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TerminatedNCT04688931ATLASUpdated Jun 6, 2024Results posted

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

A Phase 3 interventional study of UGN-102 and TURBT in Bladder Cancer, Urothelial Carcinoma and Urothelial Carcinoma Bladder, sponsored by UroGen Pharma Ltd.. Terminated at 139 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-06.

Sponsored by UroGen Pharma Ltd. · Phase 3, Interventional, and Treatment

Why this study was terminated
Alternate approach pursued
Phase
Phase 3
Study type
Interventional
Enrollment
282
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Bladder Cancer
  • Urothelial Carcinoma
  • Urothelial Carcinoma Bladder

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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. Patient who has newly diagnosed or historic LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks of Screening.

  3. 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).
  4. Negative voiding cytology for HG disease within 6 weeks of Screening.

  5. 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.
  6. Has no evidence of active urinary tract infection (UTI).
  7. 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.

Exclusion criteria

Exclusion Criteria:

  1. History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment.
  2. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.
  3. History of HG papillary UC in the past 2 years.
  4. Known allergy or sensitivity to mitomycin that in the investigator's opinion cannot be readily managed.
  5. Clinically significant urethral stricture that would preclude passage of a urethral catheter.
  6. History of pelvic radiotherapy.

  7. History of:

    • Neurogenic bladder;
    • Active urinary retention;
    • Any other condition that would prohibit normal voiding.
  8. Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract UC.
  9. Current tumor stage of T1.
  10. 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.
  11. History of prior treatment with an intravesical chemotherapeutic agent except for a single dose of chemotherapy immediately after any previous TURBT.
  12. Has previously participated in a study in which they received UGN-102.
  13. Has participated in a study with an investigational agent or device within 30 days of randomization.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
282 participants (actual)

Study arms

  • Experimental
    UGN-102 ± TURBT

    6 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).

    Drug: UGN-102 · Procedure: TURBT

  • Active comparator
    TURBT Alone

    TURBT 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).

    Procedure: TURBT

Interventions

  • DrugUGN-102

    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.

    Also known as: UGN-102 (mitomycin) for intravesical solution

  • ProcedureTURBT

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

    Also known as: Transurethral resection of bladder tumors

05

What researchers measure

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.

    Time frame: 15 months

Secondary outcomes

  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.

    Time frame: 15 months

  2. Complete Response Rate (CRR)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 6 months

06

Results

Posted Jun 6, 2024

Participant flow

Participant flow — Overall Study
MilestoneUGN-102 ± TURBTTURBT Alone
Started142140
Completed123106
Not completed1934
Withdrew: Adverse event41
Withdrew: Withdrawal by subject516
Withdrew: Physician decision35
Withdrew: Noncompliance01
Withdrew: Lost to follow-up13
Withdrew: Randomization error30
Withdrew: Not eligible13
Withdrew: Disease progression02
Withdrew: Sponsor requirement11
Withdrew: Other reason12

Outcome measures

PrimaryDisease-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.

Time frame:
15 months
Reported as:
Number · percentage of participants
Disease-free Survival (DFS)
percentage of participantsUGN-102 ± TURBTTURBT Alone
Disease-free Survival (DFS)72.0 (63.1 to 79.2)49.5 (39.6 to 58.6)
Statistical analysis
  • UGN-102 ± TURBT vs TURBT Alone · Cox proportional hazard: 0.45 · 95% CI 0.29 to 0.68The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).
SecondaryTime 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.

Time frame:
15 months
Reported as:
Number · percentage of participants
Time to Recurrence (TTR)
percentage of participantsUGN-102 ± TURBTTURBT Alone
Time to Recurrence (TTR)72.0 (63.1 to 79.2)50.3 (40.4 to 59.4)
Statistical analysis
  • UGN-102 ± TURBT vs TURBT Alone · Cox proportional hazard: 0.46 · 95% CI 0.30 to 0.70The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).
SecondaryComplete Response Rate (CRR)

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

Time frame:
3 months
Reported as:
Number · percentage of participants
Complete Response Rate (CRR)
percentage of participantsUGN-102TURBT Alone
Complete Response Rate (CRR)64.8 (56.3 to 72.6)63.6 (55.0 to 71.5)
SecondaryDuration 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.

Time frame:
12 months
Reported as:
Number · percentage of participants
Duration of Response (DOR)
percentage of participantsUGN-102TURBT Alone
Duration of Response (DOR)79.7 (69.3 to 86.9)67.7 (55.8 to 77.1)
Statistical analysis
  • UGN-102 vs TURBT Alone · Cox proportional hazard: 0.46 · 95% CI 0.24 to 0.86The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).
SecondaryObserved 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.

Time frame:
12 months
Reported as:
Number · percentage of participants
Observed CRR at Scheduled Disease Assessment Time Points
percentage of participantsUGN-102TURBT Alone
3 Months After 3-Month CR92.4 (84.9 to 96.9)71.9 (61.4 to 80.9)
6 Months After 3-Month CR80.4 (70.9 to 88.0)62.9 (52.0 to 72.9)
9 Months After 3-Month CR75.0 (64.9 to 83.4)57.3 (46.4 to 67.7)
12 Months After 3-Month CR71.7 (61.4 to 80.6)55.1 (44.1 to 65.6)
SecondaryNumber 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.

Time frame:
3 months
Reported as:
Mean · TURBT procedures
Number of TURBTs
TURBT proceduresUGN-102 ± TURBTTURBT Alone
Number of TURBTs0.2 ± 0.381.1 ± 0.34
SecondaryChanges 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.

Time frame:
Pre-treatment to 3 months after the start of treatment
Reported as:
Mean · score on a scale
Changes From Baseline in Health-related Quality of Life
score on a scaleUGN-102TURBT Alone
Urinary Symptoms-10.7 ± 17.88-4.5 ± 20.04
Malaise-4.4 ± 13.58-1.1 ± 16.41
Intravesical Treatment Issues-4.0 ± 25.61-2.9 ± 25.09
Future Worries-12.7 ± 26.49-8.3 ± 26.74
Bloating and Flatulence-7.7 ± 18.03-3.0 ± 16.68
Male Sexual Problems0.9 ± 32.99-0.6 ± 30.75
Sexual Intimacy0.0 ± 19.863.6 ± 30.12
Risk of Contaminating Partner1.6 ± 26.120.0 ± 16.80
Female Sexual Problems-10.0 ± 16.10-8.9 ± 15.26
Sexual Function0.4 ± 18.02-1.6 ± 22.20
Sexual Enjoyment8.7 ± 36.97-1.0 ± 32.26
SecondaryNumber 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.

Time frame:
Up to 21 months
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest
ParticipantsUGN-102 ± TURBTTURBT Alone
Any TEAEs10463
Any serious TEAEs127
Any TEAEs of special interest7836
SecondaryNumber of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values

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

Time frame:
Up to 6 months
Reported as:
Count of participants · Participants
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values
ParticipantsUGN-102 ± TURBTTURBT Alone
Hemoglobin < 0.8 × lower limit of normal and > 20% decrease from baseline41
Leukocytes ≤ 2.8 × 10^3/μL41
Leukocytes ≥ 16.0 × 10^3/μL10
Platelets < 75 × 10^3/μL10
SecondaryNumber of Participants With Post-baseline PCS Serum Chemistry Values

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

Time frame:
Up to 6 months
Reported as:
Count of participants · Participants
Number of Participants With Post-baseline PCS Serum Chemistry Values
ParticipantsUGN-102 ± TURBTTURBT Alone
Alanine aminotransferase > 3 × upper limit of normal (ULN)21
Aspartate aminotransferase > 3 × ULN21
Bilirubin > 1.5 × ULN32
Creatinine > 2.2 mg/dL01
Gamma glutamyl transferase > 2.5 × ULN51
Potassium < 3.0 mEq/L01
Potassium > 5.5 mEq/L1810
Sodium ≤ 130 mEq/L21
Sodium > 150 mEq/L20

Adverse events

Collected over Up to 21 months. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
UGN-102 ± TURBT0/138 (0%)12/138 (8.7%)102/138 (73.9%)
TURBT Alone1/132 (0.8%)7/132 (5.3%)62/132 (47%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventUGN-102 ± TURBTTURBT Alone
COVID-19Infections and infestations4/1382/132
SepsisInfections and infestations1/1382/132
HaematuriaRenal and urinary disorders0/1382/132
Angina unstableCardiac disorders0/1381/132
Coronary artery diseaseCardiac disorders0/1381/132
Lumbar vertebral fractureInjury, poisoning and procedural complications0/1381/132
AnaemiaBlood and lymphatic system disorders0/1381/132
Carotid artery stenosisNervous system disorders0/1381/132
PneumoniaInfections and infestations1/1380/132
Urethral stenosisRenal and urinary disorders1/1380/132
Most frequent other events
Showing 10 of 16
Most frequent other events
EventUGN-102 ± TURBTTURBT Alone
DysuriaRenal and urinary disorders42/1386/132
Micturition urgencyRenal and urinary disorders25/13810/132
NocturiaRenal and urinary disorders25/1389/132
PollakiuriaRenal and urinary disorders22/1388/132
FlatulenceGastrointestinal disorders13/1384/132
HaematuriaRenal and urinary disorders9/1385/132
Erectile dysfunctionReproductive system and breast disorders9/1384/132
MalaiseGeneral disorders8/1382/132
COVID-19Infections and infestations7/1386/132
Abdominal distensionGastrointestinal disorders6/1384/132

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)UGN-102 ± TURBTTURBT AloneTotal
<=18 years000
Between 18 and 65 years5163114
>=65 years9177168
Age, Continuous
Age, Continuous(years)UGN-102 ± TURBTTURBT AloneTotal
Median68 (23 to 85)67 (29 to 88)68 (23 to 88)
Sex: Female, Male
Sex: Female, Male(Participants)UGN-102 ± TURBTTURBT AloneTotal
Female374784
Male10593198
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)UGN-102 ± TURBTTURBT AloneTotal
Hispanic or Latino213
Not Hispanic or Latino140137277
Unknown or Not Reported022
Race (NIH/OMB)
Race (NIH/OMB)(Participants)UGN-102 ± TURBTTURBT AloneTotal
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American000
White140139279
More than one race000
Unknown or Not Reported101
Region of Enrollment
Region of Enrollment(participants)UGN-102 ± TURBTTURBT AloneTotal
Latvia9716
United States141125
Ukraine112031
Poland112
Georgia151530
Israel011
Bulgaria372663
Serbia145
Estonia10818
Russia444791
Previous LG-NMIBC Episode(s)
Previous LG-NMIBC Episode(s)(Participants)UGN-102 ± TURBTTURBT AloneTotal
Yes5465119
No8875163
Previous LG-NMIBC Episode(s) Within 1 Year
Previous LG-NMIBC Episode(s) Within 1 Year(Participants)UGN-102 ± TURBTTURBT AloneTotal
Yes414081
No101100201

4 further baseline measures are reported on the registry.

07

Study locations

139 sites
  • 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
    Ruse, 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
    H̱olon, 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)
    Kraków, 31-559, Poland
  • "City Clinic" Limited Liability Company
    Warsaw, 02-473, Poland
  • Miedzyleski Specialist Hospital in Warsaw, Department of Urology
    Warsaw, 04-749, Poland
  • Sverdlovsk Regional Clinical Hospital #1
    Ekaterinburg, 620102, Russian Federation
  • Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
    Krasnoyarsk, 660133, Russian Federation
  • D.D. Pletnyov City Clinical Hospital, Department of Oncourology
    Moscow, 105077, Russian Federation
  • Moscow City Oncology Hospital #62
    Moscow, 125130, Russian Federation
  • Murmansk Bayandin Regional Clinical Hospital
    Murmansk, 183047, Russian Federation
  • Privolzhsky Regional Medical Center, Urology Department
    Nizhny Novgorod, 603001, Russian Federation
  • Tsyb Medical Radiology Research Center, Oncourology Department
    Obninsk, 249036, Russian Federation
  • Clinical Oncology Center, Department of Urology and Oncology
    Omsk, 644013, Russian Federation
  • N.N. Burdenko Penza Regional Clinical Hospital, Department of Urology
    Penza, 440026, Russian Federation
  • Pyatigorsk City Clinical Hospital, Department of Urology
    Pyatigorsk, 357500, Russian Federation
  • Leningrad Regional Clinical Oncology Center, Department of Chemotherapy
    Saint Petersburg, 188663, Russian Federation
  • Aleksandrovskaya City Hospital, Department of Urology
    Saint Petersburg, 193312, Russian Federation
  • St. Petersburg Clinical Hospital under the Russian Academy of Sciences, Department of Urology
    Saint Petersburg, 194017, Russian Federation
  • A.M. Nikiforov Russian Center for Emergency and Radiology Medicine, Department of Urology
    Saint Petersburg, 194044, Russian Federation
  • St. Luka Clinical Hospital, Department of Urology
    Saint Petersburg, 194044, Russian Federation
  • St.-Petersburg Scientific Research Institute of Phthisiopulmonology
    Saint Petersburg, 194064, Russian Federation

Showing the first 100 of 139 sites across 10 countries.

08

References and documents

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 ↗

Study documents

  • Study protocol · Dec 20, 2021
  • Statistical analysis plan · Feb 17, 2023

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT04688931
Lead sponsor
UroGen Pharma Ltd.
Responsible party
Sponsor
First posted
Dec 30, 2020
Start date
Feb 19, 2021
Primary completion
Mar 17, 2023
Completion
Mar 17, 2023
Results posted
Jun 6, 2024
Last update
Jun 6, 2024

Study contacts

Sandip Prasad, MD
principal investigator · Atlantic Health System

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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