Update on the IRONMAN Project "Presentation" - Alicia Morgans
November 15, 2024
At the 2024 Advanced Prostate Cancer Consensus Conference (APCCC), Alicia Morgans presents an update on the IRONMAN study, a global real-world data initiative capturing prostate cancer treatment experiences and outcomes. The presentation also discusses the EMPRO substudy, an innovative digital patient monitoring system designed to reduce emergency department visits and improve survival.
Biographies:
Alicia Morgans, MD, MPH, Genitourinary Medical Oncologist, Medical Director of Survivorship Program at Dana-Farber Cancer Institute, Boston, MA
Biographies:
Alicia Morgans, MD, MPH, Genitourinary Medical Oncologist, Medical Director of Survivorship Program at Dana-Farber Cancer Institute, Boston, MA
Read the Full Video Transcript
Alicia Morgans: I think, as I consider IRONMAN, this is a truly phenomenal real-world data set that tries to reflect the world of individuals who are treated with prostate cancer. And I think that's really shown and demonstrated here, where we can see that sites have literally been activated all over the world, not yet an Antarctic site, but maybe at some point. You'll have to let us know, Paul and PCCTC team.
But as we can see, there are sites in North America, Europe, Australia, Africa, and South America as well. So really trying to capture the experience and the outcomes of patients wherever they are.
Our global enrollment summary is here, and what we can see is that a majority of patients who are screened are actually enrolled. And I think this is an accomplishment as well, because the eligibility criteria are built around trying to capture the experience of everyone, so really excluding as few people as possible. And also, the sites are really, really good at getting these people on study. And you could see as we go down this table, those are patients who are active and off the study for other reasons.
Enrollment by country is listed here, with the United States representing about 34%—so only a third of this—where we can see Spain, Canada, and England coming in right after that, and Nigeria representing almost 8% as well, all the way down to Barbados, where we're just getting started and trying to ramp up there. So again, trying to capture the experience across the world.
I think one of the most encouraging pieces of this presentation is that we can see where enrollment was projected, and that's the solid bars. And we can see the actual site activation here and projected accruals going forward. We're doing really, really phenomenally well in getting all those sites open so that we can hear those voices and see those actual data of treatment responses, as well as the biologic data that we are trying to capture across the study. So doing a phenomenal job.
And here we can see that we do have still a predominance of white patients, but we are trying to increase our diversity across ethnicities and from different cultures and races. So again, trying to enrich this wherever we can.
If there are those in the audience who want to consider opening or know their own local sites that are open and can enhance enrollment in those places, please do what you can and let us know if there's a way that we can help you or that the PCCTC and the IRONMAN group can help you do that.
Our subject characteristics are here where we can see that, interestingly, a majority of patients are enrolling in this study with metastatic hormone-sensitive disease, which I think as I see patients and recognizing them as new patients, this is really a wonderful opportunity to get them involved in a clinical trial, like IRONMAN.
And so that may be driving a lot of this, but we do have almost 30% of patients who are enrolling at that time of progression to metastatic castration-resistant prostate cancer. And down below, we can see their Gleason score at diagnosis, with many of these patients having actually quite high-risk disease.
Biospecimen compliance is reported here, with many of these patients actually having those biospecimens collected as planned, doing actually a really great job here. And here we can see the patient-reported outcome measure or quality of life compliance here, with a majority of patients, at least in the upper 2/3, really hitting those time points and getting patients to complete patient-reported outcome measures.
This can be really challenging depending on where people are practicing. And different cultures have different abilities or interests in sharing their quality of life. We also have different understanding and comfort levels with completing electronic patient-reported outcome measures versus paper and the resources involved in some of that data transcription. So this can vary. But I think as we go forward, we'll continue to hopefully improve and will continue to collect these patient voices.
So now I'll talk just for a few moments about one of the substudies that I have been so privileged to be involved with. This is called the EMPRO study. It's a study in which we're really trying to collect patient-reported quality of life to understand how patients are feeling between their clinical visits, and try to respond to concerns and symptoms that they may be having between those visits without having them necessarily come in or even call, reach out to call the clinic.
This is a bit of a busy slide, but it's trying to illustrate the workflow of how we're engaging with patients. Essentially, patients are receiving their patient-reported outcome measure queries at home, and they are completing those digitally. If they have a symptom, whether it's related to fatigue or pain, or one of the other symptoms that we're collecting in this study, they can report some level of distress in their routine collection of these prompts.
If they reach a certain threshold of distress, the system automatically triggers to provide them some self-management support, which has been built up, actually, by the Movember organization to really address some ways that they might meaningfully impact those complaints or concerns without necessarily having to even engage with the clinical teams and without having to come to clinic.
If they reach a more urgent or more severe level of distress, actually, a trigger is sent to the clinical team so that they can reach out to the patient by phone and bring the patient in if necessary, or simply counsel them over the phone.
This was in response to a study that was led through Memorial Sloan Kettering that demonstrated that if we respond to patient concerns between clinical visits, we can keep them out of emergency departments and hospitals at a better rate. And we can also, importantly, prolong their survival simply by responding to their concerns.
But what we recognized when we saw the data from that study is that it actually takes a huge amount of resource utilization to provide that level of support between clinical visits by those teams. This study is meant to actually provide that support through means that are simply computer-based and really kind of harnessing technology to meet those goals, meet those patient needs if we can. So we're excited to see where this will go.
I think in the beginning, the study launched during the pandemic, and I certainly was anxious about the rate of enrollment, as we all were, of patients into this study. And clinical trials at that time, I think, were all struggling to try to get back on track as we all came back to clinic and started seeing our patients again on a more regular basis.
But what I'm so pleased to report today is that 140 patients out of a planned 180 have been enrolled and are being actively followed on this study. And this even includes a small subset of patients who were enrolled and then were disqualified due to a technological blip. They're all fine. Those patients are all fine. We just couldn't rely on the integrity of their data.
So we are nearly there in terms of enrollment, and it is a huge accomplishment to all of the sites that we can see on this screen. Whether they're in the United States or Australia or Canada, the UK, they're working really hard to get patients onto this study, and it's amazing.
Alicia Morgans: I think, as I consider IRONMAN, this is a truly phenomenal real-world data set that tries to reflect the world of individuals who are treated with prostate cancer. And I think that's really shown and demonstrated here, where we can see that sites have literally been activated all over the world, not yet an Antarctic site, but maybe at some point. You'll have to let us know, Paul and PCCTC team.
But as we can see, there are sites in North America, Europe, Australia, Africa, and South America as well. So really trying to capture the experience and the outcomes of patients wherever they are.
Our global enrollment summary is here, and what we can see is that a majority of patients who are screened are actually enrolled. And I think this is an accomplishment as well, because the eligibility criteria are built around trying to capture the experience of everyone, so really excluding as few people as possible. And also, the sites are really, really good at getting these people on study. And you could see as we go down this table, those are patients who are active and off the study for other reasons.
Enrollment by country is listed here, with the United States representing about 34%—so only a third of this—where we can see Spain, Canada, and England coming in right after that, and Nigeria representing almost 8% as well, all the way down to Barbados, where we're just getting started and trying to ramp up there. So again, trying to capture the experience across the world.
I think one of the most encouraging pieces of this presentation is that we can see where enrollment was projected, and that's the solid bars. And we can see the actual site activation here and projected accruals going forward. We're doing really, really phenomenally well in getting all those sites open so that we can hear those voices and see those actual data of treatment responses, as well as the biologic data that we are trying to capture across the study. So doing a phenomenal job.
And here we can see that we do have still a predominance of white patients, but we are trying to increase our diversity across ethnicities and from different cultures and races. So again, trying to enrich this wherever we can.
If there are those in the audience who want to consider opening or know their own local sites that are open and can enhance enrollment in those places, please do what you can and let us know if there's a way that we can help you or that the PCCTC and the IRONMAN group can help you do that.
Our subject characteristics are here where we can see that, interestingly, a majority of patients are enrolling in this study with metastatic hormone-sensitive disease, which I think as I see patients and recognizing them as new patients, this is really a wonderful opportunity to get them involved in a clinical trial, like IRONMAN.
And so that may be driving a lot of this, but we do have almost 30% of patients who are enrolling at that time of progression to metastatic castration-resistant prostate cancer. And down below, we can see their Gleason score at diagnosis, with many of these patients having actually quite high-risk disease.
Biospecimen compliance is reported here, with many of these patients actually having those biospecimens collected as planned, doing actually a really great job here. And here we can see the patient-reported outcome measure or quality of life compliance here, with a majority of patients, at least in the upper 2/3, really hitting those time points and getting patients to complete patient-reported outcome measures.
This can be really challenging depending on where people are practicing. And different cultures have different abilities or interests in sharing their quality of life. We also have different understanding and comfort levels with completing electronic patient-reported outcome measures versus paper and the resources involved in some of that data transcription. So this can vary. But I think as we go forward, we'll continue to hopefully improve and will continue to collect these patient voices.
So now I'll talk just for a few moments about one of the substudies that I have been so privileged to be involved with. This is called the EMPRO study. It's a study in which we're really trying to collect patient-reported quality of life to understand how patients are feeling between their clinical visits, and try to respond to concerns and symptoms that they may be having between those visits without having them necessarily come in or even call, reach out to call the clinic.
This is a bit of a busy slide, but it's trying to illustrate the workflow of how we're engaging with patients. Essentially, patients are receiving their patient-reported outcome measure queries at home, and they are completing those digitally. If they have a symptom, whether it's related to fatigue or pain, or one of the other symptoms that we're collecting in this study, they can report some level of distress in their routine collection of these prompts.
If they reach a certain threshold of distress, the system automatically triggers to provide them some self-management support, which has been built up, actually, by the Movember organization to really address some ways that they might meaningfully impact those complaints or concerns without necessarily having to even engage with the clinical teams and without having to come to clinic.
If they reach a more urgent or more severe level of distress, actually, a trigger is sent to the clinical team so that they can reach out to the patient by phone and bring the patient in if necessary, or simply counsel them over the phone.
This was in response to a study that was led through Memorial Sloan Kettering that demonstrated that if we respond to patient concerns between clinical visits, we can keep them out of emergency departments and hospitals at a better rate. And we can also, importantly, prolong their survival simply by responding to their concerns.
But what we recognized when we saw the data from that study is that it actually takes a huge amount of resource utilization to provide that level of support between clinical visits by those teams. This study is meant to actually provide that support through means that are simply computer-based and really kind of harnessing technology to meet those goals, meet those patient needs if we can. So we're excited to see where this will go.
I think in the beginning, the study launched during the pandemic, and I certainly was anxious about the rate of enrollment, as we all were, of patients into this study. And clinical trials at that time, I think, were all struggling to try to get back on track as we all came back to clinic and started seeing our patients again on a more regular basis.
But what I'm so pleased to report today is that 140 patients out of a planned 180 have been enrolled and are being actively followed on this study. And this even includes a small subset of patients who were enrolled and then were disqualified due to a technological blip. They're all fine. Those patients are all fine. We just couldn't rely on the integrity of their data.
So we are nearly there in terms of enrollment, and it is a huge accomplishment to all of the sites that we can see on this screen. Whether they're in the United States or Australia or Canada, the UK, they're working really hard to get patients onto this study, and it's amazing.