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Matthew Cooperberg: Hi and welcome to another installment in our series of interviews on the UroToday Center of Excellence, focused on localized prostate cancer. Today is a real pleasure to welcome Dr. Stacy Loeb, who is Professor of Urology and Population Science at NYU. I've known Stacy for many years and have had the pleasure of watching her absolutely meteoric rise in the world of prostate cancer research. She's been a prolific researcher and writer on many, many topics within the field of prostate cancer. And of course, if anyone has not heard, is this year's very much well-deserved recipient of the AUA's Gold Cystoscope Award. So Stacy welcome.

Stacy Loeb: Thank you so much. Thanks for having me.

Matthew Cooperberg: So as always, you're doing lots of different things and involved in many different exciting projects. And I want to hear about a lot of them, but maybe a place we can start is your work at the VA and particularly the work on screening and active surveillance that you've been involved with over the last couple of years.

Stacy Loeb: Great. Well, I can start out with screening. So, prostate cancer screening has been a real difficult and controversial topic. As you know, and everyone knows, back in 2012, the US Preventive Services Task Force recommended against prostate cancer screening and then subsequently in 2017 to 2018, this was changed to recommend share decision making, which was really in line with other professional societies, but this has had quite an impact including at the VA. So, we did just recently published a study looking at trends of PSA screening in the VA healthcare system and basically found decline in the use of PSA testing among PSA eligible veterans since the US Preventive Services Task Force recommendation against PSA screening.

The good news is that still more than 50% of the PSA eligible veterans were getting screening and it did decline in men ages 70 to 80, so perhaps there was some reduction in screening for men who may have less benefits. And meanwhile, the only group where there's been a little bit of an increase in PSA testing, was in the younger men. In the men who were younger than age 55, which personally I've always thought is too high in age to begin screening anyway and so maybe we do see some good news that perhaps despite a general decrease in screening and some people not benefiting from early detection, perhaps there has been some shift also towards maybe more high value screening with some increase in the younger population and decrease among older men.

Matthew Cooperberg: So we're looking at the VA population in particular. Do you think there's any unique challenges there in terms of implementing screening? Is it easier or harder in the sense that at least there's an integrated EMR system, but do you find the population has any unique challenges in terms of screening or do you find the data are likely representative of what's going on more broadly?

Stacy Loeb: I think so. I think that it's a unique system and that it's a good place to get prostate cancer screening and prostate cancer care. There's really equal access to care. You can easily see somebody's history over a period of many, many years through the VA electronic records, so it's very clear what testing has been done, who has already had a PSA. We're not trying to track down all of these kinds of records. So, for veterans who do get their routine care in the VA system, I think it's very easy to track exactly what they've had done to make sure that if they're interested in pursuing screening, that they can do it.

Matthew Cooperberg: Do you have any thoughts on, I don't know if you've been able to look at this, I know the data are difficult, on agent orange exposure and of course the agent orange exposed population is getting older as the years go on, but it's been a tough literature to track epidemiologically because of course the VA just flags yes or no depending on whether you were potentially exposed and I've met veterans who talked about being virtually bathed in it versus just serving off shore in an area where there was exposure and it's the same checkbox. Have you been able to look or are you aware of any or do you have an opinion even, in terms of whether we should be thinking about screening differently and [inaudible 00:04:34] orange exposure?

Stacy Loeb: I think so. I mean to be honest, I've always been more of a proponent of personalized medicine and I think there is a big push towards precision care and the VA. We've been really honored to participate in the Berry Family Center of Excellence through the Prostate Cancer Foundation VA partnership and really the goal of these initiatives at many VA's around the country is to provide precision care for prostate cancer. And to me, that does not just mean targeted therapy for advanced disease. Precision care should be across the entire spectrum, from screening all the way through to advanced disease. So from my perspective, if somebody is higher risk for prostate cancer or for aggressive disease due to their individual characteristics, then it does not make sense to use the same criteria or screening or active surveillance or anything else, than somebody who is very low risk. So personally, I'm all for a tailored approach to screening and management of prostate cancer.

Matthew Cooperberg: On that topic, what about differences by race in the VA system? So, some of the national data publications out there as I'm sure you know, show slightly higher rates of screening among younger African American men, which is totally consistent with a smarter screening paradigm and probably recognizes an earlier onset of latent disease among African American men. The numbers were still too low, sort of in the 30% outside of the VA. Did you see any differences? In particular within our interaction between age and race in the VA data?

Stacy Loeb: That's a really good question and actually the trends that we saw for PSA screening in the VA were very much parallel for Black men to what was observed in the overall population, which is that there was a decrease in screening over time in really in all of the groups over age 55, but some increase among the younger men. So, I suppose that that's good news to see that the younger men, especially if they are in a high-risk population, are slightly more likely to be screened than in the past. But it's an interesting question that you asked and really in our active surveillance studies which we can talk about next, similarly we are not observing many differences in the VA population between Black men and non-Hispanic White men.

Matthew Cooperberg: That's a perfect segue. I think it's generally recognized that one of the reasons we have a more balanced recommendation now from the US Preventive Services Task Force with this C recommendation is that we have stopped universally over-treating all low-risk disease as a urology community. Although of course we still have some work to do, but your findings in the VA are really quite encouraging. It looks almost as good as Sweden in terms of the rates of surveillance for low-risk disease.

Stacy Loeb: Yeah, no question. The rates in the VA have just dramatically gone up over time, so there's been a huge reduction in over treatment of low-risk prostate cancer in the VA system. And definitely, it compares very favorably with what's been published in other US healthcare settings, so I think we could definitely say that the VA is leading the curve in these efforts.

Now, it's not perfect. One could argue, what is the target of how much, what proportion of low-risk prostate cancer, should be doing active surveillance. Now, some people may say 100%, but there's always the patient preference piece in there and the individualization and so what if you do have somebody who has multiple risk features within that population? And so, we do still see some variation even within the VA system, so even though the rate is extremely high, there is some difference in the rate of conservative management for low-risk disease between different facilities, a different region, to have a little bit of a difference. What is going on there is unclear, but it'd be external factors like perhaps advertising for new treatment technologies or something else that is popular in the region maybe, but the strongest predictors of not doing conservative management among low-risk veterans with low-risk prostate cancer were having more than six positive cores was a big one and being aged less than 55.

And these are factors that are mentioned in the guidelines as considerations. The guidelines don't say that you can never offer active treatment to somebody with low-risk disease. Certainly, active surveillance is the preferred approach or watchful waiting for somebody where there's not a curative intent, but for somebody who is let's say age 48 and has 10 cores of Gleason 6, it is reasonable to wonder if that a different person that we're talking about then somebody who is 68 years old and has one core with 5% of Gleason 6.
So yeah, I think we should try to maximize active surveillance as much as possible. That there is people who have a complication with prostate biopsy, who do not like the idea of doing serial biopsies and we just have to have a patient centered approach where we do take into consideration things like their preferences and some of these other factors that you mentioned. Agent orange exposure would be another good example

Matthew Cooperberg: That brings up. I mean, do you think these factors like race, like exposures, like genetics, should be affecting surveillance decisions that we... That this type that came out of Hopkins showing a 50% rate of progression for men with BRCA mutations. There's a lot of discussion about that. Does that mean that these men should be ineligible for surveillance or does that mean that they get counseled that there's a higher likelihood that they may eventually need treatment, but can certainly embark on surveillance with that knowledge. What's your thought?

Stacy Loeb: I think the latter. I think that we shouldn't say that anyone can't do anything. So, I wouldn't put it in absolute terms. The study by Carter and [inaudible 00:11:26] that you're referring to, those are some compelling early data, but it is still a very small sample size. And if somebody has a [BRCA2 00:11:39] mutation for example, but they have otherwise low risk or very low-risk disease and they've been appropriately counseled about the increased risk of progression, but they agree to close surveillance and acknowledge this, then I think it is still within their decision-making, but it should be discussed and considered. And so, if you're thinking about all of the factors, that weighing the pros and the cons, that would absolutely need to be a part of the discussion, but I don't think it is a completely closed door.

Matthew Cooperberg: Why do you think the numbers are so much better at the VA? Is this the fact that the patients are older and have more comorbidity? Is it because it's an integrated system that does quality feedback internally? Is it just better? I believe on average, the quality of care at the VA is often better than the average quality of care in the community, but what do you think is really driving this?

Stacy Loeb: I think there's a lot of drivers. We've done some qualitative research on decision-making about active surveillance and really there's factors at all levels. There's patient level factors and there may be some differences there and the veteran population. These are people that have served our country and what they are choosing to do may be different. Then of course, there's physician factors. So in the qualitative study, financial incentives were discussed among physicians as a potential factor, as well as education and training, where urology residency is focused most of all on training people to do surgery, to do things and maybe less emphasis on when one should not do things. And so that is important for us to make sure that our trainees leave feeling that they have a lot of education and how to follow somebody on surveillance for 20 years, not just managing somebody's surgery and their postoperative care.
So, I think this is all improving and actually being in a residency program or a fellowship where you're in a setting like the VA, with high rates of active surveillance and a lot of time with your patients to follow them through their lifelong journey, I think this will help with the future of active surveillance across our entire country.

Matthew Cooperberg: Speaking of that next generation, any advice for residents and fellows, rising junior faculty, who are interested in working with the national VA data? How's the experience been for you? How high is the activation energy to get going?

Stacy Loeb: I think the VA is a fantastic place to work. This was really a priority for me personally. In my own reasons for going into urology is due to my grandfather, who was a veteran who died from prostate cancer. So, this is very personal to me, my commitment to the veteran population, but even if you don't have veterans in your family, it's a wonderful place to work. The data is incredible. They have very rich databases.

I think it has been just a really great place to learn and this partnership between the Prostate Cancer Foundation and the VA has really further promoted research into precision oncology and the VA system, so I think there is a whole lot of opportunity there, both from the clinical and the research side and would definitely encourage any trainees to consider working at some point in their career in the VA system. And it's just also just very nice to work with the veterans and to give back.

Matthew Cooperberg: Where are you going next? What's your next set of grants projects? What's next for you to work at the VA? And I'm sure there's many-

Stacy Loeb: [inaudible 00:15:42]

Matthew Cooperberg: ... [inaudible 00:15:42] sorry.

Stacy Loeb: Okay. So a few things. We're very interested in germline testing. As we were discussing earlier, BRCA mutations and others could potentially effect clinical decision-making. And one thing that we've found recently, is that many men who are eligible for germline testing based on current guidelines, are not receiving it, so there is definitely an underutilization and there's a lot of problems at play here. The guidelines have changed relatively recently, but also there's a shortage of genetic counselors, so one study that we're doing is a randomized trial comparing traditional genetic counseling for the pre-test education versus an interactive web tool. So that trial is currently open at a few centers including Thomas Jefferson, NYU and the University of Washington, and is opening at the Manhattan VA. So, we're excited to get more involved in research regarding the implementation of germline testing and prostate cancer.
We're also very interested in survivorship care and one group who has traditionally been underrepresented in research is the partners or caregivers of prostate cancer patients and who is caring for the caregivers. So, one of our current grants is looking at the impact on partners of patients and their sexual health. So hopefully we'll be able to gather some more data there and use that to improve more holistic care to couples as they journey through prostate cancer together.

Matthew Cooperberg: Wonderful. Perfect. Well, thanks so much for spending your time with us. I would say the field of prostate cancer and the veterans are very lucky that you're a part of the team and leading these challenges and leading us all forward. So, thanks again.

Stacy Loeb: Thank you.