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The mean change in IPSS from baseline to 3 months was 12.9 in the Aquablation arm vs 13.1 in the LEP arm.

WATER III: Aquablation achieves comparable outcomes to laser enucleation for BPH

“The addition of the durvalumab did not make treatment more morbid than chemotherapy alone, and it didn't change or increase the surgical complications you saw in the ward," says James W.F. Catto, MBChB, PhD, FRCS.

Additional NIAGARA data reinforce benefit of perioperative durvalumab in MIBC

“These findings reinforce isodose MHFRT as the standard of care, offering the same cancer control as conventional treatment but with fewer side effects than dose-escalated MHFRT,” says Amar U. Kishan, MD. 

Data reinforce isodose MHFRT as standard of care radiotherapy regimen

“Our study identifies that men who were invited for screening, but do not attend screening appointments are at significantly higher risk of dying from prostate cancer compared to men who were not offered screening or accepted an invitation for screening,” says Renée Leenen MD.

Avoidance of prostate cancer screening linked to increased risk of PCSM

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"The implication for real-world decision-making is that this drug appears to hold up to what was seen in the trial," says Mark D. Tyson II, MD, MPH. 

Nadofaragene firadenovec maintains safety, efficacy in real-world population 

"At 3 months, those patients had a 79% complete response rate, which was durable in 74% at 6 months and 60% at 9 months," says Jacob A. Moyer, BS.

Investigators highlight real-world data on nadofaragene firadenovec in NMIBC

Dr. De La Cerda provides an overview of a patient case involving a 68 year-old male presenting with severe back pain, with an analysis of the clinical presentation, workup, and medical history.

Bone Predominant mCRPC Patient Case

Video content above is prompted by the following:

What are your initial impressions of the case?

Video Series

The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

News

FDA accepts BLA for subcutaneous nivolumab in solid tumors

Real-world data indicate a significantly lower incidence of all-cause bowel disorders in patients with prostate cancer who received radiotherapy treatment along with placement of a polyethylene glycol-based hydrogel spacer (spaceOAR) vs patients who did not receive a spacer.

®, Michael R. Folkert, MD, PhD, explained, “What we were doing with this study is we were trying to look at real-world data for spacer use. We have a lot of prospective data to guide us in in our care of patients, but it's nice to see what happens when you actually apply it to real patients.” Folkert is a professor of radiation oncology at the University of Washington School of Medicine, Seattle.

For the study, Folkert and his colleagues evaluated data on patients from 4 separate data sets: Medicare 5% Standard Analytic Files, Medicare 100% Standard Analytic Files, Merative MarketScan Commercial Database, and Premier Healthcare Database. Patients with prostate cancer who were treated with radiotherapy between 2015 and 2021 were included in the analysis.

“From those data sets, we were able to extract a range of codes for disorders and procedures that were related to bowel complaints to bowel disorders, and then conducted an analysis to probe associations between these codes and the use of rectal spacers, and then a comparison also of disorders and procedures the same sets of disorders and procedures related to bowel complaints and disorders on an age-matched general population that didn't have prostate cancer, to kind of ground the that experience in a general population,” Folkert said.

Regarding their findings, “4 years following radiation therapy, there is a 25% lower hazard of bowel disorders and a 46% lower hazard of related procedures [in patients who received a spacer],” Folkert said.  

1. Folkert MR, Sato R, Yu JB, et al. Bowel disorder incidence and rectal spacer use in patients with prostate cancer undergoing radiotherapy. 

. 2025;8(3):e250491. doi:10.1001/jamanetworkopen.2025.0491

A study evaluated the impact of polyethylene glycol-based hydrogel spacers on bowel disorder incidence in prostate cancer patients undergoing radiotherapy. Using real-world data from multiple databases, researchers found that patients with spacers experienced significantly lower rates of bowel disorders and related procedures compared to those without spacers. Specifically, there was a 25% reduction in the hazard of bowel disorders and a 46% reduction in related procedures four years post-radiotherapy. This study highlights the potential benefits of spacer use in reducing bowel complications in prostate cancer treatment.

"4 years following radiation therapy, there is a 25% lower hazard of bowel disorders and a 46% lower hazard of related procedures [in patients who received a spacer],” says Michael R. Folkert, MD, PhD.

Michael R. Folkert, MD, PhD, discusses real-world outcomes with spacer in prostate cancer

 show that the overall prevalence of kidney stones in US adults has remained relatively stable over the past decade but there has been a notable increase in prevalence among women.

The data were collected from the National Health and Nutrition Examination Survey (NHANES). In total, 38,329 patients aged 20 and older were captured in the analysis. The mean age of participants was 37.4 years (standard errors [SE], 0.2), and 51.1% (SE, 0.2%) of patients were female. Further, 62.6% (SE, 1.5%) of patients were White; 12.1% (SE, 0.8%) were Black; 10.3% (SE, 0.8%) were Mexican American; 8.4% (SE, 0.4%) were of another race or were multi-race; and 6.6% (SE, 0.5%) were of another Hispanic origin.

Data showed that among all patients, the weighted prevalence of kidney stones was 8.9% (SE, 0.6%) from 2007 to 2008, which remained relatively stable at 9.9% (SE, 0.6%) from 2017 to 2020 (

 = .23). The rates were also relatively stable among male patients (11.5% vs 10.8%, 

 = 0.59) as well as across all racial/ethnic groups.

However, the rate increased significantly among female patients during the same period. Between 2007 and 2008, the prevalence of kidney stones among women was 6.5% (SE, 0.5%), which rose to 9.1% (SE, 0.9%) from 2017 to 2020 (

The authors noted, “Historically, stone disease prevalence was higher in males than females, but this gap has narrowed in recent decades, especially among younger women.”

Specifically, the prevalence of kidney stones among women aged 20 to 39 increased from 4.7% (SE, 0.7%) between 2007 and 2008 to 6.4% (0.7%) between 2017 and 2020 (

 = 0.12). An increase was also observed among women aged 40 to 64, rising from 10.7% (SE, 0.9%) between 2007 and 2008 to 11.7% (SE, 1.1%) from 2017 to 2020 (

However, the prevalence of kidney stones showed a different trend among women aged 65 and older, increasing from 13.3% (SE, 1.1%) between 2007 and 2008 to 15.6% (SE, 1.1%) from 2015 to 2016. The rate decreased to 12.3% (SE, 0.9%) between 2017 and 2020 (

According to the authors, the rise in kidney stone prevalence among women, particularly those younger than 60 years, could be due to a number of factors. For example, it could be due to an increase in the prevalence of severe obesity, which increased from 30.5% to 42.4% in US adults over the past 2 decades. The authors noted that obesity increases the risk of kidney stone formation, and this risk may be greater in obese women vs obese men.

They explained, “Obese women might also be at a higher risk of forming stones compared with obese men. A previous study determined that the relative risk of incident stones in obese men is 1.27 vs that in normal weight men, whereas in obese women the risk was up to 2.09 times higher than in normal weight women.”

Other possible reasons for this rise, they suggest, could include metabolic syndrome, as well as shifting attitudes and cultural norms. On the latter, they speculate that more women in the workforce may lead to improved access to health insurance and, therefore, access to health care services, which may result in increased detection of asymptomatic stones.

However, they highlight several limitations of the current study, including its cross-sectional design and the potential for recall bias due to the reliance on self-report in the NHANES dataset. Additionally, they note, “Important factors, such as dietary habits, body composition, and environmental exposures, as well as stone-specific information like stone composition and 24-hour urinary metabolites, were not fully captured.”

1. Chen KW, Meskawi M, Miller LE, et al. Trends in kidney stone prevalence among U.S. adults: a concerning contemporary gender analysis from the NHANES database. 

. 2025;19(2):58-60. doi:10.5489/cuaj.8935

2. Taylor EN, Stampfer MJ, Curhan GC. Obesity, weight gain, and the risk of kidney stones. 

. 2005;293(4):455-62. doi:10.1001/jama.293.4.455

The prevalence of kidney stones in US adults has remained stable over the past decade, but there is a significant increase among women, particularly those under 60. Data from the NHANES survey indicate that the prevalence among women rose from 6.5% to 9.1% between 2007-2008 and 2017-2020. Factors such as increased obesity rates, metabolic syndrome, and improved healthcare access may contribute to this trend. The study's limitations include its cross-sectional design and reliance on self-reported data, which may introduce recall bias and omit important factors like dietary habits.

The overall prevalence of kidney stones remained stable, with a notable increase observed among women. 

Kidney stone prevalence is increasing in women, study findings show

 is an associate professor of urology/urologic oncology at the Keck School of Medicine of the University of Southern California in Los Angeles.

Patients undergoing radical cystectomy are confronted with not only the prospect of cancer, chemotherapy and major surgery but also with choosing a type of urinary diversion. Most patients have never heard of a urinary diversion, nor do they have any experience to help them choose which life-altering reconstruction will be best for them. As clinicians, we are tasked with counseling patients to help them make the best choice, often in a short period of time. Often, this counseling is also the first time we have met the patient. 

Unfortunately, we know that, according to the National Cancer Database, up to 88% of all diversions in the US are noncontinent as of 2015.

 Conversely, most patients express that if they have the choice, they would prefer a continent diversion. It is unclear what is driving this discrepancy, but it does not seem to entirely be patient choice. I believe it is incumbent on urologists to approach diversion counseling from a holistic perspective to help match a patient with the choice that feels right to them. When counseling patients, I use the following framework to guide the discussion of diversion.

Most of the time, tumor location will not influence available diversion types. While prostatic urethral involvement in men and bladder neck involvement in women may predict a higher likelihood of urethral involvement,

 I use the intraoperative frozen section of the urethral margin to make a final determination of eligibility for neobladder.

 In the setting of high-grade invasive disease on a frozen section, I do not perform an orthotopic diversion and would opt for a cutaneous option.

In women, a high-volume tumor in the trigone or posterior bladder with palpable mass may lead to resection of the anterior vaginal wall. However, several studies have demonstrated that even in these situations, preservation of some or all female pelvic organs is usually feasible, and preservation is not related to tumor recurrence or positive margin.

 Resection of the anterior vaginal wall may correlate with a higher risk of neobladder-vaginal fistula if a neobladder is formed,

 but an omental flap can limit this risk to a rate of approximately 5%. I counsel patients on the small risk of neobladder-vaginal fistula and discuss that continent cutaneous diversion would eliminate this risk. In men, urethral stricture disease may preclude orthotopic diversion. In general, prostatic urethral involvement alone or carcinoma in situ (CIS) on the frozen section of the urethra would not exclude orthotopic diversion.

Continent diversion is known to be associated with long-term electrolyte imbalances, such as hypokalemic, hyperchloremic metabolic acidosis.

 Patients with preoperative chronic kidney disease and an estimated glomerular filtration rate of lower than 40

 may be at higher risk of long-term metabolic issues and worsening renal functional decline with continence diversion. These patients may be best served by an ileal conduit.

Patients with underlying bowel issues such as Crohn’s disease or ulcerative colitis may be excluded as candidates for diversions requiring segments of the colon or long segments of small bowel. Patients with underlying cirrhosis or liver dysfunction are likely at risk for major metabolic disturbance with any form of diversion utilizing the bowel. In these extreme situations, cutaneous ureterostomies may be considered if feasible.

Although tumor-related or metabolic issues are more objective, the most important factors in helping patients choose a diversion are usually more subjective and personal. Thus, it is important to complete a meticulous history and physical, delver into a patient’s lifestyle and goals and explain the options thoroughly to effectively counsel a patient.

Understanding a patient’s preoperative continence is vital. Many patients will present with incontinence that is related to the recent transurethral resection of the bladder tumor, underlying tumor factors, widespread cis, or poorly functioning bladder due to intravesical therapy or prior radiation. In these cases, removing the bladder will eliminate the incontinence related to “bladder function” and should not influence diversion choice. In women with long-standing stress urinary incontinence (SUI), I do not recommend an orthotopic diversion. However, for men—even those with mild SUI or prior pelvic radiation—it is appropriate to discuss neobladder, with the understanding that a patient may require an artificial urinary sphincter at a later date.

For women, it is important to discuss the risk of needing to perform clean intermittent catheterization (CIC) of a neobladder. Although the data on hypercontinence are variable, in most studies, the range of the need for CIC is between 20% and 40%.

 If women are not willing to consider catheterization of the urethra, I generally do not recommend a neobladder. Similarly, if a patient’s body habitus, hand function, or overall mental and physical functional status do not suggest that they can catheterize independently on a schedule, I do not recommend any form of continent diversion.

Conversely, in men, obesity may favor a neobladder rather than a stoma, which carries a higher risk of parastomal hernia.

 Additionally, there is only a 2% to 20% risk of retention and need for self-catheterization in men. Patients with hand issues may have severe challenges with precisely cutting and changing appliances and may enjoy more independence with a neobladder.

Finally, most patients worry about completing routine activities, sleeping, and traveling with a urinary diversion. I reassure patients that they will have no limitations in their lifestyle with any of the forms of urinary diversion. For patients whose main form of exercise is a water sport, we do discuss that a continent diversion may be more practical than a stoma.

At the time of initial consultation, many patients are on information overload with discussions about their cancer care as well as the myriad of considerations for choosing the proper diversion. During the initial consultation, I provide written information and drawings of the various diversions,. as well as the Bladder Cancer Advocacy Network’s (BCAN) excellent “Bladder Cancer Basics” book.

 Patients and caregivers are strongly encouraged to attend a preoperative Zoom educational session with our bladder cancer team, which is led by the enterostomal nurses and includes other peri-op team members such as pelvic floor physical therapists and nutritionists. Many patients have expressed that connecting with other patients directly through either BCAN’s Survivor to Survivor network or through individually matched patients from our own practice provides invaluable support and practical advice.There are also several tools available for supporting patient decision-making offering pictoral representations of complications.

Ultimately, there is no “right choice” when it comes to urinary diversion. Because of the irreversibility of a diversion, most patients have only experienced one type of reconstruction, and have no basis for cross comparisons. Moreover, the literature suggests that patients are generally satisfied with their choice.

 It is up to providers to help the patient understand their options and the possible long-term complications of whichever urinary diversion type they choose without the overlay of our own preferences and biases. Moreover, it is incumbent on faculty surgeons to teach our trainees multiple forms of diversion so that choice is preserved for patients requiring diversion in the future.

1. Lin-Brande M, Nazemi A, Pearce SM, et al. Assessing trends in urinary diversion after radical cystectomy for bladder cancer in the United States. 

. 2019;37(3):180.e1-180.e9. doi:10.1016/j.urolonc.2018.11.003

2. Gore JL, Yu HY, Setodji C, et al; Urologic Diseases in America Project. Urinary diversion and morbidity after radical cystectomy for bladder cancer. 

. 2010;116(2):331-339. doi:10.1002/cncr.24763

3. Stein JP, Esrig D, Freeman JA, et al. Prospective pathologic analysis of female cystectomy specimens: risk factors for orthotopic diversion in women. 

. 1998;51(6):951-955. doi:10.1016/s0090-4295(98)00099-5

4. Gregg JR, Emeruwa C, Wong J, et al. Oncologic outcomes after anterior exenteration for muscle invasive bladder cancer in women. 

.2016;196(4):1030-1035. doi:10.1016/j.juro.2016.04.090

5. Gakis G, Schmid MA, Hassan F, Stenzl A, Renninger M. The accuracy of sequential urethral frozen section and its impact on urethral recurrence after radical cystectomy. 

. 2022;20(5):e390-e395. doi:10.1016/j.clgc.2022.04.007

6. Laukhtina E, Moschini M, Soria F, et al. Follow-up of the urethra and management of urethral recurrence after radical cystectomy: a systematic review and proposal of management algorithm by the European Association of Urology-Young Academic Urologists: Urothelial Carcinoma Working Group. 

. 2022;8(6):1635-1642. doi:10.1016/j.euf.2022.03.004

7. Stein JP, Clark P, Miranda G, Cai J, Groshen S, Skinner DG. Urethral tumor recurrence following cystectomy and urinary diversion: clinical and pathological characteristics in 768 male patients. 

.2005;173(4):1163-1168. doi:10.1097/01.ju.0000149679.56884.0f

8. Djaladat H, Bruins HM, Miranda G, Cai J, Skinner EC, Daneshmand S. Reproductive organ involvement in female patients undergoing radical cystectomy for urothelial bladder cancer. 

. 2012;188(6):2134-2138. doi:10.1016/j.juro.2012.08.024

9. Rosenberg S, Miranda G, Ginsberg DA. Neobladder-vaginal fistula: the University of Southern California experience. 

. 2018;37(4):1380-1385. doi:10.1002/nau.23454

10. Sperling CD, Lee DJ, Aggarwal S. Urinary diversion: core curriculum 2021. 2021;78(2):293-304. doi:10.1053/j.ajkd.2020.12.023

11. Murray KS, Arther AR, Zuk KP, Lee EK, Lopez-Corona E, Holzbeierlein JM. Can we predict the need for clean intermittent catheterization after orthotopic neobladder construction? 

. 2015;31(4):333-338. doi:10.4103/0970-1591.166460

12. Clifford TG, Shah SH, Bazargani ST, et al. Prospective evaluation of continence following radical cystectomy and orthotopic urinary diversion using a validated questionnaire

. 2016;196(6):1685-1691. doi:10.1016/j.juro.2016.05.093

13. Ghoreifi A, Allgood E, Whang G, et al. Risk factors and natural history of parastomal hernia after radical cystectomy and ileal conduit. 

Patients undergoing radical cystectomy face complex decisions regarding urinary diversion, often without prior knowledge or experience. Despite a preference for continent diversions, most patients receive noncontinent options, suggesting factors beyond patient choice influence decisions. A holistic approach to counseling is essential, considering disease, physiological, and personal factors. Tools like educational materials and support networks aid decision-making. Ultimately, no single "right choice" exists, and patient satisfaction is generally high. Providers must guide patients without bias and ensure future surgeons are trained in diverse diversion techniques to preserve patient choice.

"Ultimately, there is no 'right choice' when it comes to urinary diversion," writes Anne K. Schuckman, MD.

Jacob A. Moyer, BS

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