Zachary Klaassen: Hi, my name is Zach Klaassen, urologic oncologist at the Georgia Cancer Center in Augusta, Georgia. We are at AUA 2025 in Las Vegas on UroToday. I'm delighted to be joined by urology resident doctor Alessandro Viti, who is a San Raffaele in Milan, Italy.

Alessandro, thanks so much for joining us on UroToday.

Alessandro Viti: Thank you for the invitation.

Zachary Klaassen: So you guys are doing some-- at San Raffaele, I always have great high risk patients in PSMA-PET data. In this most recent iteration, you guys looked at early oncological outcomes in these very high risk patients from the STAMPEDE criteria, and really looking at what the impact of PSMA-PET scan is.

So maybe just set the stage for us the rationale for looking at this.

Alessandro Viti: As we all STAMPEDE trial has never designed a surgical arm. So our research question was, how surgery would impact on this cohort of patients? As we know in the STAMPEDE trial, the adverse events among these patients are pretty common. Almost 50% of the patients experienced grade III to V adverse events.

And the discontinuation rate of the therapy was about 40% in this cohort. So is it really the only therapeutic opportunity for this kind of patient? On our cohort, we realized last year, another analysis where we showed that almost 45% of those patients treated with surgery plus, so prostatectomy plus, extended lymphadenectomy, had the five-year BCR-free rate of exactly 45% or 50%.

So this year, we analyzed how PSMA-PET could impact on the stratification of these patients.

Zachary Klaassen: Now, it's great. I think when we look at trial design, just let me talk about how many patients, what the primary outcome was for this study.

Alessandro Viti: So what we found in our study is that patients stratified and studied with PSMA-PET had a lower risk of early BCR. Talking about numbers, it's 50% versus about 30%, 29% in the other cohort in patients studied with conventional imaging.

So we relied on two cohorts. The first one from our center of more than 4,000 patients that were studied by conventional imaging. And the second one from Yale group that was studied by PSMA PET.

Zachary Klaassen: I see. And so when we look at these patients, very high-risk patient, PSMA-PET stage, how do you guys counsel these patients in terms of surgery, what their risk of needing treatment is down the road?

Alessandro Viti: Yeah, we are stratifying almost all our patients with PSMA PET, especially if we're talking about high-risk patient. As nowadays, I would say that the issue is about N1 patient, miN1 patient. As we know, the guidelines changed recently last year and suggest, based on STAMPEDE trial that cN1 patient should be treated by radiotherapy plus abiraterone.

So I would say that the issue now is about miN1 patient. Are these patients candidates for surgery? Or are those patients should be considered as N1 patients?

Zachary Klaassen: Yeah, absolutely. Well, last question just revolves around very high-risk patient. Who's the patient that we should be considering maybe an operation on?

Alessandro Viti: That's the main question. And that's what we have to answer, I would say, in the next year. As for now, from our results, I would say that patients with a low disease burden and PSMA-PET, miN1 without features of cN1, so really enlarged lymph nodes can still be treated with surgery.

We should always consider the patient characteristics. A young patient, a young man of 56 years old, really fit for surgery. It's for me, a perfect candidate for surgery. Let's consider how a treatment with abiraterone or RC would impact on his lifestyle, on his life course, with all the side effects that those drugs bring with them.

Zachary Klaassen: Very well said. Great discussion.

Alessandro Viti: Thank you very much.