A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer | NCT04100018 | Trialant

A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer | NCT04100018 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Histologic confirmation of adenocarcinoma of the prostate without small cell features

Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI)

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy

Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening

Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy

Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.

Men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

Active brain metastases

Active, known, or suspected autoimmune disease

Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease

Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel

Other protocol-defined inclusion/exclusion criteria apply

Local Institution - 0305

Mobile, Alabama 36608-1753, United States

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Anchorage, Alaska 99503, United States

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Tucson, Arizona 85724, United States

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Jonesboro, Arkansas 72401, United States

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Orange, California 92868, United States

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Rancho Mirage, California 92270, United States

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Redondo Beach, California 90277, United States

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Santa Monica, California 90404, United States

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Denver, Colorado 80211-5222, United States

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West Haven, Connecticut 06516-5907, United States

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Washington D.C., District of Columbia 20010-3017, United States

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Hollywood, Florida 33021, United States

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Jacksonville, Florida 32256, United States

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Lakeland, Florida 33805, United States

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Orlando, Florida 32806, United States

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Pensacola, Florida 32503, United States

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Weston, Florida 33331, United States

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Atlanta, Georgia 30342, United States

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Marietta, Georgia 30060, United States

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Thomasville, Georgia 31792, United States

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Niles, Illinois 60714, United States

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Fort Wayne, Indiana 46804, United States

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Louisville, Kentucky 40202, United States

Local Institution - 0150

Baltimore, Maryland 21201, United States

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Brandywine, Maryland 20613, United States

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Omaha, Nebraska 68130, United States

Local Institution - 0365

East Brunswick, New Jersey 08816, United States

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Florham Park, New Jersey 07932, United States

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Albany, New York 12208, United States

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Port Jefferson Station, New York 11776, United States

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Columbus, Ohio 43210, United States

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Allentown, Pennsylvania 18103-6218, United States

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Bala-Cynwyd, Pennsylvania 19004, United States

Local Institution - 0292

Pittsburgh, Pennsylvania 15232, United States

Local Institution - 0233

Charleston, South Carolina 29414, United States

Local Institution - 0115

Myrtle Beach, South Carolina 29572-4607, United States

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Germantown, Tennessee 38138, United States

Local Institution - 0286

Austin, Texas 75251, United States

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Dallas, Texas 75251, United States

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Houston, Texas 77024-2843, United States

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Houston, Texas 77030-3721, United States

Local Institution - 0011

San Antonio, Texas 78229, United States

The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center

Tyler, Texas 75701, United States

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Seattle, Washington 98109, United States

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Spokane, Washington 99208, United States

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Mar del Plata, Buenos Aires B7602CBM, Argentina

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Pergamino, Buenos Aires B2700, Argentina

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Parana, Córdoba Province 5000, Argentina

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Río Cuarto, Córdoba Province 5800, Argentina

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Viedma, Río Negro Province 8500, Argentina

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Buenos Aires, 1280, Argentina

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La Rioja, F5300COE, Argentina

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Gosford, New South Wales 2250, Australia

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Lismore, New South Wales 2480, Australia

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Wahroonga, New South Wales 2076, Australia

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Westmead, New South Wales 2145, Australia

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South Brisbane, Queensland 4101, Australia

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Woolloongabba, Queensland 4102, Australia

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North Adelaide, South Australia 5006, Australia

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Ballarat, Victoria 3350, Australia

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Linz, Upper Austria 4020, Austria

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Anderlecht, Brussels Capital 1070, Belgium

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Bruges, 8000, Belgium

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Ghent, 9000, Belgium

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Ghent, 9000, Belgium

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Turnhout, 2300, Belgium

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Wilrijk, 2610, Belgium

Local Institution - 0097

Belo Horizonte, Minas Gerais 30110022, Brazil

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Belo Horizonte, Minas Gerais 30130090, Brazil

Local Institution - 0100

Curitiba, Paraná 80530-010, Brazil

Local Institution - 0082

Curitiba, Paraná 80810050, Brazil

Local Institution - 0321

Natal, Rio Grande do Norte 59075-740, Brazil

Local Institution - 0058

Ijuí, Rio Grande do Sul 98700-000, Brazil

Local Institution - 0063

Porto Alegre, Rio Grande do Sul 90035-001, Brazil

Local Institution - 0056

Porto Alegre, Rio Grande do Sul 90035-903, Brazil

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Porto Alegre, Rio Grande do Sul 90110-270, Brazil

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Campinas, São Paulo 13083 970, Brazil

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Santo André, São Paulo 09060-650, Brazil

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São José do Rio Preto, São Paulo 15090-000, Brazil

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Rio de Janeiro, 22250-905, Brazil

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Rio de Janeiro, 22793-080, Brazil

Local Institution - 0080

São Paulo, 01321-001, Brazil

Local Institution - 0273

São Paulo, 01327-0001, Brazil

Local Institution - 0328

São Paulo, 05652- 900, Brazil

Local Institution - 0151

Brampton, Ontario L6R 3J7, Canada

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Toronto, Ontario M2K 1E1, Canada

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Montreal, Quebec H2X 0A9, Canada

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Santiago, RM 7630372, Chile

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Providencia, Santiago Metropolitan 1234, Chile

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Santiago, Santiago Metropolitan 0, Chile

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Santiago, Santiago Metropolitan 7500653, Chile

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Viña del Mar, Valparaiso 2520598, Chile

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Beijing, Beijing Municipality 100020, China

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Beijing, Beijing Municipality 100034, China

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Beijing, Beijing Municipality 100036, China

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Beijing, Beijing Municipality 100050, China

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Beijing, Beijing Municipality 100730, China

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Beijing, Bei 100071, China

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Fuzhou, Fujian 350001, China

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Guangzhou, Guangdong 510000, China

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Baoding Shi, Hebei 071000, China

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Harbin, Heilongjiang 150081, China

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Henan Sheng, Henan 450003, China

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Zhengzhou, Henan 450003, China

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Wuhan, Hubei 430000, China

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Changsha, Hunan 410031, China

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Nanjing, Jiangsu 210000, China

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Nanjing, Jiangsu 210009, China

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Nanjing, Jiangsu 210009, China

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Nanchang, Jiangxi 330006, China

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Nanchang, Jiangxi 330029, China

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Shenyang, Liaoning 110042, China

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Jinan, Shandong 250012, China

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Shanghai, Shanghai Municipality 200032, China

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Xi'an, Shannxi 710061, China

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Hangzhou, Zhejiang 310014, China

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Brno, 656 53, Czechia

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Brno, 656 91, Czechia

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Olomouc, 779 00, Czechia

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Ostrava, 70852, Czechia

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Prague, 140 59, Czechia

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Prague, 180 81, Czechia

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Strasbourg, Alsace 67200, France

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Lille, Nord 59020, France

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Le Mans, Sarthe 72000, France

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Angers, 49055, France

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Brest, 29200, France

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Dijon, 21079, France

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Montpellier, 34070, France

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Nice, 06189, France

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Nîmes, 30029, France

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Paris, 75013, France

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Paris, 75014, France

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Paris, 75015, France

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Pierre-Bénite, 69310, France

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Reims, 51100, France

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Rennes, 35042 Rennes, France

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Strasbourg, 67000, France

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Villejuif, 94805, France

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Nürtingen, Baden-Wurttemberg 72622, Germany

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Koblenz, Rheinland Pfa 56068, Germany

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Dresden, Saxony 01307, Germany

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Bonn, 53127, Germany

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Düsseldorf, 40225, Germany

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Emmendingen, 79312, Germany

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Erlangen, 91054, Germany

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Frankfurt am Main, 60590, Germany

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Heidelberg, 69120, Germany

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München, 81675, Germany

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Münster, 48149, Germany

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Kfar Saba, 4428164, Israel

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Petah Tikva, 4941492, Israel

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Ramat Gan, 5265601, Israel

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Trento, 38122, Italy

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Nagoya, Aichi-ken 4678602, Japan

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Akita, Akita 010-8543, Japan

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Hirosaki-shi, Aomori 036-8563, Japan

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Chiba, Chiba 260-8717, Japan

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Sakura-Shi, Chiba 285-8741, Japan

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Matsuyama, Ehime 791-0280, Japan

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Fukuoka, Fukuoka 8128582, Japan

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Sapporo, Hokkaido 0608543, Japan

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Sapporo, Hokkaido 608648, Japan

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Yokohama, Kanagawa 2320024, Japan

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Kumamoto, Kumamoto 860-0008, Japan

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Kamigyō-ku, Kyoto 602-8566, Japan

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Kashihara-shi, Nara 6348522, Japan

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Osaka, Osaka 5418567, Japan

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Ōsaka-sayama, Osaka 5898511, Japan

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Hamamatsu, Shizuoka 431-3192, Japan

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Toyama, Toyama 9300194, Japan

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Ube Shi, Yamaguchi 7550046, Japan

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Nagasaki, 8528501, Japan

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Niigata, 951-8520, Japan

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Okayama, 7000914, Japan

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Osaka, 565-0871, Japan

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Tokyo, 1608582, Japan

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Wakayama, 641-8510, Japan

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Mexico City, D.F. 3100, Mexico

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Zapopan, Jalisco 45030, Mexico

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Zapopan, Jalisco 45070, Mexico

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Morelia, Michoacán 58260, Mexico

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Palmerston North, Manawatu-Wanganui 4414, New Zealand

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Hamilton, 3204, New Zealand

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Tauranga, 3112, New Zealand

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Bydgoszcz, 85-796, Poland

Local Institution - 0136

Koszalin, 75-581, Poland

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Lodz, 93-513, Poland

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Lublin, 20-090, Poland

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Poznan, 60-848, Poland

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Warsaw, 04-073, Poland

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Rio Piedras, 00935, Puerto Rico

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San Juan, 00927, Puerto Rico

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Cluj-Napoca, Cluj-Napoca 400015, Romania

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Bucharest, 022328, Romania

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Cluj-Napoca, 400015, Romania

Local Institution - 0020

Constanța, 900591, Romania

Local Institution - 0052

Craiova, 200347, Romania

Local Institution - 0035

Timișoara, 300425, Romania

SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, 163045, Russia

SAHI Republican Clinical Oncology Dispensary of MoH of RT

Kazan', 163045, Russia

Clinical Hospital MEDSI in Otradnoye

Krasnogorsk Moscow Region, 143442, Russia

Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the

Moscow, 115478, Russia

Sechenov University

Moscow, 119435, Russia

P.A. Herzen Moscow Oncology Research Institute

Moscow, 125284, Russia

FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre

Obninsk, 249036, Russia

Budgetary Healthcare Institution of Omsk Region &quot,Clinical Oncological Dispensary&quot,

Omsk, 644013, Russia

Andros Clinic LLC

Saint Petersburg, 197136, Russia

Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A.

Saint Petersburg, 197758, Russia

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Singapore, 169610, Singapore

Local Institution - 0005

Singapore, 258499, Singapore

Local Institution - 0170

Singapore, 308430, Singapore

Local Institution - 0297

Jung-gu, Daejeon 35015, South Korea

Local Institution - 0186

Songnam-si, Gyeonggi-do 13620, South Korea

Local Institution - 0391

Daegu, 42601, South Korea

Local Institution - 0298

Incheon, 405-760, South Korea

Local Institution - 0375

Jeollanam-do, 58128, South Korea

Local Institution - 0374

Seodaemun-Gu, 3722, South Korea

Local Institution - 0370

Seoul, 02841, South Korea

Local Institution - 0171

Seoul, 03080, South Korea

Local Institution - 0193

Seoul, 05505, South Korea

Local Institution - 0187

Seoul, 06351, South Korea

Local Institution - 0373

Seoul, 6591, South Korea

Local Institution - 0158

Yangsan, 50612, South Korea

Local Institution - 0141

Manresa, Barcelona 8243, Spain

Local Institution - 0073

Barcelona, 08916, Spain

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Barcelona, 8908, Spain

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Córdoba, 14004, Spain

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Girona, 17007, Spain

Local Institution - 0034

Lugo, 27003, Spain

Local Institution - 0076

Madrid, 28006, Spain

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Madrid, 28033, Spain

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Madrid, 28034, Spain

Local Institution - 0031

Madrid, 28041, Spain

Local Institution - 0364

Madrid, 28222, Spain

Local Institution - 0124

Sabadell (Barcelona), 08208, Spain

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Seville, 41013, Spain

Local Institution - 0192

Niaosng, Kaohsiung 833, Taiwan

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Taichung, 404, Taiwan

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Taichung, 40705, Taiwan

Local Institution - 0386

Tainan, 704, Taiwan

Local Institution - 0175

Taipei, 10002, Taiwan

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Taipei, 111217, Taiwan

Local Institution - 0094

Adana, 01330, Turkey (Türkiye)

Local Institution - 0119

Ankara, 06620, Turkey (Türkiye)

Local Institution - 0130

Ankara, 6100, Turkey (Türkiye)

Local Institution - 0113

Istanbul, 34098, Turkey (Türkiye)

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Izmir, 35575, Turkey (Türkiye)

Local Institution - 0112

Malatya, 44280, Turkey (Türkiye)

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London, Greater London SW3 6JJ, United Kingdom

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Manchester, Lancashire M20 4BX, United Kingdom

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Northwood, Middlesex HA6 2RN, United Kingdom

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Nottingham, Nottinghamshire NG5 1PB, United Kingdom

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Oxford, Oxfordshire OX4 6LB, United Kingdom

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Guildford, Surrey GU2 7XX, United Kingdom

Local Institution - 0154

London, NW1 2PG, United Kingdom