Neeraj Agarwal: Hi, my name is Dr. Neeraj Agarwal. I'm a professor of Medicine and director of Genitourinary Oncology Program at the Huntsman Cancer Institute, University of Utah. Today, I'm very pleased to welcome Dr. Wolfgang Fendler, the vice chair of Nuclear Medicine at the Essen University in Germany. Welcome, Wolfgang.

Wolfgang Fendler: Thank you very much for having me.

Neeraj Agarwal: First of all, I congratulate you on your presentation in the ASCO 2025 meeting.

Wolfgang Fendler: Thank you very much.

Neeraj Agarwal: And please tell us about, first of all, this large international registry you have put together. How many sites are there? And what are the goals and objectives as far as PSMA PET scans are concerned?

Wolfgang Fendler: We have presented updated risk groups based on a novel imaging test, PSMA PET, summarized by a standardized reporting, which is called PROMISE. And this was made possible by a contribution of around 50 sites internationally on all continents. And they recorded together 6,000 patients and their results from the PSMA PET scan as well as overall survival outcome.

And then we analyzed the PSMA PET scan and the overall survival outcome. And we're able to show that PSMA PET, beyond being an imaging modality, can also predict the survival outcome, both in early and also late stage of prostate cancer. And this was really only possible by the International Consortium, looking into their patient data sets with very long overall survival endpoints.

Neeraj Agarwal: So this is interesting. So far, we have been using PSMA PET scan for staging and for selection of patients for treatment with radioligand therapy, specifically, lutetium-177-based therapy for now. But you guys have taken a step further, and you are showing the data that PSMA PET scan-based findings can help us prognosticate, which can be very helpful to the patients. So could you tell us more about that?

Wolfgang Fendler: Absolutely. This stretches out beyond the current major use of PSMA PET before PSMA-directed treatment into all fields of prostate cancer. So exactly as you say, PSMA PET can now, as a prognostic biomarker, risk stratify patients into, let's say, low risk, intermediate risk, and high risk. And those risk categories have been shown to be superior to clinical risk categories, such as NCCN or the EAU criteria.

So we have a more accurate risk biomarker that can be used in hormonal therapy, chemotherapy, in many settings where we have to decide in the future whether we want to escalate treatment, de-escalate, or stay on the treatment. It tells us where the patient risk lies currently for the decision.

Neeraj Agarwal: So PSMA and PET scan, looks like it's so effective that it is dominating over traditional risk stratification, which is very encouraging if you look ahead and see how many patients are going to get PSMA PET scans or already getting PSMA PET scans, and that can help us in defining or in determining the type of treatment they should be receiving. Is that correct?

Wolfgang Fendler: That is absolutely correct.

Neeraj Agarwal: So how many patients did you have in this database used to come up with these results?

Wolfgang Fendler: So at the time of submission, we had 6,000 patients. And they were analyzed and separated for this purpose into a development cohort of around 4,000 patients, where we developed risk models. And then we validated it on around 2,000 patients in the data set. By now, we've collected more patients. So currently, the data set hosts around 15,000 patients globally, to be analyzed in the future for different risk stratification and risk groups in prostate cancer.

And exactly true, as you say, it works not only in specific scenarios, but it can also work across different treatments and across different stages for patients. So it seems to be a very solid prognostic biomarker for early and late stages.

Neeraj Agarwal: So exactly where were your findings?

Wolfgang Fendler: So what we found is that there are four major factors on PSMA PETs that determine the outcome of patients. And this is the presence of lymph nodes outside the pelvis. It's the presence and the extent of bone metastases. It's the presence of organ metastasis.

And it is the extent of disease characterized by either number of lesions or by really volumetry, the total tumor volume. By taking those four factors together and combining them in a risk model, we get a risk score that assigns patients towards low risk, intermediate risk, or high risk for dying in that certain scenario.

And this, we have tested against clinical nomograms and clinical risk scores. And we're able to show that it has a higher prognostic accuracy in most stages of prostate cancer as compared to, for example, the NCCN or the EAU criteria.

Neeraj Agarwal: So from localized high risk prostate cancer to metastatic disease, this tool seems to be helpful in prognostication and maybe treatment selection down the line. How a community oncologist or urologist, who does not have access to your analytical tool, which is used to combine all these factors you just mentioned, how can they use these data to help their practice or help their patients?

Wolfgang Fendler: So in the future, we'd like to get this nomogram and this risk score out as broadly as possible. And for this reason, we have started in an online presence, where there's an online application that works with all systems, both personal computer, but also smartphones, different systems that can be used by either urologists, uro-oncologists, or more often, by the imaging physicians to input the results from PSMA PET, and this application gives you directly a risk score and a risk assessment of the patients.

So all you need is basically a good PSMA PET report. And you can translate the report, using the web-based application, into a risk score for the patient. And this is accessible through the web page of our registry, which is promise-pet.org. And we have the online application free there and for everyone to use.

Neeraj Agarwal: So I just want to make sure I repeat the website, so my colleagues out there, including me, can benefit from this, promise-pet.org. And on this website, anyone can access your tool. And they just need to have a proper, complete PSMA PET report.

Wolfgang Fendler: Absolutely.

Neeraj Agarwal: And with that tool, all of us will be able to personalize prognostication and hopefully, treatment selection down the line. This sounds very exciting to me, frankly. Well, congratulations again for your presentation at the ASCO 2025 meeting. And thanks for taking the time to be with us today.

Wolfgang Fendler: Thank you very much for having me.