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Highlights from the 2026 American Urological Association Annual Meeting
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| Practice-Changing, Paradigm-Shifting Clinical Trials in Urology: Darolutamide + ADT in mHSPC: ARASEC – US Prospective, Open-Label Phase 2 Study with an External Control
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| Rana McKay, MD
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| Rana McKay presents the ARASEC US phase 2 trial, an open-label trial using an external control to evaluate darolutamide plus ADT in mHSPC, addressing the need for combination-therapy data when ADT alone was no longer standard of care. Darolutamide + ADT significantly improved progression-free survival, overall survival, time to mCRPC, radiographic PFS, and PSA responses versus ADT alone, with safety consistent with the known darolutamide profile and sensitivity analyses.
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| Practice-Changing, Paradigm-Shifting Clinical Trials in Urology: A Non-Viral Intravesical Gene Therapy for BCG-Unresponsive NMIBC with CIS, with or Without Papillary Disease: Pivotal Phase 2 Interim Results of Detalimogene Voraplasmid
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| Ashish Kamat, MD, MBBS
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| Ashish Kamat presents pivotal phase 2 interim results from the LEGEND trial evaluating detalimogene voraplasmid, a next-generation non‑viral intravesical gene therapy, in patients with BCG‑unresponsive high‑risk NMIBC with CIS, with or without papillary disease.
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| Extended Follow-Up Shows Accumulating Benefit for Patients Treated with CAN-2409 + Prodrug in Combination with Standard of Care EBRT in Men with Localized Prostate Cancer – An Update from a Randomized, Placebo-Controlled Phase 3 Clinical Trial
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| Mark Garzotto, MD
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| Mark Garzotto presents extended phase 3 follow-up data showing that adding CAN-2409 (aglatimagene) plus oral valacyclovir to standard external beam radiotherapy significantly reduces the risk of recurrence or death in men with intermediate- to high-risk localized prostate cancer.
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| TRCG-011: Prospective Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Sustained Release Gemcitabine Docetaxel combination (NDV-01) in High-Risk NMIBC: Update with 12-month Complete Response Data
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| Boris Chertin, MD
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| Boris Chertin presents the TRCG-011 phase 2, single-arm, open-label study of NDV-01, a 10-day sustained-release intravesical gemcitabine/docetaxel formulation, in high-risk NMIBC patients, including BCG-naïve, -exposed, and -unresponsive cases. NDV-01 achieved a 95% anytime complete response rate and a durable 76% 12-month complete response rate, with no grade ≥3 treatment-related adverse events, no progressions to muscle-invasive disease, and no cystectomies, supporting progression to the phase 3 RESCUE registrational program targeted for mid-2026.
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| ADVANCED-2 (Cohort A): Interim 12-Month Efficacy and Safety Data in BCG-Naïve Participants with High-Grade Non-Muscle Invasive Bladder Cancer
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| Mark Tyson III, MD, MPH
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| Mark Tyson presents interim 12-month efficacy and safety data from ADVANCED-2 Cohort A, a phase 2, open-label study of intravesical TARA-002 in BCG-naïve patients with high-grade non–muscle invasive bladder cancer CIS. The author shows that TARA-002 achieved high complete response rates with durable responses through 12 months, including successful conversion of many initial non-responders after re-induction, and was generally well tolerated with mostly mild, transient urinary adverse events.
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| Cost Effectiveness Analysis of Sasanlimab + BCG for High-Risk NMIBC: Analysis From CREST
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| Daniel Joyce, MD, MS
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| Daniel Joyce presents this cost-effectiveness analysis from the CREST trial evaluating sasanlimab plus BCG versus BCG alone for BCG-naïve high-risk non–muscle invasive bladder cancer. The author shows that, despite improved event-free survival, sasanlimab + BCG yields only a marginal QALY gain at very high incremental cost, making it not cost-effective over a lifetime horizon unless the per-dose price of sasanlimab is reduced by more than 90%.
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| Immune Microenvironment Signatures of Response to Cretostimogene Grenadenorepvec in BCG-Unresponsive Non–Muscle Invasive Bladder Cancer
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| Taylor Goodstein, MD
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| Taylor Goodstein presents an analysis of immune microenvironment signatures associated with response to cretostimogene grenadenorepvec, an oncolytic adenoviral gene therapy, in patients with BCG-unresponsive non–muscle invasive bladder cancer. The author shows that response appears to depend less on overall immune cell infiltration and more on the balance between effector and regulatory subsets—highlighted by higher post-treatment CD8+/FOXP3+, CD4+/FOXP3+, and CD4+/PD1+ ratios in responders compared with non-responders.
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| Duration of Response to UGN-102 by Age at Baseline Across 3 Clinical Trials in Patients with Recurrent Low-Grade Intermediate-Risk Bladder Cancer
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| Ashish Kamat, MD, MBBS
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| Ashish Kamat presents a pooled analysis of three clinical trials evaluating the duration of response to UGN-102, an intravesical reverse thermal hydrogel formulation of mitomycin, in patients with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer across different age groups, including those with young onset disease.
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