Monthly urology bulletin — September 29, 2026

Period covered: August 30 to September 29, 2026. A month dominated by urologic oncology (ASTRO in Boston, an FDA approval in kidney cancer and a European regulatory step in bladder cancer), with regulatory news in functional urology, live telesurgery at ERUS26 and little verifiable material in stone disease. Outside North America and Western Europe, we could verify only a Japanese study, telesurgery cases with patients in Poland and Morocco, and an eight-country trial; we found no verifiable items from this month from China, Korea, India, Russia, the Middle East or Latin America.

Urologic oncology

1. PACE-A: SBRT and prostatectomy show similar 8-year control with far less incontinence

[Meeting] [United Kingdom]
The phase 3 PACE-A trial (NCT01584258), presented as late-breaking abstract LBA 32 at ASTRO 2026 (Boston, September 26–30), randomized 123 men with localized prostate cancer (cT1c–T2c, Gleason ≤3+4, PSA ≤20, MRI-staged, no ADT) to stereotactic body radiotherapy (36.25 Gy in 5 fractions; n=63) or radical prostatectomy (n=60). At 8 years, biochemical/clinical failure-free survival was 91% with SBRT vs 84% with surgery (HR 0.48; 95% CI 0.16–1.46; P=.18), with no prostate cancer deaths. At 5 years, 48% of surgical patients (14/29) used at least one pad per day vs 8% after SBRT (3/36).
Why it matters: these are secondary endpoints of a small trial not powered for oncologic equivalence, but it is the longest randomized comparison of the two options and the continence data are very useful for shared decision-making; in the Dominican Republic, prostate SBRT is available in only a few centers.
https://www.urologytimes.com/view/sbrt-prostatectomy-show-comparable-long-term-disease-control-in-pace-a-trial

2. Decipher predicts who benefits from adding short-term ADT to radiotherapy

[Meeting] [USA]
An NCI-approved retrospective ancillary analysis of the phase 3 NRG/RTOG 0815 trial (dose-escalated radiotherapy with or without short-term ADT in intermediate-risk disease) was presented at ASTRO 2026 on September 29 (abstract 312). In 395 of the 1,492 patients, with a median follow-up of 10.2 years, the treatment-by-Decipher interaction for distant metastasis was significant (P<.001). With intermediate or high scores, ADT reduced 10-year distant metastasis by 8 absolute points; with low scores (44% of patients), the difference was 1 point and not significant.
Why it matters: if confirmed, it would spare nearly half of intermediate-risk patients from ADT; but it is a retrospective subset analysis publicized by the manufacturer (Veracyte), and the test has very limited cost-coverage and access in Latin America. The prospective NRG-GU010 (GUIDANCE) trial will provide the definitive answer.
https://www.globenewswire.com/news-release/2026/09/29/3370777/0/en/phase-iii-trial-demonstrates-veracyte-s-decipher-prostate-test-predicts-benefit-from-adding-hormone-therapy-to-radiation.html

3. FDA approves belzutifan + lenvatinib for clear cell RCC after immunotherapy

[Regulatory FDA] [USA / multinational]
On September 24, 2026, the FDA approved the combination for adults with advanced clear cell renal cell carcinoma that progressed after a PD-1/PD-L1 inhibitor. Approval is based on the open-label phase 3 LITESPARK-011 trial (n=747; published in The Lancet) vs cabozantinib: median progression-free survival 14.6 vs 10.6 months (HR 0.74; 95% CI 0.61–0.89), objective response 53% vs 40%. Overall survival, a co-primary endpoint, was not significant (33.7 vs 28.6 months; HR 0.85; 95% CI 0.70–1.03).
Why it matters: it adds a second-line option, but without a proven overall survival benefit and with serious adverse events in 54% of patients; the trial was sponsored by Merck and Eisai. In our setting, cabozantinib will remain the reference until registration and coverage arrive.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-combination-lenvatinib-advanced-renal-cell-carcinoma-clear-cell-component

4. Muscle-invasive bladder cancer: positive CHMP opinion for perioperative EV + pembrolizumab and FDA priority review for durvalumab + EV

[Regulatory FDA/EMA] [European Union / USA]
On September 18, the EMA's CHMP recommended extending perioperative enfortumab vedotin + pembrolizumab to all patients with resectable muscle-invasive bladder cancer, regardless of cisplatin eligibility. It is based on KEYNOTE-B15/EV-304 (n=808; NEJM 2026): vs neoadjuvant gemcitabine-cisplatin, event-free survival HR 0.53 (95% CI 0.41–0.70), 2-year EFS 79.4% vs 66.2%, overall survival HR 0.65 and pathologic complete response 55.8% vs 32.5%; grade ≥3 adverse events 75.7% vs 67.2%. On September 25, the FDA granted priority review to perioperative durvalumab + neoadjuvant EV in cisplatin-ineligible patients (VOLGA trial), with a decision expected in Q4 2026; full results have not yet been published.
Why it matters: it consolidates the paradigm shift toward chemo-immunotherapy around cystectomy; toxicity is high and cost means that in the Dominican Republic and much of Latin America, neoadjuvant cisplatin will remain the standard. VOLGA data are available only through an AstraZeneca press release.
https://www.merck.com/news/merck-receives-positive-eu-chmp-opinion-for-keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-as-perioperative-treatment-for-adults-with-resectable-muscle-invasive-bladder-can/
https://www.urologytimes.com/view/fda-grants-priority-review-to-perioperative-durvalumab-plus-enfortumab-vedotin-in-mibc

5. Nature: eight mutational footprints explain 85% of primary prostate cancers

[Publication] [International: Germany, Denmark, United Kingdom and others]
The Pan Prostate Cancer Group published whole-genome sequencing of 959 primary tumors (one per patient; median follow-up 7 years) in Nature on September 9. Eight integrated mutational footprints explain the mutational processes in 85% of tumors, with androgen receptor–mediated mutagenesis and replication stress as the main drivers. Four footprints, present in 37% of tumors, were associated with shorter time to metastasis; one of them, non-canonical homologous recombination deficiency, was enriched in patients of African ancestry.
Why it matters: this is discovery science with no clinical test yet, but the African-ancestry finding is particularly relevant to Dominican and Caribbean populations, which are underrepresented in these cohorts.
https://www.nature.com/articles/s41586-026-10468-w

6. Japan: only one third of men remain on active surveillance at 5 years

[Publication] [Japan]
A nationwide analysis of the J-CaP registry published on September 14 in the International Journal of Urology included 989 men with localized prostate cancer on initial active surveillance at 92 institutions (diagnosed 2016–2018). Surveillance persistence was 49.9% at 3 years and 33.7% at 5 years; 47% discontinued over a median follow-up of 3.4 years, mostly because of histologic progression or PSA rise. Patients at institutions with intermediate or high surveillance uptake stayed on it about 1 year longer than those at low-uptake institutions (P<.001).
Why it matters: it is retrospective, with 20% of patients at unclassifiable institutions, but it shows that institutional culture matters as much as the tumor for surveillance persistence, a lesson transferable to our own services. (source in English, Japanese group)
https://pmc.ncbi.nlm.nih.gov/articles/PMC13574298/

7. Prebiopsy prostate MRI rose from 14% to 64% in the USA

[Publication] [USA]
A retrospective study in JAMA Oncology (press release September 18) of more than 505,000 prostate biopsies in the Epic Cosmos database between 2017 and June 2026 found that MRI before first biopsy increased from 14% to 64%, and before repeat biopsy from 38% to 67%; use was lower in men with very high PSA and in those older than 80.
Why it matters: it is descriptive, with no clinical outcomes, but it sets the benchmark for current practice; in the Dominican Republic, access to quality multiparametric MRI remains the bottleneck of modern screening.
https://doi.org/10.1001/jamaoncol.2026.3620

8. RADICAL PC-2: cardiology referral at ADT start did not reduce cardiovascular events

[Clinical trial] [Multinational, 8 countries; coordinated from Canada]
A pragmatic trial published in JAMA Internal Medicine (covered September 2) randomized 2,487 men with prostate cancer starting ADT at 55 sites in 8 countries to usual care or referral to a cardiologist or internist with blood pressure targets and routine statin use. At a median of 5.8 years, the hierarchical composite outcome favored referral (win ratio 1.60; 95% CI 1.42–1.81), driven by cholesterol (statin use at close-out 63% vs 40%), but there was no difference in cardiovascular death, myocardial infarction, stroke or heart failure (subdistribution HR 1.08; 95% CI 0.79–1.49).
Why it matters: cardiovascular risk assessment remains reasonable when starting ADT, but routine referral has not shown clinical benefit; urologists can take on basic risk-factor control.
https://doi.org/10.1001/jamainternmed.2026.4773

BPH and voiding dysfunction

9. CE mark for FemPulse, a vaginal neuromodulation ring for overactive bladder

[Regulatory CE] [European Union / USA]
On September 17, FemPulse announced CE marking under the EU MDR for its wireless, non-implanted, patient-inserted vaginal ring with 8 programmable electrodes for overactive bladder. The company cites data from 4 clinical studies that were not detailed. In the USA it remains investigational: the pivotal EVANESCE-II trial (up to 151 women, randomized 2:1 vs tolterodine, 26-week endpoint) is expected to finish in December 2027.
Why it matters: needle-free, surgery-free neuromodulation would be attractive, but no comparative data have been published; a CE mark does not equal proven efficacy.
https://fempulse.com/news_home/fempulse-ring-gains-ce-mark-certification-for-the-eu/

10. FDA RMAT designation for a gene therapy in neurogenic detrusor overactivity

[Regulatory FDA] [USA]
On September 14, Cyllene Therapeutics announced a Regenerative Medicine Advanced Therapy (RMAT) designation for EG110A, a non-replicating HSV-1 vector injected into the detrusor that inhibits CGRP+ neurons, in patients with spinal cord injury and incontinence. In the open-label phase 1b/2a trial (NCT06596291; 16 patients planned), the company reports a more than 88% reduction in incontinence episodes at week 12 with the lowest dose, without specifying the number of patients.
Why it matters: these are preliminary, open-label, uncontrolled, company-reported data; an interesting future alternative to botulinum toxin, but far from practice. Data will be presented at ICS 2026.
https://cyllene-tx.com/Cyllene-Therapeutics-Receives-U-S--FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-EG110A-in-Neurogenic-Detrusor-Overactivity-NDO-.html

Stones and endourology

We found no new verifiable studies within the period this month. The 2026 AUA guideline on medical management of kidney stones (which covers children and adolescents for the first time and adds guidance on genetic testing) was discussed in September, but we could not confirm its publication date, so it is not included as news of the month.

Andrology, transplantation, pediatric urology and robotic surgery

11. ERUS26 (Padua): eight live telesurgeries and a disconnection that underlines the role of the local team

[Meeting] [Italy, with patients in Poland and Morocco]
At the 23rd meeting of the EAU Robotic Urology Section (Padua, September 9–11; more than 1,200 attendees), about 50 live surgeries were performed, 8 of them long-distance using Chinese platforms (Edge Medical and MicroPort Toumai). From the console in Padua, a prostatectomy was performed on a patient in Warsaw with latency described as practically unnoticeable. In another prostatectomy, with the patient in Casablanca, the remote surgeon could not reconnect for a few minutes after a planned handover to local control, and the Moroccan surgeon completed more of the case than planned.
Why it matters: this is a demonstration, not a trial, but the incident shows that telesurgery requires a local team able to continue the operation and redundant networks, which is key if it is ever considered in the Caribbean.
https://erus.uroweb.org/day-1-report-palpable-tension-during-live-telesurgery-session/

12. Topical sildenafil cream: far lower systemic exposure than oral sildenafil

[Publication] [USA]
An open-label phase 1 trial published in Sexual Medicine (press release September 14) randomized 62 healthy men to topical sildenafil cream (36 or 71 mg, with or without a condom) or oral sildenafil 50 mg. Relative topical bioavailability was 2.6% to 3.2%; with 36 mg, peak concentration was about 187-fold lower and area under the curve about 35-fold lower than with oral dosing. There were 14 adverse events, all mild, half of them in the oral arm.
Why it matters: a small study in healthy volunteers sponsored by Daré Bioscience; it provides no efficacy data in erectile dysfunction, so it does not change practice for now.
https://doi.org/10.1093/sexmed/qfag083

Cross-cutting

13. German Urological Congress (DGU 2026): artificial intelligence and sustainability as central themes

[Meeting] [Germany] (source in German)
The 78th congress of the German Society of Urology (Düsseldorf, September 16–19) drew about 6,800 participants. President Susanne Krege focused the program on artificial intelligence in imaging, pathology and tumor boards, and on device sustainability. The multicenter randomized 3DPN trial (370 patients) of virtual 3D models in robotic partial nephrectomy was presented, and the Maximilian Nitze Prize went to work on hyperspectral imaging with deep learning for intraoperative tissue classification.
Why it matters: it is a barometer of where the specialty is heading in Europe; the 3DPN design was already published and the rest are presentations without definitive results.
https://mgb-medizin.de/urologie/dgu-2026-highlights-urologische-forschung/

14. Devices: SpaceOAR Flex receives 510(k) and LigaSure comes to the Hugo robotic platform

[Industry] [USA]
On September 25, FDA 510(k) clearance was reported for SpaceOAR Flex (Boston Scientific), a version of the hydrogel rectal spacer with a single-syringe delivery system, visible on CT. On September 16, Medtronic announced FDA clearance of the LigaSure RAS Maryland instrument for its Hugo robotic system, sealing vessels up to 7 mm.
Why it matters: these are incremental, manufacturer-announced improvements without new clinical data; the arrival of alternative robotic platforms could lower the cost of access to robotic surgery in the region.
https://www.urologytimes.com/view/fda-grants-510-k-clearance-to-spaceoar-flex-hydrogel
https://news.medtronic.com/2026-09-16-Medtronic-announces-FDA-clearance-for-LigaSure-TM-RAS-Maryland-instrument-on-the-Hugo-TM-RAS-system

Upcoming meetings and dates

• ICS 2026, 56th Annual Meeting of the International Continence Society: Maastricht (Netherlands), October 6–9, 2026.
• 46th SIU Congress: Florence (Italy), November 11–14, 2026.
• Later: XXXIX National Urology Congress of the Dominican Society of Urology, "Urology of the Future": Hard Rock Hotel & Casino, Punta Cana, December 3–6, 2026.

Monthly urology bulletin — September 29, 2026

14 verified items from the past month, from Nature, The Lancet, NEJM, JAMA Oncology, JAMA Internal Medicine, the International Journal of Urology, ASTRO 2026, and the FDA and EMA.

Three worth your time:
• PACE-A (ASTRO 2026): SBRT vs prostatectomy showed similar 8-year disease control (91% vs 84%) and pad use at 5 years of 8% vs 48%. Limitation: 123 patients, secondary endpoints.
• FDA approves belzutifan + lenvatinib for clear cell RCC after immunotherapy: PFS 14.6 vs 10.6 months vs cabozantinib. Limitation: no overall survival benefit.
• Nature, 959 prostate cancer genomes: 8 mutational footprints explain 85% of tumors, and one poor-prognosis footprint is enriched in men of African ancestry. Limitation: not yet a clinical test.

Full bulletin, with a critical reading of each study and links to primary sources:
https://boletinesmedicos.com/en/urologia/2026-09-29.html

#Urology #ProstateCancer #KidneyCancer #GUOncology #Telesurgery

PACE-A: SBRT and prostatectomy had similar 8-yr disease control (91% vs 84%); pad use at 5 yrs 8% vs 48%. FDA approves belzutifan + lenvatinib in RCC (PFS 14.6 vs 10.6 mo). Bulletin: https://boletinesmedicos.com/en/urologia/2026-09-29.html