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Clinical Focus

Clinical Case Vignette Series: Integrating Recent Data into Practice to Improve Outcomes in Advanced Prostate Cancer

Robert Dreicer, MD, MS, MACP, FASCO; Neal Shore, MD, FACS; Michael Morris, MD; Alicia K. Morgans, MD, MPH

Medical Crossfire®: How Will Emerging Data Inform Treatment Planning for Patients With Prostate Cancer in the Community?

Howard I. Scher, MD; Scott T. Tagawa, MD, MS, FACP; Mary-Ellen Taplin, MD

Medical Crossfire®: How Does Recent Evidence on PARP Inhibitors and Combinations Inform Treatment Planning for Prostate Cancer Now and In the Future?

, highlights the recent FDA approval of flotufolastat F 18 (POSLUMA), a PSMA-PET imaging agent in prostate cancer. Schuster is a professor of radiology and imaging sciences and the director of the division of nuclear medicine and molecular imaging at Emory University School of Medicine in Atlanta, Georgia.

 in May 2023, and became commercially available in June 2023. The agent is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence. The approval was based off of findings from the phase 3 SPOTLIGHT and LIGHTHOUSE trials, which Dr. Schuster’s highlights during the discussion.

Don’t forget to subscribe to Speaking of Urology® on 

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"We're excited that the FDA approval of this radiotracer gives us yet more tools at our disposal to diagnose prostate cancer in all its forms, from early to late in the disease process," says David M. Schuster, MD, FACR. 

Dr. Schuster highlights the FDA approval of imaging agent flotufolastat F 18 in prostate cancer

The PDUFA goal date for TLX007-CDx is March 24, 2025. 

TLX007-CDx under FDA review for approval in prostate cancer 

The first commercial doses of the diagnostic have now been administered in both Austria and France. 

European market for piflufolastat F 18 continues to expand 

“The ability to gather actionable information from PSMA PET scans is important for physicians to make informed decisions about patient management for men with prostate cancer,” says Eugene Teoh, MBBS, MRCP, FRCR, DPhil. 

Studies show low urinary bladder interference on flotufolastat F 18 scans

The BLA submission is supported by findings from the phase 3 ZIRCON trial, which demonstrated high specificity and sensitivity of TLX250-CDx for PET/CT imaging of ccRCC.

Approval sought for TLX250-CDx in clear cell renal cell carcinoma

Patients with high-risk disease were shown to have a significantly higher mean value of SUVmax compared with patients with low-risk disease (23.5 ± 13.2 vs 10.6 ± 5.4; P < 0.05). 

[68Ga]Ga-PSMA-11 PET/CT shows value in initial staging of prostate cancer

Dr. Michael Stifelman highlights Iris, a 3D modeling tool for robotic-assisted surgery

Dr. Stifelman discusses 3D modeling tool for robotic-assisted surgery

, highlights Iris, a 3D modeling tool for kidney cancer management. Stifelman is a professor and chair of urology at Hackensack University School of Medicine, the chair of urology for the northern region of Hackensack Meridian Health, and the director of robotic surgery for Hackensack Meridian Health.

Iris is another name or tool called 3D modeling. So, we take cross-sectional imaging, and we create a 3D model that we can literally bring into the robotic console as we do the surgery. What it allows us to do is to get a much better representation of what's underneath the organ. So, for example, if you're going to remove a kidney tumor, Iris allows us to tell us in very, very granular detail, the arterial anatomy, the venous anatomy, the collecting system anatomy, [and] also where the tumor is located and how it is interacting with those different structures. So, we can get not only a better representation of what part of the kidney to clamp and what we don't have to clamp, but also what we're going to encounter as we cut the tumor out. What we've shown with our data and through our experience, is that by using this technology, we're able to preserve more normal kidney and disrupt less of the normal kidney. So, basically, we leave people with similar outcomes in terms of taking out the cancer, but better kidney preservation.

This transcription has been edited for clarity.

Videos

“What we've shown with our data and through our experience, is that by using this technology, we're able to preserve more normal kidney and disrupt less of the normal kidney,” says Michael D. Stifelman, MD. 

Dr. Robert Wang discusses findings from a study on the use of cutoff values for molecular imaging assessment in kidney cancer

Dr. Wang on the use of cutoff values for 99MTC-sestamibi SPECT/CT in kidney cancer

, shares the background and key findings from the study, “Limited Utility of Quantitative Thresholds on 99MTC-Sestamibi SPECT/CT for Distinguishing Renal Cell Carcinoma from Oncocytic Renal Masses,” which was presented at the 2024 American Urological Association Annual Meeting in San Antonio, Texas. Wang is a second-year SUO fellow at Fox Chase Cancer Center in Philadelphia, Pennsylvania.

99mTc-sestamibi scans are one such kind of markers that go on to a certain part of the cell called the mitochondria. Certain benign tumors and low malignancy tumors called oncocytomas and hybrid oncocytoma chromophobe tumors, they have a lot of mitochondria in them. Whereas the most common type of kidney cancer is clear cell, and also, I think, papillary kidney cancer, they do not have a lot of mitochondria. The idea is that you use this marker, you inject it into someone's veins, it goes into the tumor, and attaches to the tumor a lot. It's radioactive, so you could see how much it attaches to the tumor. If it attaches a lot to the tumor and not a lot to the surrounding kidney, that suggests the tumor has a lot of mitochondria, and therefore that would hint that the tumor is more likely to be benign.

There was a recently published meta-analysis of about 8 papers, looking at how good that scan is, and the data came out very positive. It's really sensitive and specific and has a really good positive predictive value, or a negative predictive value, in identifying these tumors. But all of these studies were done in a situation where the scan wasn't actually used to make the clinical decision. They got the scan, but they didn't really factor the scan in. These patients usually got a biopsy or surgery to begin with. This is a controlled setting to get those results. It shows that the test is very good, but we wanted to see at Fox Chase, what if we integrated this test into actual clinical practice? Does it really help us make important decisions? Is it reliable enough to hang our hat on and not do the usual workup of biopsy or just cutting the tumor out? So, my predecessor, Dr. Jared Shover, who was a fellow before me; he's at Nebraska now. At Fox Chase, a couple of the providers started to include using the 99mTc-sestamibi scans in their decision making. Sometimes the 99mTc-sestamibi suggested things didn't need surgery, and combined with other clinical data, they actually didn't get surgery or didn't get a biopsy. We don't know what the actual tumor was in those cases, we just assume it's not cancerous. And then in some cases, the scan was concerning, so they went ahead and got the biopsy or got surgery. Or the scan was not concerning, but other factors were concerning, and they went ahead and got surgery or biopsy. This is more what we call it real-world or actual practice data.

We looked at it and whenever you take something from a controlled setting to a less control setting, things don't necessarily look as good. Especially the negative predictive value. So, basically, if the test said that this was most likely benign, and then they went to surgery or biopsy, about 20% of the time it actually was cancerous. So, we say, "Oh, well, that's, that's a little bit rough."

The abstract that we're presenting is just a follow-up to that paper, basically looking at different ways of interpreting the scans. In Dr. Shover's paper, the scans were read by trained radiologists; they looked at it and said, "I think this says this is a hot scan. I think this is a cold scan." However, a lot of the other prior research for the paper used what we call quantitative cutoffs. So, they actually looked at how bright the tumor lit up and then how bright the kidney near it lit up and calculated a ratio. That's a little bit more of an objective measure. And different studies use different ratios to say whether it's a hot scan or a cold scan. We took all these ratios that previous studies in other datasets had calculated and applied them back to the dataset that Dr. Shover did his study in to see if overall, we could improve the scans ability to differentiate benign and cancerous tumors.

Ultimately, no 1 cutoff did better than the radiologists. Some cut offs have a better chance of saying if we're going to call it cancer, it's most likely cancerous. But then, by shifting the needle, it also misses. It creates an error in the other direction, where basically the false positive rate goes up. So, it tends to say, "Oh, this is benign, or it's actually not." The tradeoff was such that no single test outperformed the radiologist in both of the situations that we're looking at: the negative predictive value and the false positive rate. The negative predictive value we want to be high, and the false positive rate we want to be low. None of those beat the radiologist reads in both of those categories. We ultimately said, using these quantitative cutoffs is maybe helpful to help radiologists interpret the scan, but they don't really beat an expert radiologist's read, which is, in some ways, what we'd expect. A simple number, a simple cutoff really can't beat professional training. So, we had 2 conclusions in the study. One being what we just said. But the other is that in order for these types of scans to be more broadly incorporated into practice, we need to train radiologists to make sure they are capable of reading these scans and have some expertise.

“The negative predictive value we want to be high, and the false positive rate we want to be low. None of those beat the radiologist reads in both of those categories,” says Robert S. Wang, MD. 

David I. Lee, MD, FACS, discusses prostate-specific membrane antigen (PSMA)-PET’s potential in prostate cancer. 

Dr. David I. Lee on PSMA-PET’s potential in prostate cancer

 discusses prostate-specific membrane antigen (PSMA)-PET’s potential in prostate cancer. Lee is director of the UCI Health Comprehensive Prostate Cancer Program and professor of urology at the UCI School of Medicine.

I think one of the real big future directions in prostate cancer is going to be PSMA-PET scan evaluation and then using that technology to be able to deliver therapeutics, because that very targeted ability, which helps us now to see prostate cancer better at the initial diagnosis, and then to stage patients better, I think is actually changing things already. Our old nomograms, which we used to use in order to evaluate lymph node involvement and longer term survival, I think those are all going to change because of PSMA-PET scan evaluation. Those patients who have positive scans, which we couldn't appreciate otherwise with MRI and bone scanning before, we're seeing those patients now. And so that creates a whole different stratification method, which I think is going to impact how we take care of patients. The very interesting data out of Germany and Australia and how they actually use lutetium in order to treat [patients with] prostate cancer when they have metastasis, I think, is very encouraging. And in the United States, it's FDA approved for that use, but moving that treatment option further up in the timeline of men who have advanced prostate cancer I think is going to be really interesting to watch because we can not only detect these lesions but also treat them, and who knows how far up along the chain that it's going to get. I don't know that it's ever going to replace surgery or radiation, which are the gold standards for localized prostate cancer therapy, but it's going to be really interesting to see how we can team these therapies up together. The challenge of treating men with high-risk disease and potential micro metastatic disease with this type of targeted therapy is really exciting.

This transcription was edited for clarity.

"The challenge of treating men with high-risk disease and potential micro metastatic disease with this type of targeted therapy is really exciting," says David I. Lee, MD, FACS.

Todd M. Morgan, MD, shares some final thoughts on the AUA/ASTRO/SUO guideline for salvage therapy for prostate cancer

Dr. Morgan on the evolving field of salvage therapy in prostate cancer

 shares some final thoughts on the AUA/ASTRO/SUO guideline for salvage therapy for prostate cancer, which was recently published in the 

. Morgan is chief of urologic oncology, the Jack Lapides M.D. Research Professor and professor of urology at the University of Michigan, Ann Arbor.

Is there anything else you would like to add about the AUA/ASTRO/SUO guideline on salvage therapy for prostate cancer?

I think that this field is going to continue to evolve, especially when we think about how to incorporate PSMA-PET findings into our clinical care. There's still a lot for us to learn, and so a lot of our recommendations in that space tend to be lower level evidence or expert opinion. And I'll tell you, the experts on this panel are really good and incredibly thoughtful and really know the data, but I think it's important that people read the guideline and digest the guideline, but also really pay attention as this whole field continues to evolve over the next 3, 4, 5 years. We need to follow the data and the clinical trials that continue to inform us on which patients need, say, more intensified systemic therapy when they have oligometastatic disease in the setting of positive PSMA-PET, which patients maybe can benefit from metastasis-directed therapy alone. These are all important questions, and I expect us to have some guideline updates in the coming years.

"I think that this field is going to continue to evolve, especially when we think about how to incorporate PSMA-PET findings into our clinical care," says Todd M. Morgan, MD.

Todd M. Morgan, MD, shares some key points from the AUA/ASTRO/SUO guideline for salvage therapy for prostate cancer

Prostate cancer salvage therapy guideline incorporates PSMA-PET imaging

 shares some key points from the AUA/ASTRO/SUO guideline for salvage therapy for prostate cancer, which was recently published in the 

What are some key points from the AUA/ASTRO/SUO guideline on salvage therapy for prostate cancer?

One of the important spaces is what do we do with a patient who undergoes prostatectomy and then has a biochemical recurrence? A key piece of the guideline is that we need to offer radiation at a PSA of 0.5 ng/mL or lower and maybe even, for some patients, a PSA lower than 0.2 ng/mL. There are some ways of what we call risk stratifying patients, so saying, of course, everybody is different. But it extends beyond just our clinical intuition to some tangible clinical factors that we can use to help inform our decisions, which patients might need earlier radiation treatment, or if patients who underwent initial radiation, which of those patients are at highest risk for recurrence, and then when we're thinking about patients who get salvage radiation, which of those patients may need hormone therapy with that radiation and for how long that hormone therapy is given. So these are all really key pieces of the guideline. But there's a single table that I think is really important and I hope that people take a second to look at and think about, because it's a table that goes through some of the main prognostic factors that inform all of these risk stratification decisions. And some of those factors are high Gleason grade, high stage, the presence of node-positive disease, a shorter PSA doubling time, a shorter time to PSA recurrence—a patient who has their PSA rising, say, 3 months or 6 months after prostatectomy has a higher risk disease than that patient who has that PSA recurrence 4 or 5 or 6 years after surgery. There's also PET imaging findings. That's another really key part of this guideline. PSMA-PET is really new in our field. This is another reason why this guideline is so topical and really something that is different than the prior guideline is that patients with biochemical recurrence now have the opportunity to undergo an imaging modality that can find that cancer in many, many cases. And so whereas 5 years ago, we were only using CT scans and bone scans and maybe MRI to try to localize disease early not very successfully. Now, PSMA-PET is showing us cancer and lymph nodes that are in the prostate bed, or maybe even a distant site like a spinal metastasis that we just cannot see on a CT scanner or bone scan that totally changes our thinking. Now, we still have a long way to go to have robust clinical trial data that tell us definitively what the best approaches are in each of these little nuanced scenarios. But there are data to start to inform the guideline statements, and there are guidelines statements that we have put together that suggest using PSMA-PET or other molecular imaging modalities in patients with biochemical recurrence, and then targeting those sites of disease when there are a limited number of sites; using for example, radiation or what we call metastasis-directed therapy to targetthose particular sites, and it really does seem to help patients in terms of at least delaying further progression of their disease.

"A key piece of the guideline is that we need to offer radiation at a PSA of 0.5 ng/mL or lower and maybe even, for some patients, a PSA lower than 0.2 ng/mL," says Todd M. Morgan, MD.

 discusses the study, “Evaluation of a synergistic drug combination with 

Lu-rhPSMA-10.1 for prostate cancer: Results of an 

 proof of concept study,” which she presented, on behalf of Blue Earth Therapeutics, at the American Association for Cancer Research Annual Meeting in San Diego, California. Dr. Foxton is Vice President, R&D Strategy and Collaboration, for Blue Earth Diagnostics.

Can you elaborate on the significance of using cobimetinib in combination with 

Lu-rhPSMA-10.1 for PSMA-expressing prostate cancer? How does targeting the MEK-MAPK pathway potentially enhance the radioligand therapy?

PSMA is expressed in the majority of prostate cancers, but it's known that there is heterogeneity in terms of PSMA expression, both intra- and inter-tumor heterogeneity. So, a synergistic drug combination could improve the therapeutic response of 

Lu-rhPSMA-10.1 in tumors, or areas of tumor, with lower PSMA expression that would get a lower dose of the rhPSMA-10.1, as well as in tumors with high PSMA expression. To answer your question about the MEK-MAP kinase pathway and how it works, to date, we haven't done any mechanism of action experimentation ourselves, so we don't have any data at this stage. But our current hypothesis is based on the non-clinical literature, evidence that shows that the MEK-MAP kinase pathway is involved in regulation of the DNA damage response. Therefore, we think that inhibition of the MEK-MAP kinase pathway, in this case with cobimetinib, during the DNA damage response may be radiosensitizing the cancer cells to 

The study mentions an "in vitro screen" to identify candidate drugs. Can you explain the purpose and limitations of this type of screening method in the development of cancer therapies?

The in vitro screen we used was a cell-based assay. And in it, we tested a library of more than 150 FDA-approved anticancer drugs to identify synergistic combinations with 

Lu-rhPSMA-10.1. The cell-based assay was designed to compare the effects on clonogenic survival of a prostate cancer cell line, of each test drug alone, with that of test drug plus 

Lu-rhPSMA-10.1. These types of cell-based screens are an efficient way of identifying lead candidates from a long list, before moving into more complex non-clinical models with the shortlist of “hits.” In terms of limitations, this screen used only 1 prostate cancer cell line, which would have a certain genetic background and mutation status. With this type of model, there's always a question about how reflective this will be of the entire prostate cancer patient population, as prostate cancer is heterogeneous.

The results showed promising anti-tumor effects of the combination therapy in xenografts. How well do these results translate to potential effectiveness in human patients with advanced prostate cancer?

To determine how well these non-clinical results translate to human patients, we would need to conduct a clinical study. However, Blue Earth Therapeutics has previously presented non-clinical data showing promising antitumor effects with 

Lu-rhPSMA-10.1 as a single agent in the same xenograft model as we used in this work. And in preliminary studies of 

Lu-rhPSMA-10.1 in patients with prostate cancer, which have been published, this has translated to favorable dosimetry and efficacy in the clinic. We're hopeful that this pre-clinical combination data would translate into potential clinical performance, but we would need to do the clinical study to be certain. However, across oncology many combination approaches have been shown to be more effective than monotherapies. And we think radiation is particularly amenable to combination therapy.

The study mentions minimal overlapping toxicities observed for the single agents. How important is this finding for the potential clinical application of this combination therapy?

In terms of the minimal overlapping toxicity, our non-clinical data from the xenograft model showed minimal toxicity with the combination. And based on the single-agent safety profiles from clinical data to date, there don't appear to be any obvious overlapping toxicities. So we hope this should mean a decent safety margin in the clinic. However, a clinical trial would be needed to test this hypothesis.

Based on the results, what are the next steps for further research on this combination therapy for prostate cancer? Are there any specific challenges to address before clinical trials can be initiated?

We'd like to repeat the experiment with another MEK inhibitor in the class, because here we only used cobimetinib, and there are several others that are already approved for use in cancer. And we'd also like to try another prostate cancer cell line model to confirm that this is a generalizable finding. That would be our non-clinical next step. And we're currently considering how best to take this forward into the clinic.

The main thing to add is that Blue Earth Therapeutics conducted a systematic in vitro screen in a cell-based model and then followed up and demonstrated that the effect did carry through into efficacy in a xenograft model. This is particularly encouraging because the cell-based data did translate into proof of concept in the more complex in vivo model, which often isn't the case in non-clinical work.

"In terms of the minimal overlapping toxicity, our non-clinical data from the xenograft model showed minimal toxicity with the combination," says Caroline Foxton, PhD.

News

Dr. Foxton on results of drug combination with PSMA agent for prostate cancer

Edward M. Schaeffer, MD, PhD, discusses collaboration with nuclear medicine specialists when using PSMA-PET agents in prostate cancer

Urologist discusses collaborating with nuclear medicine when using PSMA-PET for prostate cancer

 discusses collaboration with nuclear medicine specialists when using PSMA-PET agents in prostate cancer. Schaeffer is chair and Harold Binstein Professor of Urology at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

Could you discuss any personal experience you have had collaborating with nuclear medicine specialists or radiation oncologists regarding PSMA-PET and patient management?

At Northwestern Medicine, we have very extensive and very deep experience with PET-PSMA-based imaging. We started our first randomized trial with PET-based imaging in 2017, and so our nuclear medicine physicians have tremendous experience reading these kinds of PET scans, and it certainly requires a high degree of experience to interpret them. There can be some false positives that you could maybe overcall. And so it's important to just understand where the prostate-specific PET scan also lights up; classic would be salivary gland; dorsal root ganglia is another. And so just having a understanding of what is a false positive, because these areas of the body light up vs not is really, really important. We have a really tremendous environment here and our nuclear medicine physicians have really deep experience with these tools, because we've been using them here so long. Whenever we have outside PET imaging, we often will have that re-reviewed at our oncology conference or tumor board, just to level set and make sure that we understand the reading to be as it's stated in the report.

"At Northwestern Medicine, we have very extensive and very deep experience with PET-PSMA-based imaging," says Edward M. Schaeffer, MD, PhD.

Edward M. Schaeffer, MD, PhD, discusses the importance of a multidisciplinary approach for using PSMA-PET agents in prostate cancer

Dr. Schaeffer on the importance of a multidisciplinary approach when using PSMA agents

 discusses the importance of a multidisciplinary approach for using PSMA-PET agents in prostate cancer. Schaeffer is chair and Harold Binstein Professor of Urology at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

Please discuss the importance of a multidisciplinary approach when working with PSMA PET scans.

Like any test, it's really a very powerful tool. It's just how you deploy the tool. [One factor is] how you create the tool. Is the PET PSMA agent made in-house or made with a commercial enterprise? When you actually administer the test, what is the quality of the scanner that you have that actually registers the results? And most importantly, what is the quality and the experience of the nuclear medicine physician radiologist reading the results, and then also the clinician who can actually put the whole story together and piece together what would be a potentially a positive or a negative PET scan with the clinical scenario for the patient. And so really, that requires a lot of different disciplines within a medical enterprise. And it's not just physicians, but it's actually teams of individuals, technologists, the actual imaging platforms etc.

"Like any test, it's really a very powerful tool. It's just how you deploy the tool," says Edward M. Schaeffer, MD, PhD.

, Edward M. Schaeffer, MD, PhD, discusses current uses for PSMA-PET in prostate cancer. 

Current usage of PSMA PET agents in the urology clinic

 discusses current uses for PSMA-PET in prostate cancer. Schaeffer is chair and Harold Binstein Professor of Urology at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

What are current applications for PSMA PET agents in the urology clinic?

PSMA PET imaging is used in the initial diagnostic staging and then in subsequent cases where there can be a recurrence after primary treatment. Those are the 2 main areas where PET PSMA is used. And then as I mentioned, there's also FDA approval to use PSMA-linked radiotracers in the castrate-resistant space for treatment. So the imaging agents for staging are used up front new diagnoses unfavorable intermediate, high, and very high risk prostate cancer by NCCN definitions. In the recurrence space, if your PSA is rising and you've met the technical definition of recurrence, which is a PSA over .2 by AUA guidelines and by NCCN, it would fit that umbrella of a recurrence and then also post radiation, the Phoenix criteria; that is nadir plus 2. You can use PET imaging in the initial staging and then you can use it in the space where there's a recurrence, and that's a general admission criteria to get one of those tests.

"PSMA PET imaging is used in the initial diagnostic staging and then in subsequent cases where there can be a recurrence after primary treatment.," says Edward M. Schaeffer, MD, PhD.

Edward M. Schaeffer, MD, PhD, discusses what’s on the horizon for PSMA-PET in prostate cancer

Dr. Schaeffer looks ahead on what to expect from PSMA-PET in prostate cancer

discusses what’s on the horizon for PSMA-PET in prostate cancer. Schaeffer is chair and Harold Binstein Professor of Urology at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

What is on the horizon in terms of new products or the role of PSMA-PET in the prostate cancer paradigm?

PSMA-PET is a radio nucleotide-based imaging modality that really has changed the landscape of how we initially stage and subsequently follow individuals who have a diagnosis of prostate cancer. Additionally, there have been approvals for agents that are PSMA linked that have radio nucleotides on them that are therapeutic as well. So we've already made tremendous advances in terms of what tools we have, and the options and availability of those tools. Moving forward, I think there's going to be various augmentations of the basic principle of link to a prostate-specific molecule and then highlight it. That would be some of the basic PET agents, and/or link to a prostate cancer PSMA and also target it with a, for example, radioactive alpha- or beta-emitting agent. I think the next advances will be kind of multivalent molecules that will see and bind to PSMA-expressing cells plus potentially other agents or other markers on the cell surface, which will potentially enhance the sensitivity and potentially enhance the ability to identify smaller lesions, greater affinity for particular lesions, etc. So I think in terms of the future, I'm excited about the idea of the bivalent or multivalent PET-PSMA-linked molecules and then those bivalent or multivalent agents could be linked to other cell surface molecules, or other radioactive agents that could potentially help them the tumor kill.

"PSMA-PET is a radio nucleotide-based imaging modality that really has changed the landscape of how we initially stage and subsequently follow individuals who have a diagnosis of prostate cancer," says Edward M. Schaeffer, MD, PhD.

Dr. Brian Helfand discusses how PSMA-PET may help tailor treatment for patients with prostate cancer

Dr. Helfand on escalation/de-escalation of treatment based on PSMA-PET 

, discusses the role of PSMA-PET imaging in tailoring treatment plans for patients with prostate cancer. Helfand is a urologic oncologist at NorthShore University Health System in Chicago, Illinois.

I think a lot of the trick of prostate cancer is that if we can see where the location of a tumor is, that's going to help identify where we should focus our treatment. I think that that makes sense. And certainly, [where] that comes into play is that if you only have a tumor that's localized to the prostate, that we can see even with the fanciest PSMA-PET imaging, we feel better that we may not have to treat other areas, especially when in the staging setting of a high-risk or very high-risk tumor. Certainly, when we talk about the biochemical recurrence tumor where these days, we have more focal treatments, certainly, we want to target those treatments, including SBRT, to other sites that we may see. We can intensify the treatment, so to say in those settings to say that if we have a biochemical recurrent situation where we have a rising PSA after a prostatectomy, we do a scan, and we see that there is limited uptake in the prostate bed, but there's a lymph node that may either be in the pelvis or certainly distant, we can then make our plan based on that. That plan may include an intensification and in addition to radiating the pelvis, you may actually radiate that area, if possible or feasible.

Then it also begs the question, if you see that, how much hormone therapy in the N1 or M1 or M0 type setting, and again––depending on that situation and what the images show––that you would actually offer that patient. I think it certainly adjusts that plan because again, when we know that there's disease present, especially in M1 setting, we're going to involve an intensification with more extended hormone therapies, etc. I think this is really playing a role in the decision for where we're localizing our radiation therapies as well as the addition of ADT plus an androgen receptor pathway inhibitor, ARPI, and the duration of these therapies. I think the intensification or even de-escalation when we don't see those diseases is quite appropriate and our natural reaction to those imaging results.

“I think this is really playing a role in the decision for where we're localizing our radiation therapies as well as the addition of ADT plus an androgen receptor pathway inhibitor, ARPI, and the duration of these therapies,” says Brian T. Helfand, MD, PhD. 

Dr. Brian Helfand discusses the potential for PSMA-PET imaging to play a role in active surveillance of prostate cancer

Dr. Helfand on the potential role for PSMA-PET imaging in active surveillance

, describes the potential for PSMA-PET imaging to play a role in determining the appropriateness of active surveillance for patients with prostate cancer. Helfand is a urologic oncologist at NorthShore University Health System in Chicago, Illinois.

Looking at the ability of PSMA-PET imaging into new spaces is always really exciting. I do think certainly that the ability to estimate the location and/or extent of a tumor is imperative to active surveillance. We do know that higher volume tumors certainly have higher risk of having more aggressive disease and certainly, if we knew that patients have higher volume or more aggressive tumors, they may not be suitable for active surveillance. And certainly, while most of these studies are ongoing, the initial data looks promising to say that there may be a role for a PSMA next-generation imaging in the decision for the appropriateness for active surveillance. And certainly, if you do have intense bilateral signals that may not be as appropriate as if someone has a very minimal amount of radiotracer accumulation or avidity in their prostate. So, the data still is forthcoming, but I'm very excited that this may be a new ability to more appropriately identify patients. I think also the promise of combining a lot of these technologies, so using PSMA-PET CT imaging with MRI imaging, so I guess it would be PSMA-PET MRI imaging, also adds a new dimension as well. We really have to validate the sensitivity and specificity in these settings, but again, these studies are ongoing and looking to see how they come out.

“And certainly, while most of these studies are ongoing, the initial data looks promising to say that there may be a role for a PSMA next-generation imaging in the decision for the appropriateness for active surveillance,” says Brian T. Helfand, MD, PhD. 

Jaideep S. Sohi, MD, explains how the expanded information provided by PSMA-PET imaging allows physicians to more accurately tailor treatment plans.

Dr. Sohi on why PSMA-PET results can alter treatment plans

, explains how the expanded information provided by PSMA-PET imaging allows physicians to more accurately tailor treatment plans for patients. Sohi is a nuclear medicine physician with Northwestern University and American Molecular Imaging.

PSMA-PET imaging has allowed us to get a more accurate diagnosis. We are now able to evaluate the patient’s entire body. So we now have the ability to get a more accurate perspective on patients’ disease stage. We can tell for the most part if the disease is localized to the pelvis, or if it has spread to distant organs. Of course, with that knowledge knowing we are able to more accurately tailor the patient's treatment planning paradigm.

In this video, Jaideep S. Sohi, MD, explains how the expanded information provided by PSMA-PET imaging allows physicians to more accurately tailor treatment plans for patients.

In this video, Jaideep S. Sohi, MD, explains factors to consider regarding the timing of re-imaging with PSMA-PET in patients with prostate cancer. 

Dr. Sohi on the timing of PSMA-PET imaging in prostate cancer

, explains factors to consider regarding the timing of re-imaging with PSMA-PET in patients with prostate cancer. Sohi is a nuclear medicine physician with Northwestern University and American Molecular Imaging.

We always want to know, “Okay, we've had one baseline [scan,] so when do we scan the patient next?” And it depends on multiple factors. Most importantly, it's going to be the patient's clinical condition. So after therapy, you assess how the patient is doing. Are they having any new clinical symptoms that can raise concern for the possibility of metastatic or recurrent disease? Most commonly, the patient followed by their PSA level and the urologist and/or the treating physician will evaluate the PSA and the patient’s clinical status and then make a decision on when they feel is appropriate to re-image the patient with PSMA-PET. Typically, this happens in patients who have what we call biochemical recurrence, which is a rising PSA after prostatectomy or radiation therapy.

Transcription has been edited for clarity.

In this video, Jaideep S. Sohi, MD, explains factors to consider regarding the timing of re-imaging with PSMA-PET in patients with prostate cancer.

In this video, Jaideep S. Sohi, MD, discusses the challenges with the use of conventional imaging in prostate cancer.

Conventional imaging obstacles that PSMA-PET overcomes

Jaideep S. Sohi, MD, discusses the challenges with the use of conventional imaging in prostate cancer and how PSMA-PET alleviates these issues.

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