Urology news for Saturday, September 26, 2026

Top 5 in urology

Priority review for perioperative durvalumab plus enfortumab vedotin in cisplatin-ineligible MIBC FDA priority review · Urology Times · 2026-09-25
Based on phase 3 VOLGA, where the regimen improved event-free and overall survival versus cystectomy with or without adjuvant therapy. FDA decision expected Q4 2026.
Why it matters: Would give cisplatin-ineligible patients a second perioperative immunotherapy-ADC option alongside EV-pembrolizumab.
FDA clears SpaceOAR Flex hydrogel spacer for prostate radiotherapy FDA 510(k) · Urology Times · 2026-09-25
510(k) clearance for a next-generation rectal spacer; limited US market release is planned later in 2026.
Why it matters: Relevant to programs offering spacer placement with SBRT or hypofractionated radiation.
Holmium and thulium fiber lasers show equivalent stone-free rates in RCT for kidney stone dusting RCT · J Urol · 2026-09-26
A 5-center US randomized trial of 178 patients found no significant difference in stone-free rates (about 53% for each), procedure time, or complications between pulse-modulated Holmium:YAG and Thulium Fiber Laser during retrograde intrarenal surgery for stones up to 20 mm.
Why it matters: Provides high-level evidence that laser choice for retrograde intrarenal surgery can be based on surgeon or institutional preference rather than presumed superiority.
FDA approves belzutifan plus lenvatinib for advanced clear cell RCC FDA approval · FDA · 2026-09-24
The FDA approved the combination of belzutifan and lenvatinib for advanced renal cell carcinoma with a clear cell component.
Why it matters: Adds a new combination option for patients with advanced clear cell RCC.
Reanalysis shows BCG-unresponsive CIS response rates are not comparable across trials Meta-analysis · BJU Int · 2026-09-26
A reanalysis of six registrational BCG-unresponsive CIS trials found that differences in retreatment policy and biopsy timing substantially alter reported 12-month complete response rates, with TAR-200 outperforming an adjusted reference standard once mandatory biopsy protocols were applied.
Why it matters: Cross-trial comparisons of BCG-unresponsive CIS agents should be interpreted cautiously given major methodological heterogeneity.

Prostate cancer news

Model suggests individualized, risk-adapted PSA surveillance schedules after prostatectomy Retrospective · Eur Urol Oncol · 2026-09-26
In a study of 11,552 post-prostatectomy patients, a risk-adapted follow-up schedule based on recurrence hazard suggested more intensive PSA testing early for adverse pathology patients (quarterly for 2 years) with de-intensification over time, while favorable-feature patients needed testing only every 9 months.
Why it matters: Offers a data-driven framework for tailoring PSA surveillance intensity by pathologic risk and comorbidity rather than one-size-fits-all schedules.
NADIR model validated in ARCHES trial predicts early PSA response and survival with enzalutamide Retrospective · Cancer · 2026-09-26
External validation of the NADIR model in 558 ARCHES trial patients showed good discrimination (AUC 0.80) for predicting early favorable PSA response to enzalutamide in mHSPC, and higher predicted probability was associated with lower mortality in landmark analysis.
Why it matters: A validated tool predicting early PSA response could help identify mHSPC patients likely to benefit from ARPI therapy and inform treatment intensification discussions.
Cryotherapy linked to higher cancer-specific mortality than EBRT in high-risk prostate cancer Retrospective · World J Urol · 2026-09-26
In a SEER analysis of 33,961 high-risk or very high-risk prostate cancer patients, cryotherapy (used off-guideline in a small subset) was associated with more than double the cancer-specific mortality compared with external beam radiation after propensity matching (16.7% vs 7.7% at 10 years).
Why it matters: Supports guideline recommendations against cryotherapy as primary treatment for high-risk localized prostate cancer.
Review reaffirms transperineal biopsy advantages for prostate cancer detection and infection risk Review · Eur Urol Focus · 2026-09-26
A review concludes that transperineal biopsy provides better detection of clinically significant prostate cancer and lower infection risk than transrectal biopsy, supporting an antibiotic-sparing approach despite greater patient discomfort.
Why it matters: Reinforces the ongoing shift toward transperineal biopsy as biopsy technique and antibiotic stewardship remain active practice considerations.
PHI and PHI density predict adverse pathology and grade upgrading after prostatectomy Prospective · Prostate Cancer Prostatic Dis · 2026-09-26
In a prospective study of 130 men undergoing robotic prostatectomy, PHI best predicted adverse pathologic features (AUC 0.86) while PHI density best predicted ISUP upgrading from biopsy (AUC 0.83), outperforming PSA and PSA density.
Why it matters: Adds evidence that PHI-based biomarkers can refine risk stratification before or after biopsy in localized prostate cancer.
Circulating tumor DNA fraction may guide when to stop early Lu-177 PSMA therapy Phase 1-2 · NCI · 2026-09-24
The DYNAMO trial evaluates whether ctDNA tumor fraction can identify patients with metastatic castration resistant prostate cancer who are unlikely to benefit from continued Lu-177 PSMA-617, allowing earlier discontinuation.
Why it matters: A validated ctDNA biomarker could help avoid futile cycles of radioligand therapy and guide earlier switches to alternative treatment.
New trial tests de-escalating to ADT alone after deep response to combination therapy Trial opening · ClinicalTrials.gov · 2026-09-24
This phase 2 randomized trial enrolls men with metastatic hormone sensitive prostate cancer who responded well to 6 to 7 months of doublet or triplet therapy, comparing continued combination treatment versus de-escalation to ADT alone, measured by radiographic and PSA progression free survival at 18 months.
Why it matters: Results could inform whether treatment de-intensification is feasible in strong responders, potentially reducing cumulative toxicity and cost.
Recurrence after curative-intent treatment remains an unmet need Review · Urology Times · 2026-09-23
Better detection with molecular imaging has changed how biochemical recurrence is managed, but preventing recurrence remains difficult.
Why it matters: Context for PSMA PET-driven salvage decisions.
Prebiopsy MRI now precedes nearly two-thirds of initial prostate biopsies in the US Retrospective · Urology Times · JAMA Oncology · 2026-09-21
Epic Cosmos analysis of more than 505,000 biopsies: MRI before initial biopsy rose from 14% in 2017 to 64% in early 2026, and before repeat biopsy from 38% to 67%.
Why it matters: Benchmarks institutional MRI-first adoption and shows guideline uptake tracked PRECISION-era trial publication.

Bladder cancer news

One year of Inlexzo: how BCG-unresponsive NMIBC care has shifted Perspective · Urology Times · 2026-09-25
A look back at the first year of the gemcitabine intravesical system in practice, including patient selection and workflow changes.
Why it matters: Useful for programs building an intravesical device workflow.
Sandip Prasad, MD, on selecting patients for chemoablation in LG-IR-NMIBC Interview · Urology Times · 2026-09-24
Practical criteria for identifying candidates for nonsurgical chemoablation.
Network meta-analysis ranks neoadjuvant regimens in cisplatin-eligible MIBC Meta-analysis · Urology Times · 2026-09-22
Enfortumab vedotin plus pembrolizumab showed the strongest associations with event-free and overall survival among neoadjuvant options.
Why it matters: Indirect comparison, but frames the debate on displacing cisplatin-based chemotherapy as the neoadjuvant standard.
Chemoablation widens options for recurrent low-grade intermediate-risk NMIBC Review · Urology Times · 2026-09-22
Overview of the evolving role of nonsurgical chemoablation as an alternative to repeat TURBT in selected patients.
Why it matters: Relevant to reducing cumulative anesthesia and procedural burden in older patients.
Recombinant BCG in NMIBC: where it fits Interview · Urology Times · 2026-09-21
Discussion of recombinant BCG formulations as a response to supply shortages.

Kidney cancer news

PFS and response rate only weakly predict overall survival in metastatic RCC trials Meta-analysis · Cancer · 2026-09-26
A meta-analysis of 62 randomized trials in metastatic RCC found moderate correlations between progression-free survival, objective response rate, and overall survival, with surrogate threshold effects that were imprecise, especially by histology subgroup.
Why it matters: Suggests caution in relying on PFS or ORR alone when interpreting or designing RCC trials; OS remains the preferred endpoint.
Half of eligible RCC patients declined adjuvant pembrolizumab in UK real-world cohort Retrospective · Eur Urol Oncol · 2026-09-26
Among 129 medically fit ccRCC patients eligible for adjuvant pembrolizumab per KEYNOTE-564 criteria at a UK renal cancer network, 50% declined therapy after counseling, with treated patients younger and having higher-risk features than those who chose surveillance.
Why it matters: Highlights a substantial gap between trial eligibility and real-world uptake of adjuvant immunotherapy for high-risk renal cell carcinoma.
FDA approves belzutifan plus lenvatinib for advanced clear cell RCC after immunotherapy FDA approval · Urology Times · 2026-09-24
Approval rests on phase 3 LITESPARK-011 (n=747) versus cabozantinib: median PFS 14.6 vs 10.6 months (HR 0.74) and ORR 53% vs 40%. OS favored the combination but did not reach significance (HR 0.85).
Why it matters: Adds a HIF-2α based second-line option after PD-1/PD-L1 progression, where cabozantinib has been the default.

Testicular cancer news

EAU panel recommends centralized care to improve testicular cancer outcomes Guideline · UroToday · 2026-09-25
A European Association of Urology guidelines panel report argues that treatment at higher-volume centers is associated with better outcomes for testicular cancer patients, supporting centralization of care.
Why it matters: Referral pathways and case volume may influence outcomes in a highly curable cancer where errors have long-term consequences.

Endourology and stone disease news

AUA updates guideline on medical management of kidney stones Guideline · Renal & Urology News · 2026-09-25
The American Urological Association has released an updated guideline covering medical management strategies for kidney stone disease, including prevention and pharmacologic approaches.
Why it matters: Guideline updates directly inform counseling and prescribing for stone formers in daily practice.
Antibiotic-augmented irrigation during PCNL cut infection rates in high-risk patients Retrospective · J Endourol · 2026-09-26
In a matched cohort of 100 high-infection-risk PCNL patients, intrarenal neomycin/polymyxin B irrigation reduced 30-day UTI (6% vs 34%), sepsis (0% vs 16%), and prolonged hospitalization compared with standard saline irrigation.
Why it matters: Suggests a simple intraoperative modification that could meaningfully reduce infectious complications in higher-risk stone surgery patients.
Meta-analysis quantifies ureteral perforation and avulsion risk during ureteroscopy Meta-analysis · Urolithiasis · 2026-09-26
A systematic review and meta-analysis of 15 studies (20,635 ureteroscopic procedures) found pooled ureteral perforation incidence of 1.89% and avulsion incidence of 0.32%, with rates roughly 10-fold higher in cohorts restricted to impacted stones.
Why it matters: Provides updated benchmark complication rates for informed consent discussions and quality benchmarking in ureteroscopy.
Global survey finds wide cost variation for single-use ureteroscopes and access sheaths Retrospective · Urolithiasis · 2026-09-26
A 40-country collaboration found the median purchase cost of single-use flexible ureteroscopes was 677 euros (range 310 to 1638) and access sheaths 180 euros, with reuse protocols lowering median per-procedure ureteroscope costs to 425 euros.
Why it matters: Relevant to practices considering cost-containment strategies such as device reuse amid rising single-use endourology expenditure.

BPH and male LUTS news

Rezūm beats combination medical therapy for LUTS at 1 year in VAPEUR randomized trial RCT · Urology Times · Eur Urol Focus · 2026-09-23
Multicenter pragmatic RCT: mean IPSS improved 10.8 points with water vapor therapy vs 6.2 with combination pharmacotherapy, a 4.6-point difference that exceeds the 3-point threshold patients can perceive.
Why it matters: Direct head-to-head data supporting earlier procedural therapy instead of escalating to dual medication.

Female pelvic medicine and neurourology news

FemPulse vaginal ring neuromodulation device receives EU approval for overactive bladder CE mark (EU) · Urology Times · 2026-09-24
CE marking supported by four clinical studies of safety and efficacy.
Why it matters: A wearable, nonimplanted neuromodulation option; US status pending.

Reconstruction and trauma news

Novel laparoscopic technique described for refractory piriformis-related pelvic pain Retrospective · J Endourol · 2026-09-26
A retrospective series of 200 patients across multiple institutions describes a transgluteal laparoscopic piriformis muscle transection technique for chronic pelviperineal pain syndrome, reporting technical feasibility with low morbidity and short hospital stay.
Why it matters: Introduces a minimally invasive surgical option for a difficult-to-treat and underrecognized cause of chronic pelvic pain.
Advances in artificial urinary sphincter technology Interview · Urology Times · 2026-09-14
Andrew Peterson, MD, on electronic sphincter innovations for post-treatment incontinence.
Why it matters: Relevant to survivorship care after prostatectomy and radiation.

Men's health news

Expanding sexual health conversations through digital media Podcast · Urology Times · 2026-09-24
Wendy Brant, MD, on building audiences and normalizing sexual wellness discussions online.

Infection, transplant and general urology news

FDA breakthrough device designation for rapid urine ID/AST panel FDA breakthrough · Urology Times · 2026-09-21
Assay provides rapid pathogen identification and antibiotic susceptibility directly from urine.
Why it matters: Could shorten time to targeted therapy in complicated UTI and urosepsis.

Technology and AI news

ESU course on artificial intelligence in urology, Yerevan Meeting · EAU / Uroweb · 2026-09-25
European School of Urology course on AI applications in urology, September 25 to 26.

Practice and policy news

AACU and WOCN Society urge safeguards in Medicare catheter competitive bidding Advocacy · Urology Times · 2026-09-23
Groups call for protections preserving individualized catheter access ahead of the 2028 bidding program.
Why it matters: Affects intermittent catheter supply for neurogenic and retention patients.

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