Read the Full Video Transcript

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 are used to seeing in the clinic.

I'm here today with Dr. Kendra Harris, who is Chair of Radiation/Oncology at Tulane Medical Center. We are very fortunate to have her today to talk about the experience with creating and operating a successful theranostics program. So welcome Kendra.

Kendra Harris: Thank you. Glad to be here.

Phillip Koo: Great. So I kind of wanted to first talk about the various roles that are needed to create a successful program. Clearly what we've seen after the tour is that there are so many different pieces that you see and don't see, and kind of wanted you to walk us through those various roles and what they do.

Kendra Harris: Sure. So at Tulane, a very important part of our program is actually the research team. So you will, I'm sure meet Charlotte, and the group that she works with has helped us with a lot of the regulatory applications that are part of really adding any new radiopharmaceutical. For us, that meant adding lutetium to our radiation license. We had to make new applications to the hospital RSO or radiation safety officer and committee. And we also had to take the new therapeutics through our IRB. That was the initial process-related division, and they handled a lot of that paperwork. We had to work to build expertise with the hospital radiation committee about how this was the same or different from prior radiopharmaceuticals and build confidence among the staff, frankly, that we could safely administer these medicines.

The second piece for us was or is my two physicists. So they were instrumental and in charge of doing all of the initial calibrations, we were given calibration samples in order to be able to measure the lutetium once it arrived. They also worked carefully with the manufacturers to do some of the quality assurance steps that are necessary to make sure that the sample has arrived in good shape, and that we have a sufficient dose for the men who are coming to see us that particular day. We have a number of other different trials open using a variety of isotopes. And having strong physics support is really important. They also help us follow the regulatory rules during the administrations themselves, and the surveys when we are using a shared clinic space.

And then when the patients come in, they need an IV. So we have nursing support for that. And then the partnership among the physicians on the team is the last critical piece. So obviously I do the actual injections, but Dr. Sartor and I form a team when it comes to making these injections, and these trials and expanding access, to make this new opportunity for men a priority for us.

Phillip Koo: Great. So can you talk to us a little bit more about the administration of the drug and who can administer this and sort of the licensure with regards to this, including training?

Kendra Harris: Sure. So obviously radiation oncologists are authorized users and can administer these unsealed radiopharmaceuticals. Nuclear medicine physicians can also do these administrations. And I think there is a variety of how it is done across the country.

Phillip Koo: Yeah. So for you as a radiation oncologist, I know the practice patterns might be different between different groups. How do you like to assess these patients before they start therapy with lutetium-177-PSMA?

Kendra Harris: Yeah. So I really want to see the patient once in person, before I give the first administration.  I have to do an assessment for the urinary continence we talked about. I also find that there are more questions in terms of exposure risks to spouses or children. And it allows me to do an overall sort of functional capacity assessment to see them in person. I think because of the experience that men have on this trial, wherein those that receive this medication very commonly had very nice responses and were able to have a long period of time where they did not have to consider say chemotherapy. There is a patient-driven movement where men are really seeking out this therapy, and I can understand why. As we have expanded access, we want to make sure that the men that we bring this therapy to sort of meet the criteria, lab work-wise, et cetera. And I find just a single consult visit works great. At our center, frankly, these patients are going to medical oncology. So when they come to town, some need PSMA scans and are getting that done and their visit with me is just part of that visit package.

Phillip Koo: Great. So then you will see these patients every six weeks for their doses, up to six doses. How do you manage these patients during that timeframe and have you seen any adverse events that have been challenging to manage?

Kendra Harris: Yeah. So one of the beautiful parts of the way the VISION trial was designed is it said to refer to your internal standard operating procedure, which I'm not sure that there are a lot of standard operating procedures for targeted radiopharmaceuticals that are well-developed in the country. Haven gave a lot of doses on that trial, we really just didn't see adverse events, so infusion reactions, patients developing dry mouth that was super bothersome. Monitoring of the labs is a really critical thing, but even the frequency of cytopenias for those scheduled labs was less than I expected. So my level of confidence about it being safe to give the injection and have men go home just grew and grew and grew over the trial.

So when we figured out what we were going to do to expand this access, we leveraged that knowledge and said, let's try to keep them in the clinic as little as is reasonable, both from a staff exposure standpoint and sort of maximizing the opportunity of the resource for the men who are really sort of lined up, trying to get access to this therapy.

The other thing that Dr. Sartor, Dr. Barata and Dr. Layton, and Dr. Lewis, the medical oncologists, and I are in close communication in terms of how the patient does overall.  The medical oncology team will frequently see the patient once in between doses. I typically do not see the patients in between doses, seeing them on the day that they are dosed and then we coordinate the labs, which are either done onsite or closer to home within the three days prior.

Phillip Koo: So you do the labs three days prior to their scheduled injection?

Kendra Harris: As far as, or as 72-hour old labs that are acceptable.

Phillip Koo: And then when do you have to order the dose for administration?

Kendra Harris: Yeah, so basically for the expanded access program, once the go-ahead has been provided by the company, that the patient is qualified, we order the dose with a 14 day lead time.

Phillip Koo: 14 days.  And have there been any instances where you have ordered those 14 days ahead and then the labs done within 72 hours come back, not sufficient to proceed?

Kendra Harris: Yes there have, and we treat these doses like bags of diamonds. So happily we've been able to take the dose that the man who was going to start therapy, but his labs actually took a turn for the worst, we were able to repurpose that dose to another man who had met the criteria and was approved because you do not have enough time to do anything other than administer them and you really do not want to waste them.

Phillip Koo: I agree. I mean, these days it's liquid gold.

Kendra Harris: Absolutely.

Phillip Koo: So well, great. Thank you very much for sharing your expertise with us and we'll hope to speak with you again.

Kendra Harris: Sounds great.