Cognitive Function in Men with Prostate Cancer - Claire Pernar

August 3, 2019

Alicia Morgans invites Claire Pernar to highlight her efforts on the topic of cognitive function in men with prostate cancer. Cognitive impairment is a key component of wellbeing in men with prostate cancer, and it can affect men's thinking, their language, and their memory. This is an area many seek to understand and to identify any unmet needs. Claire's work is being facilitated in the context of a registry study, the IRONMAN Registry and the work focused on assessing cognitive function in the context of systemic therapies in men with prostate cancer and implementing the findings from this work in our clinical day to day practice.

Biographies:

Claire Pernar, Ph.D., Postdoctoral Research Fellow, Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, Massachusetts. 

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.

Read the Full Video Transcript

Alicia Morgans: Hi, I'm thrilled to have here with me today Dr. Claire Pernar, who is a postdoctoral fellow at the Harvard Chan School of Public Health. Thank you so much for being here today.

Claire Pernar: Thank you for having me.

Alicia Morgans: Of course. I wanted to talk with you today about your work thinking about cognitive function in men with prostate cancer. We actually collaborate on some of this work, and so I'm really excited to highlight your efforts. Tell me a little bit about the problem, and why it's something that you're interested in studying.

Claire Pernar: Thank you, yes. Well, as we know the population of prostate cancer patients and survivors is growing. It's also an aging population. Quality of life is very important for this population. Cognitive impairment is a key component of wellbeing in this group of men, and it can affect mens' thinking and their language, memory. This is something that we want to understand and identify any unmet needs in this group.

Alicia Morgans: You're really doing this in the context of a registry study, the IRONMAN Registry, which is fascinating. As an epidemiologist, you have a unique skill set that you can bring to that analysis to help us think about it as clinicians, and to think about the findings that you have, and how we can implement them in our clinical day to day. Can you tell me a little bit about the IRONMAN Registry, and how you're using it to assess cognitive function in the context of systemic therapies in men with prostate cancer?

Claire Pernar: Yes. The IRONMAN Registry is really a unique resource. It's a large population of men with advanced prostate cancer. These men are in the United States and Canada, but also in nine countries across the globe: in Brazil, South Africa, and European countries. This registry really provides an opportunity to capture the heterogeneity of prostate cancer, and different patients and cultural practices.

Another unique aspect of this registry is that men have provided not only detailed information about their treatment and the history of their disease but also patient-reported outcomes. They provide this using questionnaires that can tell us about their experience.

Alicia Morgans: So, it's a fantastic way I think for us to capture patient-reported outcomes and clinical outcomes in the context of men across the globe receiving standard of care therapies for metastatic prostate cancer, whether that's metastatic hormone-sensitive disease or metastatic castration-resistant disease. It's just really this broad swath of patients who are reporting back this data from a standard of care perspective, which is so incredibly valuable to really obtain that real-world data.

Your particular interest thinking about cognitive change is a series of questions that some of these men are answering, or as many as possible, of these men, are answering-

Claire Pernar: Yeah.

Alicia Morgans: About their cognitive function. Can you speak to that a little bit?

Claire Pernar: Yes, that's right. Men are answering questions about their cognitive function. There's a few questions on the questionnaires that they received at enrollment in the registry, and then also over follow up every three months. So, we're able to study whether there's change in cognitive function over time in relation to the treatments that prostate cancer patients are receiving.

Alicia Morgans: I think it's also exciting and interesting that you're able to relate that to the patient-reported outcomes if you choose to do that, and you'll also have disease-specific outcomes as well. You could tie all of those into any analyses. But in your particular project, and you actually just received funding for this project, you're really looking at the longitudinal change as it relates to different therapies. Tell me a little bit about the grant that you've been awarded to study this.

Claire Pernar: Yes, yes we're very excited. We recently received an award from the Department of Defense Prostate Cancer Research Program. It's an Early Investigator Research Award. It's going to allow us to study this question of what does cognitive function look like in this population of advanced prostate cancer patients? And, what is the relationship between treatments and cognitive change over time?

We also want to understand with this study whether or not there are disparities in cognitive function decline. So, we'll be able to look at men of different age groups, and different races and ethnicities to be able to answer that question.

Alicia Morgans: Really, around the world-

Claire Pernar: Yes.

Alicia Morgans: Which is really valuable and not something that we had access to before. One of the things that I think is so important in this registry, is that the studies that led to the approval of all of these therapies didn't necessarily ask questions about cognitive function even though some of them incorporated patient-reported outcomes on overall quality of life and some prostate cancer-specific questions. No one really studied cognitive function the way that you're going to be able to do in this registry trial. So, very powerful data and a huge swath of patients. How many patients do you expect to have in the IRONMAN Registry to answer some of these questions?

Claire Pernar: Yes, well the IRONMAN Registry is aiming to enroll about 5000 men. Of course, that will take a period of years so our initial study will include a smaller group, probably about 2000 men, and we'll be following these men over time. Men in the registry are followed for at least three years.

Alicia Morgans: Fantastic. And you'll have all of the clinical and sociodemographic-type information that's built into the registry to help look at associations between things like age, or different prostate cancer interventions, plus the systemic therapies on these cognitive effects.

Claire Pernar: Yeah.

Alicia Morgans: So, very exciting.

Claire Pernar: And another strength of the registry, since this is an observational study, is that there is a lot of information that we can use to try to address these causal questions. For example, physicians are also completing questionnaires about reasons why men are beginning or stopping different treatments. So, that'll be very useful for us to be able to answer this question.

Alicia Morgans: Absolutely. Well, if patients want to get involved is there a website or a way that they can look into the IRONMAN Registry? Because I think is something that is being offered internationally at many centers, but patients also can reach out and try to participate even if they don't see a physician within one of those participating centers.

Claire Pernar: That's right. There's a website, IronManRegistry.org, that patients can go to, to learn more about the study and how to participate.

Alicia Morgans: Fantastic.

Claire Pernar: Yeah.

Alicia Morgans: Well, thank you so much for sharing your expertise, your insights. Congratulations on your-

Claire Pernar: Thank you.

Alicia Morgans: Department of Defense Award.

Claire Pernar: Thank you.

Alicia Morgans: I really look forward to partnering with you and the team as you answer these critically important questions in a registry that's reflecting the real world experience of 2000 men across the world with prostate cancer. So, kudos to you and the team.

Claire Pernar: Thank you.

Alicia Morgans: Thank you for your time.

Claire Pernar: Thank you.