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Matthew Cooperberg: Hi, and welcome to another installment in the UroToday Localized Prostate Cancer Center of Excellence series of interviews that we are doing with thought leaders around the field about emerging trends and developments in the world of localized prostate cancer. Today, it is our great pleasure and honor to be joined by Dr. Mohummad Siddiqui, who is the Director of Urologic Oncology and Robotic Surgery at The University of Maryland, and an Associate Professor there, and also the Chief of Urology at the VA in Baltimore. We are going to be talking today about a phenomenal recent grant he got from PCORI (Patient-Centered Outcomes Research Institute) to really try to highlight, to a greater extent, the patient's voice in determining the next course that we need to chart for the future of active surveillance in the US. So Mohummad, welcome.

Mohummad Siddiqui: Thank you. Thank you for having me.

Matthew Cooperberg: So tell us a little bit about this grant. What was the journey to get there and what are you going to do?

Mohummad Siddiqui: Great Thanks. So actually this grant is the culmination, of a collaboration with a couple of key people. And so the people that I really have to highlight, Mike Scott is probably the person who started all this, and many people in the prostate cancer field probably know Mike. He oversees a very large kind of newsletter for prostate cancer awareness and activity, PCI, the Prostate Cancer International newsletter. And one of his passions has been from a patient perspective, advocacy for active surveillance and just awareness of active surveillance as a good reliable management option for prostate cancer. So Mike, and then Daniel Mullins. Daniel is a professor here in the school of pharmacology at The University of Maryland, and he is the director of this program called The PATIENTS Program, all capital letters, PATIENTS.

And this is a program that is geared towards patients, patient-centered outcomes research, and they have been very successful in engaging the patient voice into various research programs. They are kind of cross-platform, not just, certainly not urology specific and not just cancer specific, but they have done, they have taken on a number of initiatives. And so the three of us together felt like this was, this was a good time to put together a proposal for studying prostate cancer active surveillance, and the kind of barriers and questions that need to be focused on in this kind of modern-day and age to make active surveillance more accessible and more reliable for the patient population.

Matthew Cooperberg: So where do you see the current holes and, you know, and I'm sure most of the viewers know active surveillance has gone from kind of an academic niche enterprise, we were never more than 10% of low-risk patients getting surveillance up until about 2010, but in the last decade, of course, it really sort of exploded. And we are now up to about 50% to 60%, but a lot of variation from place to place. So where do you see the current holes in terms of access to surveillance and what do we need to do to close those holes?

Mohummad Siddiqui: Yeah. So that, as you said, that's exactly right, and I think that the guidelines across the board for appropriate patients recommend active surveillance as first-line therapy. And so it's really great to have seen the field come all this distance so that we are now at 50%, 60%, but there is so much variation. And a lot of that variation is because of the type of information that patients receive. There are a lot of disparities issues that we still see. And there is still a lot of confusion, I think, because of the issue, one of the issues that we are seeing is, and the issue that I personally face in my own practice, is that in prostate cancer research, active surveillance research, has culminated over many years, but changes have occurred in our field in that same time period and there has been an introduction into the biomarkers and there has been an introduction of MRI that is heavily utilized now as part of a risk stratification diagnosis of prostate cancer.

And it's unclear how these new advances, which are almost standardized parts of care, should be integrated into modern-day methods of active surveillance. And so it almost feels like the groups are just on the fly, kind of adapting things, but some of them, some of the progress that was made of standardizing protocols for active surveillance almost seem hard to adapt in the current day and age. And these are like many of the questions that I think exist.

You know, the point of this conference is actually not to answer any of these questions. There seem to be so many questions. The point of the conference is actually to engage the patient and the patient advocacy community, and the kind of healthcare experts and providers and academic community, in trying to figure out which one of these questions are probably the priority questions that we should hone in on, which are going to be the high yield enterprises that we can kind of, if we were to answer these five questions, for example, we would really start to make progress on, on addressing these issues.

Matthew Cooperberg: So to step back for a second, so you got this grant to launch a conference. So what do you guys, what are you actually going to do through the grant from PCORI?

Mohummad Siddiqui: Perfect. Yeah, sorry. I did jump ahead. This conference, it's an engagement award. And so it is actually meant to be kind of a foundation [inaudible 00:06:21] language to help future projects. And so for this project, our goal is, is to establish a conference where we bring together the patient community, and the kind of key opinion leaders or academic community who are engaged in prostate cancer, and particularly the active surveillance work to discuss the current date issues with prostate cancer active surveillance. And as kind of the foundation of that project, we actually took on this structure called the PICOT, P I C O T structure for asking academic questions.

And so what happens is, is that part of doing good research is asking the right question, and there are a lot of great questions, but not all of them are easily researched and not all of them are easily studied. And so, for example, you can ask a question, "Should I do active surveillance on someone with Gleason three plus four prostate cancer?" And I guarantee you that you will never find a good answer to that question because there are so many ways to frame the analysis that you could argue either way with good evidence and good strength. So then it just depends on the perspective and the biases of who is interested in talking about that question.

PICOT stands for "population", P, "intervention", I, comparison, C, outcome, or C "control", C, "outcome", O, and T, "timing". So that question that I just mentioned, you could frame it as "In a man with Gleason three plus four prostate cancer (population), does active surveillance (intervention) compared to immediate surgery or radiation (control) lead to improved 15-year survival or improve survival (outcome) over the course of 15 years (time)?" Okay. And you can kind of play that out. It's really, it's a methodology that I got exposed to pretty recently, and it is very powerful for kind of guiding research. And so the thought was to actually apply this to our, this field of active surveillance and help frame some interesting questions and study these various components of what interesting questions should be.

Matthew Cooperberg: So who are you bringing to the table? Who will the patient voices be in particular?

Mohummad Siddiqui: So we've been very fortunate to have a large number of organizations, we've had great involvement from the AUA, and a ton of support from the American Urologic Association.  Just to start off with, and then Prostate Cancer International is the organization that Mike Scott is with, who is one of the key, kind of founding people with this. There are organizations, the Active Surveillance Patient International (ASPI), there is Male Care, Cancer ABC, Prostate Cancer Educational Council, (PHEN), Prostate Health Education Network, Us TOO. And that's the list that I have in front of me. I feel like I've actually, since then through the network been connected with so many people.  And it's the support. I mean, I think it's been really exciting to see so much support, just kind of start coming through. I think it is a topic that is on a lot of people's minds. And so, once we kind of started talking to people, they've connected us with other, other people in the advocacy space and whatnot, and it's been growing since then.

Matthew Cooperberg: I want to go back to a comment you made about disparities in surveillance. There is obviously a lot of interest right now, and very many disparities in prostate cancer outcomes and what the determinants of those are, and how much might be genomic versus environmental versus access to care. You know, the latest studies would suggest the adjustment for other social demographic factors, there's not a particular difference between African-American and Caucasian men in terms of the use of surveillance, although Hispanic men are substantially less likely to get surveillance. But despite that, we know there are differences in outcomes, potentially differences in how surveillance should be done, and obviously limitations and kind of cultural competency and in having good counseling sessions with these men. So where are you, where do you perceive the greatest barriers and greatest problems in disparity specifically in this active surveillance space?

Mohummad Siddiqui: Yeah, I mean, I think that this is an excellent question. And I think, I can't say that I have like an expertise on this topic, but it's been, I've been trying also to kind of keep up with what is a very important topic. And what I will say is that I have, as part of planning for this project, learned so much about possible contributing factors that may be leading to these disparities. And so in particular, as part of some of the work we've been doing, there are some leaders, kind of regionally in terms of the African-American community in the Baltimore, Maryland area. And, when we were just talking in general, in terms of framing this project and saying, "What should, what would be a meaningful role of this project?" Disparities came up.

And some of the topics that the leaders from the African-American community were discussing was also not just kind of biological factors that might be taking place, but also cultural factors within the community and factors such as trust factors within the community of the medical establishment and things that are honestly, I'm not sure we discuss enough in kind of the medical literature, but when I was talking to some patients, African-American patients who, they are telling me that too many of them when they hear active surveillance, what they are hearing is that we are not going to offer you care and that is a big deal. That is kind of what the perception is, and it is indeed issues like that, and perceptions like that, because of cultural and community exposures are playing a part in uptake, an adaptation of active surveillance.

I feel like a patient engaged enterprise such as a PCORI project, where voices that can come to the table and help orient us all to those issues may actually be very beneficial towards kind of better understanding, in addition to the kind of what you mentioned that the socioeconomic disparities and the biological kind of differences that may or may not exist within these populations, the community biases within the African-American and other minority communities that may also be contributing, that are outside the realm of even potentially what access to care issues or other issues that we traditionally talk about, bring up. So I think I didn't answer your question per se because I don't have an answer. Also, I've increasingly been finding it hard to actually even understand how to do disparities research, because there has been a lot more awareness now and the fact that most race is self-reported and that is, and there is, within even designations of African-American and Caucasian and all these other kinds of groups, there is a huge amount of heterogeneity.

And so how do you even accurately study biological differences in such heterogeneous populations? I don't know, but I think these are conversations that need to continue, and I am hoping that it can be an important part of this conference.

Matthew Cooperberg: I totally agree with all that. What is your ideal endpoint? Let's say that the conference is wildly successful. What is your end result? What is your product? What is the next step?

Mohummad Siddiqui: Yeah. I would love to see something like five, well thought out, meaningful questions that unite the community come out of this and lead to kind of a coalescence of energy from all the people who are involved. So, I would love to see a well-intended conference, we are literally just taking this off. So we are going to have our multi-stakeholder advisory board first kick-off meeting next week, actually. So, the grant was just kind of finalized a few weeks ago. And so, but I would love to see a kind of a well-intended conference that leads to a lot of conversation and interaction, and we are hoping to and building up to the conference to do kind of surveys and gather input from the community-at-large.

So for people who can not make the conference, that they still have opportunities to input into it so that we can focus the conference based on that input. And then ultimately coming out of it, I would love to see some degree of conversion onto various sub-topics of interest. Like I said, maybe five different topics and see the beginning of infrastructure, like a highly collaborative infrastructure that then seeks to study those questions, kind of like answer those questions and whatnot, and build kind of a long-term initiative from all this

Matthew Cooperberg: Wonderful, wonderful, well, I hope we can connect in this forum at the time of the conference. It will be great to follow the updates and share all the progress, and it's a wonderful effort. I'm sure it will be highly impactful. And thanks for your work on this topic and thanks for your time today.

Mohummad Siddiqui: Thank you so much. [crosstalk 00:16:59].

Matthew Cooperberg: Very much enjoyed it.

Mohummad Siddiqui: Thank you again.