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Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
talazoparib plus enzalutamide
Placebo plus enzalutamide
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Alabama at Birmingham
  • Arizona Institute of Urology, PLLC
  • Beverly Hills Cancer Center
  • Adventist Health Glendale
  • VA Long Beach Healthcare System
  • Yale-New Haven Hospital
  • MedStar Georgetown University Hospital
  • Washington Cancer Institute at MedStar Washington Hospital Center
  • AdventHealth Medical Group Hematology and Oncology
  • Investigational Drug Services, Advent Health Orlando
  • Investigational Drug Services
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  • Wellstar Cobb Hospital
  • Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
  • West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  • Comprehensive Urologic Care, SC
  • Mid-Illinois Hematology & Oncology Associates, Ltd
  • Willis Knighton Advanced Urology
  • Henry Ford Health System
  • Revive Research Institute, Inc.
  • David C. Pratt Cancer Center
  • New Jersey Cancer Care, P.A.
  • Premier Medical Group of the Hudson Valley PC
  • Providence Cancer Institute Clackamas Clinic
  • Providence Cancer Institute Newberg Clinic
  • Providence Cancer Institute Franz Clinic
  • Providence Portland Medical Center
  • Providence Oncology and Hematology Care Clinic - Westside
  • Keystone Urology Specialists
  • Carolina Urologic Research Center
  • Parkway Surgery Center
  • Bristol Regional Medical Center
  • Ballad Health Cancer Care - Kingsport
  • Holston Valley Hospital and Medical Center
  • Indian Path Community Hospital
  • Kelsey Research Foundation
  • Oncology Consultants, P.A.
  • oncology Consultants, P.A.
  • Kelsey-Seybold Clinic
  • Houston Metro Urology
  • Oncology Consultants P.A.
  • Urology San Antonio
  • Texas Oncology-Deke Slayton Cancer Center
  • Huntsman Cancer Institute - University of Utah
  • COIBA
  • Centro de Investigacion Pergamino SA - Clinica Pergamino SA
  • Centro de Investigaciones Clínicas - Clínica Viedma
  • Centro Medico San Roque
  • Centro Oncologico Korben
  • Instituto Médico Especializado Alexander Fleming
  • Centro Medico Privado CEMAIC
  • Chris O'Brien Lifehouse
  • Southern Medical Day Care Centre
  • Gallipoli Medical Research Foundation, Greenslopes Private Hospital
  • Gold Coast University Hospital
  • The Queen Elizabeth Hospital
  • Epworth Freemasons-Epworth HealthCare
  • Cabrini Hospital
  • Western Health, Sunshine Hospital
  • Onze Lieve Vrouw Ziekenhuis Aalst
  • Institut Jules Bordet
  • Cliniques universitaires Saint-Luc
  • AZ (Algemeen Ziekenhuis) Maria Middelares
  • AZ (Algemeen Ziekenhuis) Sint-Lucas
  • AZ (Algemeen Ziekenhuis) Groeninge
  • CHU de Liege
  • ZNA Jan Palfijn
  • Multiprofile Hospital for Active Treatment - Uni Hospital OOD
  • Complex Oncology Center - Plovdiv EOOD
  • Independent medical-diagnostic laboratory "Medisken" EOOD
  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
  • Complex Oncology Center - Shumen EOOD
  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
  • Complex Oncology Center - Stara Zagora Ltd.
  • MRI SMDLOD "Mediscan" Ltd
  • UMHAT "Prof. Dr. Stoyan Kirkovich"
  • Prostate Cancer Centre
  • Centre of Applied Urology Research, Nova Scotia Health Authority
  • London Health Sciences Centre
  • The Ottawa Hospital Cancer Center
  • University Health Network-Princess Margaret Cancer Centre
  • CIUSSS- saguenay-Lac-Saint-Jean
  • Urology South Shore Research
  • CHUM - Centre Hospitalier de l'Université de Montréal
  • Jewish General Hospital
  • McGill University Health Center
  • The First Affiliated Hospital of Anhui Medical University
  • Peking University First Hospital
  • Lanzhou University Second Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • Nanfang Hospital of Southern Medical University
  • Harbin Medical University Cancer Hospital
  • Henan Cancer Hospital
  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
  • Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
  • Hubei Cancer Hospital
  • Hunan Cancer Hospital
  • The Third Xiangya Hospital of Central South University
  • Zhongda Hospital Southeast University
  • Nantong Tumor Hospital
  • The Second Affiliated Hospital of Soochow University
  • Jiangxi Provincial Cancer Hospital
  • The First hospital of Jilin University
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Fudan University Cancer Hospital
  • West China Hospital of Sichuan University
  • The Second Hospital of Tianjin Medical University
  • Zhejiang Provincial People's Hospital
  • Ningbo First Hospital
  • The First Affiliated Hospital of Wenzhou Medical University
  • The First Affiliated Hospital Chongqing Medical University
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice Ostrava
  • Fakultni nemocnice Kralovske Vinohrady
  • Fakultni nemocnice v Motole
  • Fakultni nemocnice Bulovka
  • Helsinki University Hospital
  • Docrates Cancer Center
  • Kuopio University Hospital
  • Tampere University Hospital
  • Turku University Hospital
  • CHU Morvan de Brest
  • Hopital Henri Mondor
  • Centre Hospitalier Universitaire d'Angers
  • Clinique Belharra
  • CHU Morvan de Brest
  • Centre de Cancerologie de la Sarthe
  • Clinique Victor Hugo
  • Hopital Prive le Bois
  • Centre Leon Berard
  • Hopital Bichat - Claude Bernard
  • Hopital Bichat - Claude Bernard
  • Hopital Lyon Sud
  • Clinique La Croix du Sud - Ramsay Sante
  • Institut Jean Godinot
  • CHP Saint-Grégoire
  • Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)
  • Institut de cancerologie de Lorraine
  • Gustave Roussy
  • Universitaetsmedizin Goettingen
  • Urologische Gemeinschaftspraxis Wesel
  • Universitätsklinikum Jena
  • Charite Universitaetsmedizin Berlin - Campus Mitte
  • Urologicum Duisburg
  • Universitaetsklinikum Frankfurt
  • Institut fuer Diagnostische und Interventionelle Radiologie
  • Klinik fuer Nuklearmedizin
  • Universitaetsklinik Heidelberg
  • Jena University Hospital
  • Uro-/Onkologisches Zentrum
  • Studienpraxis Urologie
  • Universitaetsklinikum Tuebingen
  • Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet
  • Országos Onkológiai Intézet
  • Uzsoki Utcai Korhaz
  • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
  • Indraprastha Apollo Hospital
  • Rajiv Gandhi Cancer Institute and Research Centre
  • Gujarat Hospital - Gastro and Vascular Centre
  • Artemis hospital
  • Medanta- The Medicity hospital
  • Bhakti Vedanta Hospital and Research Institute
  • Bhaktivedanta Hospital and Research Institute
  • TATA Memorial Hospital
  • Sahyadri Clinical Research & Development Centre
  • Sahyadri Super Speciality Hospital
  • Valentis Cancer Hospital
  • Netaji Subhas Chandra Bose Cancer Hospital
  • Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
  • ASST Cremona
  • Istituto Romagnolo per lo Studio dei Tum.ori "Dino Amadori" (IRST)
  • Fondazione Casa Sollievo della Sofferenza
  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
  • Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
  • Ospedale Santa Chiara
  • AOU San Luigi Gonzaga
  • Ospedale San Donato
  • IRCCS Istituto Tumori "Giovanni Paolo II" di Bari
  • ASST Papa Giovanni XXIII
  • ASST degli Spedali Civili de Brescia
  • Azienda Ospedaliera Universitaria Integrata Verona
  • Nagoya University Hospital
  • Hirosaki University School of Medicine & Hospital
  • Chiba Cancer Center
  • Chiba cancer center
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • National Hospital Organization Kyushu Cancer Center
  • National Hospital Organization Kure Medical Center and Chugoku Cancer Center
  • National Hospital Organization Hokkaido Cancer Center
  • Hokkaido University Hospital
  • Kanazawa University Hospital
  • Yokohama City University Medical Center
  • Yokosukakyosai
  • Osaka International Cancer Institute
  • Kindai University Hospital
  • Osaka University Hospital
  • Hamamatsu University Hospital
  • National Hospital Organization Tokyo Medical Center
  • Keio University Hospital
  • Kagoshima University Hospital
  • National Hospital Organization Kumamoto Medical Center
  • Tokushima University Hospital
  • Yamagata University Hospital
  • National Cancer Center
  • Chonnam National University Hwasun Hospital
  • Seoul National University Bundang Hospital
  • Samsung Medical Center
  • Kyungpook National University Chilgok Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Gangnam Severance Hospital, Yonsei University Health System
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital
  • Ewha Womans University Mokdong Hospital
  • Oncologia Integral Satelite SA de CV
  • Preparaciones Oncológicas S.C.
  • Axis Heilsa S. de R.L. de C.V.
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Oaxaca Site Management Organization
  • Centro de Investigacion Clinica de Oaxaca
  • Instituto Veracruzano en Investigación Clínica S.C.
  • Meander Medisch Centrum
  • Stichting HagaZiekenhuis
  • Sykehuset Innlandet Gjoevik
  • MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia
  • Private Medical Institution "Euromedservice"
  • Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")
  • Evimed Llc
  • SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
  • Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")
  • Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of
  • Branch of the Limited Liability Company "Hadassah Medical Ltd."
  • Federal State Budgetary Institution "Central Clinical Hospital with ambulance"
  • BHI of Omsk region "Clinical Oncological Dispensary"
  • LLC "Medicina Severnoy Stolitsy"
  • LLC "Severo-Zapadny Medical Center"
  • Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"
  • SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
  • Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
  • Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
  • State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
  • Narodny onkologicky ustav
  • Vychodoslovensky onkologicky ustav, a.s.
  • UROEXAM, spol. s r.o.
  • POKO Poprad s.r.o.
  • MILAB s.r.o.
  • Privatna urologicka ambulancia, s.r.o.
  • 15 Eton Road
  • Charlotte Maxeke Johannesburg Academic Hospital
  • WCR Office
  • Sandton Oncology Medical Group (Pty) Ltd
  • Wits Clinical Research
  • Clinical Research Unit, University of Pretoria
  • Hospital General Universitario de Elche
  • Hospital Universitario Central de Asturias
  • Hospital Germans Trias i Pujol
  • Althaia, Xarxa Assistencial Universitària de Manresa
  • Hospital Universitario Lucus Augusti
  • Hospital Universitario Puerta de Hierro
  • Complejo Hospitalario de Navarra
  • Hospital Universitari Sant Joan de Reus
  • Fundación Instituto Valenciano de Oncología
  • Hospital Universitari Vall d'Hebron
  • Hospital Clínic de Barcelona
  • Hospital Universitario Reina Sofía
  • Hospital Universitario Gregorio Marañón
  • MD Anderson Cancer Center
  • Hospital Clinico San Carlos
  • Hospital Universitario Virgen de la Macarena
  • Hospital Politecnic Universitari La Fe
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Linkou Chang Gung Memorial Hospital
  • Ankara Bilkent Sehir Hastanesi
  • Adana City Training and Research Hospital
  • Ankara University Faculty of Medicine
  • Ankara City Hospital
  • Trakya University Medical Faculty
  • Istanbul University, Cerrahpasa Faculty of Medicine
  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Inonu University, Faculty of Medicine
  • MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
  • Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"
  • Asklepion Medical Center
  • National Cancer Institute
  • Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)
  • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
  • Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
  • Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of
  • Communal Non-Profit Enterprise "Regional Center of Oncology"
  • Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntr
  • Royal Devon and Exeter NHS Foundation Trust
  • Maidstone and Tunbridge Wells NHS Trust
  • Lancashire Teaching Hospitals NHS Foundation Trust
  • NHS Lothian
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • University Hospitals Birmingham NHS Foundation Trust
  • NHS Greater Glasgow and Clyde
  • The Royal Marsden NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Talazoparib plus enzalutamide

Placebo plus enzalutamide

Outcomes

Primary Outcome Measures

radiological Progression-Free Survival
time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first

Secondary Outcome Measures

Overall Survival
time from randomization to death from any cause
Objective response in measurable soft tissue disease
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
duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1
Prostate Specific Antigen (PSA) response
proportion of patients with PSA response grater than or equal to 50%
Time to PSA progression
time from baseline to PSA progression
Time to initiation of antineoplastic therapy
Time from randomization to initiation of antineoplastic therapy
Time to first symptomatic skeletal event
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
time from randomization to opiate use for prostate cancer pain
Incidence of adverse events
AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03)
Pharmacokinetic assessment of talazoparib
plasma concentrations of talazoparib
Pharmacokinetic assessment of enzalutamide and its metabolite
plasma concentrations of enzalutamide and its metabolite
Relationship between ctDNA burden and outcome
ctDNA burden at baseline and on study
Patient-reported outcomes in pain symptoms - change from baseline
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
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
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
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
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
time to definitive deterioration in disease specific urinary symptoms per EORTC QLQ-PR25
Patient-reported outcome: cancer specific functioning, and symptoms - change from baseline
change from baseline in PGI-S

Full Information

First Posted
March 25, 2021
Last Updated
October 10, 2023
Sponsor
Pfizer
Collaborators
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04821622
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
December 11, 2024 (Anticipated)
Study Completion Date
April 10, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Astellas Pharma Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
599 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Talazoparib plus enzalutamide
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Placebo plus enzalutamide
Intervention Type
Drug
Intervention Name(s)
talazoparib plus enzalutamide
Other Intervention Name(s)
Combination arm
Intervention Description
experimental arm
Intervention Type
Drug
Intervention Name(s)
Placebo plus enzalutamide
Other Intervention Name(s)
Monotherapy arm
Intervention Description
Active comparator arm
Primary Outcome Measure Information:
Title
radiological Progression-Free Survival
Description
time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first
Time Frame
randomization up to 3 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
time from randomization to death from any cause
Time Frame
randomization up to 4 years
Title
Objective response in measurable soft tissue disease
Description
proportion of patients with measurable soft tissue disease at baseline with objective response per RECIST 1.1
Time Frame
randomization up to 3 years
Title
Duration of response in measurable soft tissue disease
Description
duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1
Time Frame
randomization up to 3 years
Title
Prostate Specific Antigen (PSA) response
Description
proportion of patients with PSA response grater than or equal to 50%
Time Frame
randomization up to 3 years
Title
Time to PSA progression
Description
time from baseline to PSA progression
Time Frame
randomization up to 3 years
Title
Time to initiation of antineoplastic therapy
Description
Time from randomization to initiation of antineoplastic therapy
Time Frame
randomization up to 3 years
Title
Time to first symptomatic skeletal event
Description
time from randomization to first symptomatic skeletal event (symptomatic fractures, spinal cord compression, surgery or radiation to the bone whichever is first)
Time Frame
randomization up to 3 years
Title
Opiate use for prostate cancer pain
Description
time from randomization to opiate use for prostate cancer pain
Time Frame
randomization up to 3 years
Title
Incidence of adverse events
Description
AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03)
Time Frame
randomization up to 3 years
Title
Pharmacokinetic assessment of talazoparib
Description
plasma concentrations of talazoparib
Time Frame
Weeks 5, 9, 13, and 17
Title
Pharmacokinetic assessment of enzalutamide and its metabolite
Description
plasma concentrations of enzalutamide and its metabolite
Time Frame
Weeks 5, 9, 13, and 17
Title
Relationship between ctDNA burden and outcome
Description
ctDNA burden at baseline and on study
Time Frame
randomization up to 3 years
Title
Patient-reported outcomes in pain symptoms - change from baseline
Description
change from baseline in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)
Time Frame
randomization up to 3 years
Title
Patient-reported outcomes in pain symptoms - time to deterioration
Description
time to deterioration in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)
Time Frame
randomization up to 3 years
Title
Patient-reported outcomes in cancer specific general health status - change from baseline
Description
change from baseline in participant-reported general health status per EQ-5D-5L
Time Frame
randomization up to 3 years
Title
Patient-reported outcomes in cancer specific global health status/QoL - change from baseline
Description
change from baseline in patient-reported Global health status/QoL per EORTC QLQ-C30
Time Frame
randomization up to 3 years
Title
Patient-reported outcomes in cancer specific global health status/QoL - time to definitive deterioration
Description
time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30
Time Frame
randomization up to 3 years
Title
Patient-reported outcomes in cancer specific symptoms - time to definitive deterioration
Description
time to definitive deterioration in disease specific urinary symptoms per EORTC QLQ-PR25
Time Frame
randomization up to 3 years
Title
Patient-reported outcome: cancer specific functioning, and symptoms - change from baseline
Description
change from baseline in PGI-S
Time Frame
randomization up to 3 years

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Arizona Institute of Urology, PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Adventist Health Glendale
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Washington Cancer Institute at MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
AdventHealth Medical Group Hematology and Oncology
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Investigational Drug Services, Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Investigational Drug Services
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Wellstar Cobb Hospital
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
City
Carrollton
State/Province
Georgia
ZIP/Postal Code
30117
Country
United States
Facility Name
West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
City
Carrollton
State/Province
Georgia
ZIP/Postal Code
30117
Country
United States
Facility Name
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30121
Country
United States
Facility Name
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
City
Douglasville
State/Province
Georgia
ZIP/Postal Code
30134
Country
United States
Facility Name
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Comprehensive Urologic Care, SC
City
Lake Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Facility Name
Mid-Illinois Hematology & Oncology Associates, Ltd
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Willis Knighton Advanced Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71115
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Revive Research Institute, Inc.
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
David C. Pratt Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
New Jersey Cancer Care, P.A.
City
Belleville
State/Province
New Jersey
ZIP/Postal Code
07109
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Providence Cancer Institute Clackamas Clinic
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Providence Cancer Institute Newberg Clinic
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Facility Name
Providence Cancer Institute Franz Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Oncology and Hematology Care Clinic - Westside
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Keystone Urology Specialists
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Parkway Surgery Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Bristol Regional Medical Center
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Ballad Health Cancer Care - Kingsport
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Holston Valley Hospital and Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Indian Path Community Hospital
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Kelsey Research Foundation
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Oncology Consultants, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
oncology Consultants, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Kelsey-Seybold Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Oncology Consultants P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Oncology-Deke Slayton Cancer Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Huntsman Cancer Institute - University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
COIBA
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
B1884BBF
Country
Argentina
Facility Name
Centro de Investigacion Pergamino SA - Clinica Pergamino SA
City
Pergamino
State/Province
Buenos Aires
ZIP/Postal Code
B2700CPM
Country
Argentina
Facility Name
Centro de Investigaciones Clínicas - Clínica Viedma
City
Viedma
State/Province
RÍO Negro
ZIP/Postal Code
R8500ACE
Country
Argentina
Facility Name
Centro Medico San Roque
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
Facility Name
Centro Oncologico Korben
City
Caba
ZIP/Postal Code
C1426AGE
Country
Argentina
Facility Name
Instituto Médico Especializado Alexander Fleming
City
Caba
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Centro Medico Privado CEMAIC
City
Córdoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Southern Medical Day Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Gallipoli Medical Research Foundation, Greenslopes Private Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Epworth Freemasons-Epworth HealthCare
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Cabrini Hospital
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Western Health, Sunshine Hospital
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Onze Lieve Vrouw Ziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Institut Jules Bordet
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ (Algemeen Ziekenhuis) Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ (Algemeen Ziekenhuis) Sint-Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ (Algemeen Ziekenhuis) Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU de Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
ZNA Jan Palfijn
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
City
Panagyurishte
ZIP/Postal Code
4500
Country
Bulgaria
Facility Name
Complex Oncology Center - Plovdiv EOOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Independent medical-diagnostic laboratory "Medisken" EOOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Complex Oncology Center - Shumen EOOD
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
City
Sofia
Country
Bulgaria
Facility Name
Complex Oncology Center - Stara Zagora Ltd.
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
MRI SMDLOD "Mediscan" Ltd
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
UMHAT "Prof. Dr. Stoyan Kirkovich"
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Prostate Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Centre of Applied Urology Research, Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
The Ottawa Hospital Cancer Center
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
University Health Network-Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CIUSSS- saguenay-Lac-Saint-Jean
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
Urology South Shore Research
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H3
Country
Canada
Facility Name
CHUM - Centre Hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Jiangxi Provincial Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Facility Name
The First hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
The First Affiliated Hospital Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Fakultni nemocnice Bulovka
City
Praha 8- Liben
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Docrates Cancer Center
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
CHU Morvan de Brest
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
State/Province
ILE DE France
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Universitaire d'Angers
City
Angers Cedex 9
ZIP/Postal Code
49933
Country
France
Facility Name
Clinique Belharra
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
CHU Morvan de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Centre de Cancerologie de la Sarthe
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Hopital Prive le Bois
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Leon Berard
City
LYON Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Lyon Sud
City
Pierre-Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Clinique La Croix du Sud - Ramsay Sante
City
Quint Fonsegrives
ZIP/Postal Code
31130
Country
France
Facility Name
Institut Jean Godinot
City
Reims Cedex
ZIP/Postal Code
51726
Country
France
Facility Name
CHP Saint-Grégoire
City
Saint Gregoire
ZIP/Postal Code
35760
Country
France
Facility Name
Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Institut de cancerologie de Lorraine
City
Vandoeuvre-Les-Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Universitaetsmedizin Goettingen
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Urologische Gemeinschaftspraxis Wesel
City
Wesel
State/Province
Nordrhein-westfalen
ZIP/Postal Code
46483
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Urologicum Duisburg
City
Duisburg
ZIP/Postal Code
47169
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Institut fuer Diagnostische und Interventionelle Radiologie
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Klinik fuer Nuklearmedizin
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitaetsklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Jena University Hospital
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Uro-/Onkologisches Zentrum
City
Leipzig
ZIP/Postal Code
04105
Country
Germany
Facility Name
Studienpraxis Urologie
City
Nuertingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Indraprastha Apollo Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Rajiv Gandhi Cancer Institute and Research Centre
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Gujarat Hospital - Gastro and Vascular Centre
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395009
Country
India
Facility Name
Artemis hospital
City
Gurugram
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Medanta- The Medicity hospital
City
Gurugram
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Bhakti Vedanta Hospital and Research Institute
City
Mumbai, Thane
State/Province
Maharashtra
ZIP/Postal Code
401107
Country
India
Facility Name
Bhaktivedanta Hospital and Research Institute
City
Mumbai, Thane
State/Province
Maharashtra
ZIP/Postal Code
401107
Country
India
Facility Name
TATA Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 012
Country
India
Facility Name
Sahyadri Clinical Research & Development Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Sahyadri Super Speciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Valentis Cancer Hospital
City
Meerut
State/Province
Uttar Pradesh
ZIP/Postal Code
250001
Country
India
Facility Name
Netaji Subhas Chandra Bose Cancer Hospital
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700094
Country
India
Facility Name
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST Cremona
City
Cremona
State/Province
CR
ZIP/Postal Code
26100
Country
Italy
Facility Name
Istituto Romagnolo per lo Studio dei Tum.ori "Dino Amadori" (IRST)
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
Fondazione Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
FG
ZIP/Postal Code
71013
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
City
Napoli
State/Province
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospedale Santa Chiara
City
Trento
State/Province
TN
ZIP/Postal Code
38122
Country
Italy
Facility Name
AOU San Luigi Gonzaga
City
Orbassano
State/Province
TO
ZIP/Postal Code
10043
Country
Italy
Facility Name
Ospedale San Donato
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
IRCCS Istituto Tumori "Giovanni Paolo II" di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
ASST degli Spedali Civili de Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Hirosaki University School of Medicine & Hospital
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba City
State/Province
Chiba
ZIP/Postal Code
2608717
Country
Japan
Facility Name
Chiba cancer center
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Yokosukakyosai
City
Yokosuka
State/Province
Kanagawa
ZIP/Postal Code
238-8558
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5418567
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Meguro-Ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-gun
State/Province
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyǒnggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Facility Name
Oncologia Integral Satelite SA de CV
City
Naucalpan de Juarez
State/Province
Estado DE Mexico
ZIP/Postal Code
53100
Country
Mexico
Facility Name
Preparaciones Oncológicas S.C.
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37178
Country
Mexico
Facility Name
Axis Heilsa S. de R.L. de C.V.
City
Monterrey
State/Province
Nuevo LEÓN
ZIP/Postal Code
64040
Country
Mexico
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo LEÓN
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Oaxaca Site Management Organization
City
Oaxaca de Juarez
State/Province
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Centro de Investigacion Clinica de Oaxaca
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Facility Name
Instituto Veracruzano en Investigación Clínica S.C.
City
Veracruz
ZIP/Postal Code
91851
Country
Mexico
Facility Name
Meander Medisch Centrum
City
Amersfoort
State/Province
Utrecht
ZIP/Postal Code
3813 TZ
Country
Netherlands
Facility Name
Stichting HagaZiekenhuis
City
Den Haag
ZIP/Postal Code
2545 AA
Country
Netherlands
Facility Name
Sykehuset Innlandet Gjoevik
City
Gjoevik
ZIP/Postal Code
2819
Country
Norway
Facility Name
MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia
City
Obninsk
State/Province
Kaluga Region
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Private Medical Institution "Euromedservice"
City
Pushkin
State/Province
Saint-petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")
City
Pyatigorsk
State/Province
Stavropol Region
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Evimed Llc
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Branch of the Limited Liability Company "Hadassah Medical Ltd."
City
Moscow
ZIP/Postal Code
121205
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Central Clinical Hospital with ambulance"
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
BHI of Omsk region "Clinical Oncological Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
LLC "Medicina Severnoy Stolitsy"
City
Saint-Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Facility Name
LLC "Severo-Zapadny Medical Center"
City
Saint-Petersburg
ZIP/Postal Code
192007
Country
Russian Federation
Facility Name
Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
City
Vologda
ZIP/Postal Code
160002
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"
City
Vologda
ZIP/Postal Code
160022
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Vychodoslovensky onkologicky ustav, a.s.
City
Kosice
ZIP/Postal Code
041 91
Country
Slovakia
Facility Name
UROEXAM, spol. s r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
POKO Poprad s.r.o.
City
Poprad
ZIP/Postal Code
058 21
Country
Slovakia
Facility Name
MILAB s.r.o.
City
Presov
ZIP/Postal Code
08 001
Country
Slovakia
Facility Name
Privatna urologicka ambulancia, s.r.o.
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
15 Eton Road
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Charlotte Maxeke Johannesburg Academic Hospital
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
WCR Office
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Sandton Oncology Medical Group (Pty) Ltd
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Wits Clinical Research
City
Parktown, Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Clinical Research Unit, University of Pretoria
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08916
Country
Spain
Facility Name
Althaia, Xarxa Assistencial Universitària de Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
State/Province
Galicia
ZIP/Postal Code
27003
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28222
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitari Sant Joan de Reus
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
Facility Name
Fundación Instituto Valenciano de Oncología
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Politecnic Universitari La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Bilkent
State/Province
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Adana City Training and Research Hospital
City
Adana
ZIP/Postal Code
01415
Country
Turkey
Facility Name
Ankara University Faculty of Medicine
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Istanbul University, Cerrahpasa Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Inonu University, Faculty of Medicine
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department
City
Kryviy Rih
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"
City
Pliuty Village
State/Province
KYIV Region
ZIP/Postal Code
08720
Country
Ukraine
Facility Name
Asklepion Medical Center
City
Khodosivka
State/Province
Kyivska Oblast
ZIP/Postal Code
08173
Country
Ukraine
Facility Name
National Cancer Institute
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Communal Non-Profit Enterprise "Regional Center of Oncology"
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntr
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Royal Devon and Exeter NHS Foundation Trust
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Maidstone and Tunbridge Wells NHS Trust
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
NHS Lothian
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3441052
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

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