Read the Full Video Transcript

Zachary Klaassen: Hi, my name is Zach Klaassen. I'm a urologic oncologist. We are live with UroToday at GU ASCO 2025 in San Francisco. I'm delighted to be joined by a man who needs no introduction to UroToday, Dr. Oliver Sartor. Thanks so much for joining us, Oliver.

Oliver Sartor: Thank you, Zach.

Zachary Klaassen: We're going to be discussing the PRECISION platform, which may be new to some people listening to UroToday, but it's a super exciting database. We're going to focus our discussion on basically looking at lutetium PSMA radioligand therapy—prompt versus deferred therapy. So maybe just by way of background, tell us a little bit about this database.

Oliver Sartor: So let's talk about the big picture first. The PRECISION database has over 65,000 patients with advanced prostate cancer. Now, this is going to be divvied up between about 35,000 of the castrate-sensitive and about 18,000 castrate-resistant. The follow-up is still relatively short. It started in 2022 going on to 2024, so we're going to learn more—median follow-up is about 17 months now.

Zachary Klaassen: Excellent.

Oliver Sartor: But what I'm going to say is this particular project focused on the use of PSMA-617 lutetium, otherwise known as Pluvicto, FDA approved in what we call the VISION space. Now, let me back up for a second because people may not know what that means. So the FDA approval for Pluvicto today is for patients who have metastatic CRPC, PSMA PET-positive lesions, have had at least one ARPI, and have had at least one taxane.

So that space is now going to be carved down from that 18,000 patients just to a couple hundred. But please remember, this is a new database and only 17 months of follow-up. So we’re going to get a lot more data out of this database in the future.

Zachary Klaassen: And it's 500 practices all over the US—academic, community, urology, medical oncology. I mean, each year we're going to see iterations of this with more patients and follow-up, right?

Oliver Sartor: Absolutely. I really like the fact that it is community and academic, med onc and urology. And the fact is that we’re starting with this number of patients, and we’re going to see the evolution and have more and more valuable data over the next couple of years.

Zachary Klaassen: Outstanding. So maybe just set up the brief trial design for looking at this deferred versus prompt lutetium use. How did you guys design that?

Oliver Sartor: The idea was to look at, after one ARPI and one taxane, versus the rest of the story. Because remember, you could have had two ARPIs, two taxanes; two ARPIs, one taxane; one ARPI, two taxanes—so all the iterations that you can have. But what we decided to look at, we called the “prompt” was one ARPI, one taxane.

And so we wanted to be able to look at some simple parameters. First of all, like PSA declines, what about survival? And maybe we'll start with survival. What was really intriguing to me is in the “non-prompt,” meaning the individuals who had more than one ARPI and more than one taxane, the median survival was right around 15 months, which is almost exactly what it was in VISION. VISION was 15.3 in the New England Journal article. Here, in the real world, it's about 15.1 or thereabouts. It's really spot on.

Now, it turns out that the patients who have had only one ARPI and one taxane look like they're living longer. Now, it might just be a lead time bias, so I want to be careful about making a conclusion that earlier is better. But nevertheless, we have a good data set now where we begin to look.

We also have PSA parameters—PSA decline of 50% or more. And again, it was almost identical to VISION. We’re talking about 42% of the patients had a PSA 50% decline in the non-prompt. And in VISION, it was 43%. I mean, it’s just spot on again. But if you had only one ARPI, one taxane, then your PSA decline rate of 50% or more was running above 50%, coming in at around 53% or 54%.

So there’s a difference in PSA decline, difference in survival. And we need to understand a little bit more. There could be other distinct parameters—better hemoglobins, better PSAs, et cetera—that may contribute to the somewhat confounding of this database. But nevertheless, we'll be able to tease it out because we have so many patients we’re going to learn from.

Zachary Klaassen: And I mean, we're just talking about the first look of this database.

Oliver Sartor: Absolutely.

Zachary Klaassen: We already have—and you always talk about clinical trial data. Patient selection is always the healthiest. But we're seeing almost exactly the same data in the real world on a first pass through this database, which is really exciting.

Oliver Sartor: I liked it. I was a little bit anxious because when the Pluvicto first came out, a lot of the patients who were receiving it were very, very advanced—just run out of options, get picked up before they die, go to hospice. And the fact is that the non-prompt came in at essentially the exact same overall survival suggests this is a good capitulation of the data sets we have in clinical trials, but now in the real world. So I really like this—same on the PSA decline rate.

So some interesting data emerging at the first pass, but then we can have a second pass, third pass, fourth pass. In the future, we’re going to see this evolving.

Zachary Klaassen: So the beauty of these conversations is we can get a little provocative. So if we're thinking PSMAfore, you presented the data a couple of years ago now, some updates. And obviously, we don't have approval in that space yet. But in the real world, things get utilized differently and in different spaces. And if they get approved, they're going to get used. Are we at a point where we may see a simulation of how things look in PSMAfore in the real world versus VISION?

Oliver Sartor: Yes, with a little bit of hope. So let’s back up for a second and just explain what PSMAfore is because not everybody might know. So in the VISION study, it’s post-ARPI and taxane in PSMA PET-positive metastatic CRPC. OK. Now, PSMAfore does not involve the use of a prior taxane. So no prior chemo, taxane “naive,” if you will, but still metastatic CRPC, post-ADT and an ARPI. But that’s a lot different space.

And the survival is longer. We already know that. And currently—I’m talking about February of 2025—the FDA is evaluating these data from the PSMAfore trial, trying to make a decision about whether or not the taxane-naive population may, in fact, be subject to regulatory approval.

If it is, I’m anticipating very rapid adoption because what you’re looking at is the possibility of a taxane, which, quite frankly, most men are not that anxious to get, versus a pretty well-tolerated radiopharmaceutical, which a lot of men are anxious to get. So as we move from the current status of the PRECISION registry, as it evolves, we’re going to get a look into that PSMAfore space, assuming that it meets the FDA approval guidelines.

Zachary Klaassen: Excellent. Great conversation introducing the PRECISION data platform and really some nuanced data looking at prompt versus deferred lutetium. Any take-home messages for our listeners today?

Oliver Sartor: Take-home is probably twofold. Number one, the emerging data today in this real-world database seems to recapitulate the findings from the clinical trials really well. And I’m pleased, pleased, pleased to see that. The second message is to stay tuned because we’re going to learn a lot more in the future from the PRECISION database. And quite frankly, I think we’re going to gain some additional insights beyond what the clinical trials have provided.

Zachary Klaassen: Absolutely. Great conversation, Oliver. Thanks so much for your time on UroToday.

Oliver Sartor: Thank you. Thank you, Zach.