Monthly urology bulletin — October 6, 2026

Period covered: September 6 to October 6, 2026. The month was dominated by urologic oncology (the 2026 ASTRO Annual Meeting and two regulatory decisions in muscle-invasive bladder cancer) and by three new guidelines. We include 9 verified items. We found no verifiable items from the period in stones, andrology, pediatric urology or robotic surgery, and no confirmed items from Asia, the Middle East or Latin America; we prefer to say so rather than fill space.

Urologic oncology

1. PACE-A: SBRT and prostatectomy show equivalent disease control at 8 years

[Conference] [United Kingdom / international]
Open-label phase 3 trial (PACE platform) presented at ASTRO 2026: 123 men with localized prostate cancer (cT1c–T2c, Gleason ≤3+4, PSA ≤20, MRI-staged, no ADT) randomized to prostatectomy (n=60) or five-fraction stereotactic body radiotherapy (n=63). At a median of 8 years, biochemical/clinical failure-free survival was 91% with SBRT vs 84% with surgery (HR 0.48; P=.18), with no prostate cancer deaths. At 5 years, daily pad use was 8% vs 48%.
Why it matters: with only 13 events the trial is underpowered for superiority, but it provides long-term randomized data for shared decision-making; in the Dominican Republic, access to SBRT remains concentrated in few centers.
https://www.urologytimes.com/view/sbrt-prostatectomy-show-comparable-long-term-disease-control-in-pace-a-trial
https://www.astro.org/news-and-publications/news-and-media-center/news-releases/2026/five-treatment-radiation-therapy-offers-effective-nonsurgical-alternative-for-localized-prostate-can

2. STEEL (RTOG 3506): enzalutamide added to salvage radiotherapy

[Conference] [United States and Canada]
Randomized phase 2, n=188 with high-risk biochemical recurrence after prostatectomy (45% pT3b, 22% pN1, ~61% Gleason 8–10). All received salvage radiotherapy and 24 months of GnRH analog, with or without enzalutamide 160 mg. 2-year PFS 88% vs 79% (HR 0.62; 80% CI 0.42–0.91; P=.052; adjusted HR 0.54). Grade 3 adverse events 30% vs 19%; only 53% completed enzalutamide.
Why it matters: a positive signal but phase 2, with borderline significance and poor tolerability; not practice-changing until phase 3 data are available.
https://urologytimes.com/view/enzalutamide-plus-salvage-radiotherapy-associated-with-improved-pfs-in-high-risk-bcr

3. EMA (CHMP): perioperative enfortumab vedotin + pembrolizumab in resectable MIBC

[Regulatory EMA] [European Union]
On September 18 the CHMP recommended the combination for adults with resectable muscle-invasive bladder cancer regardless of cisplatin eligibility (the June approval was limited to cisplatin-ineligible patients). In KEYNOTE-B15/EV-304 (n=808, vs neoadjuvant gemcitabine-cisplatin): 2-year EFS 79.4% vs 66.2% (HR 0.53), OS HR 0.65 (24-month OS 86.9% vs 81.3%), and pCR 55.8% vs 32.5%. A European Commission decision is expected in Q4.
Why it matters: the strongest change of standard of care in MIBC this year; manufacturer-sponsored, and its cost will limit near-term access in the Dominican public system.
https://www.urologytimes.com/view/chmp-recommends-perioperative-enfortumab-vedotin-plus-pembrolizumab-for-mibc

4. FDA: priority review for durvalumab + enfortumab vedotin (VOLGA)

[Regulatory FDA] [United States]
On September 25 the FDA accepted with priority review the application for perioperative durvalumab with neoadjuvant enfortumab vedotin in cisplatin-ineligible or cisplatin-declining MIBC (T2–T4aN0/1M0), with action expected in Q4 2026. Per AstraZeneca, the doublet significantly improved EFS and OS vs cystectomy with or without adjuvant therapy; the triplet with tremelimumab met EFS but not OS at the interim analysis.
Why it matters: full data have not been published and the information comes from the sponsor; await publication before judging the absolute benefit.
https://www.urologytimes.com/view/fda-grants-priority-review-to-perioperative-durvalumab-plus-enfortumab-vedotin-in-mibc

5. FDA: Fast Track for pre-biopsy PSMA-PET + MRI (BiPASS)

[Regulatory FDA] [Australia / United States]
On September 30 the FDA granted Fast Track designation to Telix's BiPASS program (68Ga-PSMA-11 plus MRI to detect clinically significant cancer before biopsy). It builds on PRIMARY (n=291: sensitivity from 83% to 97% when PSMA-PET was added, with specificity falling from 53% to 40%) and PRIMARY2 (n=660: biopsy avoided in 49% with noninferior detection). BiPASS has enrolled 350 patients and will finish in 2027.
Why it matters: this is a designation, not an approval, and the program is manufacturer-run; lower specificity and PET cost limit its role as a screening tool in our setting.
https://www.urologytimes.com/view/fda-grants-fast-track-designation-to-pre-biopsy-68ga-psma-pet-program

BPH and voiding dysfunction

6. CE mark for the FemPulse vaginal neuromodulation ring in overactive bladder

[Industry] [European Union / United States]
FemPulse received a CE mark under the EU MDR for a wireless, non-implanted vaginal ring with 8 programmable electrodes delivering neuromodulation in women with overactive bladder. Published data come from small uncontrolled series (e.g., ICS 2026: two feasibility studies with 16 women in total, mean reduction of 5.2 voids/day). The pivotal EVANESCE-II trial (up to 151 women, 2:1 vs tolterodine) will finish in December 2027.
Why it matters: attractive because it is non-invasive, but current evidence does not justify preferring it over neuromodulation options backed by randomized data.
https://www.urologytimes.com/view/fempulse-ring-receives-eu-approval-for-overactive-bladder

Stones and endourology

No verifiable trials or regulatory decisions dated within the period.

Andrology, transplantation, pediatric urology and robotic surgery

No verifiable items dated within the period.

Cross-cutting

7. Updated AUA/SUO guideline on non-muscle-invasive bladder cancer

[Guideline] [United States]
Released in early September: risk stratification at each recurrence, upper-tract imaging every 1–2 years for intermediate and high risk, and TURBT, intravesical chemoablation or surveillance for recurrent low-grade disease. For BCG-unresponsive disease it adds TAR-200 (78.8% CR at 3 months in SunRISe-1) and sequential gemcitabine-docetaxel. Urinary biomarkers do not replace cystoscopy.
Why it matters: a useful guideline, but several options depend on costly drugs not registered in the region; gemcitabine-docetaxel is the most applicable alternative amid BCG shortages.
https://targetedonc.com/view/non-muscle-invasive-bladder-cancer-guideline-update

8. First ASTRO guideline on radiation therapy for bladder cancer

[Guideline] [United States]
Published September 17 in Practical Radiation Oncology. Recommends trimodality therapy (maximal TURBT + radiotherapy with a radiosensitizing systemic agent) as an alternative to cystectomy in selected patients (solitary tumor <7 cm, predominantly urothelial, no extensive CIS or hydronephrosis); conditional adjuvant radiotherapy for pT3–4, pN+ or positive margins; IMRT with daily image guidance.
Why it matters: a formal framework for bladder preservation in patients without timely access to cystectomy, always within a multidisciplinary tumor board.
https://ecancer.org/en/news/28918-first-clinical-guideline-on-radiation-therapy-for-bladder-cancer-issued

9. CUA national consensus on prostate cancer theranostics

[Guideline] [Canada]
Published October 5 in CUAJ: 32 consensus statements from 17 experts on PSMA-PET/CT and lutetium-177-PSMA. A negative PSMA-PET should not by itself withhold salvage radiotherapy, and a single positive lesion should be interpreted cautiously before labeling metastatic disease.
Why it matters: expert consensus rather than a systematic review, but practical guidance for programs starting PSMA-PET.
https://newswire.ca/news-releases/canadian-experts-release-national-guidance-on-prostate-cancer-theranostics-821440646.html

Upcoming meetings and dates

• 46th Congress of the Société Internationale d'Urologie (SIU), Florence, Italy: sources list different dates (October 14–17 and November 11–14, 2026); confirm at https://www.siu-urology.org/congress-2026/highlights
• Already held during the period: 78th Congress of the German Society of Urology (DGU), Düsseldorf, September 16–19.

Monthly urology bulletin — October 6, 2026
9 verified items from the past month: ASTRO 2026, EMA, FDA, and guidelines from AUA/SUO, ASTRO and CUA.

Three worth your time:
• PACE-A (n=123): SBRT and prostatectomy show similar 8-year control (91% vs 84%, NS) with less incontinence after SBRT (daily pads 8% vs 48%). Only 13 events.
• EMA backs perioperative enfortumab vedotin + pembrolizumab in resectable MIBC: 2-year EFS 79% vs 66%, pCR 56% vs 33%. Cost limits access.
• ASTRO issues its first bladder cancer radiotherapy guideline: trimodality therapy for selected patients. Expert guidance, not a trial.

Full bulletin, with a critical read of each study and links to primary sources:
https://boletinesmedicos.com/en/urologia/2026-10-06.html

#Urology #ProstateCancer #BladderCancer #UroOncology

PACE-A: SBRT matches prostatectomy at 8 years (91% vs 84%) with less incontinence (8% vs 48%). EMA backs perioperative EV + pembrolizumab in MIBC: 2-year EFS 79% vs 66%. https://boletinesmedicos.com/en/urologia/2026-10-06.html