Urology news for Tuesday, September 29, 2026

Top 5 in urology

FDA advisory panel narrowly backs multi-cancer blood test amid efficacy doubts FDA action · Renal & Urology News · 2026-09-28
An FDA advisory panel voted to support a multi-cancer early detection blood test despite panelists raising concerns about whether the evidence adequately demonstrates clinical benefit.
Why it matters: Multi-cancer screening tests could affect referral patterns and downstream urologic workup if authorized.
FDA expands Welireg label for additional kidney cancer indication FDA action · Zacks Investment Research · 2026-09-28
Merck's belzutifan (Welireg) received an expanded FDA label covering a new indication in kidney cancer.
Why it matters: Broader labeling may extend access to belzutifan for additional renal cell carcinoma patient populations.
PCF-sponsored consensus proposes cardiovascular risk triage schema for men on ADT/ARPi therapy Review · JCO Oncol Pract · 2026-09-29
A narrative review and clinician-industry consensus proposes a three-tier (high/intermediate/low) point-of-care schema to identify prostate cancer patients on hormone therapy who need cardiovascular referral, based on prior CVD events and risk-factor control.
Why it matters: Offers a practical framework for urologists to flag cardiovascular risk in ADT/ARPi patients before formal validation studies are completed.
Multicenter study finds 18% discordance between renal mass biopsy and final surgical pathology Retrospective · World J Urol · 2026-09-29
Among 1,301 patients from the UroCCR registry, renal mass biopsy showed an 18% overall discordance rate with surgical pathology (3.7% for malignancy, 8.4% for subtype, 5.7% non-diagnostic), with cystic tumors linked to higher discordance and greater tumor complexity linked to lower discordance.
Why it matters: Quantifies real-world limitations of renal mass biopsy that should inform counseling before active surveillance or ablation decisions.
Meta-analysis: ureteroscopic biopsy forceps yield ~85% diagnostic rate in UTUC, no device superior Meta-analysis · J Endourol · 2026-09-29
Pooling 19 studies and over 1,700 biopsies, flexible ureteroscopy forceps achieved 84.6% diagnostic yield and 78.8% grade concordance in upper tract urothelial carcinoma, with over half of apparently non-muscle-invasive tumors upstaged at nephroureterectomy, and no forceps design outperforming others.
Why it matters: Reinforces that ureteroscopic biopsy alone should not be relied upon to exclude muscle-invasive UTUC when planning kidney-sparing therapy.

Prostate cancer news

Single-institution series finds de novo neuroendocrine prostate cancer outlives treatment-emergent form Retrospective · Clin Genitourin Cancer · 2026-09-29
Among 58 patients with neuroendocrine prostate cancer, overall survival was longer for de novo versus treatment-emergent disease (26.5 vs 10.9 months) and for mixed versus pure histology; maintenance immunotherapy after carboplatin/etoposide showed no survival benefit.
Why it matters: Provides real-world benchmarks for a rare, aggressive prostate cancer subtype and suggests maintenance IO after platinum chemo may not help.
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.
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.
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.

Bladder cancer news

FDA grants priority review to durvalumab plus enfortumab vedotin regimen in bladder cancer FDA action · AllSci · 2026-09-28
AstraZeneca's Imfinzi (durvalumab) combined with enfortumab vedotin received FDA priority review designation for a bladder cancer indication.
Why it matters: A priority review shortens the timeline toward potential approval of a new combination regimen for urothelial cancer.
Frailty does not modify robotic vs open cystectomy outcomes in older adults Retrospective · Urology · 2026-09-27
In a SEER-Medicare emulated trial of 1,750 patients aged 66-89 with bladder cancer, robotic-assisted radical cystectomy showed no significant difference from open surgery in perioperative morbidity or oncologic outcomes, regardless of baseline frailty.
Why it matters: Suggests frailty status alone should not drive the choice between robotic and open cystectomy approaches.
FDA grants priority review to VOLGA regimen in bladder cancer FDA action · Oncodaily · 2026-09-26
A company representative noted FDA priority review for a combination regimen (VOLGA) targeting a bladder cancer indication, according to a brief interview item.
Why it matters: Priority review timelines could bring a new perioperative or metastatic urothelial regimen to market sooner.
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.
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.
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.

Kidney cancer news

Meta-analysis: PFS and response rate weakly predict overall survival in mRCC trials Meta-analysis · UroToday · 2026-09-28
A systematic review and meta-analysis found that progression-free survival and objective response rate are weak surrogates for overall survival across metastatic renal cell carcinoma trials.
Why it matters: Reinforces caution when using surrogate endpoints alone to judge treatment benefit in RCC trials.
Young-onset RCC shows higher survival and more germline mutations than older-onset disease Retrospective · Clin Genitourin Cancer · 2026-09-29
In a retrospective cohort of 812 nephrectomy patients, those aged 46 or younger with RCC had higher 5-year overall survival (92.4% vs 80.9%) and more frequent germline alterations in FANCI, POLD1, PTCH1, and RINT1 versus older patients.
Why it matters: Suggests germline testing may be worth considering in younger RCC patients and that age at onset carries prognostic information.
FDA approves belzutifan-lenvatinib for ccRCC after PD-1/PD-L1 therapy FDA approval · Renal & Urology News · 2026-09-28
The FDA approved the combination of belzutifan and lenvatinib for advanced clear cell renal cell carcinoma following prior immunotherapy, based on trial data supporting the regimen in this setting.
Why it matters: Adds another approved option for RCC patients who progress after checkpoint inhibitor therapy.
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.
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

CT slice thickness biases stone-free rate assessment after RIRS Retrospective · World J Urol · 2026-09-28
In a retrospective cohort of 145 patients after retrograde intrarenal surgery, reconstructing CT images at 5-mm versus 1-mm slice thickness shifted 24% of patients to a more favorable stone-free grade, with no downgrades.
Why it matters: Reported stone-free rates depend heavily on CT reconstruction protocol, complicating comparisons across studies and centers.
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.
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

Network meta-analysis: vibegron reduces OAB symptoms as BPH add-on, no clear edge over mirabegron Meta-analysis · World J Urol · 2026-09-29
A Bayesian network meta-analysis of 18 trials found vibegron and mirabegron both reduced micturition frequency and urgency as add-on therapy in alpha-blocker-treated men with BPH and persistent OAB, but indirect comparisons showed no significant advantage of vibegron over mirabegron.
Why it matters: Confirms beta-3 agonists are a reasonable add-on for persistent storage symptoms in men on alpha-blockers, without evidence to prefer one agent.
Meta-analysis supports HoLEP safety in patients on antithrombotic therapy Meta-analysis · UROsource · 2026-09-28
An updated systematic review and meta-analysis found HoLEP to be a safe option for BPH surgery in patients receiving antithrombotic medications.
Why it matters: Supports continuing or minimally interrupting antithrombotics when performing HoLEP in appropriately selected patients.
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

Institutional experience improves 5-year outcomes for gender-affirming penile prosthesis Retrospective · J Sex Med · 2026-09-28
In a retrospective cohort of 473 patients undergoing first-time gender-affirming inflatable penile prosthesis insertion, cumulative institutional experience, single-cylinder implantation, and use of one device brand were linked to lower risk of subsequent surgery, with peak proficiency identified around case 311.
Why it matters: Highlights a long learning curve for gender-affirming IPP surgery, relevant for centers building or scaling these programs.
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

Placebo injection response notably high across Peyronie's disease trials Retrospective · Renal & Urology News · 2026-09-28
An analysis of Peyronie's disease clinical trials found substantial improvement in placebo-injected control groups, complicating interpretation of active treatment effect sizes.
Why it matters: High placebo response rates in Peyronie's trials should temper enthusiasm for reported treatment effects and inform trial design.
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.

Pediatric urology news

New reference curves define expected residual hydronephrosis after pyeloplasty Retrospective · World J Urol · 2026-09-27
In 566 renal units after pyeloplasty, postoperative APD reference curves were built from units without recurrence. Renal pelvic APD above the 90th centile curve was linked to a much higher reoperation rate (11.7% vs 0.8%).
Why it matters: Offers an objective benchmark to decide which children with residual postoperative dilation need closer follow-up versus reassurance.
Insurance status and timing linked to orchiectomy odds after testicular torsion in NY state Retrospective · J Pediatr Urol · 2026-09-27
Among 4,159 children with testicular torsion in New York State over 15 years, 26% underwent orchiectomy; government or self-pay insurance and presentation timing were associated with higher orchiectomy odds, with effects varying by age group.
Why it matters: Points to potential access or systems-level disparities affecting testicle salvage rates that may warrant institutional review.

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.

More urology news

Industry and academic GU oncology trials stop early for different reasons Retrospective · Urology · 2026-09-27
Analysis of 1,597 phase II-III genitourinary oncology trials on ClinicalTrials.gov found 27.9% terminated early; academic trials mainly failed from poor accrual while industry trials stopped more often for strategic, regulatory, or interim efficacy/futility reasons.
Why it matters: Highlights structural differences in why GU oncology trials fail, relevant to trial design and site participation decisions.

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