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

NCT ID: NCT04821622

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

599 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2027-08-28

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-blind

Study Groups

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Arm 1

Talazoparib plus enzalutamide

Group Type EXPERIMENTAL

talazoparib plus enzalutamide

Intervention Type DRUG

experimental arm

Arm 2

Placebo plus enzalutamide

Group Type ACTIVE_COMPARATOR

Placebo plus enzalutamide

Intervention Type DRUG

Active comparator arm

Interventions

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talazoparib plus enzalutamide

experimental arm

Intervention Type DRUG

Placebo plus enzalutamide

Active comparator arm

Intervention Type DRUG

Other Intervention Names

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Combination arm Monotherapy arm

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Arizona Institute of Urology, PLLC

Tucson, Arizona, United States

Site Status

Beverly Hills Cancer Center

Beverly Hills, California, United States

Site Status

Adventist Health Glendale

Glendale, California, United States

Site Status

VA Long Beach Healthcare System

Long Beach, California, United States

Site Status

Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Western Health, Sunshine Hospital

St Albans, Victoria, Australia

Site Status

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, , Belgium

Site Status

Institut Jules Bordet

Anderlecht, , Belgium

Site Status

Institut Jules Bordet

Brussels, , Belgium

Site Status

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status

AZ (Algemeen Ziekenhuis) Maria Middelares

Ghent, , Belgium

Site Status

AZ (Algemeen Ziekenhuis) Sint-Lucas

Ghent, , Belgium

Site Status

AZ (Algemeen Ziekenhuis) Groeninge

Kortrijk, , Belgium

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CHU de Liege

Liège, , Belgium

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ZNA Jan Palfijn

Merksem, , Belgium

Site Status

Multiprofile Hospital for Active Treatment - Uni Hospital OOD

Panagyurishte, , Bulgaria

Site Status

Complex Oncology Center - Plovdiv EOOD

Plovdiv, , Bulgaria

Site Status

Independent medical-diagnostic laboratory "Medisken" EOOD

Plovdiv, , Bulgaria

Site Status

Complex Oncology Center - Shumen EOOD

Shumen, , Bulgaria

Site Status

Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

Sofia, , Bulgaria

Site Status

Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

Sofia, , Bulgaria

Site Status

Complex Oncology Center - Stara Zagora Ltd.

Stara Zagora, , Bulgaria

Site Status

MRI SMDLOD "Mediscan" Ltd

Stara Zagora, , Bulgaria

Site Status

UMHAT "Prof. Dr. Stoyan Kirkovich"

Stara Zagora, , Bulgaria

Site Status

Prostate Cancer Centre

Calgary, Alberta, Canada

Site Status

Centre of Applied Urology Research, Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Organisation Lawson Health Research Institute

London, Ontario, Canada

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The Ottawa Hospital Cancer Center

Ottawa, Ontario, Canada

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University Health Network-Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, Canada

Site Status

Centre integre universitaire de sante et de services sociaux Saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, Canada

Site Status

Urology South Shore Research

Greenfield Park, Quebec, Canada

Site Status

Centre Hospitalier de I'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Site Status

CHUM - Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

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Jewish General Hospital

Montreal, Quebec, Canada

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McGill University Health Center

Montreal, Quebec, Canada

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

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Peking University First Hospital

Beijing, Beijing Municipality, China

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Lanzhou university second hospital

Lanzhou, Gansu, China

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The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

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Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

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Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

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Hubei Cancer Hospital

Wuhan, Hubei, China

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Hunan Cancer Hospital

Changsha, Hunan, China

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The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

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Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

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Fakultni nemocnice v Motole

Prague, , Czechia

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Fakultni nemocnice Bulovka

Praha 8- Liben, , Czechia

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Helsinki University Hospital

Helsinki, , Finland

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Docrates Cancer Center

Helsinki, , Finland

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Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

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Nantong Tumor Hospital

Nantong, Jiangsu, China

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The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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Jiangxi Provincial Cancer Hospital

Nanchang, Jiangxi, China

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The First hospital of Jilin University

Changchun, Jilin, China

Site Status

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

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West China Hospital of Sichuan University

Chengdu, Sichuan, China

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The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

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Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

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The first affiliated hospital of Ningbo university

Ningbo, Zhejiang, China

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The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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The First Affiliated Hospital Chongqing Medical University

Chongqing, , China

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The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, , China

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Fakultni nemocnice Olomouc

Olomouc, , Czechia

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Fakultni nemocnice Ostrava

Ostrava - Poruba, , Czechia

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ASST degli Spedali Civili de Brescia

Brescia, , Italy

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Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

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Nagoya University Hospital

Nagoya, Aichi-ken, Japan

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Hirosaki University School of Medicine & Hospital

Hirosaki, Aomori, Japan

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Chiba cancer center

Chiba, Chiba, Japan

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National Cancer Center Hospital East

Kashiwa, Chiba, Japan

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National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

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National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

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National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Kure, Hiroshima, Japan

Site Status

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

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Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

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Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

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Yokosukakyosai

Yokosuka, Kanagawa, Japan

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Osaka International Cancer Institute

Osaka, Osaka, Japan

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Kindai University Hospital

Sakai, Osaka, Japan

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The University of Osaka Hospital

Suita, Osaka, Japan

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Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

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National Hospital Organization Tokyo Medical Center

Meguro-Ku, Tokyo, Japan

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Keio university hospital

Shinjuku-ku, Tokyo, Japan

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Kagoshima University Hospital

Kagoshima, , Japan

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National Hospital Organization Kumamoto Medical Center

Kumamoto, , Japan

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Tokushima University Hospital

Tokushima, , Japan

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Yamagata University Hospital

Yamagata, , Japan

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Preparaciones Oncológicas S.C.

León, Guanajuato, Mexico

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Axis Heilsa S. de R.L. de C.V.

Monterrey, Nuevo León, Mexico

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Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

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Oaxaca Site Management Organization

Oaxaca City, Oaxaca, Mexico

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Oncologia Integral Satelite SA de CV

Naucalpan, State of Mexico, Mexico

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Centro de Investigacion Clinica de Oaxaca

Oaxaca City, , Mexico

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Instituto Veracruzano en Investigación Clínica S.C.

Veracruz, , Mexico

Site Status

Meander Medisch Centrum

Amersfoort, Utrecht, Netherlands

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Stichting HagaZiekenhuis

The Hague, , Netherlands

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Sykehuset Innlandet Gjoevik

Gjøvik, , Norway

Site Status

MRRC n.a. A.F. Tsyb - branch of FSBI "NMRC of Radiology" Minzdrav Russia

Obninsk, Kaluga Oblast, Russia

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Private Medical Institution "Euromedservice"

Pushkin, Sankt-Peterburg, Russia

Site Status

Limited Liability Company "4D Ultrasound Clinic" (LLC "4D Ultrasound Clinic")

Pyatigorsk, Stavropol Kray, Russia

Site Status

Evimed Llc

Chelyabinsk, , Russia

Site Status

SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"

Chelyabinsk, , Russia

Site Status

Regional Budgetary Healthcare Institution "Ivanovskiy Regional Oncology Dispensary" (RBHI "IvROD")

Ivanovo, , Russia

Site Status

Federal State Budgetary Institution "Russian Research Center of Roentgenology and Radiology" of the

Moscow, , Russia

Site Status

Branch of the Limited Liability Company "Hadassah Medical Ltd."

Moscow, , Russia

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Federal State Budgetary Institution "Central Clinical Hospital with ambulance"

Moscow, , Russia

Site Status

BHI of Omsk region "Clinical Oncological Dispensary"

Omsk, , Russia

Site Status

LLC "Medicina Severnoy Stolitsy"

Saint Petersburg, , Russia

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LLC "Severo-Zapadny Medical Center"

Saint Petersburg, , Russia

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Private Institution Educational Organization of Higher Education "Medical University "REAVIZ"

Samara, , Russia

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SAHI Republican Clinical Oncology Dispensary under the Ministry of Health, Republic of Bashkortostan

Ufa, , Russia

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ASST Papa Giovanni XXIII

Bergamo, , Italy

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MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

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Washington Cancer Institute at MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

AdventHealth

Orlando, Florida, United States

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AdventHealth Medical Group Hematology and Oncology

Orlando, Florida, United States

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Investigational Drug Services, Advent Health Orlando

Orlando, Florida, United States

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Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Austell, Georgia, United States

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Wellstar Cobb Hospital

Austell, Georgia, United States

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Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica

Carrollton, Georgia, United States

Site Status

West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica

Carrollton, Georgia, United States

Site Status

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Cartersville, Georgia, United States

Site Status

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Douglasville, Georgia, United States

Site Status

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, United States

Site Status

Comprehensive Urologic Care, SC

Lake Barrington, Illinois, United States

Site Status

Mid-Illinois Hematology & Oncology Associates, Ltd

Normal, Illinois, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Henry Ford Medical Center - New Center One

Detroit, Michigan, United States

Site Status

Revive Research Institute, Inc.

Farmington Hills, Michigan, United States

Site Status

David C. Pratt Cancer Center

St Louis, Missouri, United States

Site Status

New Jersey Cancer Care, P.A.

Belleville, New Jersey, United States

Site Status

Premier Medical Group of the Hudson Valley PC

Poughkeepsie, New York, United States

Site Status

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

Site Status

Keystone Urology Specialists

Lancaster, Pennsylvania, United States

Site Status

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States

Site Status

Parkway Surgery Center

Myrtle Beach, South Carolina, United States

Site Status

Bristol Regional Medical Center

Bristol, Tennessee, United States

Site Status

Ballad Health Cancer Care - Kingsport

Kingsport, Tennessee, United States

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Holston Valley Hospital and Medical Center

Kingsport, Tennessee, United States

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Indian Path Community Hospital

Kingsport, Tennessee, United States

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Kelsey Research Foundation

Houston, Texas, United States

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Oncology Consultants, P.A.

Houston, Texas, United States

Site Status

Kelsey-Seybold Clinic

Houston, Texas, United States

Site Status

oncology Consultants, P.A.

Houston, Texas, United States

Site Status

Kelsey-Seybold Clinic

Houston, Texas, United States

Site Status

Houston Metro Urology

Houston, Texas, United States

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Oncology Consultants P.A.

Houston, Texas, United States

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Kelsey-Seybold Clinic

Houston, Texas, United States

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Urology San Antonio

San Antonio, Texas, United States

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Texas Oncology-Deke Slayton Cancer Center

Webster, Texas, United States

Site Status

Huntsman Cancer Institute - University of Utah

Salt Lake City, Utah, United States

Site Status

COIBA

Berazategui, Buenos Aires, Argentina

Site Status

Centro de Investigacion Pergamino SA - Clinica Pergamino SA

Pergamino, Buenos Aires, Argentina

Site Status

Centro de Investigaciones Clínicas - Clínica Viedma

Viedma, Río Negro Province, Argentina

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Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, Argentina

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Centro Oncologico Korben

Caba, , Argentina

Site Status

Instituto Médico Especializado Alexander Fleming

CABA, , Argentina

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Centro Medico Privado CEMAIC

Córdoba, , Argentina

Site Status

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

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Cancer Care Wollongong Pty Limited

Wollongong, New South Wales, Australia

Site Status

Gallipoli Medical Research Foundation, Greenslopes Private Hospital

Brisbane, Queensland, Australia

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Gold Coast University Hospital

Southport, Queensland, Australia

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The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Site Status

Epworth Freemasons-Epworth HealthCare

East Melbourne, Victoria, Australia

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Cabrini Hospital

Malvern, Victoria, Australia

Site Status

Epworth Foundation Trading as Epworth HealthCare

Richmond, Victoria, Australia

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Clinical Research Institute Helsinki University Central Hospital Ltd

Helsinki, , Finland

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Kuopio University Hospital

Kuopio, , Finland

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Tampere University Hospital

Tampere, , Finland

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Turku University Hospital

Turku, , Finland

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CHU Morvan de Brest

Brest, Brittany Region, France

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Clinique Victor Hugo Le Mans

Le Mans, Pays de la Loire Region, France

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Centre Hospitalier Universitaire d'Angers

Angers, , France

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Clinique Belharra

Bayonne, , France

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Hopital Prive le Bois

Lille, , France

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Centre Leon Berard

Lyon, , France

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Hopital Bichat - Claude Bernard

Paris, , France

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Hopital Bichat - Claude Bernard

Paris, , France

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Hopital Lyon Sud

Pierre-Bénite, , France

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Clinique La Croix du Sud - Ramsay Sante

Quint-Fonsegrives, , France

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Institut Jean Godinot

Reims, , France

Site Status

CHP Saint-Grégoire

Saint-Grégoire, , France

Site Status

Hopitaux Universitaires de Strasbourg - ICANS (Institut de Cancerologie Strasbourg Europe)

Strasbourg, , France

Site Status

Institut de cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status

Gustave Roussy

Villejuif, , France

Site Status

Hopital Henri Mondor

Créteil, Île-de-France Region, France

Site Status

Universitaetsmedizin Goettingen

Göttingen, Lower Saxony, Germany

Site Status

Urologische Gemeinschaftspraxis Wesel

Wesel, North Rhine-Westphalia, Germany

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Universitätsklinikum Jena

Jena, Thuringia, Germany

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Charite Universitaetsmedizin Berlin - Campus Mitte

Berlin, , Germany

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Urologicum Duisburg

Duisburg, , Germany

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Universitaetsklinikum Frankfurt

Frankfurt, , Germany

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Institut fuer Diagnostische und Interventionelle Radiologie

Göttingen, , Germany

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Universitaetsklinik Heidelberg

Heidelberg, , Germany

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Uro-/Onkologisches Zentrum

Leipzig, , Germany

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Studienpraxis Urologie

Nürtingen, , Germany

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Universitaetsklinikum Tuebingen

Tübingen, , Germany

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Péterfy Kórház-Rendelőintézet és Manninger Jenő Országos Traumatológiai Intézet

Budapest, , Hungary

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Országos Onkológiai Intézet

Budapest, , Hungary

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Uzsoki Utcai Korhaz

Budapest, , Hungary

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Jahn Ferenc Del-pesti Korhaz es Rendelointezet

Budapest, , Hungary

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Gujarat Hospital - Gastro and Vascular Centre

Surat, Gujarat, India

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Artemis hospital

Gurugram, Haryana, India

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Medanta- The Medicity hospital

Gurugram, Haryana, India

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Bhaktivedanta Hospital and Research Institute

Mumbai, Maharashtra, India

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Sahyadri Clinical Research & Development Centre

Pune, Maharashtra, India

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Sahyadri Super Speciality Hospital

Pune, Maharashtra, India

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Sahyadri Hospitals Private Limited

Pune, Maharashtra, India

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Indraprastha Apollo Hospital

New Delhi, National Capital Territory of Delhi, India

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Rajiv Gandhi Cancer Institute and Research Centre

New Delhi, National Capital Territory of Delhi, India

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Valentis Cancer Hospital

Meerut, Uttar Pradesh, India

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Netaji Subhas Chandra Bose Cancer Hospital

Kolkata, West Bengal, India

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Indraprastha Apollo Hospitals

New Delhi, , India

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Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi

Bologna, BO, Italy

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ASST Cremona

Cremona, CR, Italy

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Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST)

Meldola, FC, Italy

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Fondazione Casa Sollievo della Sofferenza

San Giovanni Rotondo, FG, Italy

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Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli

Napoli, Naples, Italy

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Centro di Riferimento Oncologico di Aviano (CRO) IRCCS

Aviano, PN, Italy

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Ospedale Santa Chiara

Trento, TN, Italy

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AOU San Luigi Gonzaga

Orbassano, TO, Italy

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Azienda Provinciale per i Servizi Sanitari, della Provincia Autonoma di Trento

Trento, Trentino-Alto Adige, Italy

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Azienda Unita Sanitaria Locale Toscana Sud-Est

Arezzo, , Italy

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Ospedale San Donato

Arezzo, , Italy

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IRCCS Istituto Tumori "Giovanni Paolo II" di Bari

Bari, , Italy

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Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"

Vologda, , Russia

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Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"

Vologda, , Russia

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State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"

Yaroslavl, , Russia

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Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

Banská Bystrica, , Slovakia

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Narodny onkologicky ustav

Bratislava, , Slovakia

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Vychodoslovensky onkologicky ustav, a.s.

Košice, , Slovakia

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UROEXAM, spol. s r.o.

Nitra, , Slovakia

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POKO Poprad s.r.o.

Poprad, , Slovakia

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MILAB s.r.o.

Prešov, , Slovakia

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Privatna urologicka ambulancia, s.r.o.

Trenčín, , Slovakia

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15 Eton Road

Johannesburg, Gauteng, South Africa

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Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, South Africa

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WCR Office

Johannesburg, Gauteng, South Africa

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Sandton Oncology Medical Group (Pty) Ltd

Johannesburg, Gauteng, South Africa

Site Status

Wits Clinical Research

Parktown, Gauteng, South Africa

Site Status

Clinical Research Unit, University of Pretoria

Pretoria, Gauteng, South Africa

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National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, South Korea

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Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

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Kyungpook National University Chilgok Hospital

Daegu, , South Korea

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Seoul National University Hospital

Seoul, , South Korea

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Severance Hospital, Yonsei University Health System

Seoul, , South Korea

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Asan Medical Center

Seoul, , South Korea

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Gangnam Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

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The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

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Ewha Womans University Mokdong Hospital

Seoul, , South Korea

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Hospital General Universitario de Elche

Elche, Alicante, Spain

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Hospital Germans Trias i Pujol

Badalona, Barcelona [barcelona], Spain

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Institut Català d'Oncologia de l'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

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Althaia, Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, Spain

Site Status

Hospital Universitario Lucus Augusti

Lugo, Galicia, Spain

Site Status

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Comunidad de, Spain

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Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Site Status

Fundación Instituto Valenciano de Oncología

Valencia, Valenciana, Comunitat, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

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Hospital Clínic de Barcelona

Barcelona, , Spain

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Hospital Universitario Reina Sofía

Córdoba, , Spain

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Hospital Universitario Gregorio Marañón

Madrid, , Spain

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MD Anderson Cancer Center

Madrid, , Spain

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Hospital Clinico San Carlos

Madrid, , Spain

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Hospital Universitario Virgen de la Macarena

Seville, , Spain

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Hospital Politecnic Universitari La Fe

Valencia, , Spain

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

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Taichung Veterans General Hospital

Taichung, , Taiwan

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National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

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Linkou Chang Gung Memorial Hospital

Taoyuan, , Taiwan

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Adana City Training and Research Hospital

Adana, , Turkey (Türkiye)

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Ankara University Faculty of Medicine

Ankara, , Turkey (Türkiye)

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

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Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

Site Status

Istanbul University, Cerrahpasa Faculty of Medicine

Istanbul, , Turkey (Türkiye)

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Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Inonu University, Faculty of Medicine

Malatya, , Turkey (Türkiye)

Site Status

MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department

Kryviy Rih, Dnipropetrovsk Oblast, Ukraine

Site Status

Medical & diagnostic center of LISOD-Israeli Oncological Hosp "MedX-ray International Group"

Pliuty Village, Kyiv Oblast, Ukraine

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Asklepion Medical Center

Khodosovka, Kyivska Oblast, Ukraine

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National Cancer Institute

Kyiv, Kyivska Oblast, Ukraine

Site Status

Municipal Ent "Dnipropetrovsk Regional Clinical Hosp (I.I.Mechnikov Dnipropetrovsk Regional council)

Dnipro, , Ukraine

Site Status

Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council

Dnipro, , Ukraine

Site Status

Municipal Non-Commercial Enterprise of Kharkiv Regional Council Regional Medical Clinical Center of

Kharkiv, , Ukraine

Site Status

Communal Non-Profit Enterprise "Regional Center of Oncology"

Kharkiv, , Ukraine

Site Status

Comm Noncommerc Entp Lviv Reg Council "Lviv Oncological Regional Therapeutical and Diagnostic Cntre

Lviv, , Ukraine

Site Status

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, United Kingdom

Site Status

Maidstone and Tunbridge Wells NHS Trust

Maidstone, KENT, United Kingdom

Site Status

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, Lancashire, United Kingdom

Site Status

NHS Lothian

Edinburgh, Midlothian, United Kingdom

Site Status

Greater Glasgow Health Board J B Russell House, Gartnavel Royal Hospital

Glasgow, Scotland, United Kingdom

Site Status

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Site Status

University Hospitals Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

Site Status

NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

Site Status

The Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Bulgaria Canada China Czechia Finland France Germany Hungary India Italy Japan Mexico Netherlands Norway Russia Slovakia South Africa South Korea Spain Taiwan Turkey (Türkiye) Ukraine United Kingdom

References

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Agarwal N, Saad F, Azad AA, Mateo J, Matsubara N, Shore ND, Chakrabarti J, Chen HC, Lanzalone S, Niyazov A, Fizazi K. TALAPRO-3 clinical trial protocol: phase III study of talazoparib plus enzalutamide in metastatic castration-sensitive prostate cancer. Future Oncol. 2024 Mar;20(9):493-505. doi: 10.2217/fon-2023-0526. Epub 2023 Oct 26.

Reference Type DERIVED
PMID: 37882449 (View on PubMed)

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C3441052

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Other Identifiers

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TALAPRO-3

Identifier Type: OTHER

Identifier Source: secondary_id

2024-510809-28-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

C3441052

Identifier Type: -

Identifier Source: org_study_id

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