Integrating the Use of Prostate Genomic Classifiers into Clinical Practice - A Clinical Pathway Approach - Katie Murray and Anne Lizardi-Calvaresi

January 30, 2023

Katie Murray and Anne Lizardi-Calvaresi discuss a clinical pathway approach for using the Decipher prostate cancer genomic classifier. Reviewing the level-one evidence described in the NCCN guidelines, they discuss best practices as clinicians integrate prostate cancer genomic classifiers into the care of their patients. They highlight how the test is integrated into the workflow for patient navigation, the use of the results in multidisciplinary tumor board discussions and address the following scenarios: Integrating the test post-surveillance, the use of the test post-biopsy, post-radical prostatectomy, and post-radiation. Drs. Murray and Calvaresi pivot to discussing counseling patients on using the prostate genomic classifier through their care pathway, including discussing the results with patients who are in the unfavorable intermediate-risk category and counseling patients differently if they are at high risk for progression. Lastly, they highlight tools they use to help patients understand the prostate genomic classifier risk assessment.


Katie Murray, DO, MS, FACS, Urologic Oncologist, Department of Urology at NYU Grossman School of Medicine Chief of Urology Service, Bellevue Hospital Center, New York, NY, Deputy Editor Urology Gold Journal

Anne Lizardi-Calvaresi, DNP, RNFA, Director of Clinical Operations, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA

Read the Full Video Transcript

Katie Murray: Hello. We just want to welcome everybody, and thanks so much for being here, talking about prostate genomic markers. My name's Dr. Katie Murray. I am an Associate Professor of Urology at NYU Langone Health and the Chief of Urology at Bellevue Hospital in New York City. And I am joined by an esteemed colleague and I'll let her introduce herself.

Anne Lizardi-Calvaresi: Thank you so much. I'm Anne Lizardi-Calvaresi. I'm a doctor of nursing practice. I practice with Thomas Jefferson University and The Sidney Kimmel Cancer Center in Philadelphia, Pennsylvania. I'm happy to be here today with all of you.

Katie Murray: Great. I think where we'll start off, Anne, is, in your practice in urology, but tell me a little bit about what your practice is and how much prostate cancer you're seeing, because of course we're talking about prostate cancer and genomic markers today. Explain to us your clinic and where you integrate in that whole process.

Anne Lizardi-Calvaresi: The majority of my clinic is GU cancer, and I would say about 60 to 70% of my patient population is specifically prostate cancer patients. The majority of the rest is bladder cancer with a little bit of renal cell and testis cancer sprinkled in between. But I do devote a lot of my time to prostate cancer patients and prostate cancer treatment.

Katie Murray: Is that prostate cancer across the gamut from active surveillance patients to advanced cancer patients?

Anne Lizardi-Calvaresi: You got it. I see patients who come in with an elevated PSA who are newly diagnosed with low risk disease. Of course, favorable intermediate, unfavorable intermediate risk, high risk but localized. And then I see patients with advanced disease and metastatic disease. So I'm seeing patients along the spectrum.

Katie Murray: Great. Well, you're probably able to give us a great insight as to how you use these classifiers kind of across that entire gamut of prostate cancer, which I think is a great point to look at. You use prostate genomic markers in your practice.

Anne Lizardi-Calvaresi: Absolutely.

Katie Murray: How is that integrated into your day-to-day work in 60 to 70% of your patients with prostate cancer?

Anne Lizardi-Calvaresi: The majority of my patients for whom I use genomic classifiers are for patients with favorable intermediate risk disease or potentially unfavorable intermediate risk disease, and for low risk disease when we're contemplating placing them on active surveillance for newly diagnosed prostate cancer or for patients who are already on active surveillance and we're considering whether or not we need to advance towards treatment or whether or not we can continue with active surveillance. That's one patient population. And then the other is patients with adverse pathologic features, post radical prostatectomy who we really are not sure do we need to radiate them or do we need to watch them? Those are the two patient populations where we really find value in genomic testing and it's really a tool that we use when we're determining whether or not to deliver more treatment, really is what it comes down to.

Katie Murray: I think you kind of mentioned this, or you alluded to the fact that there's a few different timings that you can order one of these genomic tests such as a Decipher, you can do it initially post biopsy or post radical prostatectomy. It can be done on either one of those specimens and how that integrates into your decision making and your decision making with the patient. In your practice, and you're doing that, you mentioned doing it post prostatectomy and that decision tree for going down the radiation path or continuing in that surveillance post prostatectomy in the GU path. Where does this come into play in your multidisciplinary tumor boards? Obviously with your medical oncologist, radiation oncologist, and anybody else that may be involved?

Anne Lizardi-Calvaresi: I always tell patients the benefit of coming to our institution is that we do have a really robust multidisciplinary clinic and we utilize those genomic classifiers in the results of them when we are evaluating patients prior to the clinic, when we do see them in person in the post pandemic era. We still see some patients virtually, but nonetheless, we're reviewing each patient before we see them in clinic. And we really do rely heavily upon those genomic classifier results with both radiation oncology and medical oncology while urology is seeing them in conjunction with those other subspecialties.

Katie Murray: This is a test that's mostly ordered by yourselves as urologists, but your medical oncology and radiation oncology are on board and know how to interpret that and have that same discussion with the patient? Is that what you're saying?

Anne Lizardi-Calvaresi: I have to be honest, our radiation oncology group has gotten really involved with ordering these tests as well. So if they're seeing a patient who's referred in for radiation and we've not ever seen them, they're also sometimes sending it out for genomic classification.

Katie Murray: Great.

Anne Lizardi-Calvaresi: And so, the whole team is on board and we really find a lot of value in those test results.

Katie Murray: Great. Talk to me a little bit as you're working in these groups, it's so great when we have these multidisciplinary clinics and everybody's on the same page and following that same pathway. And of course, what we're always looking for are big guidelines to tell us that. Of course, these classifiers such as Decipher has made it into the NCCN guidelines. And did that make any differentiating factor for you all in your practice in following those guidelines and referring to that when you're talking to patients about what this test is, what you're going to do with it, and what it may mean for them in the future?

Anne Lizardi-Calvaresi: That's a great point. Of course, we used it before it was in the NCCN guidelines. We used it many, many years ago here when it was still on trial and we really found the value in it. And now of course, we're supported with the NCCN guidelines and the NCCN guidelines recommend using it in the post biopsy space for low favorable intermediate, unfavorable intermediate, and high-risk patients. And then in the radical prostatectomy space, they recommend use in patients with an undetectable PSA, persistent PSA, and a rising PSA, so really in all disease states. What I tell patients is that it's a tool that we use when we're deciding whether or not they need additional treatment. In the post biopsy space it's, are they a good candidate for active surveillance or does the genomic test tell us that there's more aggressive disease than what the pathology test tells us alone and that really they're going to benefit from treatment as opposed to watching them and treating them later.

In the post radical prostatectomy space, it's a great tool that we use. Again, I always tell them it's a tool in our toolbox that we use when we are deciding whether or not to give them additional treatment, usually with radiation and or androgen deprivation therapy because their pathology alone is not telling us what we need to know, but the genomic classification test is telling us exactly what we need to know. What I also tell them is that the NCCN is kind of the Bible, or whatever our religious book might be, that guides us in telling us how to manage these patients. And because it's in the NCCN guidelines, it's really even more reinforcement to tell patients that, "You know what? This is really a good thing. We definitely should go ahead and get this done." And then finally, just for out-of-pocket costs for patients, there's minimal cost for most patients when we order this because it is in the guidelines.

Katie Murray: Great. Something that I've found, and I know that you've probably found a similar thing, is it's also a very visual tool, I think, for patients. I print out pathology results oftentimes, and I'll circle the T stage or I'll circle on a biopsy, I'll circle kind of the Gleason score and say it's five cores out of this many in total and kind of make it visual for people. But what I found in these scoring systems is it gives you these numbers, and that's what people are always wanting. When you see that kind of red, yellow, blue, and it says high risk or low risk, it does give that extra security blanket for patients that what we're telling them, and there's a reason we're worried about their disease being high risk in considering giving post-surgery radiation, or there's a reason that they may not need treatment right now in an active surveillance patient.

And so I find that physically showing people that visual aid of the test can really go a long way with people so I share it right there, hand it over to them to see, and then of course, it's in their chart as well.

Anne Lizardi-Calvaresi: Same. I'm always happy to share it with them. And it's a lot more cut and dry than a pathology report. Trying to explain Gleason scoring to a patient, even someone who's extremely well educated, can be very confusing, especially when they hear Gleason six or seven. Of course, they assume that it's on a scale of one to 10, not six to 10. So that low intermediate or high risk categorization is really helpful for a patient to just kind of nail it down exactly what are we talking about here, and make it much simpler in terms of their understanding.

Katie Murray: I agree. We've spent several minutes here and I think we've gone through this entire gamut of things of how this can be utilized in a clinic, how it increases our ability to serve our patients better with multidisciplinary care. It gets multiple opinions in there, it's just not reliant upon ourselves. But is there anything else that we haven't touched upon that you would send somebody home, a patient or a provider that, "Hey, this is another benefit of this test, or this is what I want you to take home as your last minute reminder of genomic classifiers"?

Anne Lizardi-Calvaresi: I think you can't go wrong with it. If a patient has it in their mind that they absolutely want to be treated and it comes back that they have low risk disease and it's low risk on genomic classification and they decide to move forward with treatment, you haven't done any harm by getting it, but you've kind of reassured everybody that they are truly low risk. And then same thing with if the patient has higher risk disease and it comes back as high risk, but the patient refuses treatment, you know that you're dealing with a higher risk patient once they decide to proceed with treatment. So I just think that always having more information is definitely a good thing.

Katie Murray: So, you're telling us there's not really situations where it guides you in the wrong direction. It either reinforces what we're already thinking or really helps us when we're stuck in a decision tree, which way to go. And I think that's a good way to kind of discuss it with our patients is if we're stuck, help us find which path to take or just reinforcing what we're already thinking.

Anne Lizardi-Calvaresi: Absolutely. We've sent, I can't even tell you, several thousand of these off, and I cannot think of a case where the genomic test results were misleading and what came to be later in the disease state was not in alignment with the genomic test results. So I do think that they're reliable and they're really helpful in planning the disease management.

Katie Murray: Great. I think that's a great final point and a great wrap up for providers and for patients, for everybody to know. Thank you so much. This was fun. I love learning how other people do practice and all the awesome things they're doing, so appreciate you.

Anne Lizardi-Calvaresi: Appreciate you. Thank you.