Study Stopped
Alternate approach pursued
A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
ATLAS
A Randomized, Controlled, Open-Label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients With Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
1 other identifier
interventional
282
10 countries
139
Brief Summary
This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2021
139 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2020
CompletedFirst Posted
Study publicly available on registry
December 30, 2020
CompletedStudy Start
First participant enrolled
February 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2023
CompletedResults Posted
Study results publicly available
June 6, 2024
CompletedJune 6, 2024
May 1, 2024
2.1 years
July 21, 2020
May 7, 2024
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free Survival (DFS)
DFS is defined as the time from randomization until the earliest date of any of the following events: failure to be rendered free of local disease at the 3-month Visit (TURBT arm only), recurrence of LG disease after the 3-month Visit (ie, during the Follow-up Period), progression to high-grade (HG) disease, or death due to any cause. Summarized is the Kaplan-Meier estimated probability of remaining event-free at 15 months from randomization.
15 months
Secondary Outcomes (9)
Time to Recurrence (TTR)
15 months
Complete Response Rate (CRR)
3 months
Duration of Response (DOR)
12 months
Observed CRR at Scheduled Disease Assessment Time Points
12 months
Number of TURBTs
3 months
- +4 more secondary outcomes
Study Arms (2)
UGN-102 ± TURBT
EXPERIMENTAL6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
TURBT Alone
ACTIVE COMPARATORTURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
Interventions
UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.
The current standard of care for treatment of LG-IR-NMIBC is TURBT under general anesthesia.
Eligibility Criteria
You may qualify if:
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Patient who has newly diagnosed or historic LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks of Screening.
- Has intermediate risk disease, defined as having 1 or 2 of the following:
- Presence of multiple tumors;
- Solitary tumor \> 3 cm;
- Recurrence (≥ 1 occurrence of LG-NMIBC within 1 year of the current diagnosis).
- Negative voiding cytology for HG disease within 6 weeks of Screening.
- Has adequate organ and bone marrow function as determined by the following routine laboratory tests:
- Leukocytes ≥ 3,000 cells per μL;
- Absolute neutrophil count ≥ 1,500 cells per μL;
- Platelets ≥ 100,000 per μL;
- Hemoglobin ≥ 9.0 g/dL;
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
- Alkaline phosphatase (ALP) ≤ 2.5 × ULN;
- +3 more criteria
You may not qualify if:
- History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment.
- Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.
- History of HG papillary UC in the past 2 years.
- Known allergy or sensitivity to mitomycin that in the investigator's opinion cannot be readily managed.
- Clinically significant urethral stricture that would preclude passage of a urethral catheter.
- History of pelvic radiotherapy.
- History of:
- Neurogenic bladder;
- Active urinary retention;
- Any other condition that would prohibit normal voiding.
- Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract UC.
- Current tumor stage of T1.
- Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.
- History of prior treatment with an intravesical chemotherapeutic agent except for a single dose of chemotherapy immediately after any previous TURBT.
- Has previously participated in a study in which they received UGN-102.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (139)
Arizona Institute of Urology, PLLC
Tucson, Arizona, 85704, United States
Loma Linda University Medical Center
Loma Linda, California, 92350, United States
Urology Group of Southern California
Los Angeles, California, 90017, United States
San Diego Clinical Trials
San Diego, California, 92120, United States
Providence Saint John's Health Center
Santa Monica, California, 90404, United States
Skyline Urology
Sherman Oaks, California, 91411, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010, United States
First Urology, PSC
Jeffersonville, Indiana, 47130, United States
Wichita Urology Group
Wichita, Kansas, 67226, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, 21204, United States
Chesapeake Urology Research Associates
Hanover, Maryland, 21076, United States
Adult & Pediatric Urology, PC
Omaha, Nebraska, 68114, United States
Urology Center
Las Vegas, Nevada, 89144, United States
New Jersey Urology
Bloomfield, New Jersey, 07003, United States
New Jersey Urology
Englewood, New Jersey, 07631, United States
Garden State Urology
Morristown, New Jersey, 07960, United States
Albany Medical Center
Albany, New York, 12208, United States
Great Lakes Physician dba WNY Urology Associates
Cheektowaga, New York, 14225, United States
AccuMed Research Associates
Garden City, New York, 11530, United States
Manhattan Medical Research
New York, New York, 10016, United States
Stony Brook Cancer Center
Stony Brook, New York, 11794, United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 13210, United States
UNC Chapel Hill Memorial Hospital
Chapel Hill, North Carolina, 27599, United States
Clinical Research Solutions
Middleburg Heights, Ohio, 44130, United States
Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Penn State Health Milton S. Hershey Medical Center and College of Medicine
Hershey, Pennsylvania, 17033, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15237, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Multiprofile Hospital for Active Treatment "Puls", Department of Urology
Blagoevgrad, 2700, Bulgaria
Multiprofile Hospital for Active Treatment - Blagoevgrad
Blagoevgrad, 2700, Bulgaria
Complex Oncology Center - Burgas
Burgas, 8000, Bulgaria
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology
Gabrovo, 5300, Bulgaria
Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom
Lom, 3600, Bulgaria
Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"
Montana, 3400, Bulgaria
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
Pleven, 5800, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology
Pleven, 5800, Bulgaria
Multiprofile Hospital for Active Treatment Park Hospital
Plovdiv, 4000, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinic of Urology
Plovdiv, 4002, Bulgaria
University Multiprofile Hospital for Active Treatment, Plovdiv, Department of Urology
Plovdiv, 4003, Bulgaria
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology
Rousse, 7000, Bulgaria
Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology
Shumen, 9700, Bulgaria
University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Urology Clinic
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
Sofia, 1606, Bulgaria
Multiprofile Hospital for Active Treatment - Targovishte
Targovishte, 7700, Bulgaria
Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology
Varna, 9000, Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic
Varna, 9002, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveta Marina"
Varna, 9010, Bulgaria
Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology
Veliko Tarnovo, 5000, Bulgaria
First Private Hospital Vratsa, Department of Urology
Vratsa, 3001, Bulgaria
Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology
Yambol, 8600, Bulgaria
East Viru Central Hospital, Surgery Clinic
Kohtla-Järve, 31025, Estonia
East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology
Tallinn, 10138, Estonia
West Tallinn Central Hospital Ltd., Department of Urology
Tallinn, 10617, Estonia
North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre
Tallinn, 13419, Estonia
Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation
Tartu, 50406, Estonia
LTD Central University Clinic After Academic N. Kipshidze
Tbilisi, 0160, Georgia
JSC Jerarsi, Department of Urology
Tbilisi, Georgia
LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department
Tbilisi, Georgia
LTD Gidmedi, Urology Department
Tbilisi, Georgia
LTD L. Managadze National Center of Urology, Department of Urology
Tbilisi, Georgia
LTD MMT Hospital, Urology Department
Tbilisi, Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD, Department of Urology
Tbilisi, Georgia
Pineo Medical Ecosystem Ltd., Department of Urology
Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department
Tbilisi, Georgia
Rambam Health Care Campus
Haifa, 31096, Israel
Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Edith Wolfson Medical Center
Holon, 58100, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Ramat Gan, 5262000, Israel
Liepajas Regional Hospital, Urology Department
Liepāja, LV-3414, Latvia
P. Stradins Clinical University Hospital, Center for Urology
Riga, LV-1002, Latvia
LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology
Riga, LV-1038, Latvia
Daugavpils Regional Hospital, Urology Department
Riga, LV-5417, Latvia
Jan Biziel University Hospital #2 in Bydgoszcz, Teaching Department of Urology
Bydgoszcz, 85-168, Poland
AKMED
Gliwice, 44-100, Poland
Prof.E Michalowski Specialist Hospital
Katowice, 40-073, Poland
SCM sp. z o.o. (LLC)
Krakow, 31-559, Poland
"City Clinic" Limited Liability Company
Warsaw, 02-473, Poland
Miedzyleski Specialist Hospital in Warsaw, Department of Urology
Warsaw, 04-749, Poland
Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
Krasnoyarsk, 660133, Russia
D.D. Pletnyov City Clinical Hospital, Department of Oncourology
Moscow, 105077, Russia
Moscow City Oncology Hospital #62
Moscow, 125130, Russia
Murmansk Bayandin Regional Clinical Hospital
Murmansk, 183047, Russia
Privolzhsky Regional Medical Center, Urology Department
Nizhny Novgorod, 603001, Russia
Tsyb Medical Radiology Research Center, Oncourology Department
Obninsk, 249036, Russia
Clinical Oncology Center, Department of Urology and Oncology
Omsk, 644013, Russia
N.N. Burdenko Penza Regional Clinical Hospital, Department of Urology
Penza, 440026, Russia
Pyatigorsk City Clinical Hospital, Department of Urology
Pyatigorsk, 357500, Russia
Leningrad Regional Clinical Oncology Center, Department of Chemotherapy
Saint Petersburg, 188663, Russia
Aleksandrovskaya City Hospital, Department of Urology
Saint Petersburg, 193312, Russia
St. Petersburg Clinical Hospital under the Russian Academy of Sciences, Department of Urology
Saint Petersburg, 194017, Russia
A.M. Nikiforov Russian Center for Emergency and Radiology Medicine, Department of Urology
Saint Petersburg, 194044, Russia
St. Luka Clinical Hospital, Department of Urology
Saint Petersburg, 194044, Russia
St.-Petersburg Scientific Research Institute of Phthisiopulmonology
Saint Petersburg, 194064, Russia
Medical and Sanitary Unit #70 of "Passazhiravtotrans"
Saint Petersburg, 195009, Russia
I.I. Mechnikov North-Western State Medical University, Department of Urology
Saint Petersburg, 195067, Russia
Railway Clinical Hospital under OAO Russian Railways
Saint Petersburg, 195271, Russia
First I.P. Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197022, Russia
N.N. Petrov National Medical Research Center of Oncology, Oncourology Department
Saint Petersburg, 197758, Russia
City Hospital #15, Urology Department #12
Saint Petersburg, 198205, Russia
Siberian State Medical University
Tomsk, 634050, Russia
Regional Oncology Center, Tyumen, Oncology Department
Tyumen, 625041, Russia
Republican Clinical Oncology Center
Ufa, 450054, Russia
Volgograd Regional Center for Urology and Nephrology, Urology Department
Volzhskiy, 404120, Russia
Medical Center for Diagnostics and Prevention Plus
Yaroslavl, 150040, Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, 620102, Russia
Clinical Center of Serbia, Clinic of Urology
Belgrade, 11000, Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology
Belgrade, 11080, Serbia
Clinical Hospital Center Zemun, Urology unit
Belgrade, 11080, Serbia
Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis
Kragujevac, 34000, Serbia
Chernihiv Medical Center of Modern Oncology
Chernihiv, 14029, Ukraine
Regional Communal Noncommercial Enterprise: Chernivtsi Regional Clinical Hospital
Chernivtsi, 58001, Ukraine
Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital", Urology Department
Chernivtsi, 58023, Ukraine
Public Enterprise "Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital" under Dnipropetrovsk Regional Council, Urology Department #2
Dnipro, 49005, Ukraine
Public Non-Profit Enterprise "City Clinical Hospital #6" under Dnipro City Council, Department of Urology
Dnipro, 49074, Ukraine
Public Non-Profit Enterprise "City Clinical Hospital #4" under Dnipro City Council, Department of Geriatric Urology Care
Dnipro, 49102, Ukraine
Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council", Department of Urology
Ivano-Frankivsk, 76008, Ukraine
Prykarpattia Clinical Oncology Center under Ivano-Frankivsk Regional Council
Ivano-Frankivsk, 76018, Ukraine
Public Non-Profit Enterprise under Kharkiv Regional Council "V.I. Shapoval Regional Medical Clinical Center for Urology and Nephrology", Urology Department #5
Kharkiv, 61037, Ukraine
Communal Non-Profit Enterprise "Regional Center of Oncology", Department of Oncourology
Kharkiv, 61070, Ukraine
Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Specialized Center for Radiation Protection of Population", Department of Surgery
Kharkiv, 61166, Ukraine
Communal non-commercial enterprise of Kherson regional council "Kherson regional oncological dispensary"
Kherson, 73000, Ukraine
State Institution: Institute of Urology under the National Academy of Medical Sciences of Ukraine
Kyiv, 04053, Ukraine
Volyn Regional Medical Oncology Centre
Lutsk, 43018, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital", Department of Urology
Lviv, 79010, Ukraine
Public Non-profit Enterprise under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center
Lviv, 79031, Ukraine
Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital", Department of Urology
Lviv, 79059, Ukraine
Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council
Odesa, 65025, Ukraine
Public Non-Profit Enterprise "City Clinical Hospital #10" under Odesa City Council, Department of Urology and Nephrology
Odesa, 65074, Ukraine
Sumy Regional Clinical Oncology Center
Sumy, 40022, Ukraine
Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center, Department of Chemotherapy
Ternopil, 46023, Ukraine
Municipal non-profit enterprise "Transcarpathian antitumor center" of the Transcarpathian Regional Council
Uzhhorod, 88014, Ukraine
Communal Nonprofit Enterprise "Podilsky Regional Center of Oncology of Vinnytsia Regional Council"
Vinnytsia, 21029, Ukraine
Municipal Nonprofit Enterprise: Zaporizhia Regional Clinical Hospital under Zaporizhia Regional Council, Department of Urology
Zaporizhia, 69600, Ukraine
Related Publications (1)
Prasad SM, Huang WC, Shore ND, Hu B, Bjurlin M, Brown G, Genov P, Shishkov D, Khuskivadze A, Ganev T, Marchev D, Orlov I, Kopyltsov E, Zubarev V, Nosov A, Komlev D, Burger B, Raju S, Meads A, Schoenberg M. 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). J Urol. 2023 Oct;210(4):619-629. doi: 10.1097/JU.0000000000003645. Epub 2023 Aug 7.
PMID: 37548555RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of Clinical Development
- Organization
- UroGen Pharma
Study Officials
- PRINCIPAL INVESTIGATOR
Sandip Prasad, MD
Atlantic Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2020
First Posted
December 30, 2020
Study Start
February 19, 2021
Primary Completion
March 17, 2023
Study Completion
March 17, 2023
Last Updated
June 6, 2024
Results First Posted
June 6, 2024
Record last verified: 2024-05