Read the Full Video Transcript

Ruchika Talwar: Hi everyone. Welcome back to UroToday's Health Policy Center of Excellence. As always, my name is Ruchika Talwar and I'm a urologic oncologist at Vanderbilt in Nashville, Tennessee. Today I'm so excited to be joined by one of my good friends and colleagues, Dr. Bashir Al Hussein Al Awamlh, who is an assistant professor of urology and urologic oncologist at NewYork-Presbyterian's Cornell Hospital. He's joining us today in this special series that we've created for patients, caregivers, urologists, and other practitioners who see patients with prostate cancer. He is an expert in the field of quality of life considerations and clinical decision-making for prostate cancer treatment, and he's going to be sharing some important insights with us today. Dr. Al Hussein, we're so grateful to have you here.

Bashir Al Hussein Al Awamlh: Thank you so much, Dr. Talwar. It's a pleasure to be here with you, and thank you to UroToday for this opportunity. So thanks again for having me. So we're going to talk about quality of life in prostate cancer. And just briefly, I'm going to discuss the idea of shared decision-making, which is truly the cornerstone for any prostate cancer care. And we're going to talk about the benefits and harms of prostate cancer briefly. And I'm going to introduce to you the study and some of the findings that we had worked on that was published last year and what the next steps are in the realm of quality of life for prostate cancer.

So generally speaking, how are patients with localized prostate cancer treated today? And it's important to distinguish between localized and metastatic prostate cancer, which is a different disease entity. Most patients, I would say 70 to 80%, probably a little bit over 70% of patients present with localized prostate cancer.

So generally speaking, as I said, shared decision-making is the cornerstone. So what is it? It's clinicians and patients usually collaborating and sharing the best available evidence when they make that decision. And if there are several reasonable alternatives for patients, they explicitly are compared using the evidence about their harms and benefits of these decisions. And briefly, shared decision-making started in the 1980s, and academic interest surged in the 1990s, and that was paralleled by patient decision aids, which we'll get to later on as part of our next steps. And shared decision-making is so important that there's a policy emphasis in it, as is mentioned in the Affordable Care Act in 2010.

So this is a little scheme here, or schema, that shows what shared decision-making is in localized prostate cancer. In the middle is the most important thing, which is communication, and what factors into that communication? On the left-hand side, you have the patient. You have the patient's values, preferences; you factor in the patient's life expectancy when they make a decision about what treatment they want to pursue. You have the family and caregivers' opinions and preferences as well, and the patient's diseases and comorbidities.

And on the right-hand side, which is also taken by the provider or the provider leads that, is the benefits and harms of these treatments. Those are combined together, and then the goal is to produce a high-quality decision for the patient that is evidence-based and then it's consistent with the patient's values and preferences. But to get to that, we need sufficient information and high-quality information about the effectiveness of the treatments and the harms of these treatments. And we need to be able to communicate this information in a patient-centered manner. And the goal really is to avoid regret. We know based on a study that we did that patients with prostate cancer, almost one in 10 do report regret based on the decision of the treatment that they pursue.

And the study also showed that this is mediated by expectations about functional outcomes and expectations in general. And that is what the perception of the adverse effects of treatment compared to the expectations that actually happen. So you know the saying: happiness is reality minus expectations. So regret in this case is managing expectations for patients. So it's important to understand the differences by how these treatments are. So going to the side where the provider is important to provide this information about the harms and benefits, we know just generally briefly that the benefits for treatments are really almost the same for all treatments for prostate cancer depending on the risk. For low and favorable-risk prostate cancer, we know that there's no difference in survival between treatment and surveillance. And for unfavorable, intermediate, and high-risk cancer, we know that there's enough data to suggest that treatment is beneficial and will lower the risk of cancer or oncologic outcomes.

But one may be preferred over the other, but generally they're equally effective in treating cancer. In terms of harms, the other arm of this, which is the adverse effects or the quality of life implications, it is really easy to name them but it's very difficult to quantify. We know briefly that surgery is associated with surgical complications and risks. We know that it may be associated with urinary incontinence, erectile dysfunction, but again, we don't know how to quantify them. And more importantly, we don't know what the current treatments' side effects on these aspects are. Radiation, similarly, we know it may be associated with some bowel function effects or urinary symptoms, and we know that it has rare effects or side effects on other problems like creating fistulae, bleeding, and secondary malignancies. And for surveillance, similarly, we know it's associated with anxiety and there's a little bit of increased risk perhaps in disease progression depending on the cancer and the burden of repeated biopsy.

So it is important to have information about these treatments. So in terms of the balance of what patients factor in—from a patient perspective, quality of life implications perhaps are the most important factors that weigh in when making a decision because, like we said, in terms of cancer they are similar for the most part. So enter the study that I will talk about, it's called the CEASAR study, and it stands for the Comparative Effectiveness Analysis of Surgery And Radiation for Prostate Cancer. And this study really, to me, is very important because it really focuses on the current treatment paradigms for prostate cancer and it provides information for patients by comparing the outcomes of quality of life for patients who undergo different treatments. The unique aspect of it is that it had patients who had robotic prostatectomy, which most patients receive these days. And in terms of radiation, it had patients who had intensity-modulated radiotherapy, which almost 80% of patients had this, and it has active surveillance patients.

So it gives us an actual snapshot of what current patients are going through, and provides information about the quality of life to help patients make a better decision. So it was a ten-year study that was population-based, it was representative of the current care that is going on in the United States, and included almost 2,500 patients. In terms of quality of life, what we focused on—the most important things for patients that are related to prostate cancer were sexual function; urinary function, which included urinary incontinence or irritative symptoms, as we would call frequency of urination, burning sensation, or an inability to urinate; and also bowel habit functions, symptoms related to abdominal pain, etc.; and hormone therapy side effects such as hot flashes for men or depression or decreased libido. In this study, what was also unique about it, aside from the fact that it had all these modern treatment therapies, we managed to stratify or divide patients into two big groups depending on the disease risk.

Because even localized prostate cancer is one bucket, we generally do put them into two separate buckets for the most part depending on the cancer risk. So the treatment intensity is different, so we expect the implications on the quality of life to be different as well. So what are the key findings that are pertaining to the quality of life for prostate cancer in general? And this is the most recent data. We found that surgery was associated with an increased risk of urinary incontinence over a span of the ten-year period that we followed these patients on compared to other treatments. In terms of providing values or percentages for patients to be counseled and just to get a general ballpark, 14 to 25% of patients who had surgery reported bother symptoms related to leaking urine compared to 4 to 11% of patients who had radiation. So it's not uncommon for men to experience urinary leakage over that period of time; at 10 years those were the numbers.

Patients who had favorable localized prostate cancer had worse sexual impairment for the first three to five years following surgery. But later on, the sexual function scores after those five years were similar depending on the treatment or according to all treatments. And that may be related because in the beginning, when prostate cancer patients undergo certain treatment, they will have these side effects, but as they get older the sexual function may decrease over time. Similarly, radiation may have a side effect related to that. And then also patients who undergo active surveillance—we know up to 50% of them may undergo treatment at some point. So the difference in sexual function for this category of patients with favorable disease is really usually felt within the first couple of years only. And we also found, when we looked at the patients who had a higher-risk disease or what we call unfavorable prognosis disease, that there are no differences in sexual function between surgery and radiation with hormones.

And that was a very important finding. And it's important for patient counseling based on the cancer diagnosis because I think a lot of us used to, or for the most part, we would dump some patients in one bucket and say, "This is what the prognosis is when we do surgery." But here this shows that actually there is no difference in sexual function, which is one of the key primary decision factors for patients. So it's important to keep that in mind. And adverse effects of sexual function for this category of patients may be de-emphasized a little bit for patients, and perhaps they can be alleviated a little bit and focus on other things. We also found that radiation therapy with hormones over a span of a ten-year period is associated with slightly worse bowel and hormone function at that period only, only after 10 years. And then ultimately what the results showed is that you have all these quality of life implications based on other treatments, but this shows the benefit of active surveillance when it is safe because patients are able to enjoy or avoid the implications associated with these treatments and live a life adverse-effect-free up until they require treatment in a safe manner if they are watched carefully and per protocol, depending on their disease risk.

So we establish these findings, we understand what we need to do, but how do we communicate that? Every patient is different, every patient walks into a clinic with a different set of issues, different set of priorities, and more importantly different baseline functions. So the communication is truly the key. So what we are developing right now—we're developing a personalized functional outcomes prediction tool. And the emphasis on this is to tailor it for patients with low health literacy. It will be a health-literacy-agnostic tool because a lot of patients do not understand the implications of prostate cancer and treatments with it. So we want to refine the language, refine the way we communicate this information in a personalized manner. Here on the right is a very preliminary schema or photo of what we would do. A patient will punch in their numbers based on what their function is and what their predicted function would be over a certain amount of time a few years later based on the disease characteristics that they have and their baseline function.

And the cornerstone of this is community-engaged research where we are eliciting feedback through certain focus group sessions to refine this into what we call a progressive web app that interacts with patients, and they'll be able to make decisions and help patient counseling and ultimately, like we said, minimize regret after treatment for prostate cancer. So that is, I think, a general overview of the quality of life implications for prostate cancer.

Ruchika Talwar: Thanks so much. I mean, incredible work, such important insights to better guide our understanding of the patient experience during and after prostate cancer treatments. And I really love your emphasis on community engagement, engaging our patient advocates, making sure that our clinical research questions address aspects of their treatment journey that are important to them. So I really love that. I'm excited to see the tool that you all are creating to help us guide our clinical decision-making. As we wrap up here, I'm curious if you can just leave us with some advice. According to your research, when patients are experiencing a lot of confusion and with the understanding that from an oncologic perspective often both treatments are equivalent in terms of outcomes, the patient quality of life experience may vary. What is your advice to clinicians when they're having these somewhat challenging discussions and trying to help counsel a patient to come to a treatment decision? How should we navigate these often confusing, challenging, complex conversations?

Bashir Al Hussein Al Awamlh: Thank you, Ruchika, for bringing this up. I think this is probably, for a urologic oncologist or urologist, this perhaps is one of the most difficult conversations that we have with patients—which treatment to choose based on their preferences. I think the number one thing is to talk to patients, understand what their preferences are, what their goals are as patients in general, I think to give them time. Prostate cancer fortunately is one of those cancers that we have a little bit of time on our side. So to provide them the information, use hopefully tools like the tool that we're developing to help them understand the differences in treatment and what to expect, and allow them to have some time to minimize additional conflict with the understanding that the goal is to minimize regret over time. And say that there is no right or wrong answer; there is the right answer for you and what works best for you. Now of course, if the cancer is managed or can be managed with active surveillance, I think that is one of the avenues that we should underscore and in turn show that different treatments may have different side effects that active surveillance will avoid for them. So very difficult conversation and it's important. I think I would start by acknowledging that it is one of the most difficult conversations because there is no right or wrong answer. There is the answer that is good for you.

Ruchika Talwar: That is so true. And that is something I often find myself telling patients, there really is no right or wrong answer here and we're here to support you through whichever treatment you choose. And so I really love that you also referenced that. Well, we're so grateful that you had some time today to share your insights. It's always a pleasure talking with you. Thank you so much.

Bashir Al Hussein Al Awamlh: Thank you so much. Thank you for having me.

Ruchika Talwar: And to our audience, thank you so much for joining us again. We'll see you next time.