IMPLEMENT Study: Addressing the Underutilization of Treatment Intensification in Metastatic Castration-Sensitive Prostate Cancer - Stacy Loeb

June 18, 2024

Zach Klaassen and Stacy Loeb discuss the IMPLEMENT Study, which investigates the underutilization of treatment intensification in metastatic hormone-sensitive prostate cancer. Despite guidelines recommending this approach, it is used in less than a third of cases. Phase one of the study identified barriers like limited knowledge of clinical trials and concerns about using up treatment options early. Phase two used a discrete choice experiment to quantify the importance of these barriers and facilitators. Results showed urologists preferred decision support tools, while oncologists favored clinical trial summaries and post-treatment options databases. Moving forward, phase three will involve developing these targeted tools to address the gaps identified. Dr. Loeb emphasizes the importance of applying these methods more broadly to improve patient care and highlights potential future applications in urologic oncology.

Biographies:

Stacy Loeb, MD, MSc, PhD (Hon), Urologic Oncologist, NYU, Langone Health, Manhattan Veterans Affairs, New York, NY

Zachary Klaassen, MD, MSc, Urologic Oncologist, Assistant Professor Surgery/Urology at the Medical College of Georgia at Augusta University, Well Star MCG, Georgia Cancer Center, Augusta, GA


Read the Full Video Transcript

Zach Klaassen: Hi, my name is Zach Klaassen. I'm a urologic oncologist at the Georgia Cancer Center in Augusta, Georgia. We are live at ASCO 2024 in Chicago, and I'm delighted to be joined by Dr. Stacy Loeb, urologic oncologist at NYU. Stacy, thanks so much for joining us.

Stacy Loeb: Thank you so much for having me.

Zach Klaassen: Always great to have you. We're going to talk about some pretty cool data that you guys have regarding the IMPLEMENT Study, and this is really looking at some of the nuances of treatment intensification with metastatic hormone-sensitive prostate cancer. Before we get into it, maybe a little background on what the unmet need is for treatment intensification.

Stacy Loeb: Yeah, for sure. For metastatic castration-sensitive prostate cancer, the guidelines actually recommend treatment intensification first line. But the really unmet need is the fact that it's greatly underutilized. In fact, less than a third of patients are treated in this fashion. So that was really the whole challenge that IMPLEMENT was designed to assess, is why is it being underutilized and what can we do about it?

Zach Klaassen: Right, and I think it's such a disconnect. We have such good data, but even at worst 20% are getting treatment intensification; at best, maybe 40 to 60. So tell us about the IMPLEMENT Study, particularly break down phase one and phase two of this study.

Stacy Loeb: Yeah, for sure. So phase one we presented at ASCO-GU, and that was a pure qualitative study. So that was really the first step to assess the barriers and facilitators of first-line treatment intensification. So why are urologists and oncologists doing it, not doing it, what are some of the challenges that they're facing? And so there we got a lot of great data. There were barriers in terms of knowledge of the clinical trial data. Also concerns about anticipated regret if they exhausted some of these treatment options first line as well as some facilitators. For example, if they had good administrative support in the clinic, that was helpful in terms of doing treatment intensification. So that was very important data.

However, the next step was to do this phase two which was a discrete choice experiment. And so the idea there is to figure out which of these barriers and facilitators is really the most important, which is driving this so that we know what is the lever that we could act upon. And so the discrete choice experiment is a way to actually quantitatively rank these barriers and facilitators to figure out where we're going to act to address the under-utilization of treatment intensification. And it's sort of complicated math, but I think the best way to explain what a discrete choice experiment is, is that you're faced with a series of choices of option A versus option B. So just in very general language, option A could be like do you prefer hotel A? And it has a swimming pool and a gym, but there's no breakfast, or hotel B, which has a more central location and it does have breakfast, but there's no swimming pool?

And you have to pick hotel A or hotel B, and then you get another set of choices. Now you're choosing between two different hotels. And the first hotel, it's a little bit noisy. So you get the idea. And so once people actually rank all these different choice A versus choice B, on the back end you can determine which of those attributes is actually driving their decision or which is the most important to them. And so that is what we did. So we had over 300 physicians, either in urology or oncology, doing these choice experiments to figure out which of the things are most important to actually help them in terms of treatment intensification.

Zach Klaassen: I see. So once you get all this data in phase two from 150 urologists, 150 oncologists, how do you pull it all together to make sort of heads and tails of it?

Stacy Loeb: Right, exactly. So on the back end all the analysis was done to actually prioritize quantitatively these factors. And what we found is actually there were some differences between the urologists and the oncologists in terms of what resources were really most needed to actually implement, as it were, treatment intensification. So for urologists, the resource that they thought would be most helpful, based on the results, was to have decision support tools. So for example, you're seeing a patient and the EMR has some pop-ups and order sets that could facilitate this. Whereas for the oncologists, what they actually thought would be most helpful would be having clinical trial summaries, like succinct reports of the clinical trials in this space, and databases of post-treatment options. So if you do intensification up front, then what would you offer the patient next, for example?

And so we do see some differences there between the specialties. Meanwhile, for both, some of the other things that came up in the qualitative interviews, like the administrative support, actually were lower down on the list in terms of importance. So now I think these results actually give a pretty clear pathway on the kinds of tools that need to be developed for each specialty to actually change this.

Zach Klaassen: That's great. So I guess the lead-in question to that is what's the next step in terms of implementation?

Stacy Loeb: Yeah, exactly. So now really phase three will be to actually start to design some of these tools and really to co-create them with people in the target audience, that is to say, urologists and oncologists, to create the tools that they wanted based on this discrete choice experiment.

Zach Klaassen: Do you think, is there any patient-specific aspects to this or was this purely focused on the providers at this point?

Stacy Loeb: Yes, exactly. So at this point, it has purely focused on providers and the resources that they need. I think it's a great question and certainly, work on the patient side would also be very important. And for certain any of these medical decisions are very much multifaceted.

Zach Klaassen: Sure, absolutely. A great discussion. Any take-home points for our listeners? This is great granularity in terms of really hitting at the point of why we're not treatment intensifying. What can you give our listeners for take-home messages?

Stacy Loeb: I think first and foremost that treatment intensification is recommended in the guidelines. Second of all, it is underutilized, but there are some things that we can do to help in terms of, for example, publishing summaries of the clinical trials. And that's even something we can do with UroToday, for example. And so I think we have some clear action items now laid out for us. And then I think also more broadly that these methods could be applied to a lot of things that are happening in urologic oncology. I think qualitative research is really underutilized, but there's just a lot of things that happen that you just can't find in a database. And without actually talking to people in depth about the reasons why they are or aren't doing something that it's hard to really figure out the root of the problem. And then things like the discrete choice experiment methodology, I mean it is a really elegant way to try to prioritize potential interventions.

Zach Klaassen: Absolutely.

Stacy Loeb: So I hope that this pathway and these methods could be applied more broadly to some other areas where our care is falling short.

Zach Klaassen: Absolutely. Well, congratulations on this great work. We'll look forward to the implementation phase three. And thanks as always for your time and expertise.

Stacy Loeb: Thank you.