Latest Advances and Updates of Treatment in the Real World at AUA

The latest therapies for prostate cancer and how treatments are being used in the real world are on display at the annual meeting of the American Urological Association (AUA), said Stephen Freedland, MD, director of the Center for Integrated Research in Cancer and Lifestyle at Cedars Sinai.

Freedland also provided a preview of 2 of his presentations. The first highlighted the findings of the phase 3 EMBARK trial, which evaluated patients’ prostate-specific antigen (PSA) to guide the decision to stop treatment or reinitiate it. The second discusses treatment sequencing and survival of localized or locally advanced prostate cancer in the real world.

Transcript

What are you looking forward to at this year’s AUA meeting?

AUA is kind of our central meeting in urology, certainly in the US. So, it’s always a great opportunity to see colleagues, connect with people again, and kind of see what the latest is going on. There have been a lot of advances—I specialize in prostate cancer and new therapies have come out. And I’m always curious to know how they’re actually being used in the real world, which is something we see at this meeting—kind of the latest updates of what’s actually happening in the real world. I’m excited to see that.

Can you provide a high-level overview of the EMBARK findings you will be presenting regarding the use of prostate-specific antigen as a guide for suspending reinitiating treatment in patients with high-risk biochemically recurrent prostate cancer?

As a high-level overview, EMBARK was a phase 3 global randomized trial of enzalutamide [and leuprolide] combination, enzalutamide alone, vs ADT [androgen deprivation therapy] alone for patients with high-risk biochemical recurrence. One of the unique criteria about it was patients got 9 months of treatment, and if they had a good PSA response, then they’re able to stop treatment. That’s just the study design.

We know a lot of patients did get that treatment suspension, more so on the enzalutamide arms, but the question is: we checked PSA at week 36 to determine whether you could get a treatment suspension, but the question is, could you do it even earlier? And the short answer is that the PSA responses tend to be pretty robust, pretty quickly. That’s kind of a high-level take home.

Is PSA being used to guide treatment decisions in the real-world or is this just being studied in trials, like minimal residual disease?

I think residual PSA can, in some ways, be thought of as minimal residual disease. And I think more and more, the question is: we’ve given it [the disease] some aggressive treatment, and you get a really, really good response—the PSA is nice and low—can I stop the treatment or not? And EMBARK was specifically designed to stop treatment if you got a good response at 36 weeks. It seems to work; we don’t know that that’s necessarily the best time to do it. We don’t know whether you should do it multiple times. There’s a lot of questions that come out of it. Could you have done this even shorter than 36 weeks? What happens if you’d waited longer? So that’s where I think we need to start to see how this is used in the real world, but a lot of people are making treatment decisions based upon PSA and PSA responses. So, it is being used in the real world.

What can attendees expect to walk away with from your presentation on real-world treatment sequence and survival in localized or locally advanced prostate cancer?

In this study, we looked at claims or medical records on a huge number of people between the two—over 100,000 people with prostate cancer—and basically saw what happened in them over time. What percent get biochemical recurrence, what [percent] die without progressing, what percent go on to get metastatic disease, and it really is just helping us understand the disease state of prostate cancer better.