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Dr. Alicia Morgans: Hi and welcome back to the 2018 AUA coverage. I am delighted to have with me, Dr. Stacy Loeb, she is an assistant professor of Urology and Population Health at the NYU Langone Medical Center, in New York. Thank you so much for being here.

Dr. Stacy Loeb: Thank you.

Dr. Alicia Morgans: So, Dr. Loeb, you've had a fantastic week, we're here at AUA, but earlier in the week, you actually had a publication in JAMA, and I would love to hear about this publication discussing or considering active surveillance at the VA, so you can share a little bit? 

Dr. Stacy Loeb: Absolutely. Yes, our paper was looking at the management of low-risk prostate cancer over the past decade in the nationwide Veterans Affairs system. We examine all of the low-risk patients diagnosed from 2005 to 2015, and what we found was really a dramatic shift in the management trends over time. Where, in 2005, very few of them were receiving conservative management. That is to say, the vast majority were getting radical treatment, which has the potential for increased side effects. Now, actually, it's completely reversed. And by 2015, among men under age 65, 72% were managed conservatively, and for men aged 65 and older, that was actually 79% that were managed conservatively. So, a complete reversal, a real reduction in over-treatment. 

Dr. Alicia Morgans: That's phenomenal. And you were able to look at this in our veterans' health system, which is really a large ... It's a care system, but the database is a really complete and thorough documentation of healthcare utilization through the VA system at least over time, so a longitudinal database. Can you tell us a little bit about how you were able to do your analysis and how you made this study work? 

Dr. Stacy Loeb: Yes, well, the VA really does have an amazing database and that's one of the really unique features about the VA system, and why I think it does have such a high quality of care, because it's a completely integrated system. There is one medical record across the whole system, so it's really an integrated care provision, we have the ability to follow patients in the long-term, to see all of the care that they've received.  So, we use the VA Central Data Warehouse, where they have all the records on cancer diagnoses, the tumor features, treatments that the patients have received. So, we really selected out the patients based on their PSA clinical stage and Gleason score, in order to determine who had low-risk prostate cancer. And then we look for treatments that they might have received for prostate cancer. 

But, that's where things got a little challenging, because some men did undergo treatment outside the VA, which was not completely captured in the registry. So, we had to do a bunch of checks and balances for this. So, we did a linkage to Medicare claims for men over 65, and through that we identified some men who received treatment outside the VA system. And then for the younger men, we were trying to think of a check and balance, so what we did across all age groups, was look for any man whose PSA dropped to < 1 during follow-up, since that's unlikely to occur in the absence of some kind of treatment and consider that that was likely somebody that received some form of treatment. So, we really did try to do a very careful job to make sure that if we called it conservative management, that they were under follow-up at the VA, and that they did not receive treatment somewhere else. 

Dr. Alicia Morgans: That's fantastic. And really encouraging that over that period of time, such a change could be made in the algorithm or the paradigm for care delivery. Very unusual in medicine. Do you anticipate that this is going to happen in a non-VA setting over time? And what is your take on actual surveillance utilization elsewhere? 

Dr. Stacy Loeb: Absolutely. I think it really is already on the rise in the community. And actually, even globally we've published very high rates of active surveillance in Sweden, where in 2014 74% of men with low-risk prostate cancer in the whole country of Sweden did active surveillance. So, it is possible even on a nationwide level, to reverse the trends of over-treatment of prostate cancer. So, I do think that that is happening across the boards in the US, although there really is some regional variation within the VA, but even more so outside the VA, where there isn't just one integrated health system, there's a lot of individual hospitals, individual providers. So, it will take time for this to diffuse. There are also some barriers in the patient level. Not all patients want to do active surveillance, for some reasons that are sensible and others that maybe we could help with more education. There is this fear of the “C” word and being diagnosed with cancer, so I think if we do a better job of educating patients, that low-risk prostate cancer really does have a very favorable prognosis even in the absence of immediate upfront treatment, that maybe more would choose it. 

However, some patients do have other legitimate concerns, for example, active surveillance does involve some serial biopsies. Prostate biopsy itself is an invasive procedure, which does have potential risks. So, you could imagine, for example, that a patient who's had an infection after a prostate biopsy and became very ill, may be less enthusiastic about committing to a protocol, which means that he may have several more biopsies during the course of his lifetime. But, I think all of that can still change, because we are getting a lot better with imaging and have new markers coming forth. So hopefully if there's more non-invasive testing options available, that will also really help the uptake of active surveillance and the follow-up.

Dr. Alicia Morgans: One of the things that you mentioned, imaging and then maybe genomic or molecular biomarker development, I think is really exciting for people who are eager to engage with active surveillance more thoroughly for more patients. I think that sort of de-escalation of the intensity of monitoring through active surveillance is also a priority potentially. Just as you're saying, if we can decrease the frequency of biopsies through these other means, that may be helpful. Where do you see these things developing over time? 

Dr. Stacy Loeb: I think this is only going to keep improving over the next several years. MRI, more and more data are coming out every month showing the utility of MRI, both in the setting of detection and in the setting of active surveillance. Certainly, out in the world at large, we are already reducing the number of biopsies that we're doing, because of improvements in MRI. Hopefully, as we continue to get more experience with this, and integrate MRIs and markers together. For example, there's a really interesting study being presented here at the AUA, showing how you can use the prostate health index, which is a blood marker test, along with MRI, and if you use the two of them together it has 97% negative predictive value. Meaning, you're only going to miss 3% of the important cancers. Even though we don't have one single test that's perfect yet, I think we can approach a very good accuracy level by combining some of the commercially available tests that we have now. 

Dr. Alicia Morgans: That's true. And studies are being done to look at these in a more prospectively validated kind of fashion, so that we can integrate them into our practices. Are there any that you see, or that you've participated in clinical trials, or that you see kind of moving to the forefront over the next few years? It's quite a vast field, and hard, I would imagine, for a clinician to kind of sort through where do I go or how do I make sense of all the available tests? 

Dr. Stacy Loeb: Definitely. I think that is a challenge for sure, because there's really a proliferation of markers, even here at the AUA and the press program this morning. We discussed two other new markers that have validation studies, so we're still figuring out how to integrate the ones we already have, and more new ones are coming down the pipeline. What we need the most are comparative studies, because that's what's really lacking, are head-to-head comparisons. Very few of these tests have actually even compared to each other. So, I think the onus is on the new marker tests to compare with existing markers that are already being used in practice, to determine whether this really is going to result in a significant benefit over, in some cases cheaper tests that are already readily available. 

Dr. Alicia Morgans: Agreed. Well, I've really enjoyed hearing your take on active surveillance. Very exciting data that you're putting forth with these rates of active surveillance in the VA community that are something to which we should aspire, I think, in the rest of our practices. Do you have any kind of closing thoughts, or over-arching themes for our listeners as we wrap up? 

Dr. Stacy Loeb: Well, I think the over-arching theme is that active surveillance is now the recommended approach for low-risk prostate cancer, both by ASCO and the AUA, so there's really consensus about that. It is something that's very important to discuss with all patients, and to give clear expectations about the prognosis of low-risk prostate cancer, so that we can hopefully continue to increase the utilization of this approach. And that there is hope on the horizon, in terms of reducing the burden of monitoring during active surveillance, because new data keep coming forth showing that combining tests, like markers and MRI, can actually pretty reliably predict who will or will not have upgrading on a biopsy. 

Dr. Alicia Morgans: That's a great message, and really encouraging as we council our patients, and I think council each other to make these decisions using the data that we have rather than the fear that we might have of a disease that's in all honesty, probably not going to harm these men. Keeping us from harming them is really important. So, thank you so much for your time and your insights today, Dr. Loeb. 

Dr. Stacy Loeb: Thank you.