer and breast cancer and colon cancer. And to date, this is all we have.

So now go to a community oncology practice and say, “Let’s spend that $1.5 million annually for a couple Pluvicto and Lutathera doses.” So that’s the real challenge. But where I think the solution lies is involving these centers with theranostic clinical trials. And so clinical trials bring new significant sources of revenue to the clinic that are providing innovative therapies to their patients. They’re lowering the financial toxicities for patients.

So in my clinic—the number one cause of bankruptcy in the United States is medical bankruptcy—in 21 years, I’ve never had a patient file a medical bankruptcy, never sent a patient to collections. Every year, we write off about $300,000 of patient debt. We don’t have to worry about reimbursement because we get paid working with sponsors. So we don’t just pad our wallet. We’re able to give back to the whole program and grow the program. And you get physician staff, professional development, and you’re really a part of new science.

So the XCancer model—again, I founded my center in 2010 to be an innovative prostate cancer clinical trials center that had high quality and efficiencies, and then to reach out to other community cancer centers for them to grow their research programs. So when I started, I had three employees. I had two clinical trials: COUGAR-301 and COUGAR-302—already closed accrual. And that was how I started.

And now, we have about 50 staff completely focused on clinical trials. 100% of our patients are evaluated. We end up putting about 30% of our patients on clinical trials. About 25% of patients go on multiple sequential trials. We average about 150 patients on trials. Nearly 2,000 patients accrued to date at my center. Twenty-three First-In-Worlds that we’ve conducted at my center.

We can open a trial—we just did one the other day. I left for Africa. We did the SQV the day I left. Came back, we had the SIV, accruing the first patient. So in weeks—not months or years—we have some proprietary research software that allows us and other centers to—we’re not doing anything fancy. If we’re a sports team, we’re really just doing the fundamentals. So that’s what we preach. We have central radiology readers so we get that extra read on our patients. And again, we’ve worked with now up to 45 community cancer centers.

Our theranostics program—we’ve done now over 50 Phase 0 to 3 clinical trials. Not only did we put the first patient on the VISION trial, we put the first 17 patients on the VISION trial. Five of our XCancer sites accrued patients to the VISION trial. We’ve worked with just about every isotope you can look at. And you can see, now, I have 14 authorized users on contract to help my program work. And we help with consultation services to set up other programs like in Dothan, Alabama.

So should we be developing theranostic clinical trial programs in the community? Well, many clinical trials are closed due to poor accrual. Rapid growth of theranostic clinical trials—there are nearly 700 global clinical trials today. The community brings the real-world experience. And again, they’re the sleeping giant, with more than 50% of patients being treated in the community. So this is data from TheranosticTrials.org.

In 2022, when we started this site, there were 155 theranostic trials for 12 tumor types. Today, 670 trials for 35 tumor types. I know this same slide from Oppenheimer was shown yesterday—the significant growth. And it’s my pleasure to announce today that Oliver Sartor, who many of you know, is now leaving Mayo Clinic and starting his own private practice in Louisiana, partnering with XCancer to run his clinical trial. So he wanted me to announce that today. Big news for us, too.

And part of this is educating community medical oncologists. Because much like was said before, the failure—what did you say, Dan? “First Attempt In Learning.” So many of these medical oncologists—I was the same way—I didn’t know the difference between alpha and beta, and what’s the importance of a linker. So there’s so much education that has to go into this.

So one of the things we created is a site called TheranosticTrials.org. Lots of education—basic stuff for patients and physicians who are new to this. There’s also a lot more complex information on here—trial stats, real-time on the number of trials for certain isotopes and tumor types. You see Dr. Morris up there. We have our Distinguished Investigators, and many of you should be added to this.

There are lists—every single isotope and target being studied today—with all of their characteristics and significant news. You can also search any tumor type. So I know when Jeremie was looking at all the tumor types yesterday, it would have been very easy to go to TheranosticTrials.org—type in “prostate cancer”—and it would list every tumor type.

The nice thing about this, though, is that pharmaceutical companies have back-end templates where they can upload their own information. So if there’s a publication, they can put a link to it. There’s a section for videos. If there’s a slide presentation or a poster, they can upload the poster. So a lot of information on the trials here. And again, Jeremie, you can put up your investigator-initiated trial.

So in conclusion, I think bringing theranostics into the community setting would dramatically expand access for more cancer patients, but it faces major challenges. Success requires thoughtful strategy, investment, infrastructure, education, personnel, licensing, and collaboration. And I do believe that a well-developed and focused theranostic clinical trials program is one solution. I’ll stop with that. And this is just hashtag proud father. And next, we have Dr. Dustin Boothe to talk about the radiation oncology in the private setting.