Current limitations of real-world data available that support the use of novel therapies, including androgen receptor inhibitors, as treatment for advanced prostate cancer.
Benjamin H. Lowentritt, MD, FACS: Some of the other data that have recently been coming out include real-world evidence out of groups, including mine, on the use of some of the different agents and whether we’re seeing different adherence or persistence on drug. One study we did looked specifically at a large group of patients who were receiving apalutamide while it was approved only for the nmCRPC [nonmetastatic castration-resistant prostate cancer] space. It was looking at a specific population and pulling out the Black patients to see if the PSA response and adherence on drug were there.
Some small studies have suggested possibly even improved responses in population subgroups like this. It was interesting to be able to look at those groups and see that even in real-world evidence in community groups, much like my own, we’re seeing patients who are adhering to the drug at a very high rate and are able to hopefully get the responses that we expected from the trial. As you said, that’s often a slightly different patient population. It’s a little more idealized. Do you glean anything from this real-world evidence? What does it mean for the structure of any future trials or anything else that might come down the road?
Julie N. Graff, MD: I’m really glad you brought that up, Ben, because 1 of the underlying themes here is that not everyone is represented in trials. One of the questions is, how do we make our trial population more diverse? There’s a lot of work underway to do that. Some of the work is being done at the VA [Department of Veterans Affairs], where we have a much higher population of African American men. We learned through the PROCEED database for sipuleucel-T that cancers in African American men respond better to sipuleucel-T, also known as Provenge, than in their Caucasian counterparts. We have to do much better in diversifying our clinical trial populations. There’s a lot of work underway.
If I may tiptoe onto my soapbox for a second, we also need to improve diversity in our researchers, because not having prominent Black leaders, at least in medical oncology doing prostate cancer, could be discouraging to patients, who maybe won’t join the trial. Real-world data are interesting but not everything. People tend to believe in these data. I just mentioned the PROCEED database. If you read some of the guidelines, they’ll say that if you see an African American man, you should really consider sipuleucel-T. But that evidence isn’t very strong. Based on that, you’d have to enroll in a prospective clinical trial. So interpret the real-world data with caution.
Benjamin H. Lowentritt, MD, FACS: I really appreciate that. The trials that incorporate more patients, not just from the academic setting but from the community, are often a little more diverse. You can find areas that are more diverse and try to recruit and get better evidence. The partnership there is the important part.
Transcript edited for clarity.