Alice Morgans: Hi. I am thrilled to have here with me today, Sarah Wise, who's the Director of Research Operations at the Prostate Cancer Clinical Trials Consortium or the PCCTC. Thank you so much for being here.

Sarah Wise: I'm so happy to be here with you.

Alice Morgans: Wonderful. Well, I wanted to talk to you a little bit about the PCCTC, what that organization really is, how it should matter to patients, and how we can potentially, as a prostate cancer community, support what it's trying to do.

Sarah Wise: Sure. I'll start with what the PCCTC is. So, the PCCTC, as you said, is the Prostate Cancer Clinical Trials Consortium. What that is, it's a group that brings together some of the best prostate cancer researchers around the country. So, the PCCTC, the concept actually started about 20 years ago. It came out of the Prostate Cancer Foundation, who their goal was to bring together researchers around the country at academic sites who are focusing on prostate cancer research, but within their singular institutions. Then the goal was to bring these researchers together to make research more effective and efficient.

Then about 15 years ago, the Department of Defense initiated a grant mechanism that actually started funding the PCCTC, and we've been fortunate enough over the past 15 years to continue getting that grant funding from the DOD. What that means as we, as the PCCTC, bring together these researchers, like yourself, from around the country, so that we can work together to advance prostate cancer research more quickly, more effectively, more efficiently.

Alice Morgans: I think that's so important for everyone to really understand, that all of the clinical trials that we do are certainly not done at a single institution. So, it's really banding together as a community across all of these institutions that we get that done, but importantly, each center has to follow the same protocol. It has to have the same resources in place to ensure that the data that we collect is high-quality and consistent so that we can really interpret the data and understand what it means in truth and not have mistakes or poor quality control kind of interfere. So, the PCCTC acts to bring everyone together to ensure that those resources are consistent to do quality control. I know they follow up. We certainly have, you know, calls and things where we're following up and make sure that the data is correct and that we are highly efficient, as you said, as a community, to complete trials and to get drugs to patients.

Sarah Wise: Exactly. You said it so well, but that's the goal of the PCCTC, to really make research happen by bringing together the researchers, who obviously are key. That's the strength of the PCCTC is our members, and those are the investigators, the sites, the cancer centers who are doing research. Obviously, the patients are a huge part of that. Then we facilitate bringing that together to complete research studies, clinical trials, and other types of research by pulling in the infrastructure of the PCCTC team, which is the data quality, the data management, the monitoring, safety oversight, the protocol development, the concept development, so really working all together to make high-quality research happen for ultimately for the benefit of the patients who are dealing with prostate cancer.

Alice Morgans: Wonderful. So, from a patient's perspective, are there things that they can do to get involved with some of the work that the PCCTC does or to support the efforts of the PCCTC?

Sarah Wise: Yeah. Definitely. I think that's really important. First of all, we're so grateful to all the patients who do participate in clinical trials that are helping advance cancer research, because clearly we can't make that progress without the patients who are actually participating. But beyond that, I think the PCCTC, we also are trying to look more at the patient perspective. So, historically we focused a lot on Phase I and Phase II drug development, which is extremely important, and that's what's led us to have the drugs that we have available to patients today, and there's been so many advances over the past 10 to 15 years.

Patients have so many options, and I know that that's both a blessing and a challenge for patients, that they have so many options. Understanding what the right choice is important, so that's where we're focusing now to look a little bit more at real-world outcomes and real-world evidence of how are the patients feeling on studies? We're doing that in studies like the IRONMAN Registry that we have that collects patient-reported outcomes and is asking patients how they feel, and then we can compare across different treatments, across different drugs or other therapies that are standard now, how are patients doing, how are different types of patients, different subsets of patients doing and really provide that information back to the patient community and the clinical community to help make decisions about their treatment choices.

Alice Morgans: What I think is so impressive about the IRONMAN Registry, which, again, is being managed really by the PCCTC and is being funded by Movember and that whole Grow-a-Mo in November organization, that's much bigger than that now. But what I think is so exciting about it is that they are teaming up 5,000 patients from literally around the world, and patients could be starting on different treatments. They're really being cataloged in certain stages of their disease and then being followed forward for their clinical outcomes, meaning how well is the cancer controlled, for certain correlative studies, so genetic tests and other things that might be done on blood samples that are given.

But, importantly, just as you said, we're following patient-reported outcomes, so directly asking patients, "How do you feel?" You can compare these patients who are on different treatments by the way that they feel, by the way that the disease is controlled and help us to understand in a very complex treatment landscape, you know, what's really the best sequence of these therapies? Or perhaps they're all just fine. They all work well. We just need to help patients make these choices more reliably for themselves, so how we do things better than we're doing now. I think the power of bringing together 5,000 men is going to be incredible, and I really look forward to seeing data as it starts to come out of that IRONMAN Registry.

Sarah Wise: I agree. I'm really excited by the project too because it's a great example of collaboration. You mentioned Movember, which obviously is a huge partner in the IRONMAN Registry, working with the PCCTC. There's also a lot of industry partners who are helping fund the project because it all comes together when we work together the best. So, that's one of the goals of the PCCTC is bringing together academic researchers around the country and the world, philanthropic partners, like Movember, and industry, who obviously they're the ones developing these drugs, and they play an important part in advancing research as well. So, bringing everyone together for the ultimate benefit of understanding treatments better, understanding outcomes better, and hopefully helping clinicians and patients work together on making treatment choices.

Alice Morgans: Great. Well, do you have any closing thoughts or messages to patients who are watching who want to know what else they can do, whether it's getting involved in IRONMAN or otherwise?

Sarah Wise: I would say just reach out to whether it's your doctor or patient support groups, and don't be afraid to ask questions about research. You know, we support everyone's interest in research and hope that part of what we're doing is helping people become more informed about their options, whether it's in the standard setting or in the research setting. So, ask questions, and get engaged, and get informed.

Alice Morgans: Thank you so much for your time.

Sarah Wise: Thanks.