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Brief Title: UGN-102 With or Without TURBT in Patients With Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (LG IR NMIBC)

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)

INTRODUCTION

  • Org Study ID: BL006
  • Secondary ID: N/A
  • NTC ID: NCT04688931
  • Sponsor: UroGen Pharma Ltd.

DESCRIPTION

For more information about the study visit https://atlasstudy.urogen.com/.

BRIEF SUMMARY

This is a global, randomized, controlled, open-label Phase 3 study 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 will be randomized in a 1:1 ratio to UGN-102 ± TURBT or TURBT alone. Randomization will be stratified by the presence of a previous LG NMIBC episode within 1 year of the current diagnosis (yes or no). Starting at Day 1, patients randomized to the UGN-102 ± TURBT group will receive 6 once-weekly intravesical instillations of UGN-102 and patients randomized to the TURBT alone group will undergo TURBT.

Patients in both treatment groups will return to the clinic at approximately 3 months after the initiation of treatment (7 weeks ± 1 week after the last weekly instillation for the UGN-102 ± TURBT group and 12 weeks ± 1 week after TURBT for the TURBT alone group) to determine response to treatment. Patients determined to have a complete response (CR) will receive no further treatment and will enter the follow-up period of the study. Patients determined to have a non-complete response (NCR) will undergo TURBT of any remaining lesions and will then enter the follow-up period of the study.

During the follow-up period, patients will return to the clinic every 3 months to determine durability of response. Patients will remain on study until completion of all follow-up visits (approximately 24 months after the initiation of treatment) or until recurrence or death is documented, whichever occurs first. Patients determined to have a protocol-defined recurrence at any follow-up or unscheduled visit will be considered to have completed the study and released to the care of their treating physician.

The study is event-driven and patients may be followed beyond 24 months or additional patients may be enrolled to achieve the target number of events required for the study.

  • Overall Status
    Recruiting
  • Start Date
    February 19, 2021
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Disease-free survival (DFS)

Primary Outcome 1 - Timeframe: Up to 24 months

CONDITION

  • Bladder Cancer
  • Urothelial Carcinoma
  • Urothelial Carcinoma Bladder

ELIGIBILITY

Inclusion Criteria:
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.
Is at intermediate risk for progression, 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 high grade (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.
Exclusion Criteria:
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 grading 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 post 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Sandip Prasad, MD

Role: Principal Investigator

Affiliation: Atlantic Health System

Overall Contact

Name: Sandip Prasad, MD

Phone: 646-809-2657, 646 768 9533

Email: christine.lentowski@urogen.com, madlen.malinowski@urogen.com

LOCATION

Facility Status Contact
Facility: Arizona Institute of Urology, PLLC
Tucson, Arizona 85704
United States
Status: Recruiting Contact: Contact
Kalpesh Patel, MD
520-784-7019 261
kpatel@aiurology.com
Facility: Loma Linda University Medical Center
Loma Linda, California 92350
United States
Status: Recruiting Contact: Principal Investigator
Kalpesh Patel, MD
909-558-0702
bhu@llu.edu
Facility: Urology Group of Southern California
Los Angeles, California 90017
United States
Status: Recruiting Contact: Contact
Brian Hu, MD
909-558-7251
tisanchez@llu.edu
Facility: San Diego Clinical Trials
San Diego, California 92120
United States
Status: Recruiting Contact: Contact
Tiffany Sanchez
213-481-7142
jkowalczyk@aireasearch.us
Facility: Providence Saint John's Health Center
Santa Monica, California 90404
United States
Status: Recruiting Contact: Principal Investigator
Brian Hu, MD
619-287-6000
mobidair@sdcclinicaltrials.com
Facility: Skyline Urology
Sherman Oaks, California 91411
United States
Status: Recruiting Contact: Contact
John Kowalczyk, DO
619-287-6000
brianhamblen@sdclinicaltrials.com
Facility: First Urology, PSC
Jeffersonville, Indiana 47130
United States
Status: Recruiting Contact: Contact
Brian Hamblen
818-990-5020
richard.david@skyuro.com
Facility: Regional Urology, LLC
Shreveport, Louisiana 71106
United States
Status: Recruiting Contact: Contact
Jennifer Linehan, MD
777-702-3080
pkagarwal@surgery.bsd.uchicago.edu
Facility: Adult & Pediatric Urology, PC
Omaha, Nebraska 68114
United States
Status: Recruiting Contact: Contact
Richard David, MD
316-636-6141
fjoudi@wichitaurology.com
Facility: Urology Center
Las Vegas, Nevada 89144
United States
Status: Recruiting Contact: Contact
Melissa Adler
316-636-6141
aho@wichitaurology.com
Facility: New Jersey Urology
Bloomfield, New Jersey 07003
United States
Status: Recruiting Contact: Principal Investigator
Richard David, MD
318-683-0411
jhenderson@regionalurology.com
Facility: Garden State Urology
Morristown, New Jersey 07960
United States
Status: Recruiting Contact: Principal Investigator
Piyush Agarwal, MD
443-471-5763
rdcura@chesuro.com
Facility: Albany Medical Center
Albany, New York 12208
United States
Status: Recruiting Contact: Contact
Ning Wu, MD, PhD
443-471-5763
wpaxton@chesuro.com
Facility: Great Lakes Physician dba WNY Urology Associates
Cheektowaga, New York 14225
United States
Status: Recruiting Contact: Contact
James Knutson
402-397-7989
atrainer@adultpediatricuro.com
Facility: AccuMed Research Associates
Garden City, New York 11530
United States
Status: Recruiting Contact: Principal Investigator
Ning Wu, MD, PhD
402-399-7894
ahoward@adultpediatricuro.com
Facility: Manhattan Medical Research
New York, New York 10016
United States
Status: Recruiting Contact: Contact
James Bailen, MD
702-212-3428
mverni@mac.com
Facility: UNC Chapel Hill Memorial Hospital
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact: Contact
Amanda Ho
856-673-1613
jpilallis@njurology.com
Facility: Clinical Research Solutions
Middleburg Heights, Ohio 44130
United States
Status: Recruiting Contact: Principal Investigator
Fadi Nabih Joudi, MD
201-970-8874
emargolis@njurology.com
Facility: Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: Contact
Ralph Henderson, MD
973-437-6744
sandip.prasad@atlantichealth.org
Facility: Penn State Health Milton S. Hershey Medical Center and College of Medicine
Hershey, Pennsylvania 17033
United States
Status: Recruiting Contact: Principal Investigator
Ralph Henderson, MD
518-262-8579
fisherh@amc.edu
Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Rian Dickstein, MD
716-844-5553
scummings@cancercarewny.com
Facility: Urology San Antonio
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Principal Investigator
Rian Dickstein, MD
516-746-2190
accumed@aol.com
Facility: Multiprofile Hospital for Active Treatment "Puls", Department of Urology
Blagoevgrad, 2700
Bulgaria
Status: Recruiting Contact: Contact
Andrew Trainer, MD
212-480-3333
william.huang@NYUMC.org
Facility: Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology
Gabrovo, 5300
Bulgaria
Status: Recruiting Contact: Contact
Michael Verni, MD
919-966-8217
hermina.munoz@stonybrookmedicine.edu
Facility: University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
Pleven, 5800
Bulgaria
Status: Recruiting Contact: Contact
Gordon A Brown, DO
610-667-0458
christopher_paterno@med.unc.edu
Facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinic of Urology
Plovdiv, 4002
Bulgaria
Status: Recruiting Contact: Contact
Eric Margolis, MD
212-728-2548
lbelkoff@ucsepa.com
Facility: University Multiprofile Hospital for Active Treatment, Plovdiv, Department of Urology
Plovdiv, 4003
Bulgaria
Status: Recruiting Contact: Principal Investigator
Eric Margolis, MD
412-605-3019
jraman@pennstatehealth.psu.edu
Facility: University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology
Ruse, 7000
Bulgaria
Status: Recruiting Contact: Contact
Sandip Prasad, MD
843-449-1010
Klehman3@pennstatehealth.psu.edu
Facility: Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology
Shumen, 9700
Bulgaria
Status: Recruiting Contact: Principal Investigator
Sandip Prasad, MD
843-839-1679
david.chen@fccc.edu
Facility: University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Urology Clinic
Sofia, 1431
Bulgaria
Status: Recruiting Contact: Contact
Hugh Fisher, MD
214-648-0389
maranchijk@upmc.edu
Facility: University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Urology Clinic
Sofia, 1431
Bulgaria
Status: Recruiting Contact: Contact
Brenda Romeo
210-617-4116
Nshore@gsuro.com
Facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
Sofia, 1606
Bulgaria
Status: Recruiting Contact: Principal Investigator
Hugh Fisher, MD
210-617-4116
srust@curcmb.com
Facility: Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic
Varna, 9002
Bulgaria
Status: Recruiting Contact: Principal Investigator
Kent Chevli, MD

kethsaly.Salinas@urologysa.com
Facility: Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology
Veliko Tarnovo, 5000
Bulgaria
Status: Recruiting Contact: Contact
Leanne Cossu

Facility: East Viru Central Hospital, Surgery Clinic
Kohtla-Järve, 31025
Estonia
Status: Recruiting Contact: Contact
Carmela Graci-Pipitone

Facility: East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology
Tallinn, 10138
Estonia
Status: Recruiting Contact: Principal Investigator
William Huang, MD

Facility: West Tallinn Central Hospital Ltd., Department of Urology
Tallinn, 10617
Estonia
Status: Recruiting Contact: Contact
David Golombos, MD

Facility: North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre
Tallinn, 13419
Estonia
Status: Recruiting Contact: Contact
Hermina Munoz

Facility: Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation
Tartu, 50406
Estonia
Status: Recruiting Contact: Principal Investigator
David Golombos, MD

Facility: JSC Jerarsi, Department of Urology
Tbilisi, 31096
Georgia
Status: Recruiting Contact: Principal Investigator
Christopher Pieczonka

Facility: LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department
Tbilisi, 3436212
Georgia
Status: Recruiting Contact: Contact
Matthew Nielsen, MD

Facility: LTD Gidmedi, Urology Department
Tbilisi, 58100
Georgia
Status: Recruiting Contact: Contact
Christopher Paterno

Facility: LTD L. Managadze National Center of Urology, Department of Urology
Tbilisi, 49100
Georgia
Status: Recruiting Contact: Principal Investigator
Matthew Nielsen, MD

Facility: LTD MMT Hospital, Urology Department
Tbilisi, 5262000
Georgia
Status: Recruiting Contact: Contact
Lawrence Gervasi, MD

Facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD, Department of Urology
Tbilisi, LV-3414
Georgia
Status: Recruiting Contact: Contact
Jennifer Kalapis

Facility: Pineo Medical Ecosystem Ltd., Department of Urology
Tbilisi, LV-1002
Georgia
Status: Recruiting Contact: Principal Investigator
Lawrence Gervasi, MD

Facility: Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department
Tbilisi, LV-1038
Georgia
Status: Recruiting Contact: Contact
Laurence Belkoff, DO

Facility: Liepajas Regional Hospital, Urology Department
Liepāja, 02-473
Latvia
Status: Recruiting Contact: Principal Investigator
David Chen, MD

Facility: P. Stradins Clinical University Hospital, Center for Urology
Riga, 04-749
Latvia
Status: Recruiting Contact: Contact
Jodi Maranchie, MD

Facility: LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology
Riga, 620102
Latvia
Status: Recruiting Contact: Principal Investigator
Jodi Maranchie, MD

Facility: Daugavpils Regional Hospital, Urology Department
Riga, 660133
Latvia
Status: Recruiting Contact: Contact
Neal Shore, MD

Facility: Jan Biziel University Hospital #2 in Bydgoszcz, Teaching Department of Urology
Bydgoszcz, 105077
Poland
Status: Recruiting Contact: Contact
Stacy Rust

Facility: AKMED
Gliwice, 125130
Poland
Status: Recruiting Contact: Principal Investigator
Neal Shore, MD

Facility: Prof.E Michalowski Specialist Hospital
Katowice, 183047
Poland
Status: Recruiting Contact: Contact
Yair Lotan, MD

Facility: SCM sp. z o.o. (LLC)
Kraków, 603001
Poland
Status: Recruiting Contact: Principal Investigator
Yair Lotan, MD

Facility: "City Clinic" Limited Liability Company
Warsaw, 249036
Poland
Status: Recruiting Contact: Contact
Daniel Saltzstein, MD

Facility: Miedzyleski Specialist Hospital in Warsaw, Department of Urology
Warsaw, 644013
Poland
Status: Recruiting Contact: Contact
Kethsaly Salinas

Facility: Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
Krasnoyarsk, 357500
Russian Federation
Status: Recruiting Contact: Contact
Stefan Kachev, MD

Facility: D.D. Pletnyov City Clinical Hospital, Department of Oncourology
Moscow, 188663
Russian Federation
Status: Recruiting Contact: Principal Investigator
Stefan Kachev, MD

Facility: Murmansk Bayandin Regional Clinical Hospital
Murmansk, 194017
Russian Federation
Status: Recruiting Contact: Principal Investigator
Petar Uzunov, MD

Facility: Tsyb Medical Radiology Research Center, Oncourology Department
Obninsk, 194044
Russian Federation
Status: Recruiting Contact: Principal Investigator
Hristo Dechev, MD

Facility: Clinical Oncology Center, Department of Urology and Oncology
Omsk, 194064
Russian Federation
Status: Recruiting Contact: Contact
Georgi Atanasov, MD

Facility: N.N. Burdenko Penza Regional Clinical Hospital, Department of Urology
Penza, 195009
Russian Federation
Status: Recruiting Contact: Principal Investigator
Georgi Atanasov, MD

Facility: Pyatigorsk City Clinical Hospital, Department of Urology
Pyatigorsk, 195067
Russian Federation
Status: Recruiting Contact: Contact
Sasho Tsvetkov, MD

Facility: Leningrad Regional Clinical Oncology Center, Department of Chemotherapy
Saint Petersburg, 195271
Russian Federation
Status: Recruiting Contact: Principal Investigator
Sasho Tsvetkov, MD

Facility: Aleksandrovskaya City Hospital, Department of Urology
Saint Petersburg, 197022
Russian Federation
Status: Recruiting Contact: Contact
Georgi Chakarov, MD

Facility: St. Petersburg Clinical Hospital under the Russian Academy of Sciences, Department of Urology
Saint Petersburg, 197758
Russian Federation
Status: Recruiting Contact: Principal Investigator
Georgi Chakarov, MD

Facility: A.M. Nikiforov Russian Center for Emergency and Radiology Medicine, Department of Urology
Saint Petersburg, 198205
Russian Federation
Status: Recruiting Contact: Contact
Nikolay Kolev, MD

Facility: St. Luka Clinical Hospital, Department of Urology
Saint Petersburg, 634050
Russian Federation
Status: Recruiting Contact: Principal Investigator
Nikolay Kolev, MD

Facility: St.-Petersburg Scientific Research Institute of Phthisiopulmonology
Saint Petersburg, 625041
Russian Federation
Status: Recruiting Contact: Contact
Assoc. Prof. Boyan Atanasov, MD

Facility: Medical and Sanitary Unit #70 of "Passazhiravtotrans"
Saint Petersburg, 450054
Russian Federation
Status: Recruiting Contact: Principal Investigator
Assoc. Prof. Boyan Atanasov, MD

Facility: I.I. Mechnikov North-Western State Medical University, Department of Urology
Saint Petersburg, 404120
Russian Federation
Status: Recruiting Contact: Contact
Angel Dimitrov, MD

Facility: Railway Clinical Hospital under OAO Russian Railways
Saint Petersburg, 150040
Russian Federation
Status: Recruiting Contact: Principal Investigator
Angel Dimitrov, MD

Facility: First I.P. Pavlov State Medical University of St. Petersburg
Saint Petersburg, 11000
Russian Federation
Status: Recruiting Contact: Contact
Prof. Ivan Dechev, MD, PhD

Facility: N.N. Petrov National Medical Research Center of Oncology, Oncourology Department
Saint Petersburg, 11080
Russian Federation
Status: Recruiting Contact: Principal Investigator
Prof. Ivan Dechev, MD, PhD

Facility: City Hospital #15, Urology Department #12
Saint Petersburg, 11080
Russian Federation
Status: Recruiting Contact: Contact
Prof. Dimitar Shishkov, MD

Facility: Siberian State Medical University
Tomsk, 34000
Russian Federation
Status: Recruiting Contact: Principal Investigator
Prof. Dimitar Shishkov, MD

Facility: Republican Clinical Oncology Center
Ufa, 58001
Russian Federation
Status: Recruiting Contact: Principal Investigator
Assoc. Prof. Pencho Genov, MD

Facility: Volgograd Regional Center for Urology and Nephrology, Urology Department
Volzhskiy, 58023
Russian Federation
Status: Recruiting Contact: Contact
Dobri Marchev, MD

Facility: Medical Center for Diagnostics and Prevention Plus
Yaroslavl, 49005
Russian Federation
Status: Recruiting Contact: Principal Investigator
Dobri Marchev, MD

Facility: Clinical Center of Serbia, Clinic of Urology
Belgrade, 49074
Serbia
Status: Recruiting Contact: Contact
Assoc. Prof. Krassimir Yanev, MD, PhD

Facility: Clinical Hospital Center Zemun, Urology unit
Belgrade, 76008
Serbia
Status: Recruiting Contact: Contact
Assoc. Prof Marincho Georgiev

Facility: Chernihiv Medical Center of Modern Oncology
Chernihiv, 61037
Ukraine
Status: Recruiting Contact: Contact
Boris Mladenov, MD

Facility: Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital", Urology Department
Chernivtsi, 61166
Ukraine
Status: Recruiting Contact: Contact
Ivan Svetulkov, MD

Facility: Public Enterprise "Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital" under Dnipropetrovsk Regional Council, Urology Department #2
Dnipro, 73000
Ukraine
Status: Recruiting Contact: Principal Investigator
Ivan Svetulkov, MD

Facility: Public Non-Profit Enterprise "City Clinical Hospital #6" under Dnipro City Council, Department of Urology
Dnipro, 04053
Ukraine
Status: Recruiting Contact: Contact
Vasyl Terzi, MD

Facility: Public Non-Profit Enterprise "City Clinical Hospital #4" under Dnipro City Council, Department of Geriatric Urology Care
Dnipro, 43018
Ukraine
Status: Recruiting Contact: Principal Investigator
Vasyl Terzi, MD

Facility: Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council", Department of Urology
Ivano-Frankivs'k, 79010
Ukraine
Status: Recruiting Contact: Contact
Assoc. Prof Tosho Ganev, MD, PhD

Facility: Prykarpattia Clinical Oncology Center under Ivano-Frankivsk Regional Council
Ivano-Frankivs'k, 79031
Ukraine
Status: Recruiting Contact: Principal Investigator
Assoc. Prof Tosho Ganev, MD, PhD

Facility: Public Non-Profit Enterprise under Kharkiv Regional Council "V.I. Shapoval Regional Medical Clinical Center for Urology and Nephrology", Urology Department #5
Kharkiv, 79059
Ukraine
Status: Recruiting Contact: Contact
Deyan Anakievski, MD

Facility: Communal Non-Profit Enterprise "Regional Center of Oncology", Department of Oncourology
Kharkiv, 65025
Ukraine
Status: Recruiting Contact: Principal Investigator
Deyan Anakievski, MD

Facility: Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Specialized Center for Radiation Protection of Population", Department of Surgery
Kharkiv, 65074
Ukraine
Status: Recruiting Contact: Contact
Georgi Baramov, MD

Facility: Volyn Regional Medical Oncology Centre
Luts'k, 88014
Ukraine
Status: Recruiting Contact: Principal Investigator
Georgi Tatarski, MD

Facility: Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital", Department of Urology
Lviv, 21029
Ukraine
Status: Recruiting Contact: Contact
Emil Milkov, MD

Facility: Public Non-profit Enterprise under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center
Lviv, 69600
Ukraine
Status: Recruiting Contact: Principal Investigator
Emil Milkov, MD

Facility: Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital", Department of Urology
Lviv,
Ukraine
Status: Recruiting Contact: Contact
Jaak Lind, MD

Facility: Public Non-Profit Enterprise "City Clinical Hospital #10" under Odesa City Council, Department of Urology and Nephrology
Odesa,
Ukraine
Status: Recruiting Contact: Contact
Toomas Tamm, MD

Facility: Sumy Regional Clinical Oncology Center
Sumy,
Ukraine
Status: Recruiting Contact: Principal Investigator
Toomas Tamm, MD

Facility: Municipal non-profit enterprise "Transcarpathian antitumor center" of the Transcarpathian Regional Council
Uzhhorod,
Ukraine
Status: Recruiting Contact: Principal Investigator
Heino-Enn Arpo, MD

Facility: Communal Nonprofit Enterprise "Podilsky Regional Center of Oncology of Vinnytsia Regional Council"
Vinnytsia,
Ukraine
Status: Recruiting Contact: Contact
Dmitri Korotots, MD

Facility: Municipal Nonprofit Enterprise: Zaporizhia Regional Clinical Hospital under Zaporizhia Regional Council, Department of Urology
Zaporizhia,
Ukraine
Status: Recruiting Contact: Principal Investigator
Dmitri Korotots, MD