Workflow Considerations from the Front Desk to Nursing Including the Supportive Care Idea: The UCLA/UCSF Experience "Presentation" - Linda Gardner & Amanda Morley

February 15, 2024

At the 2024 UCSF-UCLA PSMA Conference, Linda Gardner and Amanda Morley detail the critical steps and challenges in setting up a Radioligand Therapy (RLT) program, covering aspects from licensing and space planning to staff training and patient care logistics. They highlight the importance of adaptability, thorough planning, and the efficient use of resources, demonstrating how UCLA and UCSF navigate operational demands to provide patient-centered care in RLT.

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Biographies:

Linda Gardner, RN, MSN, Nurse Manager, UCLA, Health Department of Nuclear Medicine and Theranostics, Los Angeles, CA

Amanda Morley, RN, BSN, UCSF, Nurse Navigator, Radioligand Therapies, San Francisco, CA


Read the Full Video Transcript

Linda Gardner: Hi, my name is Linda Gardner. I'm known as Lindy. Like Jeremie said, I work at UCLA hospital in nuclear medicine. I'm the nurse manager there.

Amanda Morley: And my name's Amanda Morley, as was also said, and I'm a nurse navigator here at UCSF, and I go by Amanda.

Linda Gardner: All right, I'm going to be starting off the first half of the presentation and then I'm going to be handing it over to Amanda for the second half. So the title, it says Workflow Considerations From Front Desk to Nursing. In fact, it's really about setting up the RLT program, and we are going to go over the main points of this, but we live, breathe, and eat this every day. We have got so much information, too much to share right now, so we're just going to take the main points and go from there.

As I said, I'm taking the first half in blue. Amanda's going to be taking the second half in black there. That's what we're going to cover. We'll try and cover, we don't have any disclosures, and I'm going to start off with constructing a solid foundation.

Like any program, when you start it, you have to have the right foundation in place. So we're going to look at licensing, where the infusion takes place, if it's a shared space, restroom, workflow, logistics of that, the equipment used, your staffing plan, staffing matrix, radiation safety, your hours of operation in your clinic, your patient volumes that you're looking to have and how that'll affect it, and also escalation of care if that comes into play. So this is a really nice bright and colorful slide. I like colors, so you'll be seeing this slide a lot and the stakeholders in this patient-centric always, and these are the main groups around that patient. If you're bringing an RLT program from concept into workflow, if you're doing it as a crossover from actually already having started a net program, then the process will be a lot simpler, but I'm going to address most of it from the beginning.

So we're looking at radiation safety. That was one of the stakeholders. To give an RLT, you have to have a radioactive materials license, a RAM license. If you are in an agreement state, then you would reach out to your state official under the Department of Public Health to get an amendment to that license. If you're not in an agreement state, then you'll get it from the NRC. If you already have lutetium on your license because you're treating net patients, then you're good to go. Very important to remember here. If you don't have lutetium on your license, then you're going to have to make that amendment soon. That can take several months to get it on the license, so you've got to really consider that moving forward.

Additionally, what to take into consideration is your waste management. Are you under the FDA regulations about wasting on site any doses or used doses or waste? Do you have long-term decay? Short-term decay? Your radiation safety officer is going to be integral in that. If you don't have a decay process on site, you may have to look at a third party vendor to be able to pick that up and then decay for you. So these are a lot of things that you need to think about from the beginning.

Radiation safety plays a very important part in education. There's a lot on this slide. I know. I apologize for that. This was me actually last week treating a patient. Just so you're aware, this is what we wear. No, this just brings an important point is that radiation phobia is real, not just with patients, but with staff, and you need nursing in this arena and nurses do have a radiation phobia, so you need to get them on board and educate them to understand that process because they're an integral part of your team. Also, radiation setup, take down, room preparation. This is really important. Radiation safety is integral in this part. Setting it up, making sure it's clean, ready for the next patient. It's free of contamination. All these parts play a role in simply just treating a patient. Just to treat the patient's a simple part. It's all the preparation, and also understanding the equipment that you're using, using dose readers, Geiger counters, GM scanning, these are all important parts that your staff know how to utilize these.

Just with the education point, and I'm going to say it again, nurses, it's a different avenue for nurses to work within the nuclear arena, but real-time monitoring is a really good tool to use if your staff are very unsure about treating these patients. If you're in a shared space or you're utilizing someone else's resources, you might not be getting badged and ringed because you're not in that level of requirement to receive what the doses you're going to receive. So real-time dosing is a great way to go with it, as long as the staff understand what the equipment is and what the numbers mean. Otherwise, it's just numbers and they don't understand that. So this is a nice way to bring in that education point and keep everybody on the same page. I wanted to bring in this slide because this is perception versus reality, and this is monitoring our patients.

When we started the neuroendocrine tumor program, this is with the Lu-177 dotatate. This is a five to six-hour infusion, but we did real-time monitoring on the nurses and this gave an understanding of the exposure they're receiving during those treatments. So this is a nice overview as an education tool for them to see. Additionally, on here are the discharge reads that we discharge the patients with a one-meter read, and we noted these down too. As you can see, it's less than two mR an hour, well below the NRC guidelines to release the patient back into public.

I'm going to look now into the administration and billing and auth. You need administration at a high level to make sure that you can get this onboarded as well for billing, your pricing agreements, and also code in, and also additionally with your authorization process. Because lutetium dotatate, if you've already got that on, it paves the way for PTO under your financial clearing unit. So that helps an awful lot. If you're doing it from the beginning, then this process is going to take a lot longer because you're going to have to get onboarded, you're going to have to have a price agreement, and how you're going to cover that. Also, the schedule is extremely dynamic for your front office staff. You're going to be looking at multiple schedules. This is something that we don't normally do in nuclear medicine; it was imaging and treating, but these multiple schedules every six weeks, bringing that on board, there's not really a process there to organize that for you.

So Excel is going to be your friend. In fact, when I met up with Amanda, our Excel spreadsheets were almost identical in how we'd set it up to monitor our patients. So this is important in the beginning. You want to be ahead of anything that's going to come your way, make sure you've got all the thorough input there to move forward because you can't backtrack on this. So you need documentation and follow-through. If someone's off sick, who's going to look at the scheduling, who's going to organize things? And it seems rudimentary, but it's such an integral part of what we do. Now EPIC and IT I've got to the side, and the reason why I put that sort of on the outskirts with the providers is because we need it. We need the electronic charting and to get anything done in that charting is so difficult.

It takes months to set up a program, order sets. This needs to be started early. You want to know what that looks like. Are you going to have NPs or PAs doing the ordering or are your nuclear medicine physicians going to place those orders? So we set up an order set because it was easier for our doctors to go ahead and order all six cycles, the imaging, the blood work, so it's all in one place, a one-stop shop. If your NPs can do this, then it's also a nice drop-down for them to go ahead and work with the ordering. If you're doing order sets in a different department, if you're working with a shared resource, you need to make sure that that's visible to that treating team. They may be under a different system. We've got different names for different systems in the UC section, so you've got to make sure it's seen across the whole electronic system, which is something you don't realize until it comes time to treat. Discharge instructions.

There are after visit summaries which you utilize for all procedures, so you have to make sure you've got the build there for your after visit summary with your discharge instructions. They become electronic and paper, whichever the patient would like to receive it. Also, what does your charting look like to mention here in nuclear medicine, when we were doing therapies, the physicians didn't have the dropdown menu to chart. It was going under imaging. So the therapy was under imaging and when the other physicians from the treating oncology and GU were looking, they couldn't see the therapy note because it was under the imaging section. These are the little things that make huge problems if you don't see them early.

So you want everybody on that team to see where the treatment took place and how to locate the notes. Are you going to use armbands? Best practice now is that within the nursing field, patients are UNB banded. They can be scanned for medication. If you're going to have that process set up, it takes several months to set up that process also. These are just all food for thought, your consent process, also building that, putting that into the system and establishing your workflows. Having champions here is very important. Going to speak a little bit about radiopharmacy and ordering. Nuclear medicine technologies are used to ordering in radiopharmacies.

The ROME system is how we order the radioligand therapy. The orders are placed, and you can put all six cycles in there. You are trained by the actual company, and you can have access for anybody. It can be the front desk, physicians, nurse technologists, just assign who you want to assign, but make sure that you have one person that's in control of that. You don't want a dose coming in and a patient not there, or vice versa. So make sure everybody understands their roles and processes when moving forward. Also, if you have a cancellation dose, how are you going to manage that? Who's going to do an unused dose form if somebody cancels a week before treatment because they can't get in or they're too sick? Just things to think about moving forward. You've got a two-week cancellation time beforehand, so you have to be ahead of this curve so you don't waste resources and doses.

And your hours of delivery in the clinic. If you're treating on a Monday morning and your doses arrive on Sunday, who's going to be receiving your doses? If your clinic's closed, what's that process like for receiving? Is it going to go to the hot lab? Is it going to go to a receiving area? So these processes are really important. If a dose is coming in the morning, then schedule your patient for the afternoon so you've got leeway for when that dose comes if there's a little delay or not. And having contacts within the pharmaceutical companies is really important. Technologists are integral to this. We are working in their arena, so nurses are now working with technologists, so we need to really build a good relationship here. At UCLA, we're extremely fortunate to have a nurse-driven team with a technologist. It started off as one, now we have five nurses that cover all care within our department.

The technologists are responsible for dose receiving. Everything they do in the hot lab, that mystery in there, they're very good at it. That's what they do. They check the doses, do all the checks, follow the SOPs. It may be a little different now because you're using radioligand therapy, but they'll follow the processes through, and they're very good at safe practice and also patient safety. Great resource with radiation safety on that one. How is the dose going to be administered within your facility? Several different ways to administer it. I know B is the one that Tom and Amanda use, which is the pump with the vented needle.

The bottom one there in the middle is the gravity method, and then the one at the top is hand injection. A little bit more complicated, you have to aspirate from the vial and then hand inject, but it's the method your technologists and your providers are used to and how they want to move forward. And also, how you administer the timing of it is how it's going to be for your time of your visit. So if you're having multiple patients back to back, then how long do you want that administration process to be? And also taking into consideration the setup and cleaning of the room. So, as I stated earlier, at UCLA, we have this theranostics team together, patient-centric.

It has grown. It was not overnight. It's a continuous work in progress to try and refine and make the processes better for the patient. After we've done everything like this, what does that infusion day look like for the patient? Now Amanda's going to go into detail a lot more about patient care and follow-up. There's a few things here on the board, which is we manage the expectations. We want the patient to be comfortable when they come in. We want this to be a nice experience for them. We have them hydrate IV before we administer. That helps us get the toilet after the infusion, helps them go to the toilet afterwards to make sure that we get that void out of the way before they're discharged, and also spare clothing in case their clothing becomes contaminated. I don't think they want to walk home in a PJ set from UCLA.

Additionally, we'll do orientation. They'll see this room when they come in, they'll see the bathroom and they'll go, "Oh my God, do I have to set that up at home like this?" It's like, no, this is how we have to set it up for our institution for contamination and everything else. But it's important to educate them about the process. It's a big deal for patients coming in for this treatment. Additionally, if you have one shared restroom and you have multiple spaces or you're in a clinic and that restroom becomes contaminated, you have to close it. What is your process going to be? Because now you've lost your restroom in your clinic or for treating the patients that you're going to treat. So these are really important considerations.

The administration, again, is just a picture of how we hand inject. We verify the dose and share with the doctor and check the IV site. Again, we'll go into that a little later and discharge, as I was saying about the one-meter read and follow-up with discharge instructions, I wanted to bring you to our space. This is the current space. I'm going to share a sneak peek in a minute of our new space, but we have two chairs that are not set up here and then two chairs that are set up with one restroom. If you have a small space, your radiation safety team is integral here because if you're treating multiple patients one after the other in a small space, you have to have cushion time between that. It has to be taken down, checked, and re-prepped. If there's any contamination there, it's going to take time to decontaminate that ready for the next patient. So if you're looking at your patient volumes and your workflow, these are considerations you need to take into account moving forward.

Ideal timeline, and you know you're going to look at this and you're going to see 12 months, you're going to go say, "Oh my God." This is from a setup from the beginning where you haven't had any RLT like LUTATHERA onboarded. If you already have a system onboard with LUTATHERA, it's not going to take this long. It might take four months, but if you're starting from the very beginning, you have to be very cognizant of your time and the timeline and how long it takes to get things going, and you need a champion to keep pushing this. It seems easy at the end just to inject, but what goes on in the backend is huge and it's not conservative. I think it's a good timeline to look at. So this is a sneak peek. We got licensed last week. The pictures do not do it justice. We have eight infusion rooms with eight restrooms, so if a restroom goes down, we lose one infusion room.

It looks like a jail toilet. I know that. It might be a little cold on the body, but it is what it is. My staff are already sitting there right now waiting for it to open. So we're very excited about that. And you can't do any of this unless you've got a great team behind you, and a great team doesn't happen overnight. It's a constant process of building this team up and educating this team. If your team is comfortable and prepared, your patient care is going to be seamless, and they're going to be able to educate them at the visit and make them feel comfortable. I apologize, Jeremie and Johannes, I don't have any physician pictures on here, but we know who you are. I'm going to bid adieu here and hand over to my counterpart, Amanda, thank you.

Amanda Morley: Shorter than you. Let's see. Okay. Hello again. Alright, so before we get into the process of taking patients, I just wanted to mention one difference from the program set up at UCLA and the program set up at UCSF. At UCSF, we do not have dedicated resources, and so we share with other departments. Those resources include the clinical RNs, the treatment space, the nuclear medicine technologists, and the SPECT CT scanner. So you do not have to have a dedicated space to treat. This is our treatment space for lutetium patients. It's in a shared area of IR. We have two rooms, lead-lined rooms of course, and a dedicated bathroom. Our rooms are set up with gurneys instead of infusion chairs in their private rooms so we don't have two patients in the same for now. That's just the setup that we have. And on days that we take patients, this room area is cordoned off from the rest of IR.

You can see that it's set up and taken down by radiation safety. So, all those floor coverings and the facility coverings are done each day and then taken down, similar to what you saw at UCLA. And that means that that space on days we don't take patients is free to be used by IR. So, it is a true shared resource. The same is said for our clinical RNs. That's the picture on the right. All those lovely people take our patients on the days we have them in for infusion, but they are IR nurses. We essentially borrow them.

Another shared resource is our SPECT CT scanner. This is the one at China Basin that we use. At UCSF, we do post-therapy imaging. The picture on the right is the one we originally used and it took 75 minutes per scan. We've since upgraded to a digital scanner, which is the more intimidating picture in the center and on the left, but it's much faster, 30 minutes, and very quiet and easy for patients. This was a limiting factor in our program at the beginning. The number of appointment spaces for this scanner was difficult for us to manage. So, as we've halved the amount of time for the scans and then some, it's allowed us to expand the number of appointments we can offer per week. At some point, we'll have a dedicated facility, I think, and dedicated resources, and that will be great. But for now, sharing these resources with other departments works very well.

It just requires extra communication between departments. So, we have a monthly meeting with the managers from all the departments that work with us, and we discuss any barriers, implement changes, and we're really grateful to them for helping us grow this program over the last 12 months, 19 months, not 12. Okay, so you're ready to take patients. You've gotten all of this really beautiful infrastructure in place that Lindy mentioned, and you're ready to take patients. That means you'll start with referrals and you'll work your way through to the last treatment for the patient. But first, you need your treatment teams in place. This is our radioligand therapy team at UCSF. We have two physicians, two nurse practitioners, one practice coordinator who does the work of five practice coordinators. We have three nurse navigators, and these are different from the clinical RNs that we use for the day of infusion.

And all of us work together to work with PSMA patients, PRRT patients, and radium patients. For PLUVICTO patients, we have a high level of communication between us. We have twice-weekly meetings through Zoom with our physician to discuss all patients. We have a third meeting with our nurse practitioners and practice coordinator, and we use this time to discuss anything from symptoms to any logistical changes that need to happen with PLUVICTO. In addition, our nurse practitioner sends out a weekly email with a comprehensive list of any patients being seen for follow-up. That's for the provider to review so that we can discuss those patients before they get seen for follow-up. And then, of course, there are the daily communications between us all as needed.

Here's a picture of one of our 8:00 AM Zoom meetings where we knew we were going to be photographed, so we look very wide awake. It's not always that way. And then there's another team I wanted to mention that I don't have a good photo of, I'm afraid, and that's our GU medical oncology team at UCSF. All of our patients that are treated with PLUVICTO are seen and established by our GU medical oncology team as well. They're integral to patient management. That team sees these patients for every cycle of treatment as well with their own follow-up, and we work collaboratively to discuss these patients to manage things like transfusions, working with local oncology teams, etc.

So your next step is going to be to take referrals. And at UCSF, we get referrals internally from our oncologists as well as externally from other institutions. The nurse navigators look at the referral, make sure that they're complete. They work with our practice coordinator, get all documentation and imaging together, and then pass it on to the physician for review. The requirements for referral are pretty simple. We need a PSMA PET. We ask that that's done within the last six months, but I will say most of our referrals give us a PSMA PET from the last 30 to 60 days. So that's more common. We review the last three months' worth of lab work. We want a recent progress note from the referring provider, and then we want their medical oncology treatment history.

So when we're looking at referrals, we're looking at two different things. We're looking at whether they meet criteria to be treated with PLUVICTO and whether they are an appropriate referral for this type of treatment. As far as meeting criteria, that's pretty standard. I think we all know this: diagnosis of metastatic castration-resistant prostate cancer, previous treatment with an AR pathway inhibitor, and a taxane chemotherapy. And then their images from their PSMA PET have to meet criteria from the VISION trial.

We do receive referrals for pre-chemo patients and we work them up in anticipation of moving forward with PLUVICTO after chemo. In the more rare cases where we receive referrals where the provider would like the patient to be treated pre-chemo without receiving, we have a GU medical oncology monthly tumor board where they can be presented by that team. The team can decide to treat without them meeting full criteria. But I will say in the last 19 months, we only have two patients that have been treated in that way. They both had strict contraindications to chemotherapy. One of them, for example, was a diabetic who went into DKA with steroid infusion. So there are only two patients that have been treated at UCSF with PLUVICTO without meeting full criteria.

The next thing, as far as if the patient is appropriate for referral, what do I mean by that? I mean, is the patient independent? What's their ECOG score? Are they coming from five hours away and don't have transportation to San Francisco? Are they considering hospice instead of PLUVICTO? And what is their expectation of therapy at this point? Are they incontinent and they don't have high mobility so they're a radiation safety risk? And if they are any of those things, do they have an appropriate support system at home to take them through the appointments and through their discharge instructions? None of these items would prevent us from working through the referral, but they do need to be on our radar, and the nurse navigators will be calling the patient several times to work on these barriers. So we work with family, friends, local oncology centers, social work, etc., and we see how we can treat these patients safely.

The next step for the patient is a 60-minute video visit consultation with our physician. I say video visit; they can be done in person, but it's odd. Most patients do want to be seen by Zoom, so that works well. The physician is going to be discussing things that you would discuss with any new therapy, potential side effects, what to expect for treatment, etc. But they are going to be discussing one very important thing that brings a lot of fear to patients and their families, which is radiation safety. So this is the first conversation the patient and their family will have with what radiation safety means with PLUVICTO and what the recommendations will be after treatment. Patient education starts with the consultation. It continues with nurses. I'll explain that in a moment. And if the decision is made to treat with PLUVICTO, then the physician can put in that therapy plan order set that Lindy mentioned, which allows all the orders for scans, labs, PRN medications, etc., to be put in at once for all six cycles of treatment.

The next thing will be to work on insurance. And this slide is very bare for good reason. There's not much to say. Luckily, PLUVICTO is a standard of care treatment. Our patients meet criteria. We do not have problems with insurance for the most part. That's the good news. The thing that you should know is that Medicare and commercial insurance is, they’re different in this case. So for Medicare patients, you do not need pre-authorization. You can put them on your schedule right away, no barriers. For commercial insurance, they do need pre-authorization. It can take two weeks to get that done. At least I would give yourself two weeks, but it can take four weeks, five weeks. It really depends on the insurance and that can affect the start time for your patient. So just be aware of that.

Patient education continues after the consultation. With our nurse navigators at UCSF, we meet with the patient for another hour-long consultation, very similar to a chemo teach, which many institutions do. We go through any of the consultation items that need reinforcement, such as what to expect for side effects, and again, radiation safety. So this is the second time we go through all the radiation safety recommendations with the patient. We also discuss logistics such as where to park when you come to UCSF if you live five hours away and when to get scans, when to get labs. Where do we send the orders, etc. We also offer them ample time to get their questions answered. We encourage family and friends to join in. Anyone related to the care of the patient should be on this call so that they can get their questions answered.

And these appointments establish a point person for the patient and their family to contact with questions before and during treatment. I'll say these can be very important for your infusion day in order to keep the appointments on time. Patients that come for their first infusion have a lot of questions and concerns, and those will fall to the consenting provider or the nurse that's there. Unlike with Lindy's team, they aren't the PLUVICTO nurses. So, it is helpful to have these long conversations prior so that the patient is ready for the infusion when they get there.

The next piece of patient information will come from the consenting provider. On the day of the infusion, that provider is going to come and sign the consent form with them. The first infusion, which is good for six, but each infusion day the consenting provider will come in, well, the attending provider, and they'll discuss any questions the patient has. And for a third time, they're going to discuss radiation safety and they're going to go over a radiation safety discharge sheet, which lists out in bullet point form all of the recommendations we've now gone over for a third time.

Other instructions come to the patient in the form of our portal system, where we send a lot of information, or written instructions the day of the infusion, and of course, continue through treatment with follow-up calls and follow-up visits. Since I've mentioned radiation safety a few times, I just wanted to run through what that means for a PLUVICTO patient being treated at the appointments. Lindy mentioned the setup of the rooms, but one thing to consider is that there's a high risk of contamination during those appointments. These patients have a high level of urinary incontinence or use urinary device bags. They have frequency and urgency, and urine will be your contaminating element at the appointments. So, ways that we minimize that: we have the patients empty their bladder or their urinary device bags at the start of the appointment and at the end of the appointment before they leave. We instruct them to bring extra incontinence materials and to wear them.

Even if they say to us something along the lines of, "I don't have much leakage, just at night," tell them to wear items to these appointments, have them change out at the end of the appointment, and to clean and dry items. They can leave any soiled materials in our bathroom that's set up for radiation safety safely. If they're incontinent and don't have high mobility, we could use a condom catheter. It's not something we do often because, as many people know, they're not the most reliable, but they can be utilized during the appointments. And at the end of the appointment, when they utilize the bathroom, then they're basically going to leave. So, what happens is the PLUVICTO infusion at UCSF, it's over 10 minutes. Is it 10 minutes for you as well? Between one to 10 minutes. That happens last.

So, the appointment is set up so that everything's done upfront, the infusion's done last. And that means that's the real way to minimize the contamination risk at the appointment because they're leaving pretty much right after. So, they get the infusion, the IV gets taken out, they use the restroom, and then they go, and that leaves about 10 minutes where a contamination risk is in place. As for the discharge instructions, when they leave, they're recommended for over 72 hours from the infusion, so for three days, they include keeping a distance of three feet from others as much as possible. That includes not sleeping in the same bed as others. You want to pay particular attention to pregnant women and children. These patients are free to release. They can go out in public. They're not told to isolate or go to a facility, so we just remind them they're never sure who they're near when they're out in public.

And to be careful, you don't know if the woman standing next to you is pregnant; don't stand next to her for two hours. And then we also instruct them to increase fluids, which starts at the infusion appointment. So at UCLA, they do IV fluids during the appointment. At UCSF, we've switched over to PO fluids, and that starts the process of telling them for three days to increase their fluids in order basically to manage their kidney function. Their urinary waste will be radioactive. So, there are instructions when they go to the bathroom: they want to sit instead of stand to minimize splashing, you want to flush twice, similar to many chemo teaches actually, so many patients are familiar with this, and then wash their hands with soap and water at the end. If they're incontinent and use pads or Depends or anything that is soaked with urine that would normally go into the trash, they cannot throw it away.

They need it to decay for seven days. So they do need to keep those items in their residence for seven days, which is an interesting part of our conversation, but we always find a way to get that done. So they keep them for seven days in just a normal plastic bag, and then they toss them out in the trash. The discharge instruction sheet is given to them at each infusion, as I said. We recommend that they keep them with them on their person, in their wallet. At UCLA, they use a wallet card, in fact, for this. And the reason we tell them to keep them with them is because during the time between infusions when they are radioactive, if they go to the hospital, they would want to give that to a medical team to let them know. Or if they travel by plane, there's a possibility they'd set off a detector at the airport, and this would explain why they did so.

The treatment workflow at UCSF is listed here. It's similar to UCLA, though there are some differences. The infusions are set up for six weeks apart. Patients are treated for up to six cycles. At UCSF, we do post-infusion imaging, as I mentioned, with the SPECT scan. So for each cycle, the patient is with us for a day, one infusion, and a day two scan. They can stay in a hotel overnight. We have a lot of patients that come from far away, and for radiation safety standards, they can stay in a hotel; that's fine. They just need to follow the guidelines that we give them. We get labs mid-cycle, so every six weeks we get a CBC, a CMP, and a PSA. We also get a PSA at the day of infusion. So that's every three weeks that we're monitoring that lab. If the patient is paused from treatment, we continue to get the PSA every three weeks.

We also get CT scans every two cycles of PLUVICTO, CT of the chest, abdomen, and pelvis with contrast. So that's approximately every 12 weeks, again, even if they're paused on treatment. We have a follow-up visit four weeks after the infusion. Those are most often done through video visits, sometimes in person if the patient requests. They're almost always done with our nurse practitioner, though. They can be done with the physician if the patient requests or if there is an outlying factor that is just more appropriate for the doctor. Those appointments are used to look at their response to treatment. We can do that, obviously, by using the lab work, but also by our post-therapy imaging. That's a good way for us to be able to judge that each cycle. And then there was one more thing. I'm off my game. Oh, the other thing is that they are seen by our GU medical oncology group, as I mentioned before.

So about two weeks before each infusion, our GU medical oncology group meets with the patient as well for their own follow-up. We work collaboratively with these patients if any issues arise, and this all repeats for six cycles, unless the patient has concerning side effects that take them off of therapy for a while and we pause them, or if they progress and we take them off of therapy completely. After the sixth cycle, we'll get another CT of the chest, abdomen, and pelvis with contrast. We'll maybe get a bone scan if indicated and have them meet with our physician for future recommendations, as well as GU medical oncology to discuss what happens next.

The last thing I wanted to mention is side effect and progression management. With PLUVICTO, there are very few side effects. It's a very well-tolerated treatment. The side effects typically last between one to seven days. The most common are a little bit of nausea, usually the night of the infusion, maybe a couple of days in. Fatigue for everyone. There's no way around that one. And then dry mouth is one of the side effects we look for very closely. If the patient has nausea that prevents them from taking in all of the fluids that we recommend, we could give IV Zofran with the next cycle of treatment and we would instruct them to take antiemetics as prescribed by their oncologists. As far as the dry mouth, if it starts to get worse with subsequent cycles of treatment, that could be a reason to stop therapy or at least to pause.

We don't want to hurt their salivary glands to a point that they can't recover. And in many cases, they do recover enough while we take them off of therapy. For some patients, if we go right back into an infusion, it comes right back, so it's difficult to manage. For marrow toxicity, the nurse practitioner and the physician are looking at their mid-cycle labs, the medical oncology team as well. And if that patient needs transfusions or if their platelets drop to a low level, then we may take them off of treatment while we wait for that to recover. Again, our GU medical oncology team being very important in this process. As for progression, I'm not going to say much here except for the fact that we do monitor their PSA response. And you can see two unfortunately different PSA responses: the one on the top,

Beautiful response cycles two through five of a patient that responded nicely. And then the patient on the bottom responded really well after their first cycle but was taken off of treatment for progression after the third. And we also were looking at the post-therapy imaging in order for that to be managed, which is done by the nurse practitioner and the physician, and I think was spoken to earlier in the sessions today.

So we do have a lot of lessons learned. Lindy and I had discussed this. We honestly, this could have gone on for hours and hours. We do think about all of these details even when we're sleeping, unfortunately. Over the last few years, this is really all we've thought about, but in the essence of time, and to leave a little time for questions, I'll stop here.