Phillip Koo:

So let's move on to the final trial called LIBERTAS.

Zach Klaassen:

Yeah, LIBERTAS is one I pulled out because I think it's very relevant to patients and perfect for prostate cancer patient voices. This is really looking at hot flashes with hormone therapy and treatment for advanced prostate cancer. And I'll tell you, Phil, every clinic day, I see all sorts of patients with various levels of hot flashes, and when we go through our treatment, our shared decision making about treatment, I basically say, "You'll probably get them. I don't know how bad they're going to be. They may last for a while." It's a very sort of gray zone.

I just said I say, "You got to be ready for it." And unfortunately, there's no good magic bullet to make them go away. We're purposefully lowering the testosterone, which is leading to these hot flashes. So I like this trial design and this data. This trial is looking at patients that are newly diagnosed with metastatic hormone-sensitive prostate cancer, and then they're receiving apalutamide plus ADT, so treatment intensification.

And so what they reported on was sort of this first half of the trial design, that initial treatment phase for six months. They're going to go on to continue the randomization, so if their PSA gets less than 0.2, they're going to go to intermittent therapy, and then if the PSA becomes undetectable, they're going to go to standard of care therapy. We're going to learn about that in the subsequent years as this trial continues to evolve. But I like that they presented this sort of initial treatment phase in those first six months because it kind of gives us some numbers to go on for patients, how often are they getting hot flashes.

And so if you look in this full analysis set, at baseline, 61% of patients had hot flashes, going up to 86% at six months. So that tells me almost everybody's going to get a hot flash. And so I think when you look at a take home from this, we know that they're going to get them, and then this gives us a percentage point of 86%.

When you look at the bottom right, this is a little more granularity. So 39% had no hot flashes at baseline, 21% had mild, 22% had moderate, 6% had severe, 12% had very severe. And so when we get to that three-month point, again, only 11% of patients did not have hot flashes. So that tells me that the majority of these patients are either in that mild to very severe. And at six months, it's pretty similar. So you're going to get them early on and they're going to persist at least till six months.

What's great about this trial is this is just the beginning of this trial. I think this is a very patient-relevant trial. We're going to learn more about what happens to those that have a PSA that goes less than 0.2, whether we can de-intensify therapy a little bit. Maybe that decreases hot flashes. But they're going to continue to collect data along these time points. We're going to learn more about treatment de-intensification potentially, as well as what that long-term hot flash incidence is.

Phillip Koo:

This is wonderful. I think this goes in line with some of the other studies we talked about where, all right, how do we make this more tolerable for patients while either maintaining the same level of efficacy or perhaps even improving it, and it really, I think in some ways, shows how the field has changed where we are much more focused on the patient needs and the patient experience, the patient-reported outcomes, which we've heard a lot about more today than we ever have been in the past.

Zach Klaassen:

Absolutely.

Phillip Koo:

What are your thoughts? How should patients approach these conversations with their physicians who are often so focused just on clinical outcomes?

Zach Klaassen:

Yeah, no, it's interesting. Each year I'm in practice, I continue to hear that feedback, and I think it's an interesting conversation because we as clinicians know the patients are having it. We now know that the majority of them are having it based on this trial data. And we understand that it's a known side effect of the treatment we're giving them. We want that treatment to work, but we as clinicians have to be cognizant of those side effects. Like I said, there's no magic bullet for making them go away.

What I will tell patients, and I have this discussion with them, we have to focus on what we can control. What we can control is our diet, our exercise, our mental health, and honestly, exercise kind of helps all of that. I tell, "Man, if you're exercising now, dig in and continue to exercise. If you're not, you need to start."

And it becomes hard because your energy's lower based on the treatment we're giving you, the hot flashes are annoying, but that's what really gets and drives men through those hard times is continuing to be active, continuing to lead active lifestyle, weightlifting, swimming, running, walking, good diet, cardiovascular, healthy diet. All those things help get through these difficult times. I mean, it's not perfect, but it certainly is a good place to start.

Phillip Koo:

I think that's a wonderful take-home message for all patients, is yes, it's going to get tough, you can't avoid some of these, but these tried-and-true methods of diet, exercise, and wellbeing, mental health are so critical.