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

Phase 3

Terminated

• Conditions: Bladder Cancer; Urothelial Carcinoma; Urothelial Carcinoma Bladder
• Interventions: Procedure: TURBT; Drug: UGN-102

• Registration Number: NCT04688931
• Lead Sponsor: UroGen Pharma Ltd.

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).

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.

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-30
• Study Start: 2021-02-19
• Primary Completion: 2023-03-17
• Study Completion: 2023-03-17
• Status Verified: 2024-05
• Results First Submitted: 2024-05-07
• Results First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Results First Posted: 2024-06-06
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 282

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TURBT Alone	TURBT	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).
UGN-102 ± TURBT	UGN-102	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).
UGN-102 ± TURBT	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).

Primary Outcome Measures

Name	Time	Method
Disease-free Survival (DFS)	15 months	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR)	12 months	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.
Number of TURBTs	3 months	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.
Number of Participants With Post-baseline PCS Serum Chemistry Values	Up to 6 months	The number of patients with each type of event will be summarized.
Time to Recurrence (TTR)	15 months	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.
Complete Response Rate (CRR)	3 months	CRR is defined as the percentage of patients who achieve CR at the 3-month Visit.
Changes From Baseline in Health-related Quality of Life	Pre-treatment to 3 months after the start of treatment	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.
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values	Up to 6 months	The number of patients with each type of event will be summarized.
Observed CRR at Scheduled Disease Assessment Time Points	12 months	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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest	Up to 21 months	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.

Trial Locations

Locations (137)

Stony Brook Cancer Center; 🇺🇸 Stony Brook, New York, United States

Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom; 🇧🇬 Lom, Bulgaria

Urology Center; 🇺🇸 Las Vegas, Nevada, United States

Comprehensive Urologic Care; 🇺🇸 Lake Barrington, Illinois, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Manhattan Medical Research; 🇺🇸 New York, New York, United States

Providence Saint John's Health Center; 🇺🇸 Santa Monica, California, United States

Complex Oncology Center - Burgas; 🇧🇬 Burgas, Bulgaria

Clinical Research Solutions; 🇺🇸 Middleburg Heights, Ohio, United States

Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology; 🇧🇬 Gabrovo, Bulgaria

First Private Hospital Vratsa, Department of Urology; 🇧🇬 Vratsa, Bulgaria

East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology; 🇪🇪 Tallinn, Estonia

UNC Chapel Hill Memorial Hospital; 🇺🇸 Chapel Hill, North Carolina, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"; 🇧🇬 Montana, Bulgaria

University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinic of Urology; 🇧🇬 Plovdiv, Bulgaria

Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology; 🇺🇸 Bala-Cynwyd, Pennsylvania, United States

Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology; 🇧🇬 Shumen, Bulgaria

Great Lakes Physician dba WNY Urology Associates; 🇺🇸 Cheektowaga, New York, United States

AccuMed Research Associates; 🇺🇸 Garden City, New York, United States

Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology; 🇧🇬 Varna, Bulgaria

Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology; 🇧🇬 Veliko Tarnovo, Bulgaria

Multiprofile Hospital for Active Treatment - Blagoevgrad; 🇧🇬 Blagoevgrad, Bulgaria

University Multiprofile Hospital for Active Treatment, Plovdiv, Department of Urology; 🇧🇬 Plovdiv, Bulgaria

Regional Urology, LLC; 🇺🇸 Shreveport, Louisiana, United States

University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology; 🇧🇬 Ruse, Bulgaria

West Tallinn Central Hospital Ltd., Department of Urology; 🇪🇪 Tallinn, Estonia

LTD Central University Clinic After Academic N. Kipshidze; 🇬🇪 Tbilisi, Georgia

LTD L. Managadze National Center of Urology, Department of Urology; 🇬🇪 Tbilisi, Georgia

Albany Medical Center; 🇺🇸 Albany, New York, United States

Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic; 🇧🇬 Varna, Bulgaria

Multiprofile Hospital for Active Treatment "Puls", Department of Urology; 🇧🇬 Blagoevgrad, Bulgaria

JSC Jerarsi, Department of Urology; 🇬🇪 Tbilisi, Georgia

LTD Gidmedi, Urology Department; 🇬🇪 Tbilisi, Georgia

Multiprofile Hospital for Active Treatment Park Hospital; 🇧🇬 Plovdiv, Bulgaria

Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology; 🇧🇬 Yambol, Bulgaria

LTD MMT Hospital, Urology Department; 🇬🇪 Tbilisi, Georgia

University Multiprofile Hospital for Active Treatment "Sveta Marina"; 🇧🇬 Varna, Bulgaria

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Rabin Medical Center; 🇮🇱 Petah tikva, Israel

Chaim Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

D.D. Pletnyov City Clinical Hospital, Department of Oncourology; 🇷🇺 Moscow, Russian Federation

Volyn Regional Medical Oncology Centre; 🇺🇦 Luts'k, Ukraine

Moscow City Oncology Hospital #62; 🇷🇺 Moscow, Russian Federation

Public Enterprise "Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital" under Dnipropetrovsk Regional Council, Urology Department #2; 🇺🇦 Dnipro, Ukraine

City Hospital #15, Urology Department #12; 🇷🇺 Saint Petersburg, Russian Federation

Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis; 🇷🇸 Kragujevac, Serbia

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

Municipal Nonprofit Enterprise: Zaporizhia Regional Clinical Hospital under Zaporizhia Regional Council, Department of Urology; 🇺🇦 Zaporizhia, Ukraine

Skyline Urology; 🇺🇸 Sherman Oaks, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Urology Group of Southern California; 🇺🇸 Los Angeles, California, United States

Arizona Institute of Urology, PLLC; 🇺🇸 Tucson, Arizona, United States

University of Chicago Hospital; 🇺🇸 Chicago, Illinois, United States

Chesapeake Urology Research Associates; 🇺🇸 Hanover, Maryland, United States

Garden State Urology; 🇺🇸 Morristown, New Jersey, United States

New Jersey Urology; 🇺🇸 Englewood, New Jersey, United States

Associated Medical Professionals of NY, PLLC; 🇺🇸 Syracuse, New York, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Penn State Health Milton S. Hershey Medical Center and College of Medicine; 🇺🇸 Hershey, Pennsylvania, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic; 🇧🇬 Pleven, Bulgaria

University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology; 🇧🇬 Pleven, Bulgaria

University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic; 🇧🇬 Sofia, Bulgaria

Multiprofile Hospital for Active Treatment - Targovishte; 🇧🇬 Targovishte, Bulgaria

University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Urology Clinic; 🇧🇬 Sofia, Bulgaria

North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre; 🇪🇪 Tallinn, Estonia

East Viru Central Hospital, Surgery Clinic; 🇪🇪 Kohtla-Järve, Estonia

Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation; 🇪🇪 Tartu, Estonia

Edith Wolfson Medical Center; 🇮🇱 H̱olon, Israel

Lady Davis Carmel Medical Center; 🇮🇱 Haifa, Israel

Sverdlovsk Regional Clinical Hospital #1; 🇷🇺 Ekaterinburg, Russian Federation

Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center; 🇷🇺 Krasnoyarsk, Russian Federation

Murmansk Bayandin Regional Clinical Hospital; 🇷🇺 Murmansk, Russian Federation

Tsyb Medical Radiology Research Center, Oncourology Department; 🇷🇺 Obninsk, Russian Federation

N.N. Burdenko Penza Regional Clinical Hospital, Department of Urology; 🇷🇺 Penza, Russian Federation

Aleksandrovskaya City Hospital, Department of Urology; 🇷🇺 Saint Petersburg, Russian Federation

Leningrad Regional Clinical Oncology Center, Department of Chemotherapy; 🇷🇺 Saint Petersburg, Russian Federation

A.M. Nikiforov Russian Center for Emergency and Radiology Medicine, Department of Urology; 🇷🇺 Saint Petersburg, Russian Federation

I.I. Mechnikov North-Western State Medical University, Department of Urology; 🇷🇺 Saint Petersburg, Russian Federation

Railway Clinical Hospital under OAO Russian Railways; 🇷🇺 Saint Petersburg, Russian Federation

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

Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital", Department of Urology; 🇺🇦 Lviv, Ukraine

Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center, Department of Chemotherapy; 🇺🇦 Ternopil', Ukraine

San Diego Clinical Trials; 🇺🇸 San Diego, California, United States

Wichita Urology Group; 🇺🇸 Wichita, Kansas, United States

Chernihiv Medical Center of Modern Oncology; 🇺🇦 Chernihiv, Ukraine

Regional Communal Noncommercial Enterprise: Chernivtsi Regional Clinical Hospital; 🇺🇦 Chernivtsi, Ukraine

Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council; 🇺🇦 Odesa, Ukraine

Adult & Pediatric Urology, PC; 🇺🇸 Omaha, Nebraska, United States

Urology San Antonio; 🇺🇸 San Antonio, Texas, United States

First Urology, PSC; 🇺🇸 Jeffersonville, Indiana, United States

Clinical Hospital Center Zemun, Urology unit; 🇷🇸 Belgrade, Serbia

Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department; 🇬🇪 Tbilisi, Georgia

Daugavpils Regional Hospital, Urology Department; 🇱🇻 Riga, Latvia

Public Non-Profit Enterprise "City Clinical Hospital #6" under Dnipro City Council, Department of Urology; 🇺🇦 Dnipro, Ukraine

Prykarpattia Clinical Oncology Center under Ivano-Frankivsk Regional Council; 🇺🇦 Ivano-Frankivs'k, Ukraine

Public Non-profit Enterprise under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center; 🇺🇦 Lviv, Ukraine

Municipal non-profit enterprise "Transcarpathian antitumor center" of the Transcarpathian Regional Council; 🇺🇦 Uzhhorod, Ukraine

Pineo Medical Ecosystem Ltd., Department of Urology; 🇬🇪 Tbilisi, Georgia

P. Stradins Clinical University Hospital, Center for Urology; 🇱🇻 Riga, Latvia

LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology; 🇱🇻 Riga, Latvia

Prof.E Michalowski Specialist Hospital; 🇵🇱 Katowice, Poland

SCM sp. z o.o. (LLC); 🇵🇱 Kraków, Poland

"City Clinic" Limited Liability Company; 🇵🇱 Warsaw, Poland

Clinical Oncology Center, Department of Urology and Oncology; 🇷🇺 Omsk, Russian Federation

Pyatigorsk City Clinical Hospital, Department of Urology; 🇷🇺 Pyatigorsk, Russian Federation

St. Luka Clinical Hospital, Department of Urology; 🇷🇺 Saint Petersburg, Russian Federation

Medical and Sanitary Unit #70 of "Passazhiravtotrans"; 🇷🇺 Saint Petersburg, Russian Federation

Siberian State Medical University; 🇷🇺 Tomsk, Russian Federation

Regional Oncology Center, Tyumen, Oncology Department; 🇷🇺 Tyumen, Russian Federation

Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital", Urology Department; 🇺🇦 Chernivtsi, Ukraine

Liepajas Regional Hospital, Urology Department; 🇱🇻 Liepāja, Latvia

Jan Biziel University Hospital #2 in Bydgoszcz, Teaching Department of Urology; 🇵🇱 Bydgoszcz, Poland

AKMED; 🇵🇱 Gliwice, Poland

St. Petersburg Clinical Hospital under the Russian Academy of Sciences, Department of Urology; 🇷🇺 Saint Petersburg, Russian Federation

Miedzyleski Specialist Hospital in Warsaw, Department of Urology; 🇵🇱 Warsaw, Poland

First I.P. Pavlov State Medical University of St. Petersburg; 🇷🇺 Saint Petersburg, Russian Federation

N.N. Petrov National Medical Research Center of Oncology, Oncourology Department; 🇷🇺 Saint Petersburg, Russian Federation

Republican Clinical Oncology Center; 🇷🇺 Ufa, Russian Federation

Volgograd Regional Center for Urology and Nephrology, Urology Department; 🇷🇺 Volzhskiy, Russian Federation

Medical Center for Diagnostics and Prevention Plus; 🇷🇺 Yaroslavl, Russian Federation

LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department; 🇬🇪 Tbilisi, Georgia

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD, Department of Urology; 🇬🇪 Tbilisi, Georgia

Privolzhsky Regional Medical Center, Urology Department; 🇷🇺 Nizhny Novgorod, Russian Federation

St.-Petersburg Scientific Research Institute of Phthisiopulmonology; 🇷🇺 Saint Petersburg, Russian Federation

Clinical Center of Serbia, Clinic of Urology; 🇷🇸 Belgrade, Serbia

Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology; 🇷🇸 Belgrade, Serbia

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

Communal Non-Profit Enterprise "Regional Center of Oncology", Department of Oncourology; 🇺🇦 Kharkiv, Ukraine

Communal non-commercial enterprise of Kherson regional council "Kherson regional oncological dispensary"; 🇺🇦 Kherson, Ukraine

State Institution: Institute of Urology under the National Academy of Medical Sciences of Ukraine; 🇺🇦 Kyiv, Ukraine

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

Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council", Department of Urology; 🇺🇦 Ivano-Frankivs'k, Ukraine

Communal Nonprofit Enterprise "Podilsky Regional Center of Oncology of Vinnytsia Regional Council"; 🇺🇦 Vinnytsia, Ukraine

Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital", Department of Urology; 🇺🇦 Lviv, Ukraine

Sumy Regional Clinical Oncology Center; 🇺🇦 Sumy, Ukraine