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Phillip Koo: Hello, my name is Phillip Koo from Banner MD Anderson Cancer Center in Phoenix, Arizona. I'd like to welcome you all to UroToday for a special feature that we have focusing on radioligand therapies in the clinic, and really focusing on the practical aspects of these therapies, especially since we now have the positive results from the VISION trial which will hopefully lead to eventual FDA approval, which presents a lot of challenges for practices around the country and around the world with regards to how we operationalize this therapy which is very new and different from what we're used to seeing in the clinic.

Welcome to UroToday on our special feature focusing on the practical aspects of starting a theranostics program. We are very fortunate to have with us today, Charlotte Manogue, who is the GU Program Manager at Tulane Cancer Center. Welcome.

Charlotte Manogue: Thanks for having me.

Phillip Koo: Great. So you've really served as the catalyst of starting a very large radiopharmaceutical clinical trial portfolio and supporting the operations of this, which has led to its success and really has had a tremendous impact globally with regards to radiopharmaceuticals. Can you talk a little bit about your plans with regards to how you transition from a very research-focused program to a more clinically-focused program when it comes to radiopharmaceuticals?

Charlotte Manogue: I think a lot of it is handing things back off into the clinic to the nurses and to the schedulers and the authorization team and making sure that they are educated about how these programs kind of work. At the moment, I'm still pretty heavily involved in terms of this whole applications piece and having to still need to go through the IRB, but we have started to prior authorize the injections, which was a piece that does not happen in the clinical trials because the trial pays for itself. So finding codes and things like that and then just letting the nurses do what they kind of do every day, right? Blood draws, IV management, you know, starts, all of that kind of stuff. So relinquishing control, I think, from the clinical research side, and putting it back into the clinic where we would love for it to belong.

Phillip Koo: I agree 100%. It's interesting when I look back at my own career and I've seen the trials that we have been able to start and then how it leads into the clinic. It really creates a much smoother transition and allows us to sort of get a jump on things.

Charlotte Manogue: Yeah, I certainly don't want to dump it into their lap. So kind of giving them piece by piece and letting it kind of ramp up. And the more that we do, the more they are willing to kind of take on and hopefully, I won't be needed at all.

Phillip Koo: That's great. You've created a sustainable program even without you. So you've been side-by-side with so many of these patients as they start the journey of these therapies. What are some things that you hear from patients with regards to good things and bad things, some challenges, or overall feedback that you get from them?

Charlotte Manogue: I think most of them are excited, right? To have the opportunity to get this therapy. With the results and the well-publicized results of the VISION trial, which were kind of on various news networks and local programming as well, people have an inkling about what's going on, but I think the radiation piece still makes them a little nervous. Most of the time the only radiation piece that they have had before may be from true external beam radiation where I have to come every day, and I have to lay in that machine. And this is a whole different ball game in terms of this targeted radiotherapy. So explaining that to them in a really... with lots of allegories and making sure that they understand that they are not a threat to their friends and family, right, but that there are precautions that need to be taken.

I think that is the biggest thing that patients worry about, is can I still hold my grandkids, or I have responsibilities to take care of my grandkids and that is how my family works. Can I still do all of that? I think from a side effect profile-wise, people feel really well and they are appreciative that they feel well. Maybe a lot of these guys are coming off of chemotherapy where they didn't or they feel like they lost a lot of themselves. And this lets them get back to life in a way because there is such a gap between therapies and they can do the things that they want to do. Dry mouth is always a big one, but I think a lot of the side effects that we see are more in their blood work than patients actually feeling a whole lot different.

Phillip Koo: So a final question. Can we talk a little bit about access and scheduling and logistics? So I believe right now you only offer these therapies one day a week. Is that due to delivery issues or is it more staffing? How do you think it will look in the future?

Charlotte Manogue: I think it will look like Xofigo^® in the future. I think when operationally on both sides, both in the clinic and on the drug operations and delivery side, it will become really routine, the way that we think of Xofigo, it just arrives and we inject it, and people go on their way. The drug is being manufactured in Italy, so it takes two weeks for it to arrive. So we have to schedule to order it two weeks in advance. I think that's the biggest rate-limiting step for us at this moment, is just waiting those two weeks for the drug to actually get here.

In terms of doing it on any day of the week, I think it's per your clinic's convenience. It was easier for our team to kind of operationalize things on Thursdays just for the staff that needed to be involved like Dr. Harris and others. And it's easier to kind of do a bunch of them all in one day. So you have one shipment or one per patient, but one shipment comes in from Italy one day where you are kind of like, "This is our focus and we're going to do three or four of these." As we grow I think we will open up other days and we've kind of already started to plan what those days will be, but trying to keep the focus on one thing at a time seems to be a little bit easier instead of having to do one every single day.

Phillip Koo: Sure. That makes a lot of sense. And I agree. I think as this grows in various types of therapies and volume and whatnot, it does make sense that it could be offered more days of the week. And from what we've seen at Tulane, clearly, it's doable.

Charlotte Manogue: Yeah.

Phillip Koo: And the fact that patients can come in and walk back out the door in 30, 40 minutes, it's pretty amazing. So, well, that's wonderful. Thank you very much for your time.

Charlotte Manogue: Thank you.