Published on July 1, 2016
Why should patients consider participating in a clinical trial? Patient Power founder and host, Andrew Schorr, leads a discussion with advanced prostate experts, Dr. William Catalona and Dr. Russell Szmulewitz. Together, they explore various approaches to deciding if a clinical trial is right for you. From understanding who should be participating in a clinical trial, to the long-term and short-term benefits, Dr. Catalona and Dr. Szmulewitz work to break down the barriers to understanding why and how clinical trials work.
Sponsored by the Patient Empowerment Network through educational grants from Astellas, Medivation, Inc. and Sanofi. Produced by Patient Power in partnership with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and Us TOO International.
Transcript | Why Should Advanced Prostate Cancer Patients Consider a Clinical Trial?
So, Dr. Catalona, a lot of men, you’ve met thousands, they’re dealing with their disease. It’s a heavy load. And yet, maybe this stuff is going on. But they don’t necessarily know whether they want to go through the load that they might see of being in a trial. They say just tell me what I can do. Give me what we know. What do you say to men about clinical trials? You’re at a research institution.
Right. So I think, basically, you need to stratify them for their risk for recurrence. So if their tumor is completely contained within the prostate, the lymph nodes are negative, all of the margins are clear, then the likelihood that they’re going to have a recurrence is low. And they really don’t need to go into a clinical trial. But if they have adverse findings on their radical prostatectomy specimen, and we know there is a substantial risk for recurrence, I think this is the role for clinical trials.
And as Dr. Szmulewitz mentioned, based on the sipuleucel-T studies, it shows that, in the tumors that are growing more slowly, if you use immunotherapy, it has a chance to control them, because it takes time to work. But if you have a tumor that’s growing very rapidly, it can completely run over the immune response so that, as he mentioned, timing is very, very important. So it’s really a matter of determining which agents should go into the trial and the timing of the agents. And this can really only be determined by prospective randomized clinical trials.
It cannot be determined by just trying this or trying that and having anecdotal responses of I know a patient who tried this, and he did okay.
We should mention that all of the drugs we mentioned, the approved therapies, all had clinical trials. And it was men who decided that it was right for them with their doctor. And they participated. And if you’re taking abiraterone acetate (Zytiga) or radium Ra 223 dichloride (Xofigo) or one of those newer drugs now, you’re getting it because it was approved. And there were men who went before you who chose to participate. So what would you say about trials?
So I would say what you just said. And what I would say is that in order for us to move the field forward, we need active participation in all phases of clinical trials. One of the challenges in prostate cancer, I’m a man, and I don’t want to see doctors. I don’t want to talk about anything with anybody medically. I want to just be quiet about it, do what I have to do, and sort of keep it in the background. And if you look at breast cancer or other diseases, the community is so vociferous.
And they’re so active. And it’s a badge of honor to them to be in a clinical trial and to participate and move the field forward. And I think the prostate cancer community, we have to take the mantle through us, too, and through other support groups to say, you know what, let’s be proud about our fight. Let’s participate in trials. Let’s be the shoulders that others will stand on in the future. It is hard. It does take commitment. And I realize that it’s not going to be feasible for everybody. But I think that those that do participate should be proud about it.
I’ve been in two clinical trials.
And I was in a Phase II trial for leukemia. And, fortunately, it worked for me that I’ve had no treatment now for 16 years for that leukemia. I’m very delighted. And the treatment that I received was FDA approved 10 years later.
And the Phase II trial, I got 10 years ahead of time. But the other thing I’d say about trials, gentlemen and your partners, is I love the attention. Yes, I had to be poked and prodded. And there might be biopsies, which are no fun. In leukemia, it’s bone marrow biopsies, which are certainly no fun. But you know what? Here I am. And I think we’re going to talk to other men. We did do a poll. And here’s one of the results. The results of the first poll, 70 percent of the men with us today have been living with advanced prostate cancer for less than five years. So they’re really engaged to everything we’re saying.
And hopefully, what’s next? So 20 percent 5 to 10 years in, 8 percent more than 10. And, Ralph, who we’re going to meet more again in just a few minutes is in that category. But your goal is to have living with advanced prostate cancer be more chronic, right?
And Dr. Szmulewitz, can it be—I mean, see ads on TV for diabetes and Crohn’s disease and all of these. And there have been, in some cases, miracle drugs that come out where people live with this. Can you see that day where you’re living with prostate cancer, you’re just going on with your life?
Well, yes. But first, let me back up. So I don’t think our goal should be to make it a chronic disease. I think our goal should be to…
Right, cure it. And that’s where we have to collaborate with Dr. Catalona and his colleagues that are really at the forefront of getting rid of what tumors that we see. Now, that being said, if it’s not cured, then A) I think we already, in part, are making it a disease that men can live with for years. And I think that we will continue to push that farther. And I think the balance is quality of life with quantity of life and managing side effects of therapy, managing side effects of the disease just like managing the side effects of diabetes and heart disease.
But, yes, I think that we are and will continue to make it a chronic illness. And I tell patients that I’m just meeting that, hey, we’re going to know each other. We’re going to be together or many years. And we’re going to have a prolonged relationship. And you’re going to see me however many months or weeks. And we’re going to check in. And it’s going to be a chronic illness just like your high blood pressure.
I hope so. Dr. Catalona, just to put the curly Q, the end, on our discussion about clinical trials, what would you say to me? What questions should they be asking their urologist, medical oncologist about whether a trial might be right for them or when it’s available at that institution or another.
Well, to be honest, I think that there are many clinical trials out there.
And there are very few physicians who are aware of what all these trials are. So I think that they should ask their urologist or their primary care physician. But if they’re urologist or primary care physician is not knowledgeable about it, then they should seek other information about what clinical trials are available for their particular stage of disease. And there are certainly resources for this.
And we talk about them on patientpower.info and our partners, Us TOO. Certainly, they have people you can talk to individually. In the support groups, the men talk about it as well. And we’re going to hear about that. And, certainly, our partner, the Patient Empowerment Network, has a lot of information just to understand what is a clinical trial. So I’ve benefited from two. I would not be sitting here above ground, I don’t believe, had I not been in a trial. So I’d like you to consider it.