Clinical trial NCT04821622: Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC
Official title: TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: DDR
prostate cancer
castration-sensitive
PARP-inhibitor
hormone-sensitive
metastatic hormone-sensitive prostate cancer
Advanced prostate cancer
Metastatic castration-sensitive prostate cancer
mCSPC
enzalutamide
metastatic prostate cancer
DNA Damage Response
DNA Damage Repair
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
First posted: 2021-03-29
Enrollment: 599
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male participants at least 18 years of age at screening (20 years for Japan, 19 years for Republic of Korea).
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Prior treatment of mCSPC with docetaxel is not permitted.
9. Treatment with estrogens, cyproterone acetate, or first-generation anti-androgens is allowed until randomization.
10. 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.
11. 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.
12. ECOG performance status 0 or 1.
13. 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.
14. 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.
15. 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).
16. 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.
17. Capable of giving signed informed consent.
18. For France only: Participants affiliated with the social security system or beneficiaries of an equivalent system.

Exclusion Criteria:

1. 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.
2. 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.
3. Major surgery (as defined by the investigator) within 4 weeks before randomization.
4. Known or suspected brain metastasis or active leptomeningeal disease.
5. Symptomatic or impending spinal cord compression or cauda equina syndrome.
6. 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.
7. In the opinion of the investigator, any clinically significant gastrointestinal disorder affecting absorption.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. Prior treatment with a PARPi, or known or possible hypersensitivity to enzalutamide, any of enzalutamide capsule excipients or to any talazoparib/placebo capsule excipients.
14. Prior treatment in any setting with NHT, except as described in Inclusion Criterion #10.
15. Current use of potent P-gp inhibitors within 7 days prior to randomization.
16. 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.
17. 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.
18. 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.
19. 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.

Primary outcomes:
measure: radiological Progression-Free Survival
timeFrame: randomization up to 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: randomization up to 4 years
measure: Objective response in measurable soft tissue disease
timeFrame: randomization up to 3 years
measure: Duration of response in measurable soft tissue disease
timeFrame: randomization up to 3 years
measure: Prostate Specific Antigen (PSA) response
timeFrame: randomization up to 3 years
measure: Time to PSA progression
timeFrame: randomization up to 3 years
measure: Time to initiation of antineoplastic therapy
timeFrame: randomization up to 3 years
measure: Time to first symptomatic skeletal event
timeFrame: randomization up to 3 years
measure: Opiate use for prostate cancer pain
timeFrame: randomization up to 3 years
measure: Incidence of adverse events
timeFrame: randomization up to 3 years
measure: Pharmacokinetic assessment of talazoparib
timeFrame: Weeks 5, 9, 13, and 17
measure: Pharmacokinetic assessment of enzalutamide and its metabolite
timeFrame: Weeks 5, 9, 13, and 17
measure: Relationship between ctDNA burden and outcome
timeFrame: randomization up to 3 years
measure: Patient-reported outcomes in pain symptoms - change from baseline
timeFrame: randomization up to 3 years
measure: Patient-reported outcomes in pain symptoms - time to deterioration
timeFrame: randomization up to 3 years
measure: Patient-reported outcomes in cancer specific general health status - change from baseline
timeFrame: randomization up to 3 years
measure: Patient-reported outcomes in cancer specific global health status/QoL - change from baseline
timeFrame: randomization up to 3 years
measure: Patient-reported outcomes in cancer specific global health status/QoL - time to definitive deterioration
timeFrame: randomization up to 3 years
measure: Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration
timeFrame: randomization up to 3 years
measure: Patient-reported outcome: cancer specific functioning, and symptoms - change from baseline
timeFrame: randomization up to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: Arizona Institute of Urology, PLLC
state: Arizona
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Glendale
country: United States
facility: Adventist Health Glendale
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Washington Cancer Institute at MedStar Washington Hospital Center
state: District of Columbia
city: Orlando
country: United States
facility: AdventHealth Medical Group Hematology and Oncology
state: Florida
city: Orlando
country: United States
facility: Investigational Drug Services, Advent Health Orlando
state: Florida
city: Austell
country: United States
facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
state: Georgia
city: Austell
country: United States
facility: Wellstar Cobb Hospital
state: Georgia
city: Carrollton
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
state: Georgia
city: Carrollton
country: United States
facility: West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
state: Georgia
city: Cartersville
country: United States
facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
state: Georgia
city: Douglasville
country: United States
facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
state: Georgia
city: Lake Barrington
country: United States
facility: Comprehensive Urologic Care, SC
state: Illinois
city: Normal
country: United States
facility: Mid-Illinois Hematology & Oncology Associates, Ltd
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One
state: Michigan
city: Farmington Hills
country: United States
facility: Revive Research Institute, Inc.
state: Michigan
city: Saint Louis
country: United States
facility: David C. Pratt Cancer Center
state: Missouri
city: Belleville
country: United States
facility: New Jersey Cancer Care, P.A.
state: New Jersey
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley PC
state: New York
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Lancaster
country: United States
facility: Keystone Urology Specialists
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center, LLC
state: South Carolina
city: Myrtle Beach
country: United States
facility: Parkway Surgery Center
state: South Carolina
city: Bristol
country: United States
facility: Bristol Regional Medical Center
state: Tennessee
city: Kingsport
country: United States
facility: Ballad Health Cancer Care - Kingsport
state: Tennessee
city: Kingsport
country: United States
facility: Holston Valley Hospital and Medical Center
state: Tennessee
city: Kingsport
country: United States
facility: Indian Path Community Hospital
state: Tennessee
city: Houston
country: United States
facility: Kelsey Research Foundation
state: Texas
city: Houston
country: United States
facility: Oncology Consultants, P.A.
state: Texas
city: Houston
country: United States
facility: Kelsey-Seybold Clinic
state: Texas
city: Houston
country: United States
facility: oncology Consultants, P.A.
state: Texas
city: Houston
country: United States
facility: Kelsey-Seybold Clinic
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Houston
country: United States
facility: Oncology Consultants P.A.
state: Texas
city: Houston
country: United States
facility: Kelsey-Seybold Clinic
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Webster
country: United States
facility: Texas Oncology-Deke Slayton Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute - University of Utah
state: Utah
city: Berazategui
country: Argentina
facility: COIBA
state: Buenos Aires
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino SA - Clinica Pergamino SA
state: Buenos Aires
city: Viedma
country: Argentina
facility: Centro de Investigaciones Clínicas - Clínica Viedma
state: RÍO Negro
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque
state: Tucuman
city: Caba
country: Argentina
facility: Centro Oncologico Korben
city: Caba
country: Argentina
facility: Instituto Médico Especializado Alexander Fleming
city: Córdoba
country: Argentina
facility: Centro Medico Privado CEMAIC
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Wollongong
country: Australia
facility: Cancer Care Wollongong Pty Limited
state: New South Wales
city: Brisbane
country: Australia
facility: Gallipoli Medical Research Foundation, Greenslopes Private Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: East Melbourne
country: Australia
facility: Epworth Freemasons-Epworth HealthCare
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: St Albans
country: Australia
facility: Western Health, Sunshine Hospital
state: Victoria
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis Aalst
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Gent
country: Belgium
facility: AZ (Algemeen Ziekenhuis) Maria Middelares
city: Gent
country: Belgium
facility: AZ (Algemeen Ziekenhuis) Sint-Lucas
city: Kortrijk
country: Belgium
facility: AZ (Algemeen Ziekenhuis) Groeninge
city: Liege
country: Belgium
facility: CHU de Liege
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Panagyurishte
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Uni Hospital OOD
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center - Plovdiv EOOD
city: Plovdiv
country: Bulgaria
facility: Independent medical-diagnostic laboratory "Medisken" EOOD
city: Shumen
country: Bulgaria
facility: Complex Oncology Center - Shumen EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
city: Stara Zagora
country: Bulgaria
facility: Complex Oncology Center - Stara Zagora Ltd.
city: Stara Zagora
country: Bulgaria
facility: MRI SMDLOD "Mediscan" Ltd
city: Stara Zagora
country: Bulgaria
facility: UMHAT "Prof. Dr. Stoyan Kirkovich"
city: Calgary
country: Canada
facility: Prostate Cancer Centre
state: Alberta
city: Halifax
country: Canada
facility: Centre of Applied Urology Research, Nova Scotia Health Authority
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: University Health Network-Princess Margaret Cancer Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS- saguenay-Lac-Saint-Jean
state: Quebec
city: Greenfield Park
country: Canada
facility: Urology South Shore Research
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Lanzhou
country: China
facility: Lanzhou university second hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First hospital of Jilin University
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The first affiliated hospital of Ningbo university
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Chongqing
country: China
facility: The First Affiliated Hospital Chongqing Medical University
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava - Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha 8- Liben
country: Czechia
facility: Fakultni nemocnice Bulovka
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Helsinki
country: Finland
facility: Docrates Cancer Center
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Brest
country: France
facility: CHU Morvan de Brest
state: Bretagne
city: Creteil
country: France
facility: Hopital Henri Mondor
state: ILE DE France
city: Le Mans
country: France
facility: Clinique Victor Hugo Le Mans
state: Pays-de-la-loire
city: Angers Cedex 9
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Bayonne
country: France
facility: Clinique Belharra
city: Brest
country: France
facility: CHU Morvan de Brest
city: Lille
country: France
facility: Hopital Prive le Bois
city: LYON Cedex 08
country: France
facility: Centre Leon Berard
city: Paris cedex 18
country: France
facility: Hopital Bichat - Claude Bernard
city: Paris
country: France
facility: Hopital Bichat - Claude Bernard
city: Pierre-Benite
country: France
facility: Hopital Lyon Sud
city: Quint Fonsegrives
country: France
facility: Clinique La Croix du Sud - Ramsay Sante
city: Reims Cedex
country: France
facility: Institut Jean Godinot
city: Saint Gregoire
country: France
facility: CHP Saint-Grégoire
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)
city: Vandoeuvre-Les-Nancy
country: France
facility: Institut de cancerologie de Lorraine
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: Göttingen
country: Germany
facility: Universitaetsmedizin Goettingen
state: Niedersachsen
city: Wesel
country: Germany
facility: Urologische Gemeinschaftspraxis Wesel
state: Nordrhein-westfalen
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte
city: Duisburg
country: Germany
facility: Urologicum Duisburg
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Goettingen
country: Germany
facility: Institut fuer Diagnostische und Interventionelle Radiologie
city: Heidelberg
country: Germany
facility: Universitaetsklinik Heidelberg
city: Leipzig
country: Germany
facility: Uro-/Onkologisches Zentrum
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Budapest
country: Hungary
facility: Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Budapest
country: Hungary
facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet
city: New Delhi
country: India
facility: Indraprastha Apollo Hospital
state: Delhi
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
state: Delhi
city: Surat
country: India
facility: Gujarat Hospital - Gastro and Vascular Centre
state: Gujarat
city: Gurugram
country: India
facility: Artemis hospital
state: Haryana
city: Gurugram
country: India
facility: Medanta- The Medicity hospital
state: Haryana
city: Mumbai
country: India
facility: Bhaktivedanta Hospital and Research Institute
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Clinical Research & Development Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Super Speciality Hospital
state: Maharashtra
city: Meerut
country: India
facility: Valentis Cancer Hospital
state: Uttar Pradesh
city: Kolkata
country: India
facility: Netaji Subhas Chandra Bose Cancer Hospital
state: WEST Bengal
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
state: BO
city: Cremona
country: Italy
facility: ASST Cremona
state: CR
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST)
state: FC
city: San Giovanni Rotondo
country: Italy
facility: Fondazione Casa Sollievo della Sofferenza
state: FG
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
state: Naples
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
state: PN
city: Trento
country: Italy
facility: Ospedale Santa Chiara
state: TN
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga
state: TO
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Bari
country: Italy
facility: IRCCS Istituto Tumori "Giovanni Paolo II" di Bari
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Brescia
country: Italy
facility: ASST degli Spedali Civili de Brescia
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University School of Medicine & Hospital
state: Aomori
city: Chiba City
country: Japan
facility: Chiba cancer center
state: Chiba
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center
state: Hiroshima
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosukakyosai
state: Kanagawa
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita
country: Japan
facility: The University of Osaka Hospital
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Meguro-Ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio university hospital
state: Tokyo
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Naucalpan de Juarez
country: Mexico
facility: Oncologia Integral Satelite SA de CV
state: Estado DE Mexico
city: Leon
country: Mexico
facility: Preparaciones Oncológicas S.C.
state: Guanajuato
city: Monterrey
country: Mexico
facility: Axis Heilsa S. de R.L. de C.V.
state: Nuevo LEÓN
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo LEÓN
city: Oaxaca de Juarez
country: Mexico
facility: Oaxaca Site Management Organization
state: Oaxaca
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
city: Veracruz
country: Mexico
facility: Instituto Veracruzano en Investigación Clínica S.C.
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
state: Utrecht
city: Den Haag
country: Netherlands
facility: Stichting HagaZiekenhuis
city: Gjoevik
country: Norway
facility: Sykehuset Innlandet Gjoevik
city: Obninsk
country: Russian Federation
facility: MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia
state: Kaluga Region
city: Pushkin
country: Russian Federation
facility: Private Medical Institution "Euromedservice"
state: Saint-petersburg
city: Pyatigorsk
country: Russian Federation
facility: Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")
state: Stavropol Region
city: Chelyabinsk
country: Russian Federation
facility: Evimed Llc
city: Chelyabinsk
country: Russian Federation
facility: SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
city: Ivanovo
country: Russian Federation
facility: Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of the
city: Moscow
country: Russian Federation
facility: Branch of the Limited Liability Company "Hadassah Medical Ltd."
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Central Clinical Hospital with ambulance"
city: Omsk
country: Russian Federation
facility: BHI of Omsk region "Clinical Oncological Dispensary"
city: Saint-Petersburg
country: Russian Federation
facility: LLC "Medicina Severnoy Stolitsy"
city: Saint-Petersburg
country: Russian Federation
facility: LLC "Severo-Zapadny Medical Center"
city: Samara
country: Russian Federation
facility: Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"
city: Ufa
country: Russian Federation
facility: SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
city: Vologda
country: Russian Federation
facility: Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
city: Vologda
country: Russian Federation
facility: Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
city: Kosice
country: Slovakia
facility: Vychodoslovensky onkologicky ustav, a.s.
city: Nitra
country: Slovakia
facility: UROEXAM, spol. s r.o.
city: Poprad
country: Slovakia
facility: POKO Poprad s.r.o.
city: Presov
country: Slovakia
facility: MILAB s.r.o.
city: Trencin
country: Slovakia
facility: Privatna urologicka ambulancia, s.r.o.
city: Johannesburg
country: South Africa
facility: 15 Eton Road
state: Gauteng
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital
state: Gauteng
city: Johannesburg
country: South Africa
facility: WCR Office
state: Gauteng
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Group (Pty) Ltd
state: Gauteng
city: Parktown
country: South Africa
facility: Wits Clinical Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Clinical Research Unit, University of Pretoria
state: Gauteng
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona [barcelona]
city: Manresa
country: Spain
facility: Althaia, Xarxa Assistencial Universitària de Manresa
state: Barcelona
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
state: Galicia
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid, Comunidad DE
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Tarragona
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Valencia
country: Spain
facility: Hospital Politecnic Universitari La Fe
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University, Cerrahpasa Faculty of Medicine
city: Istanbul
country: Turkey
facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital
city: Malatya
country: Turkey
facility: Inonu University, Faculty of Medicine
city: Kryviy Rih
country: Ukraine
facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
state: Dnipropetrovska Oblast
city: Pliuty Village
country: Ukraine
facility: Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"
state: KYIV Region
city: Khodosivka
country: Ukraine
facility: Asklepion Medical Center
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: National Cancer Institute
state: Kyivska Oblast
city: Dnipro
country: Ukraine
facility: Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)
city: Dnipro
country: Ukraine
facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
city: Kharkiv
country: Ukraine
facility: Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of
city: Kharkiv
country: Ukraine
facility: Communal Non-Profit Enterprise "Regional Center of Oncology"
city: Lviv
country: Ukraine
facility: Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
state: Devon
city: Maidstone
country: United Kingdom
facility: Maidstone and Tunbridge Wells NHS Trust
state: Kent
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Foundation Trust
state: Lancashire
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
state: Midlothian
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: