Trinity Bivalacqua: Thank you so much. Glad to be here.
Ashish Kamat: So much happening. Obviously at the AUA, we're all running around from here to there, everywhere. You've been at multiple presentations, posters, but today I want to pick your brains a little bit on the SUO, the SUO-CTC essentially, which you're obviously an integral part of. So what's happening there that's exciting you? What's new? What's up and coming?
Trinity Bivalacqua: Thinking about the SUO-CTC, actually when I became a member and actually was invited to be part of the Bladder Committee, you were one of the main people that was driving and pushing trials to be done in the bladder cancer space. So I actually remember, as a more junior person, watching you and admiring what you did for the SUO-CTC, which is essentially when I first started and maybe when you first started, it was dominated by a lot of kidney trials, a lot of prostate trials. And now it is unbelievable the amount of trials where it's flipped, and we're now really being supported by a number of bladder cancer initiatives. The SUO-CTC is also expanding. We're now including phase one trials. So there's now the inclusion of phase one trials and all disease spaces, could be rare tumors. So things like penile cancer, sarcomas, and the like. And it's also expanding in the sense that we now have members that are more multidisciplinary. So a lot more medical oncologists, radiation oncologists that are being invited into the committees.
And lastly, or not lastly, but maybe another couple of points is that we're now starting to partner with the cooperative groups. So the cooperative groups are now coming to us at the SUO-CTC to be able to help them conduct trials in order to get trials completed quickly and efficiently. You're very aware of how the cooperative groups work, and sometimes they need help, and they're now coming to us to do that. And obviously we welcome helping any organization with conducting the trials. And I think the other thing that's exciting about the SUO-CTC is just the fact that we're now going to be including more young urologic oncologists. So now on each committee is going to be a YUO member, but then we're also going to have YUO members that are partnering with the PIs for each of the trials to help them learn more about trial design and whatnot. So lots going on with the SUO-CTC at this time.
Ashish Kamat: So that's a fantastic initiative, getting the young urologic oncologists partnering with the PIs. For, obviously, the young folks that are listening to us right now, share a little bit about how someone can apply or get that.
Trinity Bivalacqua: So what'll happen is you'll see, just like we get emails from the SUO asking us RFAs for different grants or whatnot, you're going to start to see applications if you'd like to be a standing committee member in the prostate, bladder, and kidney committees. So you would apply for a position there. And then we, as the leadership in the different committees, would then ask for certain trials, maybe not all the trials, but maybe some of the more bigger trials, more those that have maybe phase three, maybe registration, whatnot, we'll then ask for applications to partner with the SUO-CTC PI.
Ashish Kamat: And that's very encouraging. I think that's what we need to do with our young investigators and young colleagues that are learning to do this. We didn't have this when we started.
Trinity Bivalacqua: No.
Ashish Kamat: I didn't have it. You didn't have it, but this is something really needed. When the SUO-CTC first started, and thank you for your kind words and it takes a village, but when it first started, it was obviously just one company doing the trial. Then we had to go out and get companies to try to believe in us. Now it looks like, and I recommend to anybody, any pharma company, whether that's big or small, that's trying to do a study in our field, to work with the SUO-CTC, but I'm sure there's a triaging that occurs. So can you share some of how you go about selecting what's worth pushing through the SUO-CTC?
Trinity Bivalacqua: Yeah. And I think another person that deserves a lot of credit is Rob Uzzo, who really championed going out talking with the different big pharma, smaller biotech, for example, companies. We actually have a company from Asia that wants to do a trial with the SUO-CTC. And what we do as investigators is if they come to us about serving as maybe the PI or just opening the trial at your place, we say, "Well, wait a minute, we have a mechanism to be able to have lots of members have the opportunity to do the trial." The trial then comes to the SUO-CTC. If it's a prostate trial, it goes to the prostate trial. The prostate committee then reviews and makes the determination if they feel like they could open it up, and the members of the SUO-CTC would embrace the trial. And that happens in both prostate, kidney, and bladder.
I can tell you from experience with bladder, we have meetings probably now, every quarter where we're reviewing trials, and then we make the determination if we can open it up. Currently in non-muscle-invasive bladder cancer, as you're very well aware, there's lots of disease spaces now, right? So we try to prioritize a trial in each disease space. So we don't want to open up, for example, four trials in the BCG-naive space. We want to open up maybe one or potentially two. With the BCG-unresponsive space, we usually have between two to three trials running at any given time, usually about two. And then when one concludes, we then open up another. So it gets reviewed and triaged by our members, and then ultimately we vote on what we're going to open up.
Ashish Kamat: And over the years, how has the process changed? Because initially we would give a lot of feedback to the companies. They would accept that feedback, and then modify the trials. Today, the way pharmas work is a lot of times they come with the actual finished protocol. Has that evolved? What's going on right-
Trinity Bivalacqua: Yeah. I think what I've seen over the years is two things happen. Either they come to the SUO-CTC committee, and maybe they go to the kidney committee and say, "Listen, we have an adjuvant trial. We'd like to partner, and we'd like to get your input on how to do that post, for example, cytoreductive nephrectomy." And then we, as committee members, then design the trial and work with them, obviously within the restraints of the company. And then we decide if then we're more encouraged and more enthusiastic about opening that trial. The other end of the spectrum is exactly that, big pharma. So for example, J&J came to us with all of their SunRISe trials, and we only opened up two because we felt like the other two weren't necessarily within the reach of our membership. So we had no say in that, and therefore, we didn't open up all the trials.
Now the trials that we did open accrued quickly. We were able to move them, get them across the finish line. So I can tell you from my experience, we like to be part of the process and be able to help design it because we feel like we have a lot of input into that. However, it doesn't always have to be like that. It could be, we've got this large trial, it's got 800 patients. We'd like to open it up, and we decide if it fits into our portfolio. I think for the phase one trials that have come in more recently, there's a lot more input. So the phase one, we are providing input, we're asking for more data, for example, like we have one currently that's being reviewed where we want more safety data. We weren't sure if this is something we felt we can provide safely to our patients. So we have a lot more input in the phase one trials.
Ashish Kamat: And Trinity, you've been a big champion always of doing correlative studies, right? So how does the correlative study part of it work with the SUO-CTC? Again, you and I know this, but it's more for our audience that's listening.
Trinity Bivalacqua: Yeah, absolutely.
Ashish Kamat: If a young investigator wants to come in and propose something to the SUO, and say, "Hey, I have this idea," what's the mechanism today?
Trinity Bivalacqua: Yeah. So I think that all of the... At least, I can speak for the bladder trials, right? So for the bladder cancer trials, the majority are doing correlative studies. And that is being... And if the site is not willing to, for example, obtain the urine samples, get the blood samples, be able to send the path, nowadays it's being sent by digital imaging, but back in the day, you'd have to send an extra couple of blocks or slides. If they're not willing to do that, then they probably shouldn't open up the trial because we're obviously interested in all aspects of the bladder cancer treatment, and our ultimate goal is to figure out which one of these therapeutics, intravesical therapeutics, is going to work and why. So we're very enthusiastic about that. And frankly, if you're not going to do it, then you probably shouldn't open up the trial.
And the majority of the trials nowadays do have some piece to that. Some don't, some don't, but a lot do. And for example, with some of the prostate trials, they will have where they're doing prostate biopsies. So the prostate biopsies, a number of the cores or the digital imaging is being sent, and then that's ultimately being utilized for predictive and prognostic biomarkers using AI. At least that's more what we're seeing these days.
Ashish Kamat: Great. Trinity, thanks for spending the time. Any closing thoughts or any message you want to put out to the young folks or anyone that's listening early?
Trinity Bivalacqua: Yeah. I mean, I think if you're a member of the SUO, you can become a member of the SUO-CTC automatically. You're going to have the opportunity. It doesn't matter if you're in academic medicine, in a large urology group practice, or even in community practice. If you're a member of the SUO, you can become a member of the SUO-CTC, and it provides you with an opportunity to enroll patients in trials that will ultimately shape how we treat various cancers, GU cancers. So we're obviously very excited about the organization. It's growing. It's growing every year, which is really exciting. And we see the growth everywhere. We see it with large urologic group practices, academic, VA centers and the like. So obviously we embrace and welcome anyone.
Ashish Kamat: Thank you so much. I think the way the SUO-CTC has grown over the years, it's really refreshing to watch. And again, having folks like you now leading it is phenomenal. So thank you.
Trinity Bivalacqua: Thank you.