Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT04821622
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.
- Detailed Description
The study will have 5 periods: prescreening, screening, double-blind treatment, safety follow-up, and long-term follow-up.
Approximately 550 men with mCSPC will be randomized. Eligible participants will be randomly assigned to either of 2 treatment groups as follows:
* Talazoparib in combination with enzalutamide.
* Placebo capsules identical in appearance to talazoparib capsules in combination with enzalutamide.
Talazoparib or identical placebo treatment will be blinded. Enzalutamide (160 mg/day) will be open label. The dose of talazoparib/placebo to be given in combination with enzalutamide is 0.5 mg once daily. Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m2 by the MDRD equation) at screening may be enrolled and the talazoparib/placebo dose will be 0.35 mg once daily.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 599
-
Male participants at least 18 years of age at screening (20 years for Japan, 19 years for Republic of Korea).
-
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell or signet cell features. If the participant does not have a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis and may also be used to support biomarker analysis.
-
Confirmation of DDR gene mutation status by prospective or historical analysis (with sponsor pre-approval) of blood (liquid biopsy) and/or de novo or archival tumor tissue using FoundationOne Liquid CDx or FoundationOne CDx.
-
Willing to provide tumor tissue when available (de novo or archived) for retrospective molecular profiling analysis, if not already provided as part of inclusion criterion 3.
-
Unless prohibited by local regulations or ethics committee decision, consent to a saliva sample collection for retrospective sequencing of the same DDR genes tested on tumor tissue and blood (liquid biopsy), or a subset thereof, and to serve as a germline control in identifying tumor mutations.
-
Ongoing ADT with a GnRH agonist or antagonist for participants who have not undergone bilateral orchiectomy must be initiated before randomization and must continue throughout the study.
-
Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on CT or MRI scan (for soft tissue). Participants whose disease spread is limited to regional pelvic lymph nodes are not eligible. Note: a finding of superscan at baseline is exclusionary.
-
Prior treatment of mCSPC with docetaxel is not permitted.
-
Treatment with estrogens, cyproterone acetate, or first-generation anti-androgens is allowed until randomization.
-
Other prior therapy allowed for mCSPC; ≤3 months of ADT (chemical or surgical) with or without approved NHT in mCSPC (ie, abiraterone + prednisone, apalutamide, or enzalutamide), if required prior to randomization, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.
-
Participant may have received palliative radiation or surgery for symptomatic control secondary to prostate cancer, which should have been completed at least 2 weeks prior to randomization. NOTE: Radical prostatectomy or definitive radiotherapy to the primary tumor for metastatic castration-sensitive prostate cancer with curative intent is not permitted.
-
ECOG performance status 0 or 1.
-
Adequate organ function within 28 days before the first study treatment on Day 1, defined by the following:
- ANC ≥1500/µL, platelets ≥100,000/µL, or hemoglobin ≥9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology laboratory tests at screening).
- Total serum bilirubin <1.5 × ULN (<3 × ULN for participants with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).
- AST or ALT <2.5 × ULN (<5 × ULN if liver function abnormalities are due to hepatic metastasis).
- Albumin >2.8 g/dL.
- eGFR ≥30 mL/min/1.73 m2 by the MDRD equation.
-
Sexually active participants that in the opinion of the investigator are capable of ejaculating, must agree to use a condom when having sex with a partner (female or male) from the time of the first dose of study treatment through 4 months after last dose of study treatment (or, if talazoparib/placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide). Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment (or, if talazoparib / placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide) when having sex.
-
Must agree not to donate sperm from the first dose of study treatment to 4 months after the last dose of study treatment (or, if talazoparib/placebo has been stopped more than a month earlier than enzalutamide, through 3 months after last dose of enzalutamide).
-
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including being able to manage electronic diaries. The PRO assessments are not required to be completed if a patient does not understand the language(s) available for a specific questionnaire and/or cannot complete the specific questionnaire independently.
-
Capable of giving signed informed consent.
-
For France only: Participants affiliated with the social security system or beneficiaries of an equivalent system.
-
Other acute or chronic medical (concurrent disease, infection, including chronic stable HIV, HBV, or HCV infection, or co-morbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that interferes with a participant's ability to participate in the study, may increase the risk of associated with study participation or study treatment administration, or may interfere with the interpretation of study results, and, in the investigator's judgment, make the participant inappropriate for entry into the study. HIV/HBV/HCV testing is not required unless mandated by local health authority.
-
History of seizure or any condition (as assessed by investigator) that may predispose to seizure (eg, prior cortical stroke, significant brain trauma), including any history of loss of consciousness or transient ischemic attack within 12 months of randomization.
-
Major surgery (as defined by the investigator) within 4 weeks before randomization.
-
Known or suspected brain metastasis or active leptomeningeal disease.
-
Symptomatic or impending spinal cord compression or cauda equina syndrome.
-
Any history of MDS, AML, or prior malignancy except for the following:
- Carcinoma in situ or non-melanoma skin cancer.
- A cancer diagnosed and treated ≥3 years before randomization with no subsequent evidence of recurrence.
- American Joint Committee on Cancer Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence in the opinion of the investigator and the sponsor.
-
In the opinion of the investigator, any clinically significant gastrointestinal disorder affecting absorption.
-
Clinically significant cardiovascular disease, including any of the following:
- Myocardial infarction or symptomatic cardiac ischemia within 6 months before randomization.
- Congestive heart failure New York Heart Association class III or IV.
- History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes) within 1 year before screening.
- History of Mobitz II second degree or third-degree heart block unless a permanent pacemaker is in place.
- Hypotension as indicated by systolic blood pressure <86 mm Hg at screening.
- Bradycardia as indicated by a heart rate of <45 beats per minute on the screening electrocardiogram.
- Uncontrolled hypertension as indicated by systolic blood pressure >170 mm Hg or diastolic blood pressure >105 mm Hg at screening. However, participants can be rescreened after adequate control of blood pressure is achieved.
-
Active COVID-19 infection detected by viral test or based on clinical diagnosis (as assessed by investigator). Asymptomatic participants with no active COVID-19 infection detected but positive antibody tests, indicating past infection are allowed.
-
Prior ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was less than 12 months prior to randomization and the total duration of ADT exceeded 36 months.
-
Participant received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to randomization, intended for the treatment of prostate cancer.
-
Any previous treatment with DNA-damaging cytotoxic chemotherapy (ie, platinum based therapy) within 5 years prior to randomization, except for indications other than prostate cancer.
-
Prior treatment with a PARPi, or known or possible hypersensitivity to enzalutamide, any of enzalutamide capsule excipients or to any talazoparib/placebo capsule excipients.
-
Prior treatment in any setting with NHT, except as described in Inclusion Criterion #10.
-
Current use of potent P-gp inhibitors within 7 days prior to randomization.
-
Treatment with any investigational study intervention within 4 weeks before randomization. Exception: COVID-19 vaccines authorized under an emergency use authorization (or equivalent) can be administered without a washout period.
-
Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF interval >470 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >470 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 470 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
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Investigator site staff or Sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
-
For France only: Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care, as well as adults subject to a legal protection measure (guardianship, curatorship, and safeguard of justice) covered by Articles 1121-6 to 1121-8 of the Public Health Code.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 talazoparib plus enzalutamide Talazoparib plus enzalutamide Arm 2 Placebo plus enzalutamide Placebo plus enzalutamide
- Primary Outcome Measures
Name Time Method radiological Progression-Free Survival randomization up to 3 years time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first
- Secondary Outcome Measures
Name Time Method Overall Survival randomization up to 4 years time from randomization to death from any cause
Objective response in measurable soft tissue disease randomization up to 3 years proportion of patients with measurable soft tissue disease at baseline with objective response per RECIST 1.1
Duration of response in measurable soft tissue disease randomization up to 3 years duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1
Prostate Specific Antigen (PSA) response randomization up to 3 years proportion of patients with PSA response grater than or equal to 50%
Time to PSA progression randomization up to 3 years time from baseline to PSA progression
Time to initiation of antineoplastic therapy randomization up to 3 years Time from randomization to initiation of antineoplastic therapy
Time to first symptomatic skeletal event randomization up to 3 years time from randomization to first symptomatic skeletal event (symptomatic fractures, spinal cord compression, surgery or radiation to the bone whichever is first)
Opiate use for prostate cancer pain randomization up to 3 years time from randomization to opiate use for prostate cancer pain
Incidence of adverse events randomization up to 3 years AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03)
Pharmacokinetic assessment of talazoparib Weeks 5, 9, 13, and 17 plasma concentrations of talazoparib
Pharmacokinetic assessment of enzalutamide and its metabolite Weeks 5, 9, 13, and 17 plasma concentrations of enzalutamide and its metabolite
Relationship between ctDNA burden and outcome randomization up to 3 years ctDNA burden at baseline and on study
Patient-reported outcomes in pain symptoms - change from baseline randomization up to 3 years change from baseline in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)
Patient-reported outcomes in pain symptoms - time to deterioration randomization up to 3 years time to deterioration in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)
Patient-reported outcomes in cancer specific general health status - change from baseline randomization up to 3 years change from baseline in participant-reported general health status per EQ-5D-5L
Patient-reported outcomes in cancer specific global health status/QoL - change from baseline randomization up to 3 years change from baseline in patient-reported Global health status/QoL per EORTC QLQ-C30
Patient-reported outcomes in cancer specific global health status/QoL - time to definitive deterioration randomization up to 3 years time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30
Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration randomization up to 3 years time to definitive deterioration in disease specific urinary symptoms per EORTC QLQ-PR25
Patient-reported outcome: cancer specific functioning, and symptoms - change from baseline randomization up to 3 years change from baseline in PGI-S
Trial Locations
- Locations (311)
Kelsey Research Foundation
🇺🇸Houston, Texas, United States
Urology San Antonio, PA dba USA Clinical Trials
🇺🇸San Antonio, Texas, United States
Urology San Antonio
🇺🇸San Antonio, Texas, United States
Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Preparaciones Oncológicas S.C.
🇲🇽Leon, Guanajuato, Mexico
Maidstone and Tunbridge Wells NHS Trust
🇬🇧Maidstone, Kent, United Kingdom
Indraprastha Apollo Hospital
🇮🇳New Delhi, Delhi, India
Institut Jules Bordet
🇧🇪Anderlecht, Belgium
Cliniques universitaires Saint-Luc
🇧🇪Brussels, Belgium
Turku University Hospital
🇫🇮Turku, Finland
Artemis hospital
🇮🇳Gurugram, Haryana, India
AZ (Algemeen Ziekenhuis) Maria Middelares
🇧🇪Gent, Belgium
CHU de Liege
🇧🇪Liege, Belgium
Complex Oncology Center - Plovdiv EOOD
🇧🇬Plovdiv, Bulgaria
AZ (Algemeen Ziekenhuis) Sint-Lucas
🇧🇪Gent, Belgium
AZ (Algemeen Ziekenhuis) Groeninge
🇧🇪Kortrijk, Belgium
MRI SMDLOD "Mediscan" Ltd
🇧🇬Stara Zagora, Bulgaria
Epworth Freemasons-Epworth HealthCare
🇦🇺East Melbourne, Victoria, Australia
Uzsoki Utcai Korhaz
🇭🇺Budapest, Hungary
Western Health, Sunshine Hospital
🇦🇺St Albans, Victoria, Australia
Onze Lieve Vrouw Ziekenhuis Aalst
🇧🇪Aalst, Belgium
Complex Oncology Center - Stara Zagora Ltd.
🇧🇬Stara Zagora, Bulgaria
UMHAT "Prof. Dr. Stoyan Kirkovich"
🇧🇬Stara Zagora, Bulgaria
Docrates Cancer Center
🇫🇮Helsinki, Finland
Medanta- The Medicity hospital
🇮🇳Gurugram, Haryana, India
Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")
🇷🇺Pyatigorsk, Stavropol Region, Russian Federation
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
🇭🇺Budapest, Hungary
SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
🇷🇺Chelyabinsk, Russian Federation
Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")
🇷🇺Ivanovo, Russian Federation
LLC "Medicina Severnoy Stolitsy"
🇷🇺Saint-Petersburg, Russian Federation
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
🇸🇰Banska Bystrica, Slovakia
Narodny onkologicky ustav
🇸🇰Bratislava, Slovakia
Independent medical-diagnostic laboratory "Medisken" EOOD
🇧🇬Plovdiv, Bulgaria
Complex Oncology Center - Shumen EOOD
🇧🇬Shumen, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
🇧🇬Sofia, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
🇧🇬Sofia, Bulgaria
Helsinki University Hospital
🇫🇮Helsinki, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Oaxaca Site Management Organization
🇲🇽Oaxaca de Juarez, Oaxaca, Mexico
State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
🇷🇺Yaroslavl, Russian Federation
Vychodoslovensky onkologicky ustav, a.s.
🇸🇰Kosice, Slovakia
TATA Memorial Hospital
🇮🇳Mumbai, Maharashtra, India
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Bhakti Vedanta Hospital and Research Institute
🇮🇳Mumbai, Thane, Maharashtra, India
Bhaktivedanta Hospital and Research Institute
🇮🇳Mumbai, Thane, Maharashtra, India
Sahyadri Super Speciality Hospital
🇮🇳Pune, Maharashtra, India
LLC "Severo-Zapadny Medical Center"
🇷🇺Saint-Petersburg, Russian Federation
SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
🇷🇺Ufa, Russian Federation
UROEXAM, spol. s r.o.
🇸🇰Nitra, Slovakia
Oncologia Integral Satelite SA de CV
🇲🇽Naucalpan de Juarez, Estado DE Mexico, Mexico
Keio university hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo LEÓN, Mexico
Sykehuset Innlandet Gjoevik
🇳🇴Gjoevik, Norway
Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
🇷🇺Vologda, Russian Federation
Privatna urologicka ambulancia, s.r.o.
🇸🇰Trencin, Slovakia
Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of the
🇷🇺Moscow, Russian Federation
Federal State Budgetary Institution "Central Clinical Hospital with ambulance"
🇷🇺Moscow, Russian Federation
MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia
🇷🇺Obninsk, Kaluga Region, Russian Federation
Private Medical Institution "Euromedservice"
🇷🇺Pushkin, Saint-petersburg, Russian Federation
BHI of Omsk region "Clinical Oncological Dispensary"
🇷🇺Omsk, Russian Federation
Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"
🇷🇺Samara, Russian Federation
National Cancer Institute
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of
🇺🇦Kharkiv, Ukraine
Lancashire Teaching Hospitals NHS Foundation Trust
🇬🇧Preston, Lancashire, United Kingdom
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"
🇺🇦Pliuty Village, KYIV Region, Ukraine
Asklepion Medical Center
🇺🇦Khodosivka, Kyivska Oblast, Ukraine
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
🇺🇦Ivano-Frankivsk, Ukraine
Royal Devon and Exeter NHS Foundation Trust
🇬🇧Exeter, Devon, United Kingdom
Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan City, Taiwan
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
🇺🇦Kryviy Rih, Dnipropetrovska Oblast, Ukraine
Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)
🇺🇦Dnipro, Ukraine
Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre
🇺🇦Lviv, Ukraine
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
🇺🇦Dnipro, Ukraine
Communal Non-Profit Enterprise "Regional Center of Oncology"
🇺🇦Kharkiv, Ukraine
Studienpraxis Urologie
🇩🇪Nuertingen, Germany
Adventist Health Glendale
🇺🇸Glendale, California, United States
Washington Cancer Institute at MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Mid-Illinois Hematology & Oncology Associates, Ltd
🇺🇸Normal, Illinois, United States
Arizona Institute of Urology, PLLC
🇺🇸Tucson, Arizona, United States
Wellstar Cobb Hospital
🇺🇸Austell, Georgia, United States
West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
🇺🇸Carrollton, Georgia, United States
Comprehensive Urologic Care, SC
🇺🇸Lake Barrington, Illinois, United States
Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
🇺🇸Carrollton, Georgia, United States
New Jersey Cancer Care, P.A.
🇺🇸Belleville, New Jersey, United States
Willis Knighton Advanced Urology
🇺🇸Shreveport, Louisiana, United States
Klinik fuer Nuklearmedizin
🇩🇪Goettingen, Germany
Institut fuer Diagnostische und Interventionelle Radiologie
🇩🇪Goettingen, Germany
Universitaetsklinik Heidelberg
🇩🇪Heidelberg, Germany
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Ankara Bilkent Sehir Hastanesi
🇹🇷Bilkent, Ankara, Turkey
Trakya University Medical Faculty
🇹🇷Edirne, Turkey
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Galicia, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona [barcelona], Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
MD Anderson Cancer Center
🇪🇸Madrid, Spain
Hospital Politecnic Universitari La Fe
🇪🇸Valencia, Spain
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Fundación Instituto Valenciano de Oncología
🇪🇸Valencia, Valenciana, Comunitat, Spain
Adana City Training and Research Hospital
🇹🇷Adana, Turkey
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Henry Ford Medical Center - New Center One
🇺🇸Detroit, Michigan, United States
Providence Cancer Institute Franz Clinic
🇺🇸Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic - Westside
🇺🇸Portland, Oregon, United States
Huntsman Cancer Institute - University of Utah
🇺🇸Salt Lake City, Utah, United States
AOU San Luigi Gonzaga
🇮🇹Orbassano, TO, Italy
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Clinique Belharra
🇫🇷Bayonne, France
Clinique La Croix du Sud - Ramsay Sante
🇫🇷Quint Fonsegrives, France
CHP Saint-Grégoire
🇫🇷Saint Gregoire, France
Universitätsklinikum Jena
🇩🇪Jena, Thüringen, Germany
Uro-/Onkologisches Zentrum
🇩🇪Leipzig, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Jena University Hospital
🇩🇪Jena, Germany
Althaia, Xarxa Assistencial Universitària de Manresa
🇪🇸Manresa, Barcelona, Spain
Hospital Universitario Virgen de la Macarena
🇪🇸Sevilla, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
POKO Poprad s.r.o.
🇸🇰Poprad, Slovakia
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
🇺🇸Douglasville, Georgia, United States
Ballad Health Cancer Care - Kingsport
🇺🇸Kingsport, Tennessee, United States
Indian Path Community Hospital
🇺🇸Kingsport, Tennessee, United States
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Beverly Hills Cancer Center
🇺🇸Beverly Hills, California, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
🇺🇸Marietta, Georgia, United States
Revive Research Institute, Inc.
🇺🇸Farmington Hills, Michigan, United States
Providence Cancer Institute Clackamas Clinic
🇺🇸Clackamas, Oregon, United States
David C. Pratt Cancer Center
🇺🇸Saint Louis, Missouri, United States
Premier Medical Group of the Hudson Valley PC
🇺🇸Poughkeepsie, New York, United States
Providence Cancer Institute Willamette Falls
🇺🇸Oregon City, Oregon, United States
Providence Cancer Institute Newberg Clinic
🇺🇸Newberg, Oregon, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Parkway Surgery Center
🇺🇸Myrtle Beach, South Carolina, United States
Bristol Regional Medical Center
🇺🇸Bristol, Tennessee, United States
Holston Valley Hospital and Medical Center
🇺🇸Kingsport, Tennessee, United States
Oncology Consultants, P.A.
🇺🇸Houston, Texas, United States
oncology Consultants, P.A.
🇺🇸Houston, Texas, United States
Oncology Consultants P.A.
🇺🇸Houston, Texas, United States
Kelsey-Seybold Clinic
🇺🇸Houston, Texas, United States
Houston Metro Urology
🇺🇸Houston, Texas, United States
Baptist M&S Imaging (STONE OAK)
🇺🇸San Antonio, Texas, United States
COIBA
🇦🇷Berazategui, Buenos Aires, Argentina
Centro de Investigacion Pergamino SA - Clinica Pergamino SA
🇦🇷Pergamino, Buenos Aires, Argentina
Centro de Investigaciones Clínicas - Clínica Viedma
🇦🇷Viedma, RÍO Negro, Argentina
Texas Oncology-Deke Slayton Cancer Center
🇺🇸Webster, Texas, United States
Centro Oncologico Korben
🇦🇷Caba, Argentina
Centro Medico San Roque
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Instituto Médico Especializado Alexander Fleming
🇦🇷Caba, Argentina
Centro Medico Privado CEMAIC
🇦🇷Córdoba, Argentina
Cancer Care Wollongong Pty Limited
🇦🇺Wollongong, New South Wales, Australia
Southern Medical Day Care Centre
🇦🇺Wollongong, New South Wales, Australia
Gold Coast University Hospital
🇦🇺Southport, Queensland, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Gallipoli Medical Research Foundation, Greenslopes Private Hospital
🇦🇺Brisbane, Queensland, Australia
Cabrini Hospital
🇦🇺Malvern, Victoria, Australia
ZNA Jan Palfijn
🇧🇪Merksem, Belgium
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
🇧🇬Panagyurishte, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
🇧🇬Plovdiv, Bulgaria
Prostate Cancer Centre
🇨🇦Calgary, Alberta, Canada
University Health Network-Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean
🇨🇦Chicoutimi, Quebec, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
The Ottawa Hospital Cancer Center
🇨🇦Ottawa, Ontario, Canada
CHUM - Centre Hospitalier de l'Université de Montréal
🇨🇦Montreal, Quebec, Canada
Urology South Shore Research
🇨🇦Greenfield Park, Quebec, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Lanzhou university second hospital
🇨🇳Lanzhou, Gansu, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Jiangxi Provincial Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The First hospital of Jilin University
🇨🇳Changchun, Jilin, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
The First Affiliated Hospital Chongqing Medical University
🇨🇳Chongqing, China
Fakultni nemocnice Ostrava
🇨🇿Ostrava - Poruba, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Fakultni nemocnice Bulovka
🇨🇿Praha 8- Liben, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Kuopio University Hospital
🇫🇮Kuopio, Finland
CHU Morvan de Brest
🇫🇷Brest, France
Centre Hospitalier Universitaire d'Angers
🇫🇷Angers Cedex 9, France
Hopital Henri Mondor
🇫🇷Creteil, ILE DE France, France
Centre de Cancerologie de la Sarthe
🇫🇷Le Mans, France
Clinique Victor Hugo
🇫🇷Le Mans, France
Hopital Prive le Bois
🇫🇷Lille, France
Hopital Lyon Sud
🇫🇷Pierre-Benite, France
Centre Leon Berard
🇫🇷LYON Cedex 08, France
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
Institut Jean Godinot
🇫🇷Reims Cedex, France
Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)
🇫🇷Strasbourg, France
Institut de cancerologie de Lorraine
🇫🇷Vandoeuvre-Les-Nancy, France
Gustave Roussy
🇫🇷Villejuif Cedex, France
Universitaetsmedizin Goettingen
🇩🇪Göttingen, Niedersachsen, Germany
Urologische Gemeinschaftspraxis Wesel
🇩🇪Wesel, Nordrhein-westfalen, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte
🇩🇪Berlin, Germany
Urologicum Duisburg
🇩🇪Duisburg, Germany
Universitaetsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet
🇭🇺Budapest, Hungary
Országos Onkológiai Intézet
🇭🇺Budapest, Hungary
Gujarat Hospital - Gastro and Vascular Centre
🇮🇳Surat, Gujarat, India
Sahyadri Clinical Research & Development Centre
🇮🇳Pune, Maharashtra, India
ASST Cremona
🇮🇹Cremona, CR, Italy
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
🇮🇹Bologna, BO, Italy
Valentis Cancer Hospital
🇮🇳Meerut, Uttar Pradesh, India
Netaji Subhas Chandra Bose Cancer Hospital
🇮🇳Kolkata, WEST Bengal, India
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
🇮🇹Napoli, Naples, Italy
Istituto Romagnolo per lo Studio dei Tum.ori "Dino Amadori" (IRST)
🇮🇹Meldola, Italy
Fondazione Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, FG, Italy
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
🇮🇹Aviano, PN, Italy
Ospedale Santa Chiara
🇮🇹Trento, TN, Italy
Ospedale San Donato
🇮🇹Arezzo, Italy
IRCCS Istituto Tumori "Giovanni Paolo II" di Bari
🇮🇹Bari, Italy
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Italy
ASST degli Spedali Civili de Brescia
🇮🇹Brescia, Italy
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Hirosaki University School of Medicine & Hospital
🇯🇵Hirosaki, Aomori, Japan
Chiba Cancer Center
🇯🇵Chiba City, Chiba, Japan
Chiba cancer center
🇯🇵Chiba-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama, Ehime, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka-shi, Fukuoka, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
🇯🇵Kure, Hiroshima, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo, Hokkaido, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Yokosukakyosai
🇯🇵Yokosuka, Kanagawa, Japan
Kindai University Hospital
🇯🇵Osakasayama, Osaka, Japan
Osaka International Cancer Institute
🇯🇵Osaka-shi, Osaka, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Meguro-Ku, Tokyo, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Tokushima University Hospital
🇯🇵Tokushima, Japan
Yamagata University Hospital
🇯🇵Yamagata, Japan
Chonnam National University Hwasun Hospital
🇰🇷Hwasun-gun, Jeollanam-do, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Kyǒnggi-do, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Axis Heilsa S. de R.L. de C.V.
🇲🇽Monterrey, Nuevo LEÓN, Mexico
Centro de Investigacion Clinica de Oaxaca
🇲🇽Oaxaca, Mexico
Instituto Veracruzano en Investigación Clínica S.C.
🇲🇽Veracruz, Mexico
Meander Medisch Centrum
🇳🇱Amersfoort, Utrecht, Netherlands
Stichting HagaZiekenhuis
🇳🇱Den Haag, Netherlands
Evimed Llc
🇷🇺Chelyabinsk, Russian Federation
Branch of the Limited Liability Company "Hadassah Medical Ltd."
🇷🇺Moscow, Russian Federation
MILAB s.r.o.
🇸🇰Presov, Slovakia
15 Eton Road
🇿🇦Johannesburg, Gauteng, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
🇿🇦Johannesburg, Gauteng, South Africa
WCR Office
🇿🇦Johannesburg, Gauteng, South Africa
Sandton Oncology Medical Group (Pty) Ltd
🇿🇦Johannesburg, Gauteng, South Africa
Wits Clinical Research
🇿🇦Parktown, Johannesburg, Gauteng, South Africa
Clinical Research Unit, University of Pretoria
🇿🇦Pretoria, Gauteng, South Africa
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Comunidad DE, Spain
Hospital Universitari Sant Joan de Reus
🇪🇸Reus, Tarragona, Spain
Hospital Universitario Reina Sofía
🇪🇸Cordoba, Spain
Ankara City Hospital
🇹🇷Ankara, Turkey
Ankara University Faculty of Medicine
🇹🇷Ankara, Turkey
Istanbul University, Cerrahpasa Faculty of Medicine
🇹🇷Istanbul, Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
🇹🇷Istanbul, Turkey
Inonu University, Faculty of Medicine
🇹🇷Malatya, Turkey
NHS Lothian
🇬🇧Edinburgh, Midlothian, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, South Yorkshire, United Kingdom
NHS Greater Glasgow and Clyde
🇬🇧Glasgow, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Keystone Urology Specialists
🇺🇸Lancaster, Pennsylvania, United States
Centre of Applied Urology Research, Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
National Hospital Organization Kumamoto Medical Center
🇯🇵Kumamoto, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
AdventHealth Medical Group Hematology and Oncology
🇺🇸Orlando, Florida, United States
Investigational Drug Services, Advent Health Orlando
🇺🇸Orlando, Florida, United States
Investigational Drug Services
🇺🇸Orlando, Florida, United States
Rajiv Gandhi Cancer Institute and Research Centre
🇮🇳New Delhi, Delhi, India
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Carolina Urologic Research Center, LLC
🇺🇸Myrtle Beach, South Carolina, United States