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BackTable / Urology / Article
Integrating ExosomeDx with Prostate Cancer Diagnostics for Precision Care
Kaitlin Sheppard • Updated Jan 23, 2025 • 33 hits
Prostate cancer care has entered a new era, defined by personalized approaches and advanced diagnostic tools that emphasize shared decision-making. Screening guidelines now focus on stratified recommendations based on factors such as family history, race, and age, enabling earlier detection for high-risk individuals. Innovations like ExosomeDx and multi-parametric MRI have improved the precision of prostate cancer risk assessment, minimizing unnecessary biopsies and enhancing the identification of clinically significant cancers. For low-risk cases, active surveillance has become a central management strategy, allowing many patients to avoid overtreatment.
Dr. David Albala explains his algorithm for stratifying prostate cancer risk and how it informs treatment, focusing on the role of new biomarkers, imaging methods, and biopsy techniques. This article includes excerpts from the BackTable Urology Podcast. We’ve provided the highlight reel in this article, but you can listen to the full podcast below.
The BackTable Urology Brief
• High-risk patients (e.g., family history, African American men) should begin screening for prostate cancer at ages 40-45; others may start at 55. Shared decision-making between clinicians and patients ensures screening aligns with individual risk profiles.
• Nearly 50% of newly diagnosed prostate cancer cases may not require immediate treatment. Regular follow-ups and monitoring are essential to assess disease progression.
• ExosomeDx scores provide a quantifiable prostate cancer risk prediction, correlating higher scores with increased likelihood of Gleason 7 or higher cancers.
• MRI Fusion biopsies allow for more targeted sampling of suspicious lesions seen on MRI, surpassing the limitations of traditional ultrasound-guided biopsies.
• Layered diagnostic approaches, including PSA, ExosomeDx, and MRI, enable tailored care strategies for diverse patient populations. The shift towards personalized care has redefined prostate cancer management, emphasizing individualized risk assessment and targeted intervention.
Table of Contents
(1) Understanding ExosomeDx Scores & Their Clinical Implications
(2) Advancing Biopsy Techniques with MRI Fusion
(3) A Contemporary Prostate Cancer Screening Algorithm
(4) Individualized Screening: Adapting to Patient Risk Profiles
Understanding ExosomeDx Scores & Their Clinical Implications
ExosomeDx scores provide clinicians with a quantifiable tool for estimating the likelihood of detecting high-grade prostate cancer, defined as Gleason 7 or higher. The score-to-risk relationship is nearly linear up to 50%, offering a straightforward metric for stratifying patients into low-risk (e.g., Gleason 6) or higher-risk categories. This predictive accuracy helps refine clinical decision-making, enabling targeted biopsies for intermediate or high-risk cancers while sparing unnecessary interventions for indolent cases.
[Dr. Jose Silva]:
Regarding the results of the ExosomeDx, the closer you are to 100, the more chances you have a high-grade cancer? Is that how it's read?
[Dr. David Albala]:
The higher the score, the more likely of a high-grade prostate cancer is going to be detected. If you have an exosome test that's 10, and you have an exosome patient that comes in and it's 50, he has about a 50% chance of high-grade prostate cancer. It's almost a one-to-one ratio up to 50%, and then you start to see it plateau off. If you come in and your exosome's about 30, they have about a 30% chance of a high-grade prostate cancer. We define high-grade prostate cancer as a Gleason 7 or higher. Gleason 6 is really not considered, you know, a high-grade prostate cancer. We use the term low-risk prostate cancer or low-grade prostate cancer.
[Dr. Jose Silva]:
We're talking about group 2 or above or intermediate risk or above?
[Dr. David Albala]:
Exactly.
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Advancing Biopsy Techniques with MRI Fusion
Prostate biopsy techniques have progressed from random sampling methods to precision-guided approaches that integrate advanced imaging. MRI fusion biopsy combines the detailed imaging of multi-parametric MRI with real-time ultrasound guidance to target suspicious lesions with increased accuracy. Urologist, Dr. David Albala, highlights the clinical impact of this technology, which improves the detection of significant prostate cancers while reducing unnecessary procedures.
[Dr. Jose Silva]:
Dave, in terms of, you mentioned the multi-parametric MRI, how do you integrate that to your practice? Are you using MRI fusion biopsies or what are you doing?
[Dr. David Albala]:
We are. Again, this has been a significant evolution and change in the way we think of things.
For a number of years, the best way to biopsy was doing a transrectal ultrasound. I remember when I was a resident, we would take patients to the operating room and do perineal biopsies, put our finger in, do it maybe either transrectal or transperineal and essentially biopsy, just putting-- we tried not to stick our fingers and have finger tissue in the biopsy specimen. Then ultrasound came along and that changed the dynamics. We could image, we could stick a needle in, but an ultrasound provided a random biopsy. In other words, you wouldn't know exactly where you were doing the biopsy. You know it's maybe right apex or right base, or whatever. Then MRI fusion biopsies came in, and that again changed the playing field. In those biopsies, you could do the MRI and it became a targeted biopsy. You could aim, when you fuse the images on the MRI with the ultrasound, you could target a specific abnormality that you saw on the MRI with the ultrasound, so you were sure to get that tissue. That's the difference. Even up to a couple of years ago, we were still doing regular transrectal ultrasound biopsies.
Because many insurance companies would only approve it if you had a transrectal ultrasound and it was negative, and the PSA kept rising. They've changed their guidelines now. I go exclusively to MRI fusion biopsies. I'm a believer in the technology. There is a cost with the MRIs and it's much higher than with an ultrasound, but I think the biopsies are better quality. Plus you also have a record of where the biopsies were taken. In other words, if you come in and I do a biopsy, and then your PSA fluctuates a little bit and then goes up again, I can pull your MRI up. I can see exactly where we biopsied and if you have a new lesion, it shows me where the biopsies were the first time. It's very useful information.
A Contemporary Prostate Cancer Screening Algorithm
The integration of PSA tests, biomarkers like ExosomeDx, and multi-parametric MRI has set a new standard for precision and personalization in prostate cancer screening. Dr. Albala details his algorithm, which begins with PSA testing and follows with ExosomeDx to stratify risk. Patients with elevated ExosomeDx scores undergo multi-parametric MRI to identify suspicious lesions, guiding targeted MRI fusion biopsies when appropriate. This structured approach enhances risk stratification and ensures interventions are patient-specific.
[Dr. Jose Silva]:
Dave, in your practice, are you using both? You're doing the MRI and the ExosomeDx?
[Dr. David Albala]:
I do. My workflow algorithm is PSA test, repeat it if necessary. Then men age 50 and higher that have a PSA between 2 and 10, those individuals, I'll get an exosome test. If the test is less than 15.6, I'll say I'll see you back in six months and repeat the PSA. If it's above 15.6, I'll set those patients up for an MRI fusion biopsy. We get the MRI and then we can target any abnormalities that are seen on the MRI. That's my workflow. You could do it the other way. You could do MRIs and then do the exosome test. There's different variations. We just recently wrote a paper showing how layering biomarkers with MRIs really does provide enhanced information to the clinician to diagnose prostate cancer.
[Dr. Jose Silva]:
I've been doing it the other way around. Back in COVID, I started doing the MRI, and since I've been doing MRI, I guide it. I get a lot of patients that are reading from the radiologist that says chronic prostatitis, but their PSA continues to creep up. Last couple of months, I started using ExosomeDx in the practice. Most of those patients, I will say the index is more than 15.6. Those patients that, let's say the MRI is negative but the ExosomeDx is positive or more than 15.6, are you doing a random biopsy? Are you doing a saturation biopsy? What are you doing with those?
[Dr. David Albala]:
Again, a rule of thumb based on clinical information is up to 50%. If your exosome test is 35, there's about a 35% chance of a high-grade prostate cancer. That's where you have to use a little bit of clinical judgment. If it's 17 and the patient is 78, you may say, listen, I'm not going to really worry about this. You're going to act differently with an exosome score of 20 in a 55-year-old versus 75-year-old. You use a little bit of clinical judgment. I like that one-to-one relationship really holds true for me. I can tell you if the exosome test is below 15.6, the likelihood of a bad prostate cancer, a high-grade, grade group 2 or higher prostate cancer, extremely low.
The beauty of the exosome is the negative predictive value, ie those patients that have numbers below 15.6, really probably have a very, very low risk of prostate cancer, and the sensitivity, it's much better. This is much better than PSA testing. It's much better than using the calculators, the prostate cancer prevention calculator, the European calculator for detecting prostate cancer. I like this test because it's simple and I can do it and patients do it at home. Then I can set up a video visit. Then if it's elevated, then I will do the biopsy in those patients.
[Dr. Jose Silva]:
If it's elevated, you will do the MRI first to see if there's a targeted lesion that you can biopsy, but you already are going to do the biopsy regardless.
[Dr. David Albala]:
If the number is just slightly elevated, I may not do the biopsy again, depending on the age and using that clinical information. Remember MRIs, there's a lot of variability with MRIs. It depends on reader subjectivity. The negative predictive value, if you have a very small lesion, if it's less than a centimeter lesion on the MRI, that's going to be a much harder cancer to detect. The location, the multilaterality and focality of these tumors. There's a lot of issues that go in with MRIs. There are many people that hang their hats on MRIs, but again, it's not 100% technology or we'd all be doing MRIs. We use them a lot. They're a useful test, but they're not 100% foolproof.
[Dr. Jose Silva]:
Probably more expensive, the MRI, rather than the urine test.
[Dr. David Albala]:
The urine test I believe is actually a little bit higher. Again, I don't know the cost of the urine test. What's interesting is these now, the biomarker, you know, ExosomeDx is in the NCCN guidelines. It's paid by Medicare. Many insurance companies, private insurers pay for this test. Like any new test, I talked about this earlier, looking at efficacy, side effects, ease of use, cost, and then durability, those are the five things. When I see a new technology. If it's, say, BPH, I ran the FDA trial for the low-energy microwave.
It was great on efficacy. We got good results. The side effects, it was pretty minimal, easy to do. The cost was reasonable. Where it failed, it was durability. After a number of years, three to five years, these patients all became symptomatic again. When I see a new technology, whether it's a urine test, a blood test, a new procedure, in my head, I think of these five categories and I say, does it check the box? To me, the exosome test checks those boxes. I've used it and integrated it into my workflow.
[Dr. Jose Silva]:
You convinced me. I already use it, but I'm going to change the way I use it. Like I mentioned, I use it after the MRI because I was already doing the MRI, but definitely probably it's easier, patients do it at home. I'll probably start doing it the other way around. Also I can start doing less MRIs and I can rule out patients already if they have a low index score.
[Dr. David Albala]:
It's a great adjuvant marker to use with the tools that we have to try to diagnose prostate cancer. Again, there are other tests. There's blood tests out there. There's other urine tests. You're old enough to know PCA3 where we'd go in and massage these men with their prostate. What I like about this test is we don't have to do that. The validation study really have shown that it can reduce not only patients that are undergoing an initial biopsy.
Jim McKiernan from Columbia wrote a very nice paper showing in patients that have had a negative biopsy, first biopsy, that you can use this to try to enhance and identify more patients that potentially might have had prostate cancer that was missed. These are really the risks at two populations that the test is approved for; patients undergoing initial biopsies, and patients that have had a negative first biopsy that you want to decide, should I do a repeat biopsy on?
[Dr. Jose Silva]:
Dave, you mentioned that there's data out there between comparing the MRI with or using it in conjunction, the MRI with the ExosomeDx. Can you talk about that a little bit more?
[Dr. David Albala]:
We just published-- we've just submitted a paper. It's not published, we haven't received any word on the paper, but looking at layering biomarkers. The first biomarker, PSA is a biomarker. It's a blood test. If that blood test is elevated, if then we add the exosome test to that and that's elevated, then we can enhance the detection of prostate cancer by doing an MRI. When you combine all those three pieces of clinical information, it's going to be a much higher value in detecting prostate cancer than just using a single test alone, whether it's MRI or PSA.
We know PSA is not prostate cancer-specific test. It's a good screening test. It's been used for years. I think it should continue to be used, but it's not sensitive enough to pick up the prostate cancers that we really want to identify. That's why I think this layering concept, much like what we've seen with advanced prostate cancer. When I train, if you have metastatic prostate cancer, you either did an orchiectomy, the removal of the testicles, or you gave people injections to fool the body to shut down the production of testosterone. In 2023, patients with metastatic prostate cancer don't get just hormone injections or orchiectomy. We now are layering drugs like enzalutamide or abiretarone, or a variety of these newer androgen receptor agents to help with prostate cancer. When you look at the data, there's no question that this layering or this combination of different treatments is much more effective. I think it's now spilling into diagnostic testing, that we're using this layering to try to enhance our ability to pick up prostate cancer.
[Dr. Jose Silva]:
Just out of curiosity, a patient that has elevated the score, if you do a biopsy, have you had patients that have negative biopsies?
[Dr. David Albala]:
Sure. I've had patients that have-- again, this is not 100% foolproof, but the higher the exosome score, the higher the likelihood of detecting prostate cancer. If you have an exosome score that's 20 and you compare it to a patient that has an exosome score of 55, there's a difference. About 55% of those guys in that upper group are going to have prostate cancer versus 20% of patients in that other group. 80 patients, if I have 100 patients, we'll have no prostate cancer whatsoever. What we're trying to identify much like what the genomic markers do, try to identify the wolf in sheep's clothing, is that patient a candidate for active surveillance?
This test helps us identify those patients at a higher risk. All of these tools are risk assessment tools. We've now branched out from, do you have prostate cancer or not, to try to assess the risk? If you have low-grade prostate cancer and low risk, more likely than not you don't need to do anything. That's where this evolution, and over my 34 years of practicing, I've really seen this change.
Like everything else, things change. When I first finished my residency and did my fellowship in St. Louis, we were still doing ureterolithotomy, making an incision in the ureter to take a stone out. We wouldn't think of that today in 2023. We have scopes that are small lasers, shock waves. That's the beauty of what we do. There's this evolution of technology. These biomarkers and MRIs are just evolutions of different technologies to make us better at detecting different diseases.
Individualized Screening: Adapting to Patient Risk Profiles
Prostate cancer screening is evolving toward a more personalized approach, driven by individual risk factors such as family history and genetic predisposition. High-risk groups are advised to begin screening as early as age 40 to 45, while others can typically wait until age 55. This tailored strategy moves away from a “one size fits all” approach, recognizing the variability in patient risk and the importance of optimizing early detection. Advanced tools, such as ExosomeDx testing, further refine screening by identifying candidates who may avoid unnecessary biopsies, ensuring screening is both precise and patient-specific.
[Dr. Jose Silva]:
Dave, I think you already summed it up, but anything else you want to add?
[Dr. David Albala]:
To me, the takeaway message is be smart, get screened. If you're at a high-risk group or you have a family history, get screened at age 40 to 45. If you don't, if you're not a high-risk group, you can get screened at age 55, but the bottom line is get screened. What you don't know is ignorance is not bliss. If you have prostate cancer and you're diagnosed with it, you don't necessarily need to get treated. Almost 50% of patients that are diagnosed today don't need to get treated. We can follow them. That's very unique to prostate cancer.
I can't think of a single disease state in which you follow these. Early on, many patients were essentially bewildered that you would come in and I'd say, Dr. Silva, we know we've diagnosed prostate cancer, but we're not going to do anything. People didn't understand that concept. They now understand it. The takeaway message is have a discussion with your physician, shared decision-making. Each case is individualized. We're getting more towards personalized medicine. All of these tests in some ways are ways of personalizing your medical care.
One shoe doesn't fit everybody anymore. I think, get screened. If you need to get a biopsy, there are tests, the exosome is a perfect example, that you may prevent 30% of patients from getting a biopsy that's not necessary.
Podcast Contributors
Dr. David Albala
Dr. David Albala is the chief of urology at Crouse Hospital in Syracuse, New York.
Dr. Jose Silva
Dr. Jose Silva is a board certified urologist practicing in Central Florida.
Cite This Podcast
BackTable, LLC (Producer). (2023, August 16). Ep. 112 – Preliminary Complementary Data for Pairing mpMRI and the ExoDx Prostate Test [Audio podcast]. Retrieved from https://www.backtable.com
Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.
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