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Alicia Morgans: Hi, I'm so excited to be here with Dr. Hiten Patel, who is a urologist, assistant professor of urology at Northwestern University, and who is also at the Jesse Brown VA. Thank you so much for being here with me today.

Hiten Patel: Yeah, thank you for having me.

Alicia Morgans: Wonderful. I'm so excited to talk to somebody who has a lot of time and clinical effort at the VA, and also somebody who is actively engaged in research, also research that's happening at the VA. I'd love to hear you really talk about some of the exciting opportunities and initiatives that might be available for us as a research community to think about within the VA system.

Hiten Patel: And I think the veteran healthcare and kind of prostate cancer in general is a big deal in the Veterans Health Administration and the system and the hospitals. It's just something that, as men are getting older, it's something that taking care of our veterans is a big priority for the government as well as just physicians and others working in the VA system as well.

So I think from the research side, clinically, that makes sense why prostate cancer priorities, I think make sense in the VA. I think as a system, and this is before I had joined, but in 2018, they had really set up a few prostate cancer centers of excellence or precision oncology excellence, and the goal was to say, "Well, we have this huge system in the VA. Bigger than most of the private institutions healthcare systems." But there weren't as many coordinated efforts to say, "Well, how can we improve oncology care, improve survival, and improve care for our veterans in general?"

And so, coming up with the Precision Oncology Program, or POP, was an effort across cancers, and then specifically for prostate cancer, I think it was really the Prostate Cancer Foundation that really partnered with the VA and created what we call the POPCaP, the Precision Oncology Program for the Cancer of the Prostate. I think POPCaP is where I think a lot of the exciting developments are. Even though it's more medical oncology driven, they have a lot of partners, like myself in urology, plenty of others in radiation oncology that really support those efforts and see a lot of these patients at diagnosis and doing, often, their initial treatment, since 85% of men who are diagnosed are usually going to be getting more local therapy initially.

So there's a couple, and I think the first effort that was now it seems more routine is just sequencing is finding and saying, "Hey, are there identifiable mutations that patients may have in their tumors, even hereditary, but really in their tumors, that we can target and do better for?" And there's lots of trials that have been coming around that. I think with PCF's help and setting up the Prostate Cancer Foundation POPCaP effort, they really said, "Well, if we can increase how many patients are getting sequenced, these tumors and tissue that's available, and even blood, circulating tumor cells or liquid biopsies, can we identify what treatments they may be eligible for," or that could be used in research to say, "These are avenues we don't know about, but we can study and basically improve veterans health."

A couple examples, I think two of the early ones they had started were CHOMP and COBRA. We know androgens axis has been the primary treatment for systematic treatment for prostate cancer, but I'd say, I'll start with CHOMP, the goal there is to say, "Well, can we bring checkpoint inhibitors, the CH being for checkpoint, into the mix?" We know that it works well for patients who have mismatch repair mutations, and then also this kind of CDK1/12 mutation. So basically specifically targeted mutations. And they said, "Let's start a phase II study where we can actually identify patients who have these mutations and provide them with pembrolizumab or other treatments that have metastatic castration-resistant prostate cancer and study their outcomes." They're recruiting 50 men, and this is one of the early studies that were started.

So I think that was just a targeted thing to say, "Hey, we know these are mutations and things that we're interested in. Now that we have a system in place, which took a few years to get in place, of, how do we get all these patients in tumor sequenced now what do we do with the information?" And I think these trials that are coming and being designed around this information that's now available are very exciting.

Alicia Morgans: Absolutely. And I think it's so interesting that of all of the organizations that they could invest in the Prostate Cancer Foundation is so committed to the veterans' health, and to your point, helped to work within the VA to help get some of these initiatives going, which is really, really exciting. I know that this has been going on at various places, even at UCLA with Isla Garraway and certainly at the Jesse Brown VA. I know there's been an investment for years. What other studies are you interested in? What are things that you hope or maybe plan to do within the VA as time goes on?

Hiten Patel: And I think UCLA was very much a powerhouse to help coordinate a lot of these efforts and bringing all the other VAs in. I think they started with a few, and they've added, each year, extra centers of excellence that have been able to participate. So I think a big goal of it was just to bring together providers and researchers who are interested in this area and to be able to collaborate and communicate. When I start came on a year or so ago, the system's already in place and it's been exciting to learn, "Hey, how much happened over those 5 years?" And so I think they made out so much progress in these 5 years.

Another study that more on the medical oncology side is also a randomized study, phase II, and they're randomizing men who have metastatic hormone-resistant prostate cancer to getting carboplatin or olaparib. The goal there is to say, "Well, mutations in homologous recombination, BRCA mutations, and 10 others are things that we know these PARP inhibitors are good for." And we also know carboplatin, and now cabazitaxel and carboplatin, these are combinations that are being used in this space. And so they said, "Well, really, let's find these men who have these mutations who may benefit from this targeted therapy and let's randomize them to two potentially standard of care treatments." Just to get early data. There's 100 men who that are going to be randomized 50/50.

It's a little bit more involved, it takes a little bit of effort, but I think that these two studies have shown what the barriers are to get these studies up and running and how we can use information that's available. So that's a kind of second inroad there.

Alicia Morgans: And I think when I think about that particular approach, it's so thought-provoking because if we can see that a carboplatin approach may be as effective as a PARP inhibitor like olaparib, this might be a really cost-effective way to treat patients. Actually, we'll, of course, be able to compare their side effect profile. There are differences there. Maybe one will be more tolerable, maybe one will be preferred by patients, maybe they'll both be preferred, and then we'll know that we have both options for our patients. So it's really, really exciting.

I would also say it's interesting because we do not have a prospective, even a single-arm, study of platinum agents in these patients to even give that information. So you'll have that 50 patient arm that'll be a platinum, either platinum alone or platinum combination, however it is that you're doing it, but you'll have that data for us to inform the field even without the comparison with a PARP inhibitor. So that'll be really, really, really interesting. And of course the VA's bringing it home for us. That's fantastic.

Hiten Patel: I think these were just interesting examples of what was being planned from the beginning. And then I think more recently, taking it even beyond just the medical oncology treatments to the Hines VA where Abhi Solanki has really spearheaded and kind of put together a trial that's been ongoing now for just within the last year or two called the STARPORT study. And so, there, instead of the systemic treatments being what's being randomized or being studied, basically that's assumed in all men who have oligo recurrent prostate cancers. So patients who have had local treatment or other treatments now have recurrence and have metastatic disease. Sometimes we struggle with, "Hey, what should we do with sites of disease? And if they have limited metastatic burden, do we just treat them with systemic therapy? Do we target these lesions? And with PET PSMA or PSMA PET scans becoming more available and easier to get access to, and in the VA we have good access to them as well, and so now what do we do with that information?"

And so the study that they're doing, and that is probably the biggest one to date, I would say, or the most exciting to me to date, is actually randomizing men of oligometastatic recurrent disease, limited metastatic burden, and randomizing them to PET-directed therapy. They get standard of care systematic therapy. It doesn't matter what it is, it's all the acceptable standard of care. But besides staying on that, they would then be randomized to treating these PET-avid lesions, whether it's locally in the prostate or in the bed or in the lymph nodes or in the bones, anywhere in the body as long as there's limited burden. And whether with surgery or radiation, randomizing men to just getting standard of care, which is systematic therapy alone, or getting that plus this PET-directed therapy, which I think is exciting because is another biological marker that we have. PET avidity.

Not that all prostate cancers will, especially if they've been treated, but early on in this recurrent disease, a lot of men who are probably naive to hormone treatments at that time that are starting them up and getting the standard of care, it's probably the right timer and opportune time to potentially treat these metastatic sites to see if that's going to improve their survival and reduce progression.

Alicia Morgans: Well, I'm really excited about it too because I think that this is an area where we think, we know that adding SBRT is going to be really helpful, but we don't necessarily know if that's helpful in addition to maximal systemic therapy in terms of really shifting the trajectory of the disease. And so, I think, especially in a setting where this does have side effects, SBRT, there's certainly a cost and there are side effects for some patients, we absolutely should understand if this is going to be something that adds value to the patient in terms of disease control. So, fantastic, and thank you for reminding everyone of this study as well.

As you think about this work at the VA and the ongoing collaboration of the VA with the Prostate Cancer Foundation, what else are you excited about or where else do you want this to go? What would your message be to listeners in terms of what we can expect from research within the VA in the next few years?

Hiten Patel: Yeah, and I think what's been exciting recently was that even the last month, there's some legislation out that actually acknowledged this work, and specifically Prostate Cancer Foundation's partnership with the VA to be able to put together something like POPCaP across centers and how that's really hopefully going to be a model going forward of how we can use this information, genetic information, and things that are really going to be able to push the boundaries on treatment. So I think that's good, and that's been something in 5, 6 years they've kind of put together here. And so coming into it where the system's already going, I'm excited about that.

The second thing that, personally, as a young investigator, I'm excited about is that both Prostate Cancer Foundation and the VA where we do a lot of the research. Career development awards system is something that has been supporting a lot of radiation oncologists, medical oncologists, urologists, who are interested in this to be able to support and do both health services research, clinical research in the field. So I think that kind of support is really going to push who's going to be the next leaders in these systemic trials, both radiation and surgery, kind of, what do we do to hybridize these things to improve our veterans' health, patients with prostate cancer, and the Veterans Health Administration.

Alicia Morgans: Wonderful. So this is certainly a patient population in need and a patient population that deserves our attention. I'm so grateful that you are taking the time and your wonderful expertise and enthusiasm to help this patient population and to talk to us about all of the studies and initiatives that we could think about within the Veterans Administration. Thank you so much for your time and your expertise today.

Hiten Patel: Yeah, thanks for talking with me and giving us an opportunity to be able to talk about these topics in the VA and with the PCF support.