The IRONMAN - An International Registry for Men with Advanced Prostate Cancer - Dana Rathkopf
November 8, 2019
The IRONMAN registry is a population-based observational study currently in nine countries at 61 sites, collecting data on patients at baseline, including questionnaires and blood samples, following these patients longitudinally to see patient and physician preferences and collecting blood work at times of treatment changes to use in a biorepository that the community can use to test concepts, ideas, and generate hypotheses. It is an unbiased registry, not run by a single sponsor or a single PI and owned by the community.
The aim is to change the face of how we treat prostate cancer globally. It plans to enroll 5,000 men from around the world, and one of the benefits is following real patients in their real-world settings with the clinicians that are treating them and in their day to day lives, getting an understanding of sequencing that isn’t captured from clinical trials.
Dana E. Rathkopf, MD, Medical Oncologist, Associate Chair, Junior Faculty Development, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
Alicia Morgans, MD, MPH Associate Professor of Medicine in the Division of Hematology/Oncology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois.
IRONMAN Registry An International Registry for Men with Advanced Prostate Cancer
The Prostate Cancer Clinical Trials Consortium (PCCTC)
Watch: Movember Session: Outcomes Research – IRONMAN Project - Alicia Morgans and Ian Davis
Watch: IRONMAN: An International Registry To Improve Outcomes in Men with Advanced Prostate Cancer- Lorelei Mucci
Clinical Trial Information: Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men With Advanced Prostate Cancer (IRONMAN)
Alicia Morgans: Hi, I am so excited to have here with me today, Dr. Dana Rathkopf, who is here from Memorial Sloan Kettering, where she is a GU Medical Oncologist and really a strong contributor to the IRONMAN registry trial, which is running through the PCCTC and has been a brainchild of many GU Medical Oncologists in the field and you're really just hitting it out of the park with that study. So I'm really excited to talk to you about it. Can you tell us what is IRONMAN? Why is it so important? Why does it even matter?
Dana Rathkopf: Yeah, Alicia, thank you for having me today because this registry is really, really important so I always love the opportunity to talk about it. So the IRONMAN registry was actually the brainchild of Phil Kantoff, Lorelei Mucci, Dan George, in concert with the Prostate Cancer Foundation and the Prostate Cancer Clinical Trials Consortium and Movember, thinking about all of the drugs that have been approved for our patients over the past several years and how we can apply that information in a more global scope to make sure that we are taking into account not just treatments that work, but how they work, who has access to them, thinking about physician's choices, patient's choices.
You know when you do a clinical trial it's usually just a single question, but there's so many layers of complexity that go into that. So the IRONMAN registry is a population-based observational study where they are collecting data on patients around the world. I think right now they're in nine countries at 61 sites, which is really unbelievable. And what they're doing is they're collecting data on patients at baseline, including questionnaires and blood samples, and they're following these patients longitudinally to see patient preferences and physician preferences and collecting blood work at times of treatment changes to use in a biorepository that the community can use to test concepts, ideas, generate hypotheses. It's just really exciting and unprecedented. It's also unbiased, it's not run by a single sponsor or a single PI. It's owned by the community. So everybody who takes part in it is vested in this registry collecting data in a very unbiased way.
And then what will happen is there'll be a scientific oversight committee where people, anyone, physicians, and even patients, patients' advocates, anyone in the healthcare field who has ideas or concerns or thoughts can have a say. They can contact the PCCTC or the scientific oversight committee and give ideas. And we can use this information to really, I think, change the face of how we treat prostate cancer globally.
Alicia Morgans: I agree. So one of the powers of registry trials and this I think aims to enroll 5,000 men from around the world, which is an incredible undertaking, but one of the benefits is that if we're following real patients in their real-world settings with the clinicians that are treating them and in their day to day lives, we can understand things about sequencing that we certainly can't understand from clinical trials. We can understand things about biomarkers that may help us identify patients who could respond to this therapy more robustly than that therapy.
And like you said, it is unbiased. It's not from a single pharmaceutical company sponsor but really supported through Movember's efforts and the community of researchers. But what I love too, as you mentioned, is that patients, clinicians, anyone can actually come to that scientific oversight committee and ask questions and certainly that's happening. There are a number of sub-studies that I'm sure you're engaged with that are trying to answer additional questions. Can you tell us a little bit about the working groups within the IRONMAN registry team and what are some of the other things that they're trying to enhance?
Dana Rathkopf: So you know there are a number of different working groups and there'll be more I'm sure as we go, but the working groups are looking for example at the patient-reported outcome measures. So the questionnaire is very, very detailed and I think that that's very important because patients' voices need to be heard. And when they're in clinic we don't always have the time to sit down and listen to the extent of what patients have to say.
And sometimes we have our own goals in that meeting. Patients need a venue I think to express their thoughts and their feelings and their experience over time. Of course, Ethan Basch and you have really pioneered this field in patient-reported outcomes, and we've learned how important they are, not just in terms of collecting data but actually predicting response to treatments over time, and so that's important. Some of the other working groups are advocacy groups. There's global groups on the global initiative. Groups to ensure the quality of the data biomarker group, of course, to think about how the biomarker repository will be used over time. The biomarkers being collected are really important and timely. They are blood ctDNA, mRNA to look at splice variants and such, and there's any number of questions that we can ask in this enormous 5,000 patient population over time.
So these working groups are really going to carry forward a lot of ideas and science into the general population that I think will ultimately inform clinical trials going forward and really make sure that we deliver the best care we can to patients with advanced prostate cancer.
Alicia Morgans: And getting to that, answering these questions, you, as I mentioned before, have helped many patients enroll in this registry, and it's not always easy, I don't think, to talk to patients about engaging in clinical trials, particularly if there's not some new-fangled drug that they're going to have access to. But it is so important because if they don't enroll, then we don't have the opportunity to hear their voice in these patient-reported outcomes or to see how their biology may drive outcomes and people like them will not have that information in the future.
So how do you talk to patients about enrolling? What are some recommendations you have and also for patients who don't have physicians who are working in centers where IRONMAN is open, what are ways that they can get involved?
Dana Rathkopf: Sure. So I'm glad you asked that. Thank you. Because I think that there is a little bit of concern when patients come to a center about clinical trials and what they mean and what the goals are and what will happen with their blood or their tissue or their questionnaires or their information. And, patients, of course, are interested in treatments, but what I've really been surprised by in the best possible way is how eager patients are to contribute to science. I mean, they're giving of themselves in every way.
So when I speak to a patient and I start talking about the IRONMAN registry and explain it's a global study, trying to look at varied experiences with different people of different cultures, races, geography, socioeconomic status, access to healthcare and drugs, and what we're trying to do with this information, I don't even have to complete a sentence and many patients are like, "Yes, sign me up!". But it's also an opportunity in those moments for patients to ask, what does happen, what will happen with my blood samples, my questionnaire. And I make sure to explain to them what we're trying to achieve and that ultimately the goal is to improve patient outcomes. That their personal data will be of course anonymous, but we'll use it to understand patterns. And I find that patients are very, very eager to participate and ask me often, "What's going on Doc?" or, "When's the next questionnaire?".
The other thing that's really been surprising to me in the best way is that when I started to look at the questionnaires myself, because I wanted to know what I was asking patients to look at and when I, I also have a questionnaire, so that's another really unique and wonderful part of this study is that they're also trying to understand physician preferences. You know, even in the same institution, we might have different reasons for giving the same drug. And so as I fill out my own questionnaire, I've started to think of things very, very differently and I think patients do as well. And as I read the questionnaires and the questions that have been gathered for them to talk about, I start to think about their experience more as well and what's important to them. So it's really been really a wonderful experience because what ends up happening is that it's a partnership between the patients, their caregivers, myself, and it's a real venue for me to think in a different way, which I'm so appreciative of.
And also for patients to have a voice in this process. You know when you're diagnosed with cancer and particularly I should mention for this registry, we are asking patients to participate at a particularly vulnerable time. They're either newly diagnosed with metastatic disease or their cancer is changing in a way where they need a new treatment.
So this has allowed me to understand the journey a little bit better but also for us to develop a trust because I really want to make sure they understand that we worry about the side effects of these drugs. I mean particularly in prostate cancer where there can be physical, emotional, sexual, urinary, a whole gamut of side effects, and I want to make sure that patients have a way to express that to us and that they know that we're listening and we're really going to try and change things for them going forward. Choose treatments not just because they work for the statistical median, but try and make sure that we get treatments that work for the individual.
I would say at its macro level what the IRONMAN registry is doing is trying to personalize care for patients based on not just their genomic qualifications, but also their physical, emotional co-morbidities, location. Just take everything into account.
Alicia Morgans: The power of this registry is enormous and I'm glad that there are researchers like you who are helping patients to engage because these are the big questions that without a registry of this size and the dedication of all these patients, we would never be able to answer these questions. So if a patient wants to be involved and he's not being seen at one of the sites, like my site or your site, what can he do to engage?
Dana Rathkopf: Absolutely, yes. Yes. Engage. So there's websites I would direct them to. The ironmanregistry.org is one. Also the Prostate Cancer Clinical Trial Consortium, which helps administrate this program, they have a link on their site as well, which is I believe pcctc.org. There's also a clinical trials website where this trial is listed and it has more information about people to contact. So I would absolutely encourage, and I hope that more people participate because we really want every voice to be heard.
Alicia Morgans: Absolutely. And we will make sure that we have links to those places right next to this video so people can really engage that way as well. Well, I sincerely appreciate your time. I'd love to hear closing thoughts, main messages for the audience, whether they're patients, clinicians, or loved ones. What's your take-home message on the IRONMAN registry?
Dana Rathkopf: You know, we're all a community. I sometimes hesitate to say patient, physician, caregiver. You know we're all one in this and so I would say that you are not alone and we are going to answer these questions together.
Alicia Morgans: We're all in this together. Well, thank you for that message of hope, for your contributions to IRONMAN and for sharing this about the registry and for your own passion and thoughts today. Thank you.
Dana Rathkopf: It's a pleasure. Really. Thank you for asking me to speak today.