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Corinna Hughes, DNP, sits down with Amy Pearlman, MD, to discuss the evolving recognition of APPs in urology. 

Pearls & Perspectives: Evolving role of APPs in urology, with Corinna Hughes, DNP, at AUA 2025

Articles

Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

Twelve-month physical functioning scores were comparable between the radical cystectomy arm and the bladder-sparing therapy arm.

CISTO: Radical cystectomy has key role in recurrent high-grade NMIBC

The investigators reported an overall incidence of AEs of 29.6%.

Safety, efficacy of vibegron sustained in men with OAB treated for BPH

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

FDA updates in urology: April 2025

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Clinical Focus

Leonard G. Gomella, MD, FACS; Maha Hussain, MD, FACP, FASCO; Daniel P. Petrylak, MD

18th Annual Interdisciplinary Prostate Cancer Congress® and Other Genitourinary Malignancies

"The combination demonstrated clinical activity and an acceptable safety profile in the perioperative setting for locally advanced, non-metastatic clear cell RCC," says Mehmet Asim Bilen, MD. 

Perioperative lenvatinib/pembrolizumab shows promise in non-metastatic ccRCC

"We must lobby to maintain our current funding levels and push for increased support to continue driving progress in cancer care," says Michael S. Cookson, MD, MMHC, FACS.

The importance of federal funding in cancer research: A call to action

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

FDA updates in urology: March 2025

The European Commission must issue a decision on the application on or by June 2, 2025.

Subcutaneous nivolumab under review in EU for solid tumors

"The positive results from this phase 3 study of the sintilimab and fruquintinib combination represent a significant advancement in the treatment of advanced renal cell carcinoma,” says Prof Zhisong He. 

Sintilimab/fruquintinib combo meets primary PFS end point in advanced RCC 

found that in the oncology medical literature, women had a 15% lower Altmetric Attention Score (AAS) as first authors, and an 8% lower (AAS) in the last author position.

®, study author Rebecca A. Campbell, MD, described the background for the study.

“We focused on oncology specifically, and looked at various oncology subspecialties [as well as] medical oncology as a whole. We looked at 2 things mainly. One [was] citation rates, so rates of over- or under-citation. [We also looked at] a metric called Altmetric Attention Score, which takes into account media mentions, Twitter or X mentions, patent mentions—a wide variety of ways that research can be cited. We specifically were looking at combinations of first and last authors. We had author of papers that were male first authors/male last authors, women first authors/women last authors, as well as other combinations like male-women and women-male. We looked at over 600,000 citations, so quite a large amount of studies included,” said Campbell, a urologic oncology fellow at Cleveland Clinic in Cleveland, Ohio.

Rebecca A. Campbell, MD, discusses gender disparities in oncology research citations

Study data point to gender disparities in oncology research citations

In addition to the gender disparities seen in AAS as first and last authors, Campbell and her coauthors looked at mean citation percentage difference, “which would be that if men were over-cited, they would be positive, and if women were under-cited, they would be negative,” Campbell said. Men-men combinations, she said, were over-cited by 16% and women-women combinations were under-cited by 7.7%.

“Another main finding is that there was a lot of variation across all of the oncology subspecialties. So overall, we did find that there were significant gender disparities with both citation rates and with all metric attention score,” Campbell said.

1. Campbell RA, Helstrom E, Chew L, et al. Gender disparities in citations and Altmetric Attention Score in oncology. 

2025 Apr 10:OP2400767. doi: 10.1200/OP-24-00767

Videos

Receiving an initial diagnosis of renal cell carcinoma (RCC) is often an overwhelming experience for patients. As a result, they may struggle to retain the wealth of new information given to them at this point, including treatment options, potential outcomes, and other next steps.

In an effort to help patients navigate this aspect of their cancer journey, Hackensack University Medical Center has launched a 

 specifically for patients who have received a diagnosis of RCC.

 This website is meant to educate patients and their caregivers on what kidney cancer is, the different stages of the disease, possible treatment options, what to expect when living with RCC, and more.

, outlines the rationale for the creation of this tool as well as the benefits of this resource for patients and their caregivers.

“It took us 2 years to get everything together,” explained Yerram. “We got multiple different leaders in the field—pharmacists, the palliative care team, radiation oncologists, medical oncologists—to come together in an interdisciplinary way to put together a resource center for patients. That's what we want it to be. This is purely for patients and their caregivers, because they're a large part of this whole treatment process as well. We felt like the best type of patient, the best outcomes, come from someone who's informed and who's educated about their disease, and we really wanted to be able to provide that for them.”

Yerram is a urologic oncologist at Hackensack University Medical Center in New Jersey.

Nitin K. Yerram, MD, outlines the rationale for the creation of this tool as well as the benefits of this resource for patients and their caregivers/

Nitin Yerram, MD, highlights new resource center for patients with renal cell carcinoma

Yerram also explained that the website includes videos and diagrams to help patients digest information in a different way. The hope, he says, is that patients can come to their next visit better informed and prepared to ask key questions about their specific treatment plan.

“Having [a] more informed discussion with the patient really helps everyone,” said Yerram. “I think it's a helpful resource for anyone, whether it be clinicians or caregivers or patients. The website is 

, so we really hope to see patients use it.”

1. Hackensack University Medical Center launches educational website for people with kidney cancer. News release. Hackensack Meridian Health. January 8, 2025. Accessed April 20, 2025. https://www.hackensackmeridianhealth.org/en/news/2025/01/08/hackensack-university-medical-center-launches-educational-website-for-people-with-kidney-cancer

The website is meant to educate patients and their caregivers on several aspects of the kidney cancer journey. 

The 40th Annual European Association of Urology Congress in Madrid, Spain, featured an extensive scientific program. In a recent video for 

, Betty Wang, MD, provided insight on 3 presentations that she believes “may be game changing” in urology.

The first study Wang highlighted was “Micro-ultrasound-guided versus MRI-guided biopsy for prostate cancer diagnosis: The OPTIMUM randomized clinical trial.”

“OPTIMUM was an international randomized study that compared micro-ultrasound guided vs MRI-guided biopsy for prostate cancer diagnosis,” explained Wang, a Society of Urologic Oncology fellow at Cleveland Clinic in Cleveland, Ohio.

“The authors noted that OPTIMUM demonstrated [that] micro ultrasound is non inferior to MRI fusion biopsy for detecting clinically significant prostate cancer and established itself as an appealing alternative to MRI for image guided biopsy. This would mean having a single procedure for both imaging and biopsy, and that could potentially be less expensive without using IV contrast, which is currently needed for multi-parametric MRIs,” Wang said.

The second study she highlighted was “Surgical outcomes and neoadjuvant safety with perioperative durvalumab for muscle-invasive bladder cancer (NIAGARA).”

 Previously reported data from the NIAGARA trial showed that perioperative durvalumab (Imfinzi) plus neoadjuvant chemotherapy extended event-free survival and overall survival vs neoadjuvant chemotherapy alone in muscle-invasive bladder cancer (MIBC).

 The FDA recently approved this treatment regimen for adult patients with MIBC.

At EAU, Wang said, investigators presented data on “the perioperative safety of durvalumab.”

“One of the main takeaways from this presentation was that durvalumab had no significant impact on the patient's ability to undergo surgery. In fact, if you look at the divide between the 2 arms, the addition of durvalumab actually increased the percentage of patients who underwent radical cystectomy from 83% (the chemo arm), compared to 88% (the chemo plus durvalumab arm). So if anything, it did not reduce the number of patients that could get their surgery in terms of cystectomy timing,” Wang said.

Betty Wang, MD, provided insight on 3 presentations that she believes “may be game changing” in urology.

Betty Wang, MD, recaps 3 key urologic cancer studies from EAU 2025

The final study Wang discussed was “AURORAX-0087A: Urine Glycosaminoglycan Scores for Surveillance of Recurrence in Intermediate and High-risk Non-metastatic Clear Cell Renal Cell Carcinoma - An Observational Prospective Multicenter Diagnostic Test Cohort Study.”

“This study demonstrates that urine GAGome scores can be a promising biomarker for clear cell RCC [renal cell carcinoma] recurrence. It has a 97% negative predictive value, meaning a negative test can almost definitely rule out a recurrence. In terms of clinical impact, this could potentially reduce unnecessary imaging costs and radiation exposure to the patient,” Wang said.

1. Kinnaird A, Luger F, Cash H, et al. Micro-ultrasound-guided versus MRI-guided biopsy for prostate cancer diagnosis: The OPTIMUM randomized clinical trial. Presented at: 40th Annual European Association of Urology Congress. March 21-24, 2025. Madrid, Spain

2. Catto JWF, Al-Ahmadie H, van der Heijden MS, et al. Surgical outcomes and neoadjuvant safety with perioperative durvalumab for muscle-invasive bladder cancer (NIAGARA) Presented at: 40th Annual European Association of Urology Congress. March 21-24, 2025. Madrid, Spain

3. Powles T, Catto JWF, Galsky MD. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. 

. 2024;391:1773-1786. doi:10.1056/NEJMoa2408154

4. FDA approves durvalumab for muscle invasive bladder cancer. News release. US Food & Drug Administration. Published online and accessed March 28, 2025. 

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer

5. Dabestani S. AURORAX-0087A: Urine Glycosaminoglycan Scores for Surveillance of Recurrence in Intermediate and High-risk Non-metastatic Clear Cell Renal Cell Carcinoma - An Observational Prospective Multicenter Diagnostic Test Cohort Study. Presented at: 40th Annual European Association of Urology Congress. March 21-24, 2025. Madrid, Spain

Betty Wang, MD, provides insight on 3 presentations that she believes “may be game changing” in urology.

The phase 2 STARLITE 2 trial (NCT05239533) is assessing the safety and efficacy of 

Lu-girentuximab in combination with nivolumab for the treatment of patients with advanced clear cell renal cell carcinoma (ccRCC) that has the CAIX protein.

, shared the background/rationale for the trial, which was also presented at the 

2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium

 Feldman is a GU medical oncologist, associate attending physician, and section head of the germ cell cancer program within the GU oncology service at Memorial Sloan Kettering Cancer Center in New York, New York.

Darren R. Feldman, MD, shared the background/rationale for the STARLITE 2 trial

Darren Feldman, MD, on study of 177Lu-girentuximab plus nivolumab for ccRCC

In total, the study plans to enroll 41 patients across 7 clinical trial sites in the US.2 The study will be conducted with a safety lead-in to determine the maximum tolerated dose (MTD) of 177Lu-girentuximab in this patient population. Dosing in this phase will begin at 1804 MBq/m

 (75% of single agent MTD), which may be escalated to 2405 MBq/m

 (cohort 2; single agent MTD) or de-escalated to 1353 MBq/m

 (cohort -1). Once the MTD is determined, the study will proceed to the expansion phase.

The primary end point for the expansion phase is response rate per RECIST v1.1, assessed within 24 weeks. Secondary end points will include progression-free survival, overall survival, and toxicity.

Zr-girentuximab PET/CT is used as the tracer for imaging, and 

Lu-girentuximab is used for the therapeutic. 

Zr-DFO-girentuximab is currently under review for approval in the US, with a PDUFA date set for August 27, 2025.

1. Feldman DR, Motzer RJ, Knezevic A, et al. STARLITE 2: Phase 2 study of nivolumab plus 177lutetium-labeled anti–carbonic anhydrase IX (CAIX) monoclonal antibody girentuximab (177Lu-girentuximab) in patients with advanced clear cell renal cell carcinoma (ccRCC). Presented at: 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium. February 13-15, 2025. San Francisco, California

2. Study of Nivolumab in Combination with 177Lu-girentuximab for Kidney Cancer. ClinicalTrials.gov. Last updated February 3, 2025. Accessed March 21, 2025. https://clinicaltrials.gov/study/NCT05239533

3. FDA accepts BLA for TLX250-CDx (Zircaix) for kidney cancer imaging, grants priority review. News release. Telix Pharmaceuticals. February 25, 2025. Accessed February 26, 2025. https://telixpharma.com/news-views/fda-accepts-bla-for-tlx250-cdx-zircaix-for-kidney-cancer-imaging-grants-priority-review/

The phase 2 STARLITE 2 trial is assessing 177Lu-girentuximab plus nivolumab in advanced clear cell renal cell carcinoma.

Francesca Jackson-Spence, MBChB, BMedSc, MRCP, highlights the ongoing phase 3 SAMETA trial (NCT05043090) in MET-driven locally advanced or metastatic papillary renal cell carcinoma. 

Francesca Jackson-Spence, MBChB, details the ongoing SAMETA trial in papillary renal cancer

Francesca Jackson-Spence,MBChB, BMedSc, MRCP, 

highlights the ongoing phase 3 SAMETA trial (NCT05043090) in MET-driven locally advanced or metastatic papillary renal cell carcinoma. The trial was initiated based on findings from the study, “Final overall survival and new ctDNA analysis in MET-driven advanced papillary renal cancer (CALYPSO; NCT02819596),” which was presented at the 

2025 American Society of Clinical Oncology Genitourinary Cancers Symposium

Jackson-Spence is a clinical research fellow in genitourinary oncology at Barts Cancer Institute, Queen Mary’s University in London.

SAMETA is an open-label randomized phase 3 study. It has 3 arms. It's comparing the savolitinib and durvalumab combination, durvalumab monotherapy, and sunitinib monotherapy. It's completed its enrollment; we've recruited around 200 patients globally. The study is conducted in that MET-driven subset, so patients with advanced papillary renal cancer that have MET-driven tumors. The primary end point is progression-free survival, and the secondary end points are overall survival, objective response rates, duration of response, and safety.

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

“The primary end point is progression-free survival, and the secondary end points are overall survival, objective response rates, duration of response, and safety.”

Kate H. Gessner, MD, PhD, discusses when to switch to a different systemic agent vs metastasis-directed therapy (MDT) following failure of immunotherapy in metastatic renal cell carcinoma.

Kate Gessner, MD, on systemic agents vs MDT after kidney cancer progression

, discusses when to switch to a different systemic agent vs metastasis-directed therapy (MDT) following failure of immunotherapy in metastatic renal cell carcinoma. Gessner took part in the discussion, “Case-Based Session: Failure of Immunotherapy in Renal Cell Cancer—What’s Next?” at the 

Gessner is an associate professor of urology at the University of North Carolina School of Medicine in Chapel Hill.

When we're deciding whether to switch to different systemic agents or to consider metastasis-directed therapy, we're really taking the whole clinical picture into account. Dr. Maria Bourlon today will talk about oligoprogression vs widespread metastatic progression. In the setting of oligoprogression, you can consider more of a metastasis-directed therapy, such as in the form of radiation therapy, which Dr. Raquibul Hannan and Dr. Leslie Ballas will talk about today. In that setting, in oligoprogression, radiation therapy to metastatic sites can extend progression-free survival. However, in the setting of widespread metastatic progression or failure, then we typically prefer more systemic therapy with metastasis-directed therapy for symptomatic sites.

“In the setting of widespread metastatic progression or failure, we typically prefer more systemic therapy with metastasis-directed therapy for symptomatic sites,” says Kate H. Gessner, MD, PhD.

Taylor Goodstein, MD, highlights an ongoing research project on the rates of upstaging and downstaging in larger kidney tumors

Taylor Goodstein, MD, highlights project on staging in larger kidney tumors

, highlights an ongoing research project on the rates of upstaging and downstaging in larger kidney tumors. Goodstein is an SUO fellow at Emory Urology in Atlanta, Georgia.

There's a study I'm working on right now. I'm actually working with one of my colleagues back at Ohio State. I started on this project when I was still there, with Dr. Eric Singer as the PI. What we're looking at is the upstaging of kidney tumors. The reason why we started asking that question [is that] kidney tumor upstaging has always been reported for smaller stage 1 tumors, because it might change your management from partial to radical nephrectomy, but there hasn't really been a need to know what the upstaging is between these larger tumors to more invasive tumors. Except for now we've got these perioperative trials that are happening, like the PROSPER-RCC trial (NCT03055013), which looked at giving a dose of nivolumab prior to doing a nephrectomy and then following with another short course of nivolumab. Ultimately, it was a negative study, but it required them to actually clinically stage patients for inclusion in that trial. When it came out as a negative study, there was a lot of questions. Why was it a negative study?

One of the big concerns was did we choose the right cohort of patients? These were clinically staged patients. How accurate was that clinical staging? If you look at the table of that trial, there was a significant amount of upstaging and even some downstaging that happened from their clinical to pathological stage. What we've been working on is a giant 30,000 patient database study using the National Cancer Database to see exactly what the rates are of upstaging and downstaging for these larger kidney tumors, and then taking that a step further and trying to see if there's a survival difference if the patient was upstaged or downstaged or not. So, I don't think anybody's really looked too much at that before. I'd say that's something that we're doing that's pretty novel.

“What we've been working on is a giant 30,000 patient database study using the National Cancer Database to see exactly what the rates are of upstaging and downstaging for these larger kidney tumors,” says Taylor Goodstein, MD. 

Tang discusses the limitations in available data, but nonetheless high potential, of SBRT in kidney cancer.

Chad Tang, MD: Considerations for SBRT in metastatic RCC

American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting

 in Washington DC, this month, Chad Tang, MD, of the department of GU Radiation Oncology at the MD Anderson Cancer Center, discussed the utility of stereotactic body radiation therapy (SBRT) in the treatment of patients with metastatic 

As Tang noted in his ASTRO 2024 presentation topic, SBRT has been linked to significantly high rates of patients achieving progression-free survival, even without systemic therapy, for kidney cancer over about the span of a year now—though more research needs to inform the promising early evidence.

“There’s no high-level data, there’s no phase 3 randomized trials comparing these different strategies for both oligometastatic and oligo-progressive (RCC),” Tang said. “Another area I would want to highlight is that there’s a big gap in treating the primary in patients with metastatic disease.”

Regardless, SBRT’s position as an option to spare use of systemic therapy or possibly even change patients’ natural history is not being undone by any more recent study findings.

“And as we all know, (RCC) can be quite indolent sometimes,” Tang said. “We know it can be quite heterogeneous sometimes in terms of its genetic makeup, and sometimes one site just has a different evolution and it progresses while on IO/IO and IO/TKIO, and we can control that.”

Regarding the clinician-patient discussion around SBRT to treat metastatic RCC, Tang recommended his colleagues practice frankness around the level of available data supporting the treatment strategy—especially based on the patient’s age.

“In my experience, a lot of younger patients want the kitchen sink thrown at them for any possible benefit,” Tang said. “You have to be frank about, 'We can do this, but the level of evidence is thus, and not robust usually.' But usually, we also say that a lot of these techniques that we've done, the side effect profile is relatively modest.”

Stereotactic body radiation therapy (SBRT) is emerging as a promising treatment for metastatic renal cell carcinoma (RCC), potentially offering progression-free survival without systemic therapy. Despite the lack of high-level data or phase 3 trials, SBRT remains a viable option, especially for oligometastatic and oligo-progressive RCC. The treatment's efficacy may vary due to RCC's genetic heterogeneity. Clinicians are advised to discuss the limited evidence supporting SBRT with patients, particularly younger ones, while noting its relatively modest side effect profile.

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Zaorsky discusses the patient safety misconceptions around radiotherapy for RCC, and considering patient-reported outcomes in future randomized controlled trials.

Kidney Cancer

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