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Bladder CancerPhase 3ATLASNCT04688931

A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

A Phase 3 study testing UGN-102 and TURBT in people with Bladder Cancer and Urothelial Carcinoma, run by UroGen Pharma Ltd. at 139 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
UGN-102 and TURBT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
282 participants
Where
139 sitesin 10 countries
Study dates
19 Feb 2021to 17 Mar 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 18Show fewer
  • 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;
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
  • Has no evidence of active urinary tract infection (UTI).
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for clinical study participants. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.
  • Has participated in a study with an investigational agent or device within 30 days of randomization.

Trial locations and contacts

139 sites in 10 countries.

139 sites in 10 countries

United States33 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Chesapeake Urology Research Associates

    Baltimore, Maryland, 21204

  • New Jersey Urology

    Bloomfield, New Jersey, 07003

  • UNC Chapel Hill Memorial Hospital

    Chapel Hill, North Carolina, 27599

  • Great Lakes Physician dba WNY Urology Associates

    Cheektowaga, New York, 14225

  • University of Chicago Hospital

    Chicago, Illinois, 60637

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • New Jersey Urology

    Englewood, New Jersey, 07631

  • AccuMed Research Associates

    Garden City, New York, 11530

  • Chesapeake Urology Research Associates

    Hanover, Maryland, 21076

  • Penn State Health Milton S. Hershey Medical Center and College of Medicine

    Hershey, Pennsylvania, 17033

  • First Urology, PSC

    Jeffersonville, Indiana, 47130

  • Comprehensive Urologic Care

    Lake Barrington, Illinois, 60010

  • Urology Center

    Las Vegas, Nevada, 89144

  • Loma Linda University Medical Center

    Loma Linda, California, 92350

  • Urology Group of Southern California

    Los Angeles, California, 90017

  • Clinical Research Solutions

    Middleburg Heights, Ohio, 44130

  • Garden State Urology

    Morristown, New Jersey, 07960

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Manhattan Medical Research

    New York, New York, 10016

  • Adult & Pediatric Urology, PC

    Omaha, Nebraska, 68114

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15237

  • Urology San Antonio

    San Antonio, Texas, 78229

  • San Diego Clinical Trials

    San Diego, California, 92120

  • Providence Saint John's Health Center

    Santa Monica, California, 90404

  • Skyline Urology

    Sherman Oaks, California, 91411

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794

  • Associated Medical Professionals of NY, PLLC

    Syracuse, New York, 13210

  • Arizona Institute of Urology, PLLC

    Tucson, Arizona, 85704

  • Wichita Urology Group

    Wichita, Kansas, 67226

Other trials in United States

Russia27 sites

  • Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center

    Krasnoyarsk, 660133

  • D.D. Pletnyov City Clinical Hospital, Department of Oncourology

    Moscow, 105077

  • Moscow City Oncology Hospital #62

    Moscow, 125130

  • Murmansk Bayandin Regional Clinical Hospital

    Murmansk, 183047

  • Privolzhsky Regional Medical Center, Urology Department

    Nizhny Novgorod, 603001

  • Tsyb Medical Radiology Research Center, Oncourology Department

    Obninsk, 249036

  • Clinical Oncology Center, Department of Urology and Oncology

    Omsk, 644013

  • N.N. Burdenko Penza Regional Clinical Hospital, Department of Urology

    Penza, 440026

  • Pyatigorsk City Clinical Hospital, Department of Urology

    Pyatigorsk, 357500

  • Leningrad Regional Clinical Oncology Center, Department of Chemotherapy

    Saint Petersburg, 188663

  • Aleksandrovskaya City Hospital, Department of Urology

    Saint Petersburg, 193312

  • St. Petersburg Clinical Hospital under the Russian Academy of Sciences, Department of Urology

    Saint Petersburg, 194017

  • A.M. Nikiforov Russian Center for Emergency and Radiology Medicine, Department of Urology

    Saint Petersburg, 194044

  • St. Luka Clinical Hospital, Department of Urology

    Saint Petersburg, 194044

  • St.-Petersburg Scientific Research Institute of Phthisiopulmonology

    Saint Petersburg, 194064

  • Medical and Sanitary Unit #70 of "Passazhiravtotrans"

    Saint Petersburg, 195009

  • I.I. Mechnikov North-Western State Medical University, Department of Urology

    Saint Petersburg, 195067

  • Railway Clinical Hospital under OAO Russian Railways

    Saint Petersburg, 195271

  • First I.P. Pavlov State Medical University of St. Petersburg

    Saint Petersburg, 197022

  • N.N. Petrov National Medical Research Center of Oncology, Oncourology Department

    Saint Petersburg, 197758

  • City Hospital #15, Urology Department #12

    Saint Petersburg, 198205

  • Siberian State Medical University

    Tomsk, 634050

  • Regional Oncology Center, Tyumen, Oncology Department

    Tyumen, 625041

  • Republican Clinical Oncology Center

    Ufa, 450054

  • Volgograd Regional Center for Urology and Nephrology, Urology Department

    Volzhskiy, 404120

  • Medical Center for Diagnostics and Prevention Plus

    Yaroslavl, 150040

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

Other trials in Russia

Ukraine24 sites

  • Chernihiv Medical Center of Modern Oncology

    Chernihiv, 14029

  • Regional Communal Noncommercial Enterprise: Chernivtsi Regional Clinical Hospital

    Chernivtsi, 58001

  • Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital", Urology Department

    Chernivtsi, 58023

  • Public Enterprise "Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital" under Dnipropetrovsk Regional Council, Urology Department #2

    Dnipro, 49005

  • Public Non-Profit Enterprise "City Clinical Hospital #6" under Dnipro City Council, Department of Urology

    Dnipro, 49074

  • Public Non-Profit Enterprise "City Clinical Hospital #4" under Dnipro City Council, Department of Geriatric Urology Care

    Dnipro, 49102

  • Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council", Department of Urology

    Ivano-Frankivsk, 76008

  • Prykarpattia Clinical Oncology Center under Ivano-Frankivsk Regional Council

    Ivano-Frankivsk, 76018

  • Public Non-Profit Enterprise under Kharkiv Regional Council "V.I. Shapoval Regional Medical Clinical Center for Urology and Nephrology", Urology Department #5

    Kharkiv, 61037

  • Communal Non-Profit Enterprise "Regional Center of Oncology", Department of Oncourology

    Kharkiv, 61070

  • Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Specialized Center for Radiation Protection of Population", Department of Surgery

    Kharkiv, 61166

  • Communal non-commercial enterprise of Kherson regional council "Kherson regional oncological dispensary"

    Kherson, 73000

  • State Institution: Institute of Urology under the National Academy of Medical Sciences of Ukraine

    Kyiv, 04053

  • Volyn Regional Medical Oncology Centre

    Lutsk, 43018

  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital", Department of Urology

    Lviv, 79010

  • Public Non-profit Enterprise under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center

    Lviv, 79031

  • Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital", Department of Urology

    Lviv, 79059

  • Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council

    Odesa, 65025

  • Public Non-Profit Enterprise "City Clinical Hospital #10" under Odesa City Council, Department of Urology and Nephrology

    Odesa, 65074

  • Sumy Regional Clinical Oncology Center

    Sumy, 40022

  • Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center, Department of Chemotherapy

    Ternopil, 46023

  • Municipal non-profit enterprise "Transcarpathian antitumor center" of the Transcarpathian Regional Council

    Uzhhorod, 88014

  • Communal Nonprofit Enterprise "Podilsky Regional Center of Oncology of Vinnytsia Regional Council"

    Vinnytsia, 21029

  • Municipal Nonprofit Enterprise: Zaporizhia Regional Clinical Hospital under Zaporizhia Regional Council, Department of Urology

    Zaporizhia, 69600

Other trials in Ukraine

Bulgaria22 sites

  • Multiprofile Hospital for Active Treatment "Puls", Department of Urology

    Blagoevgrad, 2700

  • Multiprofile Hospital for Active Treatment - Blagoevgrad

    Blagoevgrad, 2700

  • Complex Oncology Center - Burgas

    Burgas, 8000

  • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology

    Gabrovo, 5300

  • Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom

    Lom, 3600

  • Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"

    Montana, 3400

  • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic

    Pleven, 5800

  • University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology

    Pleven, 5800

  • Multiprofile Hospital for Active Treatment Park Hospital

    Plovdiv, 4000

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinic of Urology

    Plovdiv, 4002

  • University Multiprofile Hospital for Active Treatment, Plovdiv, Department of Urology

    Plovdiv, 4003

  • University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology

    Rousse, 7000

  • Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology

    Shumen, 9700

  • University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Urology Clinic

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic

    Sofia, 1606

  • Multiprofile Hospital for Active Treatment - Targovishte

    Targovishte, 7700

  • Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology

    Varna, 9000

  • Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic

    Varna, 9002

  • University Multiprofile Hospital for Active Treatment "Sveta Marina"

    Varna, 9010

  • Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology

    Veliko Tarnovo, 5000

  • First Private Hospital Vratsa, Department of Urology

    Vratsa, 3001

  • Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology

    Yambol, 8600

Other trials in Bulgaria

Georgia9 sites

  • LTD Central University Clinic After Academic N. Kipshidze

    Tbilisi, 0160

  • JSC Jerarsi, Department of Urology

    Tbilisi

  • LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department

    Tbilisi

  • LTD Gidmedi, Urology Department

    Tbilisi

  • LTD L. Managadze National Center of Urology, Department of Urology

    Tbilisi

  • LTD MMT Hospital, Urology Department

    Tbilisi

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD, Department of Urology

    Tbilisi

  • Pineo Medical Ecosystem Ltd., Department of Urology

    Tbilisi

  • Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department

    Tbilisi

Other trials in Georgia

Poland6 sites

  • Jan Biziel University Hospital #2 in Bydgoszcz, Teaching Department of Urology

    Bydgoszcz, 85-168

  • AKMED

    Gliwice, 44-100

  • Prof.E Michalowski Specialist Hospital

    Katowice, 40-073

  • SCM sp. z o.o. (LLC)

    Krakow, 31-559

  • "City Clinic" Limited Liability Company

    Warsaw, 02-473

  • Miedzyleski Specialist Hospital in Warsaw, Department of Urology

    Warsaw, 04-749

Other trials in Poland

Estonia5 sites

  • East Viru Central Hospital, Surgery Clinic

    Kohtla-Järve, 31025

  • East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology

    Tallinn, 10138

  • West Tallinn Central Hospital Ltd., Department of Urology

    Tallinn, 10617

  • North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre

    Tallinn, 13419

  • Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation

    Tartu, 50406

Other trials in Estonia

Israel5 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Edith Wolfson Medical Center

    Holon, 58100

  • Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000

Other trials in Israel

Latvia4 sites

  • Liepajas Regional Hospital, Urology Department

    Liepāja, LV-3414

  • P. Stradins Clinical University Hospital, Center for Urology

    Riga, LV-1002

  • LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology

    Riga, LV-1038

  • Daugavpils Regional Hospital, Urology Department

    Riga, LV-5417

Other trials in Latvia

Serbia4 sites

  • Clinical Center of Serbia, Clinic of Urology

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology

    Belgrade, 11080

  • Clinical Hospital Center Zemun, Urology unit

    Belgrade, 11080

  • Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis

    Kragujevac, 34000

Other trials in Serbia

About this study

Official title: 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)

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).

Read the detailed description

Eligible patients were randomized in a 1:1 ratio to UGN-102 ± TURBT or TURBT alone. Randomization was stratified by the presence of a previous LG-NMIBC episode within 1 year of the current diagnosis (yes or no). Starting on Day 1, patients randomized to the UGN-102 ± TURBT arm will receive 6 weekly intravesical instillations of UGN-102 and patients randomized to the TURBT alone arm underwent TURBT.

All patients returned to the clinic approximately 3 months after the start of treatment for a disease assessment visit. Response to treatment was determined based on visual observation (white light cystoscopy), histopathology of any remaining or new lesions, and voiding urine cytology. Patients confirmed to have a complete response (CR), defined as having no detectable disease (NDD) in the bladder, received no further treatment and entered the Follow-up Period of the study. Patients confirmed to have a non-complete response (NCR) due to residual LG disease in either treatment arm underwent TURBT of any remaining lesions and then entered the Follow-up Period of the study.

During the Follow-up Period, patients returned to the clinic every 3 months to determine if they remained disease free. Patients remained on study until completion of all follow-up visits or until disease recurrence, disease progression, or death was documented, whichever occurred first. Patients determined to have a protocol-defined recurrence or progression at any follow-up or unscheduled visit were considered to have completed the study and released to the care of their treating physician.

Study enrollment was stopped early by the sponsor to pursue an alternative development strategy for UGN-102 in the treatment of bladder cancer. Patients who had consented at the time the trial terminated were permitted to continue, but follow-up was terminated once the last patient had been followed for 15 months after the start of treatment.

Being tested
UGN-102, TURBT
Keywords
Non-muscle invasive bladder cancer, Low grade non-muscle invasive bladder cancer, Intermediate risk non-muscle invasive bladder cancer, NMIBC, UGN-102, Mitomycin, Transurethral resection of bladder tumors, TURBT
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UGN-102Drug

    Also called UGN-102 (mitomycin) for intravesical solution

    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.

  • TURBTProcedure or surgery

    Also called Transurethral resection of bladder tumors

    The current standard of care for treatment of LG-IR-NMIBC is TURBT under general anesthesia.

Study groups in NCT04688931
Study groupRoleWhat they receive
UGN-102 ± TURBTExperimental6 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).
Receives: Drug: UGN-102; Procedure: TURBT
TURBT AloneActive 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).
Receives: Procedure: TURBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 15 months

Secondary outcomes (9)

  1. Time to Recurrence (TTR)

    TTR 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), or progression to HG disease. Summarized is the Kaplan-Meier estimated probability of remaining event-free at 15 months from randomization.

    Measured: 15 months

  2. Complete Response Rate (CRR)

    CRR is defined as the percentage of patients who achieve CR at the 3-month Visit.

    Measured: 3 months

  3. Duration of Response (DOR)

    DOR is defined as the time from first documented CR until the earliest date of recurrence of LG disease, progression to HG disease, or death due to any cause. DOR applies only to patients who achieve CR at the 3-month Visit. Summarized is the Kaplan-Meier estimated probability of remaining in response at 12 months after 3-month CR.

    Measured: 12 months

  4. Observed CRR at Scheduled Disease Assessment Time Points

    Observed CRR at scheduled disease assessment time points is defined as the percentage of patients who achieve CR at the 3-month Visit and maintain CR up to a particular follow-up visit. Summarized is the observed percentage of patients remaining in response at 3, 6, 9, and 12 months after 3-month CR.

    Measured: 12 months

  5. Number of TURBTs

    Number of TURBTs is defined as the average number of per protocol TURBTs per patient in each arm. Per protocol TURBTs are defined as the Day 1 TURBT for patients in the TURBT alone arm and TURBT due to residual LG disease at the 3-month disease assessment in either arm.

    Measured: 3 months

  6. Changes From Baseline in Health-related Quality of Life

    The European Organisation for Research and Treatment of Cancer (EORTC) 24-item quality of life questionnaire for patients with NMIBC (QLQ-NMIBC24) is a patient-reported instrument that assesses 11 domains (urinary symptoms, malaise, future worries, bloating and flatulence, intravesical treatment issues, sexual intimacy, risk of contaminating partner, male sexual problems, female sexual problems, sexual function, and sexual enjoyment).

    All of the domains range in score from 0 to 100 with lower scores reflecting better functioning/quality of life and higher scores reflecting worse functioning/quality of life.

    Summarized is the change from baseline in domain scores at the 3-month Visit. Changes in domain scores were calculated for patients with non-missing answers at both time points.

    Measured: Pre-treatment to 3 months after the start of treatment

  7. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest

    The number of patients with each type of event will be summarized. TEAEs were defined as adverse events (AEs) that occurred on or after the day of first instillation of UGN-102 for patients in the UGN-102 ± TURBT arm or the day of initial TURBT for patients in the TURBT alone arm, or pre-treatment events that worsened during the study.

    Measured: Up to 21 months

  8. Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values

    The number of patients with each type of event will be summarized.

    Measured: Up to 6 months

  9. Number of Participants With Post-baseline PCS Serum Chemistry Values

    The number of patients with each type of event will be summarized.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2020
  2. Study start19 Feb 2021
  3. Primary completion17 Mar 2023
  4. Study completion17 Mar 2023

Why it stopped: Alternate approach pursued

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04688931
Sponsor's protocol ID
BL006
Acronym
ATLAS
Status last verified
May 2024
First submitted
21 Jul 2020
Last updated
6 Jun 2024
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 37548555

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing UGN-102 and TURBT in people with Bladder Cancer and Urothelial Carcinoma, run by UroGen Pharma Ltd. at 139 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, Russia, Ukraine, Bulgaria, Georgia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (DFS) (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04688931, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.

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