Evidence map›Paper›PMID 39561384›Full record

Trial reportThe Journal of urology2025

Long-Term Outcomes of Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma With UGN-101, a Mitomycin Reverse Thermal Gel.

Phillip M Pierorazio, Nir Kleinmann, Ahmad Shabsigh, Brian Hu, Jay D Raman, Hristos Kaimakliotis, Alexander Sankin, Nirmish Singla, Andrew Meads, Brent Burger and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of urology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02793128 (A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of UGN-101 on Ablation of Upper Urinary Tract Urothelial Carcinoma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02793128 phase3completednot on this map

A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of UGN-101 on Ablation of Upper Urinary Tract Urothelial Carcinoma

TypeinterventionalSponsorUroGen Pharma Ltd.Ran2017 to 2020Enrolled71ConditionsCarcinoma, Transitional Cell, Transitional Cell Carcinoma of Renal PelvisArmsUGN-101 instillations
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Phillip M PierorazioSection of Urology, Department of Surgery, The University of Pennsylvania, Philadelphia, Pennsylvania.ORCID 0000-0003-0766-9981
Nir KleinmannDepartment of Urology, Sheba Medical Center, Ramat Gan, Israel.
Ahmad ShabsighDepartment of Urology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Brian HuDepartment of Urology, Loma Linda University, Loma Linda, California.
Jay D RamanDepartment of Urology, Milton S. Hershey Medical Center Penn State Health, Hershey, Pennsylvania.
Hristos KaimakliotisDepartment of Urology, Indiana University School of Medicine, Indianapolis, Indiana.
Alexander SankinDepartment of Urology, Albert Einstein College of Medicine, Bronx, New York.
Nirmish SinglaThe Brady Urological Institute, The Johns Hopkins University, Baltimore, Maryland.
Andrew MeadsUrogen Pharma, Princeton, New Jersey.
Brent BurgerUrogen Pharma, Princeton, New Jersey.
Sunil RajuUrogen Pharma, Princeton, New Jersey.
Michael J LouieUrogen Pharma, Princeton, New Jersey.
Karim ChamieDepartment of Urology, University of California Los Angeles, Los Angeles, California.
Alon WeizerDepartment of Urology, Mount Sinai Medical Center Division of Columbia University, Miami Beach, Florida.
Mark SchoenbergDepartment of Urology, Albert Einstein College of Medicine, Bronx, New York.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe evaluate long-term outcomes of primary chemoablation using a mitomycin reverse thermal gel (UGN-101) in patients with low-grade upper tract urothelial carcinoma. MATERIALS AND

methodsPatients who participated in the OLYMPUS trial (IRB No. TC-UT-03, NCT02793128) and achieved a complete response (CR) after 6 weekly doses of UGN-101 were followed up to 12 months after initial CR. Those with CR at study completion were eligible for long-term follow-up for up to 5 years or until disease recurrence, progression, or death.

resultsOf the 71 patients enrolled in the OLYMPUS trial, 42 patients achieved CR 4 to 6 weeks after completing ≥ 1 instillation of UGN-101. Among the 41 patients followed after initial CR, median follow-up was 28.1 months (95% CI, 13.1-57.5), and median duration of response was 47.8 months (95% CI, 13.0-not estimable [NE]). Twenty patients (49%) had long-term follow-up (median 53.3 months [95% CI, 27.9-65.3]). Seventy-five percent of patients had no evidence of recurrence at the last follow-up, with median duration of response NE (95% CI, 43.5-NE) because of a low event rate.

conclusionsPrimary intracavitary chemoablation with UGN-101 for low-grade upper tract urothelial carcinoma is associated with favorable long-term durability.

Indexed as

Antibiotics, AntineoplasticCarcinoma, Transitional CellKidney NeoplasmsMitomycinUreteral NeoplasmsAgedAged, 80 and overFemaleFollow-Up StudiesGelsHumansMaleMiddle AgedNeoplasm GradingTime FactorsTreatment OutcomeAntibiotics, AntineoplasticGelsMitomycincarcinomaclinical trialmitomycintransitional cell

Identifiers

PMID39561384
PMCPMC12708039

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.