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Articles

A recap of the FDA submissions and regulatory decisions in urology from February 2025. 

FDA updates in urology: February 2025

Overall, 84.2% of patients achieved a 50% or greater reduction in urgent leaks.

Pivotal study data show efficacy of percutaneous SNM device for UUI 

The updates emphasize a risk-stratified approach to the management of microhematuria.

AUA, SUFU release amendment to microhematuria guideline

 is compliance officer and medical director of coding and reimbursement, United Urology Group and Chesapeake Urology, in Towson, Maryland.

"For telephone-only (audio only) visits, Medicare has officially stated that such a visit would be considered the same as an in-person visit, with a few qualifications," write Jonathan Rubenstein, MD, and Mark Painter.

How to bill for telephone-only urology visits

The prostate cancer section is a comprehensive resource for urology news and expert insights. Read more at Urology Times.

Prostate Cancer | Urology News & Expert Insights | Urology Times

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Clinical

1rem

Clinical Focus

2025 GU Satellite Symposia in San Francisco

, discusses the need to increase diversity in clinical trials, specifically focusing on studies in prostate cancer. He also highlights the recent Northwestern-led course, “Enhancing Recruitment of Ethnic Minorities in Cancer Clinical Trials,” which took place on February 16, 2024. Murphy is a urologist at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

During the discussion, Murphy provides some advice for researchers looking to increase diversity in their trials. He also references a study in which 64% of Black patients indicated that they would be willing to discuss clinical trials in prostate cancer, compared with 82% of White patients.

 While there is a difference, Murphy notes that the percentage of more than half of Black patients being willing to discuss clinical trials is not insignificant, and the data supports the idea of clinicians continuing to make the ask to their patients in order to help increase diversity in prostate cancer trials.

Murphy ends the discussion by sharing some of his thoughts on future work building on the Northwestern-led course, such as a session focused on mock recruitments with patients who have previously enrolled in clinical trials.

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

, or anywhere that podcasts are available.

1. Senft N, Hamel LM, Manning MA, et al. Willingness to discuss clinical trials among Black vs White men with prostate cancer. 

. 2020;6(11):1773-1777. doi:10.1001/jamaoncol.2020.3697

In this podcast episode, Adam B. Murphy, MD, MBA, MSCI, discusses the need to increase diversity in clinical trials, specifically focusing on studies in prostate cancer.

Dr. Murphy on increasing diversity in cancer clinical trials 

On an episode of Cleveland Clinic’s Cancer Advances podcast, host Dale Shepard, MD, PhD, talked with Zeyad Schwen, MD, about the use of focal therapy to treat patients with localized prostate cancer.

Schwen, who is a urologic oncologist at Cleveland Clinic, covers these topics:

The difference between traditional treatments and focal therapies

Factors that make a patient a good candidate for focal therapy

Focal procedures, including Nanoknife, high-intensity focused ultrasound and cryotherapy

Clinical trials devoted to focal therapies

Zeyad Schwen, MD, a urologic oncologist at Cleveland Clinic, discusses how patient factors and cancer characteristics are key to deciding between focal therapies and whole gland treatment for prostate cancer. 

Dr. Schwen on focal therapies for prostate cancer

In this episode of Speaking of Urology®, 

, discuss precision medicine and the use of biomarker tests in prostate cancer screening and detection. Albala is the chief of urology at Crouse Hospital in Syracuse, New York, and Punnen is an associate professor of urologic oncology and an associate professor and vice chair of research at the Desai Sethi Urology Institute at the University of Miami in Florida.

This discussion originally took place during a live X (formerly Twitter) Spaces event held by Urology Times. In this exclusive interview, Albala and Punnen discussed the significance of advances such as liquid biopsies in prostate cancer, reviewed the current liquid biopsy tests available, and shared their own clinical experiences with the tests in their practice. They also highlighted data on the ExoDx prostate test from studies of clinical utility and validation studies.

Albala and Punnen ended their discussion by highlighting current education gaps surrounding the use of biomarker tests in practice and their predictions for the future of precision medicine.

In this episode, David M. Albala, MD, and Sanoj Punnen, MD, discuss precision medicine and the use of biomarker tests in prostate cancer screening and detection.

Speaking of Urology: Liquid biopsy in prostate cancer 

 (NCT04384770), which compared Magnetic Resonance Imaging-guided stereotactic body radiotherapy with Computed Tomography-guided stereotactic body radiotherapy in localized prostate cancer. Kishan is an associate professor of radiation oncology and urology and the chief of genitourinary oncology for radiation oncology at University of California, Los Angeles. 

Don’t forget to subscribe to Speaking of Urology

Amar Kishan, MD, highlights findings showing that MRI-guided SBRT is superior to CT-guided SBRT in localized prostate cancer.

Dr. Kishan highlights findings from the MIRAGE trial in prostate cancer

® spoke with Dr. Aaron Laviana, who discusses decisional regret in patients with prostate cancer. Laviana is an assistant professor of surgery and perioperative care and a courtesy faculty member of the department of oncology at The University of Texas at Austin Dell Medical School.

“Localized prostate cancer is a very complicated disease space,” says Aaron A. Laviana, MD, MBA.

Dr. Laviana on decisional regret after prostate cancer treatment

®Assistant Editor Janelle Hart spoke with 

. She discusses the findings of a recent 

 study, “Representation in Online Prostate Cancer Content Lacks Racial and Ethnic Diversity: Implications for Black and Latinx Men.” More specifically, she explains how these findings emphasize the need for content creators to focus more on equity, diversity, and inclusion when it comes to online medical literature. Loeb is a professor in the departments of urology and population health at the NYU Grossman School of Medicine in New York City, New York.

“The current landscape of online materials about prostate cancer is generally pretty bleak,” says Stacy Loeb, MD, PhD, MSc.

Study finds lack of Black and Latinx representation in online prostate cancer literature

® Assistant Editor Janelle Hart spoke with 

 She discusses the role that high-intensity focused ultrasound (HIFU) has played among other minimally invasive and robotic technologies to mitigate the side effects and complications of treatment for prostate cancer, compared toe other treatment options. Linehan is an associate professor of urology and urologic oncology at the John Wayne Cancer Institute in Santa Monica, California.

“It's really become the epicenter of all the surgeries that we do in urology,” says Jennifer Linehan, MD.

Emerging HIFU technology shows promise in men with prostate cancer

 He discusses how even though there are stigmas surrounding active surveillance, a lot of research actually suggests that this form of care is preferred in patients with prostate cancer. Therefore, he emphasizes that this treatment method should be counseled accordingly by clinicians. Ehdaie is a urologic surgeon at the Memorial Sloan Kettering Cancer Center, New York City, New York.

“It doesn't need to be surgery or radiation. Setting that stage, really focusing on those conversations, using the appropriate tools that we've grasped from behavioral psychologists that are being used by negotiation specialists, are critical in medicine,” says Behfar Ehdaie, MD, MPH.

Destigmatizing Urology: Dr. Ehdaie discusses active surveillance

. She discusses the benefits of plant-based diets given the promising findings of the prospective study, “Association of plant-based diet index with prostate cancer risk,” published recently in the 

. Loeb is a professor in the departments of urology and population health at the NYU Grossman School of Medicine, New York City, New York.

“We find that consuming more healthy, plant-based foods is associated with a lower risk of aggressive and lethal prostate cancer, and has many other health benefits, too,” says Stacy Loeb, MD, PhD, MSc.

Dr. Loeb on the association between plant-based diets and prostate cancer risk

 He discusses how his new technology, The PrecisionPoint Transperineal Access System, is used for detecting prostate cancer in patients. Matthew J. Allaway, MD, is the founder and president of Perinealogic and a urologist and managing partner at Urology Associates, Cumberland, Maryland.

“We need to do a better job sampling the prostate,” says Matthew J. Allaway, MD.

Dr. Allaway on the increased efficiency of transperineal biopsies

Data from the VAPOR 2 trial are intended to support a submission to the FDA for 510(k) clearance of the device.

Enrollment goal met in trial of Vanquish device for localized prostate cancer

Myriad is planning to launch its first AI-driven prostate cancer clinical test later this year.

Myriad Genetics, PATHOMIQ enter agreement for usage of AI platform for prostate cancer

The trial plans to enroll up to 80 adult patients with mCRPC who have progressed on prior systemic therapies.

Phase 1/2 trial launches of first-in-class RIPTAC therapeutic in mCRPC

Median PFS was 35 months in the MDT plus SOC group vs 21 months in the SOC alone group. 

WOLVERINE findings highlight benefits of MDT in oligometastatic prostate cancer

Rana R. McKay, MD, FASCO, shares the background and key findings from the study, “Effectiveness and safety of radium-223 in men with metastatic castration-resistant prostate cancer (mCRPC): A systematic literature review of 48 real-world studies.” 

Rana McKay, MD, on real-world data of radium-223 in mCRPC

, shares the background and key findings from the study, “Effectiveness and safety of radium-223 in men with metastatic castration-resistant prostate cancer (mCRPC): A systematic literature review of 48 real-world studies.” These data were presented at the 

2025 American Society of Clinical Oncology Genitourinary Cancers Symposium

McKay is a genitourinary medical oncologist at the University of California, San Diego (UCSD) and a professor of urology and medicine at UCSD School of Medicine.

Could you describe the background/rationale for this analysis?

Radium-223 is a radiopharmaceutical that was FDA approved for the treatment of prostate cancer nearly a decade ago. It was approved during an era where we the treatment landscape was very different for metastatic castration-resistant prostate cancer, and also for metastatic hormone-sensitive prostate cancer. There's been a series of additional studies that have been conducted, various retrospective studies [and] prospective studies, smaller studies that have been conducted, real-world studies that have been conducted with radium. What we proposed to do was do a systematic review of all of this data.

In our systemic review, we examined 48 real world studies involving over 15,000 men with metastatic castration-resistant prostate cancer who were treated with radium. Our findings highlight that completing 5 cycles or more of radium was associated with a 2 to 5-fold increase in overall survival. We found that earlier use of radium-223 before multiple other lines of therapy was also associated with better outcomes.

We looked at various study populations and observed that most patients were in the age bracket of mid to late 60s, early 70s. About 25% of the patients in these studies had really high burden of disease, with 20 plus bone metastases. Over half of the patients in about 23 different studies had received prior chemotherapy, and half of the patients from about 22 different studies had received a prior ARPI. Additionally, the data is global in nature. There was representation across both North America, Europe, and the globe. These findings, I think, are really important, as radium is a life-prolonging agent, though it was FDA approved at a time where the treatment landscape was very different for advanced prostate cancer treatment. Understanding the evolution of its utilization in the real world and the modern era is really important.

This transcript was AI generated and edited by human editors for clarity.

Videos

"Our findings highlight that completing 5 cycles or more of radium was associated with a 2- to 5-fold increase in overall survival," says Rana R. McKay, MD, FASCO. 

Channing J. Paller, MD, discusses the most critical next step in advancing the use of natural products as effective and safe complementary therapies in prostate cancer

What is needed to advance the use of natural products in prostate cancer?

discusses the most critical next step in advancing the use of natural products as effective and safe complementary therapies in prostate cancer. She is the senior author of the recent 

paper, “Harnessing nature's therapeutic potential: A review of natural products in prostate cancer management.” Paller is an associate professor of oncology at the Johns Hopkins University School of Medicine, director of Prostate Cancer Clinical Research, and associate director of oncology, Johns Hopkins Clinical Research Network, Baltimore, Maryland.

In your opinion, what is the most critical next step in advancing the use of natural products as effective and safe complementary therapies in prostate cancer?

The most critical next step is to focus on enhancing both the scientific rigor of our clinical trials and the personalization of our treatment. There has been progress in improving the bioavailability of natural products, such as through nanoparticle formulations or chemical modifications, but there still needs to be more robust and personalized approaches to better match natural products with individual patients. For example, using advanced models like patient-derived xenografts or organoids may allow for more accurate testing of natural products, and personalized approaches should be employed. Genetic profiling, tailored dosing, individual treatment plans, just like we do with immunotherapy for MSI high or BRCA and PARP inhibitors. We need to start doing these for our natural products as well. We have started to look at these, like SOD and other biomarkers, but we need to study them more rigorously and more systematically to help us figure out who really will benefit and who might not. The other big thing we need is large-scale diet trials in the prostate cancer population. We don't have those in the same way that we do for breast cancer. I just worked with a bunch of breast cancer doctors to summarize the effects of soy, green tea, enterolactone, so those are lignans like in flax and sulforaphane like in Brussel sprouts, to help us understand what may help prevent breast cancer or recurrence of breast cancer. We don't have data like that at such a large scale in prostate cancer yet, and so I think we need to start looking at intake in our patients as well on a broader scale to see how diet may actually be helping our patients and things that they can do every day to take care of themselves and live a happier, healthier life.

"The most critical next step is to focus on enhancing both the scientific rigor of our clinical trials and the personalization of our treatment," says Channing J. Paller, MD.

Vanita Gaglani, RPT, gives advice to men with post-prostatectomy incontinence or prostatitis

A physical therapist’s advice for men with post-prostatectomy incontinence

gives advice to men with post-prostatectomy incontinence or prostatitis. Gaglani is a registered physical therapist and owner of Vanita’s Rehab in Melbourne, Florida. She was interviewed at the 2025 Desai Sethi Urology Institute Urology on the Beach meeting in Miami Beach, Florida.

What advice would you give men who have post-prostatectomy incontinence or prostatitis?

I would say, talk to each other. Talk to other men about it. You are not the only one leaking. Think about how many Depends and diapers and pads are sold. Think about how many different type of products are there. Depends advertises on TV that you can play with your grandchildren. So this concept that "I am the only one leaking," and "it's an embarrassing thing," it is not. It is not a stigma. It can be overcome with the help of a therapist and a doctor. So seek help. Do not feel that you cannot do anything about it. Same with the men who have pelvic pain: persist. Find a doctor who will listen to you and find a more holistic approach, along with the medication approach.

"I would say, talk to each other. Talk to other men about it. You are not the only one leaking," says Vanita Gaglani, RPT.

Alicia Morgans, MD, MPH, shares ways to improve reporting of prostate-specific antigen (PSA) doubling time

How to improve urologists’ reporting of PSA doubling time in prostate cancer

 shares ways to improve reporting of prostate-specific antigen (PSA) doubling time. She is an author of the study “Impact of physicians’ awareness of prostate-specific antigen doubling time (PSADT) on treatment (Tx) decisions in high-risk (HR) biochemically recurrent (BCR) prostate cancer (PC),” which she presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California. Morgans is a genitourinary medical oncologist and the director of the Survivorship Program at Dana-Farber Cancer Institute in Boston, Massachusetts.

What strategies do you recommend to improve physician awareness and routine assessment of PSA doubling time in clinical practice?

I think the most important thing to improve our reporting of PSA doubling time is to remind clinicians why it's important to even calculate this number. This number is really most useful in the biochemical recurrent population of patients who have had previous treatment with either radiation or with surgery, and it's used for risk stratification, because patients who have a very long PSA doubling time don't necessarily need treatment, whereas those who have a shorter PSA doubling time may benefit more intensely from treatment, and these treatments we know can prolong the time to metastasis and potentially prolong survival, although that, I would say, is still being assessed. The most important thing is to be aware of this. The second most important thing, I think, is to understand where we can find online these reliable and valid PSA doubling time calculators, because the finding that some physicians are trying to calculate the PSA doubling time but really not getting it right and overestimating it also suggests that we're not really using the right tools to get to this number. Use of these online calculators, I think, can be really helpful rather than just guessing or doing mental math. The final thing would be, if it existed, or could be in some people's EMRs, is if there was a PSA doubling time calculator or algorithm within the electronic medical record, that would be a simple way for the system to pull and calculate these numbers, which are structured data, so this should be possible, and insert them directly into the medical record, into the note in patients in whom it's relevant. Again, this is really just relevant in the biochemical recurrent population, where we know that it's actually really important for making treatment choices.

This transcription was AI generated and edited by human editors for clarity.

"I think the most important thing to improve our reporting of PSA doubling time is to remind clinicians why it's important to even calculate this number," says Alicia Morgans, MD, MPH.

Nima Sharifi, MD, shares key findings from the study, “HSD3B1 and overall survival (OS) in high-risk non-metastatic (M0) and metastatic (M1) prostate cancer starting androgen deprivation therapy (ADT) in the enzalutamide (ENZ) and abiraterone acetate plus prednisolone (AAP) STAMPEDE phase 3 trial."

Nima Sharifi, MD, on the link between HSD3B1 and OS in prostate cancer

, shares key findings from the study, “

 and overall survival (OS) in high-risk non-metastatic (M0) and metastatic (M1) prostate cancer starting androgen deprivation therapy (ADT) in the enzalutamide (ENZ) and abiraterone acetate plus prednisolone (AAP) STAMPEDE phase 3 trial,” which he presented at the 

Sharifi is a professor and the scientific director at the Desai Sethi Urology Institute of the University of Miami in Florida.

That study is based on some basic mechanistic work on this gene, 

, in which half of all men inherit a hyperfunctioning form of this enzyme that drives androgen biosynthesis from non-testicular precursor steroids and allows tumors to become resistant to castration more quickly. There's a wealth of clinical data out there showing that men, specifically men with low volume metastatic castrate-sensitive prostate cancer, when they inherit this enzyme, they progress more quickly; they have shorter overall survival.

This study specifically, in STAMPEDE, looked at a randomized phase 3 clinical trial out of the UK that randomized men to either standard of care, which is basically medical castration, vs medical castration plus abiraterone plus enzalutamide, all in the setting of castrate-sensitive prostate cancer, non-metastatic disease, M1 low volume and M1 high volume. We hypothesized based on prior work that specifically men with low-volume disease, if they inherit this hyperactive form of 

, they'll have shorter overall survival. It turns out that that's true. We see that signal across the entire cohort.

There are 2 observations based on these data. One is that these outcomes in men treated in standard of care arm, meaning medical castration, that validates prior data that we published in CHAARTED. The second thing, which is perhaps a bit surprising, is that when you inherit this hyperfunctioning form of the enzyme, 

, even men who get more intensive therapy with medical castration plus enzalutamide plus abiraterone continue to have worse overall survival. So, getting that intensified therapy doesn't appear to reverse the outcomes. A bit surprising, but I think something that we need to understand much better.

“We hypothesized based on prior work that specifically men with low-volume disease, if they inherit this hyperactive form of HSD3B1, they'll have shorter overall survival. It turns out that that's true,” says Nima Sharifi, MD. 

Alicia Morgans, MD, MPH, gives an overview of the study “Impact of physicians’ awareness of prostate-specific antigen doubling time (PSADT) on treatment (Tx) decisions in high-risk (HR) biochemically recurrent (BCR) prostate cancer (PC)."

Alicia Morgans, MD, MPH, on physician awareness of PSA doubling time in prostate cancer

 gives an overview of the study “Impact of physicians’ awareness of prostate-specific antigen doubling time (PSADT) on treatment (Tx) decisions in high-risk (HR) biochemically recurrent (BCR) prostate cancer (PC),” which she presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California. Morgans is a genitourinary medical oncologist and the director of the Survivorship Program at Dana-Farber Cancer Institute in Boston, Massachusetts.

Please provide an overview of this study and its notable findings.

This study was a retrospective, observational, multi-site study that was really pulled from physician abstracted medical chart reviews from an EMR using Cardinal Health oncology data. And I think it's really important, as we set the stage for the study, that we were doing this to better understand how treatment decisions are being made for patients who have hormone-sensitive, high-risk biochemical recurrence, or this kind of newer name for it: non-metastatic castrate-sensitive prostate cancer, and we were just trying to explore, in particular, PSA doubling time and whether physicians were using this routinely to understand the risk and to stratify their patients who had this high risk biochemical recurrent state disease. What we did was use this sort of registry of data...and pull out different data points so that we could understand the patient population. And one of those points was to understand whether or not physicians were reporting in their notes this concept of PSA doubling time, which, of course, is really just, in essence, the time it takes for the PSA to double. Importantly, we don't just make a gestalt, or guess with our heads. We actually have to plug these numbers and dates into calculators to get reliable and valid assessments of PSA doubling time. Ideally, we are able to plug numbers back over the preceding 6 to 12 months to get something that's a bit of a stable estimate. In any event, when we did this and we looked at whether or not patients were reporting this, we found that actually, many, many physicians were not reporting PSA doubling time, and actually, it was more common to have an unknown PSA doubling time in the chart, rather than a known PSA doubling time. The other thing that I think was really important is that when physicians were reporting the PSA doubling time, they were often reporting that it was longer than it was when we went back and double checked their work and plugged those PSAs into the calculator to see what the valid and reliable, stable, PSA doubling time actually was on a double check calculation. They were essentially estimating it to be longer than it was, meaning that they were underestimating the aggressiveness of the cancer. I would also say that when we looked into which patients were having these doubling times calculated, we found that it was more commonly calculated for people who were older, had a recurrence of their prostate cancer or a rising PSA more quickly after the initial treatment. These patients often had higher Gleason scores, higher performance statuses, so they were frailer patients, and they may have had higher baseline PSA levels as well. So physicians were trying to kind of target those individuals, I think, who they believed, may have had higher risk disease when they were actually doing the calculation. But in general, they were really under calculating, or at least under reporting this number in a large number of patients.

"We found that actually, many, many physicians were not reporting PSA doubling time," says Alicia Morgans, MD, MPH.

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