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"This trial will be the benchmark for research reporting in the future," says Melissa R. Kaufman, MD, PhD, FACS. 

Artificial urinary sphincter for SUI shows safety, efficacy in prospective study

Patient-reported pain scores were significantly improved with stent omission. 

Stent omission after ureteroscopy is safe, improves patient-reported outcomes 

“We do not feel that our results undermine the importance of fluid intake for stone prevention," says Alana C. Desai, MD. 

Intervention to increase fluid intake does not reduce recurrent stones

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

Data showed that physical function and self-reported frailty assessments were poorly correlated.

Physical function and frailty measures offer distinct insights in patients with bladder cancer 

Urology Times is the leading resource for urologists & allied health professionals offering clinical analysis, policy perspectives, & practical advice.

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Authors

"I want to add that the safety profile was impeccable for this. No one experienced a [device-related] adverse event," says Matthew J. Mutter, MD. 

Matthew Mutter, MD, shares data on Separo vessel sealing system for vasectomy

"The biggest thing that I took away from using the device is that it allowed me to do the procedure by myself, without an assistant," says Matthew J. Mutter, MD. 

FDA market clearance sought for Separo sealing system for vasectomy 

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

Use of the Cxbladder Triage test appears to significantly decrease utilization of cystoscopy and imaging in patients who are identified as low risk, according to data presented at the 

2025 American Urological Association Annual Meeting

The results were presented by Christopher Filson, MD, MS, a urologist at Kaiser Permanente in Los Angeles, California.

According to the investigators, Cxbladder Triage “uses mRNA biomarkers and clinical information to classify a patient’s risk of having bladder cancer.” Kaiser Permanente – Southern California (KP-SCAL) utilizes a validated Hematuria Risk Index (the standard of care [SOC]) to guide both the use of cystoscopy as well as type of imaging modality. For the study at AUA 2025, the investigators sought to evaluate “real-world utility of adding the Cxbladder Triage test to the standard KP-SCAL microscopic hematuria diagnostic workflow.”

Patients were included in the study if they had a urinalysis with microscopic hematuria, had an encounter with a urologist between September 2021 and September 2024, were between 38 and 88 years of age, and had 6 months of membership with Kaiser Permanente before and after the encounter. Patients were excluded if they had gross hematuria within 6 months prior to the encounter or had a prior diagnosis of bladder cancer. The investigators identified patients who underwent testing with Cxbladder Triage and created a 1:1 matched cohort of non-tested patients based on the date of the encounter and hematuria risk index.

Based on their Cxbladder Triage test result, patients were divided into 2 groups: low probability of bladder cancer (<4.00) and physician-directed protocol (≥4.00). Outcomes of interest for the study included cystoscopy within 6 months, CT urography within 6 months, and bladder cancer diagnosis within 6 months and 1 year.

“Of 5242 patients who received the Cxbladder Triage test, 3,353 (64%) were included for analysis and matched 1:1 with SOC patients,” the investigators wrote. Mean age (standard deviation) was 61.3 (12.4) years in the Cxbladder Triage arm and 62.1 (12.9) years in the SOC arm. More than half of patients were female in both cohorts.

The investigators reported that 2670 patients had a low probability score in the Cxbladder Triage and SOC groups, and that 683 patients had physician-directed protocol. The 6-month CT urogram rate was 7.5% (201 patients) in the low probability patients receiving CxBladder Triage and 11.7% (313 patients) in the low probability patients receiving SOC. The 6-month CT urogram rate was 19.5% (133 patients) in the physician-directed protocol patients receiving Cxbladder Triage and 13.3% (91 patients) in the physician-directed protocol patients receiving SOC. The 6-month bladder cancer rate was 0.1% (3 patients) in the low probability patients receiving Cxbladder Triage and 0.7% (19 patients) in the low probability patients receiving SOC. The 6-month bladder cancer rate was 2.5% (17 patients) in the physician-directed protocol patients receiving Cxbladder Triage and 0.6% (4 patients) in the physician-directed protocol receiving SOC. The 1-year bladder cancer rate was 0.1% (3 patients) in the low probability patients receiving Cxbladder Triage and 0.7% (19 patients) in the low probability patients receiving SOC. The 1-year bladder cancer rate was 2.6% (18 patients) in the physician-directed protocol patients receiving CxBladder Triage and 0.7% (5 patients) in the physician-directed protocol receiving SOC.

All told, the study population was able to avoid 952 cystoscopies and 70 CT scans, according to the investigators.

“Cxbladder Triage testing significantly decreased cystoscopy and imaging utilization among low-risk microscopic hematuria patients while simultaneously increased use among higher-risk patients. Further population-level evaluations of the Cxbladder Triage test are warranted to reduce the burden of unnecessary cystoscopy,” the investigators wrote in their poster.

In a news release about the study, Pacific Edge Chief Executive Peter Meintjes, PhD, said, “The Kaiser Permanente study is important because it demonstrates the real-world impact of Cxbladder Triage with tremendous statistical power given the sample size of 3353 patients. The design of the study prospectively managed hematuria patients according to the new Triage-based standard of care and then retrospectively compared those clinical outcomes to a cohort of 'risk-matched' patients from Kaiser Permanente nation-wide EMR who did not. This kind of study and evidence generation is uniquely available in the Kaiser Permanente system and underscores the value of our partnership and our shared commitment to improving patient outcomes.”

AUA 2025 also featured discussion of the organization’s recent microhematuria guideline, which “specifically mentions Cxbladder Triage as the only urine-based biomarker test that has ‘Grade A’ evidence from a randomized controlled trial — the STRATA Study,

 which demonstrated the test can reduce cystoscopies by up to 59% without compromising tumor detection,”according to the news release.

1. Filson C, Loo RK, Slezak JM, Jhaveri J, Aboushwareb T, et al. Clinical utility of a urinary biomarker (Cxbladder Triage) compared to standard of care for microscopic hematuria evaluations in a large independent delivery network. 2025;213(5S):e246. doi:10.1097/01.JU.0001109788.99555.df.11

2. Cxbladder's clinical utility in focus at AUA 2025. News release. Pacific Edge. April 23, 2025. Accessed April 28, 2025. 

https://www.pacificedgedx.com/news-and-events/news/2025/cxbladders-clinical-utility-in-focus-at-aua-2025/

3. Lotan Y, Daneshmand S, Shore N, et al. A multicenter prospective randomized controlled trial comparing cxbladder triage to cystoscopy in patients with microhematuria: the safe testing of risk for asymptomatic microhematuria trial. 2024;212(1):41-51. doi:10.1097/JU.0000000000003991

The Cxbladder Triage test, utilizing mRNA biomarkers, significantly reduces the need for cystoscopy and imaging in low-risk patients with microscopic hematuria, as demonstrated in a study by Kaiser Permanente. The study, involving 3,353 patients, showed a marked decrease in cystoscopy and CT scan utilization among low-risk patients, while higher-risk patients saw increased use. The findings underscore the test's potential to optimize diagnostic workflows and reduce unnecessary procedures. The study's design and outcomes highlight the value of integrating Cxbladder Triage into standard care practices.

The study population was able to avoid 952 cystoscopies and 70 CT scans, according to the investigators.

Cxbladder Triage may help patients avoid unnecessary cystoscopies

The CD46-targeting antibody-drug conjugate (ADC) FG-3246 (formerly FOR46) demonstrated encouraging clinical activity while maintaining a manageable safety profile in patients with metastatic castration-resistant prostate cancer (mCRPC), according to data from a phase 1 trial (NCT03575819).

“I am excited to see the results from the phase 1 monotherapy study of FG-3246 published in the 

,” said lead author Rahul Aggarwal, MD, a professor of medicine at the University of California, San Francisco, in a news release on the findings.

 “This is the first clinical trial targeting CD46 in patients with prostate cancer, and the totality of the data highlights the promising potential of FG-3246 anti-cancer activity, especially when considering the unselected, heavily pre-treated patient population in the trial. The trial results provide key insights into the potential clinical impact of targeting CD46 in the treatment of mCRPC and support its further development in this disease space with high unmet need.”

In total, the study enrolled 56 patients with mCRPC across both the dose escalation and dose expansion phases. The maximum tolerated dose was determined to be 2.7 mg/kg, using adjusted body weight, every 3 weeks.

According to the authors, “Dose-limiting toxicities included neutropenia (n = 4), febrile neutropenia (n = 1), and fatigue (n = 1).”

Across all dose levels, the most frequently reported grade 3 or higher adverse events were neutropenia (59%), leukopenia (27%), lymphopenia (7%), anemia (7%), and fatigue (5%). Grade 3 febrile neutropenia was also observed in 1 patient. No treatment-related deaths were reported.

A total of 40 patients were evaluable for efficacy, which was defined as patients with adenocarcinoma who received a dose of 1.2 mg/kg or higher. In these patients, the median radiographic progression-free survival (rPFS) was 8.7 months (range, 0.1 to 33.9). A prostate-specific antigen (PSA) decline of at least 50% (PSA50) was observed in 36% of patients (14 of 39). A PSA50 response was also noted among 4 of 8 (50%) patients who received docetaxel in the castrative-sensitive setting.

Additionally, 25 patients were included in the RECIST-evaluable set. Among those patients, the confirmed objective response rate was 20%, with all objective responses observed among patients who received a dose of 2.7 mg/kg or higher. The median duration of response was 7.5 months.

Further, the disease control rate was 80%. The duration of treatment was longer than 24 weeks in 48% (12) of patients.

Immunohistochemistry showed that 12 of 15 (80%) evaluable baseline tumors were positive for CD46 expression. Patients who responded to treatment with FG-3246 were found to have a significantly higher frequency of effector T cells as well as a lower frequency of immunosuppressive myeloid cells.

Overall, the first-in-human, open-label phase 1 trial enrolled 56 patients with mCRPC across 5 clinical trial sites in the US.

Those enrolled were biomarker unselected and heavily pretreated, with a median of 5 lines of prior therapy.

The dose-escalation phase of the trial included 33 patients who received FG-3246 at doses ranging from 0.1 mg/kg and 3.0 mg/kg intravenously every 3 weeks. The dose-expansion phase included 23 patients, of whom 18 had adenocarcinoma mCRPC (cohort 1) and 5 had neuroendocrine prostate cancer (cohort 2). Patients in the dose-expansion phase received FG-3246 at the dose level of 2.7 mg/kg using adjusted body weight to a maximum of 270 mg for every 3 weeks.

Primary outcome measures included dose-limiting toxicities and disease response.

“We are looking forward to advancing FG-3246 in the clinic and remain on track for initiating the phase 2 monotherapy study by mid-2025 as well as disclosing topline results from the combination trial of FG-3246 and enzalutamide in the second half of 2025,” said Thane Wettig, CEO of FibroGen, in the news release.

 “FG-3246 represents a potential first-in-class, non-PSMA approach to treating mCRPC and we, along with the medical community, are excited about the potential for CD46 to become a next generation target in the prostate cancer treatment paradigm.”

1. Aggarwal RR, Vuky J, VanderWeele D, et al. Phase I, first-in-human study of FOR46 (FG-3246), an immune-modulating antibody-drug conjugate targeting CD46, in patients with metastatic castration-resistant prostate cancer. 

. 2025:JCO2401989. doi:10.1200/JCO-24-01989

2. FibroGen announces publication of results from phase 1 monotherapy study of FG-3246 in patients with metastatic castration-resistant prostate cancer in the Journal of Clinical Oncology. News release. FibroGen, Inc. March 28, 2025. Accessed April 3, 2025. https://investor.fibrogen.com/news-releases/news-release-details/fibrogen-announces-publication-results-phase-1-monotherapy-study

3. A phase 1 study of FOR46 in patients with metastatic castration-resistant prostate cancer (mCRPC). ClinicalTrials.gov. Last updated February 1, 2024. Accessed April 3, 2025. https://www.clinicaltrials.gov/study/NCT03575819

FG-3246, a CD46-targeting antibody drug conjugate, showed promising clinical activity and a manageable safety profile in a phase 1 trial for metastatic castration-resistant prostate cancer (mCRPC). The trial enrolled 56 heavily pre-treated patients, determining a maximum tolerated dose of 2.7 mg/kg every three weeks. Notable adverse events included neutropenia and fatigue, but no treatment-related deaths occurred. Efficacy was observed with a median radiographic progression-free survival of 8.7 months and a 36% PSA50 response rate. The trial supports further development of FG-3246 in mCRPC treatment.

The company plans to initiate the phase 2 monotherapy trial by mid-year. 

CD46-targeting ADC shows encouraging clinical activity in mCRPC

2025 American Urological Association (AUA) Annual Meeting

 in Las Vegas, Nevada showed no difference in stone-free rate between pulse-modulated Holmium:YAG (Ho:YAG) or the thulium fiber laser (TFL) for laser lithotripsy.

® to share her insights on the trial results.

Overall, data showed a stone-free rate of 53.6% with Ho:YAG compared with 52.9% with TFL (

 = .948). Residual fragments of 2 mm or less were reported in 58.9% of patients with Ho:YAG vs 64.7% of patients with TFL (

 = .539). Additionally, residual fragments of 4 mm or less were reported in 78.6% of patients with Ho:YAG vs 88.2% of patients with TFL (

The authors also reported, “Preoperative stone size, procedure time, laser time, ablation speed and complication rates also did not differ between the two groups.”

Knoedler is a urologist at University of Wisconsin Health and an assistant professor of medicine at the University of Wisconsin School of Medicine and Public Health.

Margaret A. Knoedler, MD, connected with Urology Times® to share her insights on the trial results. 

Margaret Knoedler, MD, on Ho-YAG vs thulium fiber laser for ureteroscopy

In total, the study included 152 patients, of whom 46.7% were women. The average BMI was 29.9 ± 6.9.

Knoedler concluded, "The decision for which laser to use in your institution should be left up to the urologist and the hospital system. They both have slightly different benefits and risks associated with them, but they're both good lasers for uteroscopy."

"The decision for which laser to use in your institution should be left up to the urologist and the hospital system," says Margaret A. Knoedler, MD.

Margaret Knoedler, MD, on Ho:YAG vs thulium fiber laser for ureteroscopy

The FDA has cleared Clarius Mobile Health’s Clarius Prostate AI, an artificial intelligence application that measures prostate volume during handheld ultrasound examination, the company announced in a news release.

Clarius Mobile Health said it will be demonstrating the application at the American Urological Association Annual Meeting in Las Vegas, Nevada.

"95% of clinicians we recently surveyed believe AI-powered measurements would save them time and allow them to see more patients. Manual ultrasound prostate volume measurements are repetitive and time-consuming, regardless of experience. With Clarius Prostate AI, what used to take several minutes now takes seconds, no matter your experience level,” said Sarah Leverett, the vice president of marketing at Clarius Mobile Health, in a news release.

The application is currently available for use with “Clarius handheld ultrasound scanners that are customized for urology exams, including the curvilinear C3 HD3 for transabdominal ultrasound, and the endocavitary EC7 HD3,” according to the company. Prostate AI users activate it within the Clarius App on a smartphone or tablet. The tool then highlights the prostate and then, once the image has been frozen, places calipers that can be fine-tuned manually. The app is also able to calculate prostate-specific antigen (PSA) density by incorporating the patient’s PSA level and prostate volume.

"We're excited about the potential of our AI-powered tools to enable more physicians, including primary care physicians, to use ultrasound to identify high risk prostate cancer patients sooner, without relying on a specialist referral," Leverett said in the release.

Clarius’ product portfolio also includes Bladder AI, which is used for measuring bladder volume.

1. FDA clears new Clarius Prostate AI to help physicians assess and diagnose common urologic conditions in minutes. News release. Clarius Mobile Health. April 25, 2025. Accessed April 25, 2025. https://www.prnewswire.com/news-releases/fda-clears-new-clarius-prostate-ai-to-help-physicians-assess-and-diagnose-common-urologic-conditions-in-minutes-302437687.html

The FDA has approved Clarius Mobile Health's Clarius Prostate AI, an AI application designed to measure prostate volume during handheld ultrasound exams. This tool, which integrates with Clarius handheld ultrasound scanners, aims to streamline the process of prostate volume measurement, reducing the time required from several minutes to seconds. It also calculates PSA density by incorporating patient PSA levels. The application is expected to enhance efficiency, allowing clinicians to see more patients and potentially enabling primary care physicians to identify high-risk prostate cancer patients earlier.

Clarius Mobile Health said it will be demonstrating the application at the AUA Annual Meeting in Las Vegas, Nevada.

Matthew J. Mutter, MD

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