Top 10 urology headlines you missed in Q1 2026

The first quarter of 2026 brought a wave of pivotal developments across urology, from landmark clinical trial results to meaningful FDA actions reshaping treatment standards. Bladder and prostate cancer saw some of the most significant advances, with the KEYNOTE-B15 trial establishing a new perioperative standard of care in muscle-invasive disease and the PRIMARY2 trial offering a smarter diagnostic path that could spare men from unnecessary biopsies.

Rounding out a busy quarter, regulators cleared novel devices and therapies, including a non-invasive lithotripsy system for kidney stones and the first oral dissolving film for erectile dysfunction. Concurrently, early-stage innovations like antiandrogen-eluting implants for localized prostate cancer earned fast track status, signaling a robust pipeline ahead.

Take a look through the top 10 stories in urology from January through March 2026.

KEYNOTE-B15: EV/pembro sets new benchmark before cystectomy in MIBC

Results from the phase 3 KEYNOTE-B15/EV-304 trial (NCT04700124) were presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium, demonstrating that perioperative enfortumab vedotin-ejfv (EV; Padcev) plus pembrolizumab (Keytruda) significantly improved event-free survival (EFS), overall survival, and pathologic complete response vs neoadjuvant cisplatin-based chemotherapy in cisplatin-eligible muscle-invasive bladder cancer (MIBC), marking the first regimen in nearly 25 years to surpass the long-standing standard of care. At the time of data report, the median EFS was not reached in the EV/pembrolizumab arm vs 48.5 months in the neoadjuvant chemotherapy arm (HR, 0.53; 95% CI, 0.41 to 0.70; P < .0001).¹

These results—combined with prior data from KEYNOTE-905 in cisplatin-ineligible patients—support perioperative EV/pembrolizumab as a new standard of care for patients with MIBC regardless of cisplatin eligibility.

PRIMARY2: PSMA-PET/CT can safely reduce prostate biopsies in men with equivocal MRI

Results from the phase 3 PRIMARY2 trial (NCT05154162), presented at the 41st Annual Congress of the European Association of Urology in London, showed that incorporating prostate-specific membrane antigen (PSMA)-PET/CT into the diagnostic pathway for biopsy-naïve men with non-suspicious or equivocal MRI findings (PI-RADS 2 or 3) allowed 49% of patients to avoid biopsy altogether. The PSMA-PET strategy achieved non-inferior detection of clinically significant prostate cancer compared with standard systematic biopsy (12% vs 16%), while dramatically reducing the diagnosis of clinically insignificant disease (14% vs 32%). These findings suggest that PSMA-PET/CT after MRI offers a more precise risk-stratification tool that could meaningfully address the longstanding challenge of prostate cancer overdiagnosis and reduce unnecessary biopsies.²

FDA approves label changes for first batch of menopausal hormone therapy products

On February 12, 2026, the FDA approved labeling changes for 6 hormone replacement therapies (HRT), removing boxed warning language related to cardiovascular disease, breast cancer, and probable dementia. This action was initiated following a comprehensive review of the scientific literature, representing the first wave of labeling updates among 29 companies that have submitted proposed changes. According to the FDA, the labeling changes reflect a broader effort to align HRT labeling with the current evidence.³

Estradiol Patches in Prostate Cancer: Evidence and Impact

In part 3 of a 5-part series, Richard Wassersug, PhD, and Paul F. Schellhammer, MD, FACS, discuss emerging evidence supporting transdermal estradiol as an effective and potentially superior alternative to traditional LHRH analogue androgen deprivation therapy (ADT) for advanced prostate cancer.

FDA grants 510(k) clearance to Break Wave lithotripsy device for kidney stones

In January 2026, the FDA granted 510(k) clearance to SonoMotion's Break Wave lithotripsy device for the management of kidney stones. The technology’s safety and efficacy were evaluated in the prospective, open-label SOUND trial. The Break Wave device can also be used in conjunction with SonoMotion's previously cleared Stone Clear device, creating a comprehensive non-invasive workflow to both fragment and clear residual kidney stone fragments in a single setting.⁴

RCMIGI trial supports feasibility of reduced margins in image-guided prostate radiotherapy

The phase 2 RCMIGI trial (NCT03254420) found that intensity-modulated (IMRT) and image-guided (IGRT) radiotherapy with reduced treatment margins and real-time Calypso System tracking led to improved patient-reported urinary symptoms and dosimetric parameters for rectal and bladder dose in patients receiving conventional fractionation. The findings reinforce margin reduction as a key principle of precision radiotherapy, with relevance to emerging technologies that enable even tighter margins.⁵

FDA approves sildenafil oral film for men with erectile dysfunction

On February 5, 2026, IBSA USA announced FDA approval of VYBRIQUE, a sildenafil oral film for the treatment of erectile dysfunction in men aged 18 and older.² This approval is based on results from a 12-week, phase 3 randomized trial (NCT05490680) in 475 adult men, in which the sildenafil oral film demonstrated statistically significant improvements in sexual function vs placebo. VYBRIQUE is a single-dose, orally dissolving film that can be taken with or without water. The film, which is designed for discreet administration, is expected to be commercially available in the US in March 2026.⁶

Urologist explains science behind HA penile injections

In an interview discussing rumors surrounding ski jumpers at the 2026 Winter Olympics, urologist Alex Tatem, MD, explained the biological effects and clinical realities of hyaluronic acid (HA) penile injections.

CREST and POTOMAC: Redefining immunotherapy’s role in NMIBC

In an interview with Urology Times, Daniel Antonio González Padilla, MD, a urologist with Clínica Universidad de Navarra in Madrid, Spain, discussed the rationale, findings, and clinical implications of the CREST (NCT04165317) and POTOMAC (NCT03528694) trials evaluating immune checkpoint inhibitors (ICIs) in high- and very high-risk non–muscle invasive bladder cancer (NMIBC).

FDA grants fast track designation to Enolen for localized prostate cancer

On January 8, 2026, Alessa Therapeutics announced that the FDA had granted fast track designation to Enolen for the treatment of low- to intermediate-risk localized prostate cancer. This designation is based on preclinical data supporting sustained local delivery of enzalutamide via antiandrogen-eluting implants with high intraprostatic drug concentrations and minimal systemic exposure. Enolen is currently being evaluated in a phase 1 trial, with initial readouts planned in 2026.⁷

REFERENCES

1. Galsky MD, Pérez-Valderrama B, Maruzzo M, et al. Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: randomized, open-label, phase 3 KEYNOTE-B15 study. Abstract LBA630. Presented at: 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium; February 26-28, 2026; San Francisco, CA. https://meetings.asco.org/meetings/2026-asco-genitourinary-cancers-symposium/334/16924

2. Buteau JP, Moon D, Fahey MT, et al. Impact of [68Ga]Ga-PSMA-11 PET/CT in the diagnosis of prostate cancer in men with equivocal or non-suspicious findings on multi-parametric MRI (PRIMARY2): a multi-centre, phase III, randomised trial. Presented at: 41st Annual Congress of the European Association of Urology. London, UK. March 13-16, 2026

3. FDA approves labeling changes to menopausal hormone therapy products. News release. FDA. February 12, 2026. Accessed March 31, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products

4. SonoMotion announces FDA clearance for its Break Wave™ lithotripsy device for treatment of kidney stones. News release. SonoMotion, Inc. January 21, 2026. Accessed March 31, 2026. https://www.prnewswire.com/news-releases/sonomotion-announces-fda-clearance-for-its-break-wave-lithotripsy-device-for-treatment-of-kidney-stones-302666229.html

5. Riou O, Fenoglietto P, Jarlier M, et al. Image-guided intensity-modulated radiotherapy with reduced margins in patients with prostate cancer: Results of the RCMIGI randomized phase II trial. Radiother Oncol. 2025:215:111322. doi:10.1016/j.radonc.2025.111322

6. IBSA USA announces FDA approval of VYBRIQUE™, the first and only oral film to treat men with erectile dysfunction. News release. IBSA USA. February 5, 2026. Accessed March 31, 2026. https://www.businesswire.com/news/home/20260205186522/en/IBSA-USA-Announces-FDA-Approval-of-VYBRIQUE-the-First-and-Only-Oral-Film-to-Treat-Men-with-Erectile-Dysfunction

7. Alessa Therapeutics announces FDA fast track designation for Enolen, a first-of-its-kind treatment for localized prostate cancer. News release. Alessa Therapeutics. January 8, 2026. Accessed March 31, 2026. https://alessatherapeutics.com/news/alessa-therapeutics-announces-fda-fast-track-designation-for-enolen-a-first-of-its-kind-treatment-for-localized-prostate-cancer/