Hannah Clarke

A recap of the FDA submissions and regulatory decisions in urology from August 2026.

The FDA has granted clearance to a phase 1 trial of ADI-212, a PSMA-targeted, gene-edited, armored cell therapy candidate under development for mCRPC.

This FAQ outlines what the State of Men's Health Act would do, how a federal Office of Men’s Health could affect research and clinical care, and what urologists can do to support the effort.

A TRUMPET registry analysis found that initial disease presentation and family history were associated with survival outcomes in metastatic castration-resistant prostate cancer.

Datopotamab deruxtecan will be assessed alone and in combination with rilvegostomig as adjuvant treatment for patients with high-risk muscle-invasive urothelial carcinoma.

A national cohort study found that metabolic syndrome and its components were frequently documented within the first year of concurrent ADT and ARPI therapy for prostate cancer.

The phase 2 MODeFIRe-1 trial will evaluate investigational MRT-2359 plus apalutamide in AR-mutated metastatic castration-resistant prostate cancer.

Water vapor thermal therapy also provided greater QoL improvement vs combination pharmacotherapy while preserving sexual function.

The designations were based on preliminary clinical data with 68Ga-NYM096, including a small, multicenter study presented at ASCO 2026.

The phase 2 RadiCaL trial found that adding radium-223 to cabozantinib did not improve skeletal event-free survival in metastatic renal cell carcinoma.

The phase 3 NRG-GU005 trial found SBRT improved bowel quality of life vs MH-IMRT but did not improve urinary outcomes or disease-free survival.

The NDA submission is supported by data from the phase 3 UTOPIA trial.

A recent study found active surveillance use for low-risk prostate cancer rose from 27% to 93% among veterans from 2005 to 2024.

A national analysis found that 51% of focal therapy procedures for prostate cancer occurred in patients with low-, high-, or very-high-risk disease, outside current guideline-supported settings.

The DIRECT-AI registry has enrolled its first patient to prospectively assess how the ArteraAI Prostate Test influences treatment decisions and outcomes in routine care.

Belzutifan plus lenvatinib significantly improved progression-free survival vs cabozantinib in patients with previously treated advanced clear cell renal cell carcinoma.

An analysis of NHANES data found that higher intake of ultra-processed foods was associated with increased prostate cancer risk among US men.

A claims-based analysis found blue light cystoscopy was associated with increase health care resource utilization in NMIBC without significantly increasing total costs.

A real-world analysis found that achieving a PSA level below 0.2 ng/mL was associated with improved overall survival in mCSPC.

These FAQs highlight key recommendations and practical takeaways from the 2026 AUA/ASTRO Clinically Localized Prostate Cancer guideline amendment.

The phase 3 PSMAddition trial found that adding lutetium Lu 177 vipivotide tetraxetan to ADT and an ARPI significantly improved rPFS in mHSPC.

The registrational trial will compare ivonescimab plus enfortumab vedotin vs pembrolizumab plus enfortumab vedotin for locally advanced or metastatic urothelial carcinoma.

The next-generation implant is designed to extend the implant longevity from 10 years to 15 years.

A recap of the FDA submissions and regulatory decisions in urology from July 2026.

OMCAZIO demonstrated bioequivalence to CABOMETYX at a lower dose and was found to have no clinically significant food effect.

The approval is supported by data from the phase 3 PSMAddition trial.

A reference on the key recommendations from the AUA Testosterone Deficiency guideline.

AI in medicine is here. What happens next matters for the future of health care delivery.

A 10-year registry analysis found focal HIFU and cryotherapy achieved durable cancer control and low prostate cancer mortality in localized disease.

This FAQ outlines the major recommendations from PCWG4 for urologists and clinical investigators involved in prostate cancer clinical trials.