Transcript:Raoul S. Concepcion, MD, FACS: We know that the survival benefit of nuclear medicine infusion is for six cycles. How are you following these patients in terms of their markers, such as their PSA, alk phosphatase, and albumin levels? We know you have to get CBCs before you infuse. What are you doing for these patients specifically? Are you following the lab at three months, six months?

Michael Fabrizio, MD, FACS: So we get a series of labs after their first infusion—again, CBC—just to make sure everything is going well for the protocol. And then we get these patients in at an every-two-month rhythm of basically every one to two months. They’re coming in, they’re getting their infusions, and they’re alternating getting their labs in between. And they’re getting their testosterone, and their PSA, and their Vitamin D, their calcium levels. We’re not doing their testosterone, calcium levels, and Vitamin D levels that often, but we have routine intervals where we get these labs. And once they’re getting this drug, once they have bone mets, they need to be followed closely.

You can’t let these guys come back every six months, every four months. I think you need to follow these patients every couple months, even if you’re coming in with one of your extenders, which is how we work it. We have two extenders that see advanced prostate cancer patients. We have a nurse navigator, so we have a whole team of people that will see these patients in between our visits, and I think that’s important. And we adopted that model from our medical oncology friends here on our panel.

Judd W. Moul, MD, FACS: Good point. I think, culturally, most urologists are in the mindset of seeing patients every three months, three to six months. And to change the culture to see patients monthly and making that transition from the three-month visit to the one-month visit is something that is a teachable moment.

Michael Fabrizio, MD, FACS: Most of my partners were catatonic at the suggestion.

Jorge A. Garcia, MD, FACP: I think that when you think logistically, at least from the medical oncology perspective, as to how should you manage those patients getting radium-223, I think the most important thing is not who owns the patient (nuclear medicine, radiation, oncology, or what have you), but to make sure that you have one person as a quarterback of that patient. At the end of the day, yes, the median number of cycles given in ALSYMPCA was six cycles, but in practice, in the postchemotherapy setting, we have one of the largest experiences with radium-223 in the country.

I can tell you that the median number of cycles given in the postchemotherapy space was actually three to four cycles or so. And patients do have side effects, specifically myelosuppression. And by label, you may not need to actually have hemoglobin all the time at 10.5 or so, but you can see sometimes patients drifting down. And the biggest question is, how do you support those patients? So, I think for me, in my group, we see those patients on a monthly basis. They either see a nurse practitioner, the physician assistant, or myself. We’ll check their labs and then they go straight to nuclear medicine, they get the infusion, and then we’ll see them.

For those patients who are really adamant to see their PSA, we oftentimes have to do PSA just to follow and to have a cohesive approach. But the reality of it is we do a scan only when we actually believe we need to make changes in treatment decisions. In the ALSYMPCA [trial], there was no imaging follow-up, so that’s why we actually think skeletal symptomatic events, not skeletal-related events (SREs) defined by imagining. None of us know, in fact, how to follow those patients, imaging-wise. None of us know the impact of radium-223 with regards to fluoride PET, choline PET, technetium 99, and so forth.

So, the reality of it is most of us will complete therapy and then re-stage the patient. Some of us believe that maybe getting a scan in the middle, especially a CT, would be useful for us not to miss those patients who are about to develop visceral metastases. But most of us, we probably will just wait until they complete the therapy and give them a scan.

Raoul S. Concepcion, MD, FACS: See, I would say that if you got a scan in the middle, it’s not necessarily to stop therapy.

Jorge A. Garcia, MD, FACP: Correct.

Raoul S. Concepcion, MD, FACS: Because we know the survival benefit is with six cycles. It would be if somebody is progressing, should you add another agent. I think it’s important to remember that, for radium-223, there’s a survival benefit. It’s an alpha emitter, so it has less myelosuppression, although there is still a risk. There is a benefit in terms of reduction of symptomatic skeletal events. It does reduce the amount of analgesics that the patient requires in terms of opioids or nonopiates.

It needs to be administered, however, either by radiation oncologists or nuclear medicine. We have a lot of interest by large independent practices in the United States of urologists who want to incorporate this in terms of how to do this within their own centers. So, Mike, again, I know you guys have recently adopted this. Operationally, take us through that, how difficult it is, and those types of things.

Michael Fabrizio, MD, FACS: Sure. So, first, it’s not difficult and I think this ties into having the infrastructure to support these services: whether you’re dispensing the oral oncolytics or whether you’re giving Xofigo. And I think you have to do it for the right reasons, which are to really follow the patient and take control of the patient. Once you’ve made that decision, then you have to have a conversation. We are a COPN state, so we do not have radiation oncology within our practice, so we talk to our independent radiation group that we’ve been working with for years. And we approach them and ask them if they would want to consider doing infusions at our site because we’re already doing the majority of other things, including all of our research trials on site.

They agreed to it and, from that process, it was licensure with the state of Virginia, going through radiation safety plans, which they helped create. We hired a physics company to go through the logistics of what we needed to do in our office, and it was about a 45- to 60-day process to get up and running. They come in and we actually have a multidisciplinary clinic where they see the patients, evaluate the patients, and then we set the patient up on another subsequent appointment for them to be infused by the radiation oncologist and the therapist who we’ve hired.

Raoul S. Concepcion, MD, FACS: Great. Again, I think everybody should understand there are some regulatory issues and some of it’s also going to be state by state.

Michael Fabrizio, MD, FACS: Absolutely.

Raoul S. Concepcion, MD, FACS: But it can be delivered either by a radiation oncologist or nuclear medicine.

Transcript Edited for Clarity