Considering Clinical Trials for Prostate Cancer? Key Questions to Ask

Katherine Banwell:

You mentioned a number of therapies like targeted therapy, and immunotherapy, radiation, et cetera. How do clinical trials fit into treatment options?

Dr. Daniel Sentana Lledo:

Yeah, absolutely. So, the first thing I’ll say is that there are a lot of misconceptions about clinical trials, but pretty much every therapy that we use nowadays to treat prostate cancer at some point was in a clinical trial. So, that’s a framework on how cancer advances in medicine. So, what a clinical trial is, broadly speaking, is a study of an intervention to see if it changes or improves the way that we manage care.

And I always tell my patients, clinical trials come in two shapes. The ones that are using things that we know work in prostate cancer, but we’re using them in a different situation, in a different setting. So, for example, I was talking earlier about using some of our medications we use for advanced prostate cancer, maybe we use them for people where the cancer is still in the prostate. And the other type of clinical trials are the ones that I think a lot of people think about, which is the experimental or newer things that we’re learning how they work.

And we obviously have those studies because that’s how we discover, “Okay, is this treatment really going to work?” But certainly at any point in your cancer journey, you should be asking your doctors, “Is there a clinical trial for me?” And sometimes there is, sometimes there isn’t. I will say here at Dana-Farber, we’re lucky that we have a large number of studies at any given time, but this is a rotating menu and some studies are open, some are closed. There might be some pauses in getting patients on the study, but it certainly doesn’t hurt to ask.

And really, as I said, it’s a way to move science forward, and they’re not for everyone. There could be barriers from the patient, and there could be things from our end that we’re not sure it’s the right fit for you, but it doesn’t hurt to ask. And again, I think it greatly benefits the bigger prostate cancer survivorship community who get on these studies and advance the care that we’ve been providing.

Katherine Banwell:

What type of question should patients be asking about participating in a trial?

Dr. Daniel Sentana Lledo:

It’s a misconception, I think, that clinical trials only happen in places such as this, like very large academic centers. In fact, there are many times studies that are happening in smaller community sites. And so, you’re never wrong to ask your provider, “Do you have any clinical trials?” But certainly, what I think patients should be thinking about is, “What type of study do you think would benefit me? Is there something that you think is potentially better or different about the way you would treat me now if I was on this study?”

And I have some patients that come from long distance to consider a clinical trial, but certainly I think if a patient has an expectation or a number of questions that they’re hoping to address, that will let us know. So, are you looking for a special type of therapy? Or are you looking for a certain approach to treating your cancer? If we know that information ahead of time or you bring it up on that first visit, then I don’t have to tell you about perhaps some things that are just not applicable or you would not be interested in.

But certainly, as I started saying, no matter where you’re getting your cancer care, you’re never wrong to ask, “How about a clinical trial?” Because again, in the long run, this is how science advances and how we come up with better treatments for men with prostate cancer.

Katherine Banwell:

Could you walk us through the common misconceptions that patients may have about participating in a trial?

Dr. Daniel Sentana Lledo:

Yes. Well, there are certainly many of them, but I think probably one that, for historical reasons, one that normally comes up is this idea of being either like a guinea pig or going on placebo. So, just to say that obviously, when you go on a clinical study, we don’t know your outcome, but the same is true for any of the established treatments we use. So, we have just more information on the established options than a clinical trial, but for better or worse, when someone is getting care, we cannot predict the future.

And so, the other thing I want to say is that for the most part, clinical trials nowadays, especially in oncology, do not involve placebo. And that’s because we have learned over time that it’s not ethical to withdraw care for patients that could get otherwise very good treatment. And so, while there are some studies that still use placebo, I would say these are generally when you’re kind of running out of options, those can be a good reason to use it because we don’t know if this new therapy is going to help you.

The vast majority of studies that patients go on, they are offered – so, either they all get the study drug, or at certainly the alternative, which is the best standard of care. And in prostate cancer, that could be one of the hormonal agents, it could be chemotherapy, it could be a type of surgery, a type of radiation.

So, just because you go on a trial does not mean you’re not going to get appropriate care. It means that you could get potentially better care, but we don’t know. At the very least, most studies make sure you get the standard, and if there’s that option to go on the study arm that has the newer option, the newer approach, then potentially you can do better. But that’s the purpose of the study, we’re learning if they help or not.

Katherine Banwell:

Exactly. If someone is worried or anxious about participating in a clinical trial, what would you say to them?

Dr. Daniel Sentana Lledo:

Yes, and I think it’s very natural for anyone with cancer to worry about their outlook and what this treatment is going to do, but certainly on a clinical trial, where the level of uncertainty increases. I think what I can say to them is that every treatment that we have these days, at some point, was in a clinical trial, and certainly there are medications or a procedure that didn’t end up being used, and we acknowledge that all the time. When a study is presented or when we discuss the findings of a big study, everyone always says, “We thank patients and their families for taking the step and being courageous at going on a trial.”

So, I would say the uncertainty is part of medicine and part of oncology. Clinical trials are a promise and are a hopeful way to perhaps improve the care that we get. So, it’s very understandable to be anxious or to be concerned about some things. But if you want to not only perhaps improve your options, but also contribute to other patients down the line to know that this is an effective way to treat your cancer, then certainly that altruistic behavior and that leap of faith can only benefit others and potentially even you right now.