Metastatic Castration-Sensitive Prostate Cancer: Real-World Characteristics and Treatment by Disease Volume With Stephen Freedland, MD

Oncology Data Advisor: Welcome to Oncology Data Advisor. Today, we're here at the ASCO Annual Meeting, and I'm joined by Dr. Stephen Freedland. Thanks for coming on today.

Stephen Freedland, MD: Hello, absolutely. Thanks for having me.

Oncology Data Advisor: Would you like to introduce yourself and share what your work and your research focus on?

Dr. Freedland: Yes, I'm Steve Freedland. I'm a urologist—a little bit of out of place here at ASCO, but it's fun to be here. I'm at Cedars-Sinai Medical Center as well as the Durham Veterans Affairs (VA) Hospital in Durham, North Carolina.

Oncology Data Advisor: Great. You have a study here on real-world baseline characteristics and first-line treatment in patients with de novo metastatic castration-sensitive prostate cancer by disease volume. For background, why did you decide to investigate this?

Dr. Freedland: There's been a lot of data looking at patients with metastatic castrate-sensitive prostate cancer. When you look at clinical trials and guidelines, it's pretty clear that we should be giving them intensified treatment consisting of androgen deprivation therapy (ADT) plus a novel hormonal therapy, chemotherapy, or both—something more than just ADT alone.

Yet when you look at real-world practice patterns, we actually don't see that happening nearly as often as it should. But the data that says that is based upon claims data, and that was one of the questions we had. By doing a chart review, we can get much more granular details on these patients and really get a sense as to who is getting this intensified therapy and who is not. That was really the background idea behind this.

Oncology Data Advisor: How did you and your team go about designing the study and conducting it?

Dr. Freedland: We looked at data from the VA, identified patients with metastatic castrate-sensitive prostate cancer, and then looked at what treatments they were receiving—whether it was ADT or ADT plus a nonsteroidal therapy or ADT plus a novel hormonal therapy. There wasn't a lot of chemotherapy use that we saw. Then we did a detailed chart review to understand the characteristics.

One of the things in particular that we were looking at was high-volume disease versus low-volume disease, because invariably, in the real world, the decisions of who to treat are often complex. There are higher prostate-specific antigens (PSAs), more bone metastases (mets), higher grades, or younger, healthier patients we can be more aggressive with. But if there's one simple way of dividing all of that, it's high volume, where we think chemotherapy. Really, we should be intensifying versus low volume, where the data are certainly strong, but people may not be as aware of that data. That's how we divided the patients—the high volume, low volume—and then saw what treatments they were receiving.

Oncology Data Advisor: What were the results that you found?

Dr. Freedland: What we found is a little bit disappointing. I don't think it's specific to the VA. Again, it's been seen a lot outside the VA, but the rate of treatment intensification was relatively modest. Though it was slightly higher in those who had high-volume disease, as you would hope and expect, even in that subset, it was still relatively low. I think the take-home is that we've still got a lot of work to do to educate physicians and understand what the barriers are. It's the VA, so it's equal access. Cost of the drugs is really not as much of a barrier as it would be out in Medicare or the real world or with private insurance and other different situations. We can semi-eliminate that, yet we're still seeing under-utilization. Now the next step is to find out why and how can we fix this?

Oncology Data Advisor: Are there any ways, as of now, that this knowledge can be used to impact treatment selection, or is it kind of still in progress?

Dr. Freedland: In the treatment sense, there are a lot of different options, but our goal is to be doing something. It doesn't matter to me as much whether you're doing doublet or triplet, or which drug is going to be part of your doublet. Just do something, and yet we're not seeing that happening. It's not for every patient. Every now and then, you have the really old, frail patient, with a slow-moving tumor, but to the point where I want to do something, I don't need to be super aggressive. It's not going to be 100% utilization, but when we're consistently seeing 50% or lower, that's way too low.

It's really about understanding and talking to physicians and really educating them, making sure they're aware of the guidelines. Physicians are busy; they treat a lot of different tumors, and they often aren't always aware of the latest, greatest advances. So, make sure that they're aware, and identify the logistical barriers of actually writing for these agents. It's not, "Hey, I have some off my shelf here. Let me give you some pills, get you started. Go down to your local CVS pharmacy, pick this up." It needs specialty pharmacy and prior authorizations.

There are some logistical barriers. There are some knowledge barriers. Maybe the patients aren't as aware of things. I think we have our work cut out for us, but we know some of the challenges and now we've just got to, as a community, get together and do this.

Oncology Data Advisor: Definitely. Do you have any next steps for the study or any future directions for analysis?

Dr. Freedland: One of the next steps that we're looking at is the outcomes of the patients. We know from the clinical trials that these novel hormonal therapies certainly have dramatic impact. That's one of the questions is—do we see that in the real world? That would be a next step. Then again, the challenge is that, even in a chart review of claims-based data, we're really good at identifying the "what" but not always the "why." It gets back to what we were just talking about—what are the barriers to doing better?

That's a challenge that I'm involved with in different studies, not necessarily this team and this exact study we're looking at, but we have been looking at some of these questions and how we can do better. I think part of it is if we can show in the real world that these treatments are making a difference, again, it provides more of a comfort level that yes, what you're seeing in trial after trial, after trial, after trial, we actually do see in the real world. This is comforting and hopefully building a stronger evidence base to justify these agents. I think it's very strong, but it could always be stronger. But then getting people to actually read them and know the literature, that's the hard part.

Oncology Data Advisor: One last question I'll ask you is, since the theme of ASCO this year is "Partnering with Patients," how do you strive to partner with patients through both your work and your research?

Dr. Freedland: It's a great question. If you look back at my own personal history, I've been very interested in the research side of medicine. My dad was a PhD, I grew up in the lab, and I actually decided early on that I wanted to be a physician because it would make me a better researcher. I was interacting with patients in the clinic, talking to patients, hearing their concerns, learning what the barriers are, and seeing it from their point of view.

We're trying to bring more patient advocates into the work we do. It's another area where we've got a lot of work to do, and we need to do better, but we are starting to partner with patient advocates. Again, I think having MDs be involved in the research is important. PhDs bring in tremendous wealth and skills and everything, but having that patient voice, whether it's the patients themselves or the clinician side of things, is so important to help make sure we're asking and answering the right questions.

Oncology Data Advisor: Very important, and that's a great perspective. Thank you so much for stopping by to talk about this today.

Dr. Freedland: Absolutely, thanks for having me.

About Dr. Freedland

Stephen Freedland, MD, is a Professor of Urology and the Warschaw Robertson Law Families Chair in Prostate Cancer at Cedars-Sinai Medical Center in Los Angeles, California. In addition, he is the Director of the Center for Integrated Research on Cancer and Lifestyles, Co-Director of the Cancer Genetics and Prevention Program, and Associate Director for Education and Training at Samuel Oschin Comprehensive Cancer Institute. He also has a joint appointment as a Staff Physician at the Durham VA Medical Center in Durham, North Carolina. Dr. Freedland specializes in the treatment of patients with prostate cancer and benign prostatic hyperplasia. His research focuses on the roles of diet and lifestyle in prostate cancer development and progression, disparities among racial groups, risk stratification, and adverse event management.

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Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of Oncology Data Advisor.