Zachary Klaassen: Hi. My name is Zach Klaassen, urologic oncologist at the Georgia Cancer Center in Augusta, Georgia. We are in Las Vegas for AUA 2025. I'm pleased to be joined on UroToday by Dr. Madison Krischak, who is a urology resident at the University of Michigan. Madison, thanks for joining us on UroToday.

Madison Krischak: Thank you so much. I'm really excited to be here, Dr. Klaassen.

Zachary Klaassen: We're going to be talking about clinical trials in the VA for prostate cancer. And you presented some great data at AUA and really some remarkable data we're going to get into. But maybe just to set the stage, why is it important, when we look at clinical trial enrollment, to enroll patients that look like the patients who are going to be treated in the real world?

Madison Krischak: Yeah, of course. I think there are really two main reasons. First and foremost, we want our data to be generalizable. So our population needs to reflect the population that will be treated. And I think that's just an underlying foundational concept of our clinical trials and what makes a great clinical trial. I think the second thing is we want to make sure that everyone has equitable access. And in this case, in particular, we looked at veterans and making sure they have good access to prostate cancer trials.

Zachary Klaassen: Absolutely. And I know when you look at the rationale, and you'll get into this, we know Black patients have been historically underrepresented in trials. And the VA population has a lot of African-American patients. What was the reason to look specifically at this question for prostate cancer?

Madison Krischak: Yeah. I think veterans are often a group that are overlooked. And I think, oftentimes, that's the patient population we're working with when we're talking about prostate cancer or older gentlemen in that age group. And I really felt that this was an interesting group to look at, to see if they might have any issues getting access, especially between the two different health systems, the standardized VA health system and the more academic or other institutions.

Zachary Klaassen: Awesome. So just tell us about the design. How many sites? What was your outcomes and aims for this study?

Madison Krischak: Yeah. So we went to clinicaltrials.gov and we extracted data from all of the phase II and III trials dating back to when the registry first began in 2007. And we ran a custom script to look at which of those trials had VA sites available. And then we mapped that across the 159 known VA sites in America and divided it by the census divisions.

Zachary Klaassen: Cool. And so there are some great results. So take your time walking through some of those highlights, because when I was reading through this, there's a lot to unpack here.

Madison Krischak: Yeah, absolutely. And certainly a lot of surprises from our end. So our total trial inclusion was about 1,900 trials.

Zachary Klaassen: Wow.

Madison Krischak: Of those, only 6% had a VA site over the trial period, which I found to be just shocking and a little bit upsetting, truthfully. And if you look even closer, only 42%, less than half, had ever had a prostate cancer clinical trial. And in the more current space, when we pulled this data back in early 2024, only about a third were actively having a trial that was a phase III trial.

Zachary Klaassen: Wow. And talk a little bit about some of the geographic differences. I don't know--

Madison Krischak: Yeah.

Zachary Klaassen: What did you make of that?

Madison Krischak: It was a little bit different. So on the West Coast, we saw, of 19 different VA sites within the census region, they were having 10 of 19, whereas maybe on the East Coast it wasn't quite as strong. There wasn't anything that was super stark, but it did seem to have a little bit of a preference towards the West Coast and even a little bit towards the South, where it was a little bit more represented.

Zachary Klaassen: I see. When you look at the implications of this in terms of the enrichment of African-American patients in the VA-- almost 9 million veterans, give or take, use the VA for their care. And this is probably an unfair question, but I'm going to ask it anyways. How do we start to fix this? And it's a big conversation.

Madison Krischak: Yeah. And it's a huge problem. And I think this gives a lot of information and hopefully a little bit of power behind the question of why. I think there are probably several types of barriers, and I think a lot of that may come just from interfacing with the VA system and getting a trial integrated into that such that you can enroll veterans.

I think there's also probably a component of a lot of these veterans are being entered in a clinical trial that's maybe not associated with the VA, but perhaps associated with the university that's affiliated with that VA. And that data is a little bit harder to capture. But those barriers, I think we need to better understand them and really need some resources to explore what they might be so we can appropriately tackle them.

Zachary Klaassen: Yeah. Great answer. And I think these are great studies because it's hypothesis-generating. It really gives us some actionable points to jump off on and try to improve this. So congratulations on this great work. Maybe just a take-home or concluding remark for our listeners today.

Madison Krischak: Yeah. Absolutely. Thank you again. I think the big take-home message here is, consider the veterans as potentially underserved when we're talking about the prostate cancer clinical trials landscape. And when we think about the future, I think we really need to consider that veterans need equitable access, because they also deserve to have those benefits of enrolling in a clinical trial.

Zachary Klaassen: Yeah. Well said. Great interview. Congratulations again.

Madison Krischak: Great. Thank you so much.