Treatment of Low-grade Intermediate-risk Nonmuscle-invasive Bladder Cancer With UGN-102 - Transurethral Resection of Bladder Tumor Compared to Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS)

Sep 24, 2026

Transurethral resection of bladder tumor (TURBT) is standard for low-grade intermediate-risk nonmuscle-invasive bladder cancer, but frequent recurrence drives patients toward repeated surgery with risks. UGN-102, a reverse thermal gel containing mitomycin delivered via urethral catheter, was tested against TURBT monotherapy in a randomized phase 3 trial (ATLAS). Induction UGN-102 achieved similar complete response rates at 3 months (65% vs 64%), while disease-free survival at 15 months was numerically higher (72% vs 50%). Adverse events were typical local urinary symptoms and no serious treatment-related events occurred.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Study Need and Importance

What We Found

Limitations

Interpretations for Patient Care

[www.auajournals.org/journal/juro](www.auajournals.org/journal/juro) JU Insight Treatment of Low-grade Intermediate-risk Nonmuscle-invasive Bladder Cancer With UGN-102 ± Transurethral Resection of Bladder Tumor Compared to Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS) Sandip M. Prasad, William C. Huang, Neal D. Shore, et al. Correspondence: Sandip M. Prasad (email: [Sandip.Prasad@atlantichealth.org](Sandip.Prasad@atlantichealth.org)). Full-length article available at [https://doi.org/10.1097/JU.0000000000003645](https://doi.org/10.1097/JU.0000000000003645). Study Need and Importance: Transurethral resection of bladder tumor (TURBT) is the current standard of care for treatment of low-grade intermediate-risk (IR) nonmuscle-invasive bladder cancer (NMIBC) . The disease is highly recurrent, however, causing patients to undergo repetitive surgery with the attendant risks. A search for alternatives to TURBT led to the development of UGN- 102, a reverse thermal gel containing mitomycin that can be delivered via urethral catheter in an ambulatory setting. In this study, we sought to compare efﬁcacy and safety of initial chemoablation with UGN-102 (with subsequent TURBT at 3 months only if needed) to TURBT monotherapy. What We Found: Patients receiving induction treatment with UGN-102 achieved complete response rates at 3 months that were comparable to the TURBT control group (65% vs 64%, respectively); however, initial treatment with UGN-102 with or without subsequent TURBT resulted in a numerically greater probability of disease-free survival at 15 months compared with TURBT alone (72% vs 50%, see Figure). Common adverse events associated with UGN-102 (dysuria, micturition urgency, nocturia, and pollakiuria) were typical of local therapy for bladder cancer, and no serious treatment-related adverse events were observed. Limitations: A key limitation of this study is that enrollment was halted early by the sponsor to pursue an alternative development strategydafter Figure. Kaplan-Meier estimates of disease-free survival (intentto-treat analysis set) . TURBT indicates transurethral resection of bladder tumor. fewer than half of the planned number of patients had been enrolleddrendering the trial underpowered to determine whether primary chemoablation with UGN-102 􀀁 TURBT is statistically superior to TURBT monotherapy. Interpretations for Patient Care: UGN-102 is a minimally invasive, nonsurgical treatment that may provide an alternative to repetitive TURBT for patients with low-grade IR NMIBC. Further evaluation ofUGN-102 in the treatment of recurrent IRNMIBC is now underway in a phase 3, open-label, single-arm study (ENVISION, NCT05243550) that will further clarify its role in patient care. THE JOURNAL OF UROLOGY® 􀀁 2023 The Author(s) . Published on behalf of the American Urological Association, Education and Research, Inc. [https://doi.org/10.1097/JU.0000000000003645](https://doi.org/10.1097/JU.0000000000003645)[ ](https://doi.org/10.1097/JU.0000000000003645)Vol. 210, 619-629, October 2023 Printed in U.S.A. [www.auajournals.org/jurology](www.auajournals.org/jurology j 619)[ j](www.auajournals.org/jurology j 619)[ 619](www.auajournals.org/jurology j 619) [www.auajournals.org/journal/juro](www.auajournals.org/journal/juro) Treatment of Low-grade Intermediate-risk Nonmuscle-invasive Bladder Cancer With UGN-102 ± Transurethral Resection of Bladder Tumor Compared to Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS) Sandip M. Prasad, 1 * William C. Huang,2 Neal D. Shore,3 Brian Hu,4 Marc Bjurlin,5 Gordon Brown,6 Pencho Genov,7 Dimitar Shishkov,8 Alexandre Khuskivadze,9 Tosho Ganev, 10 Dobri Marchev, 11 Igor Orlov, 12 Evgeny Kopyltsov, 13 Vadim Zubarev, 14 Alexander Nosov, 15 Dmitrii Komlev, 16 Brent Burger, 17 Sunil Raju, 17 Andrew Meads, 17 and Mark Schoenberg 17,18 on behalf of The ATLAS

FAQs

What treatment does UGN-102 provide for low-grade intermediate-risk NMIBC?

UGN-102 is a reverse thermal gel containing mitomycin delivered via urethral catheter, designed for minimally invasive intravesical chemoablation.

How did UGN-102 compare with TURBT monotherapy at 3 months?

Complete response rates at 3 months were comparable between UGN-102 and TURBT monotherapy (65% vs 64%).

What safety concerns were observed with UGN-102?

Common adverse events included dysuria, urinary urgency, nocturia, and pollakiuria, with no serious treatment-related adverse events reported.

Sep 24, 2026

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