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Phillip Koo: Hi, this is Phillip Koo, and welcome back to UroToday's special feature looking at the integration of PLUVICTO into a large urology group practice. We're moving on to a segment to discuss and look at radiation safety considerations and authorized user considerations with regards to setting up a program. We're very fortunate to have with us Dr. Glen Gejerman, who is the Chair of Radiation Oncology at Summit Health. Welcome, Dr. Gejerman.

Glen Gejerman: Thank you.

Phillip Koo: So let's first start off by talking about the authorized user process. For those people who aren't familiar with it, educate us; inform us about what an AU is and how you qualify to be an authorized user.

Glen Gejerman: Yes, to be an authorized user, you have to demonstrate that you have experience dealing with radionuclides. I think that as radioligands become increasingly more important in radiation departments, it will be very important for radiation oncologists to get listed as an authorized user, become familiar with the radiation safety protocols, and then set up their programs.

Phillip Koo: So authorized users could be a variety of specialties. Typically, we think of it as radiology, nuclear medicine, radiation oncology. Is that correct?

Glen Gejerman: Yes.

Phillip Koo: After you identify an authorized user, here at Summit Health, I guess you guys were fortunate because there was someone like yourself on staff. Do you have recommendations for how other practices might look at finding an authorized user for their group?

Glen Gejerman: Most groups will have a Radiation Safety Officer, and that's probably where you want to start. There are certain steps to follow. It's not difficult, but you really want to speak to someone experienced in that area, so you don't encounter surprises later on.

Phillip Koo: Yes, I agree. The Radiation Safety Officer piece really can help guide you through every step of the process, work on getting certain names added to the RAM license, and so on, and really make sure you're doing it correctly from the beginning. So let's transition to the discussion about radiation safety. I think when we're talking about radioligand therapies and when we're talking about radiation in general, especially when it's unsealed, when it's more systemic, a lot of things come to mind. I think patients are thinking, "Oh, am I going to glow?" I often hear that. Let's demystify some of those false narratives that are out there.

Glen Gejerman: The important first step is to work with your department because sometimes your nursing staff, your dosimetry, will hear that you're adding this program and say, "Wait a minute, I didn't sign up for that. I'm comfortable with external beam therapy, not so much with injecting these radionuclides that really can pose a radiation exposure." So I think sitting down with your department, explaining some of the radiation physics and the radiation safety, is crucial. I always stress that this is safe. Once they're comfortable with it, then you move on and explain that to your patients.

Phillip Koo: I think that's a really great point to start off with your internal staff because they are actually a lot of the people who are going to interact with patients. If they're not comfortable, obviously the patients aren't going to be comfortable. So then when you do have patients who are going to undergo a PLUVICTO treatment, what are some of the highlights in terms of radiation safety that you instruct them on before, during, and after the procedure?

Glen Gejerman: Yes, so I think it's important for every department to work with your Radiation Safety Officer and then the local regulations in terms of how you set up your protocol, because that's really step one. You've got to set up a protocol. How long do you want the patient to be isolated? How far from their family members? And then what is the procedure, just in terms of bathroom hygiene, in terms of getting their meals? I explain to the patients that if they follow the protocol, they and their family members will be safe.

Phillip Koo: So when it comes specifically to bathroom hygiene, let's go a little deeper in that space. I think there are questions about having a dedicated bathroom or not. What's your recommended advice that you give to patients and their families?

Glen Gejerman: First, I explain to them that when you think about PLUVICTO, in terms of just the kinetics, about 70% of the dose is excreted within the first 12 hours. So that first day is really important. I have the patients remain very well hydrated before they come in. Once we inject it, we actually send them out. We don't have them urinate in our department. Now we have a bathroom ready, so it's shielded. Everything is good to go. It's covered. But generally, they'll go home. We explain to them that their task for the first 24 to 48 hours is to drink a lot of fluid and to urinate because we know that the drug is excreted via the kidney system; therefore, they're accumulating the drug in their bladder, and we wouldn't want them to just leave it there and delay using the bathroom. So we just have them drink a lot and urinate a lot and really get a majority excreted out within the first day.


Having said that, we still recommend that they're careful not to be around children or pregnant women, and that family members should really limit activity that's close to them for the first couple of days. Now, there's a wide spectrum in what's considered too close. Some people say three days; some say seven days. Again, I urge everyone to work with your Radiation Safety Officer and your local regulations. But as long as the patients understand that they're going to need to have some modification to their living arrangements, where they need an isolated bathroom, they alone should use that bathroom, recommend sitting while urinating, flush twice. If there are any spills, we tell them how to handle that. We actually give them a protocol on how to deal with that, and we spend a lot of time educating the patient and their family members.


Phillip Koo: I think that's a really good point that we need to emphasize, that these safety precautions are going to vary, and it varies based on local regulations, state, federal, and people's RSOs' familiarity with some of these topics. It's interesting because, in certain countries, patients will be admitted, which personally I think might be a little too much, but again, that's what they do. What are some common questions or concerns that patients and their families bring to you, perhaps on subsequent visits after they've gone through perhaps a dose?

Glen Gejerman: They want to check to make sure they did it right. Again, that's why it's so important to give them something in writing they can refer back to. You can really debate: should it be three days of isolation? Five days of isolation? When it comes to pregnant women and children, is it seven days? Ten days? Whatever you and your RSO decide, put that in writing so the patient can refer back to it. We review that with them. I think after the second, especially after the third dose, they're very comfortable, and they understand that as long as they're following those basic precautions, particularly the first three days at least, to avoid family members and really limit the exposure to family members or caretakers, they feel comfortable with that.

Phillip Koo: Great. So let's shift a little bit towards radiation safety for yourself and the staff. What steps have you taken, or can you take, to minimize radiation exposure for those who work in these facilities?

Glen Gejerman: We were fortunate in that we had a very robust Radium 223 program, so most of our staff is very familiar with the protocol, establishing an IV, just making sure that you have good access, you have good flow. What they noticed is that just the pig itself, the protection around what we inject, is much thicker. It's much bigger. That made them a little apprehensive. So again, we sat down with our staff, we educated them a bit on the differences in the physics between Lutetium and Radium 223. Once they saw that, they felt very comfortable. What we did in addition to that is we got a shielded IV pump that made everyone very comfortable. So really, we limit the exposure to the staff.

Phillip Koo: Well, thank you very much, Dr. Gejerman, for educating us on this very important topic. I think as we all agree, education is the way we're going to overcome some of these challenges, and we really appreciate your contributions.

Glen Gejerman: Absolutely. Thank you.