RecruitingPhase 3NCT06952803

A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation

A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients With BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy (EvoPAR-Prostate02).


Sponsor

AstraZeneca

Enrollment

700 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival in participants with high-risk and very high-risk localised/locally advanced prostate cancer with a breast cancer gene mutation (BRCAm).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a drug called saruparib (a type of PARP inhibitor) to standard hormone therapy can help men with high-risk prostate cancer stay cancer-free for longer. It targets men whose prostate cancer carries a specific inherited gene mutation (BRCA1 or BRCA2), which makes them more likely to respond to this type of drug. **You may be eligible if...** - You are a man with high-risk or locally advanced prostate cancer, or you had your prostate removed and your PSA levels are rising again - You carry a BRCA1 or BRCA2 gene mutation confirmed by tumor testing - You have already completed radiation therapy and hormone therapy (with a GnRH analogue) - Scans show no cancer spread outside the pelvis - You are in reasonably good health (able to carry out everyday activities) **You may NOT be eligible if...** - You have a history of certain blood cancers (MDS or AML) - You have had a stroke, active stomach ulcers, or serious bleeding problems within the past 6 months - You have previously received chemotherapy or a PARP inhibitor for prostate cancer - You have uncontrolled hepatitis B, hepatitis C, or HIV - You have severe heart conditions or uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSaruparib

Saruparib will be administered orally.

DRUGPlacebo

Matching placebo to saruparib will be administered orally.

DRUGAbiraterone + Prednisolone/Prednisone

Abiraterone will be administered orally in combination with prednisone/prednisolone.

DRUGAndrogen Deprivation Therapy (ADT)

Standard of care ADT will be administered.


Locations(329)

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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La Jolla, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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San Luis Obispo, California, United States

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Lakewood, Colorado, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Tampa, Florida, United States

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Newnan, Georgia, United States

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Chicago, Illinois, United States

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Chicago Ridge, Illinois, United States

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Greenwood, Indiana, United States

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Jeffersonville, Indiana, United States

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Bethesda, Maryland, United States

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Towson, Maryland, United States

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Plymouth, Massachusetts, United States

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Rochester, Minnesota, United States

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Hackensack, New Jersey, United States

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Voorhees Township, New Jersey, United States

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New York, New York, United States

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Syracuse, New York, United States

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Columbus, Ohio, United States

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Springfield, Oregon, United States

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Hershey, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Myrtle Beach, South Carolina, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Spring, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Roanoke, Virginia, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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CABA, Argentina

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CABA, Argentina

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Ciudad de Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Córdoba, Argentina

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Córdoba, Argentina

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Cuidad Autónoma de Buenos Aire, Argentina

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La Plata, Argentina

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Pergamino, Argentina

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Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Viedma, Argentina

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Kingswood, Australia

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Murdoch, Australia

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Orange, Australia

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South Brisbane, Australia

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St Leonards, Australia

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Waratah, Australia

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Woolloongabba, Australia

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Graz, Austria

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Innsbruck, Austria

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Linz, Austria

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Vienna, Austria

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Vienna, Austria

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Brussels, Belgium

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Brussels, Belgium

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Jette, Belgium

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Kortrijk, Belgium

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Libramont-Chevigny, Belgium

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Roeselare, Belgium

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Wilrijk, Belgium

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Cachoeiro de Itapemirim, Brazil

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Curitiba, Brazil

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Curitiba, Brazil

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Jaú, Brazil

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Londrina, Brazil

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Pelotas, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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Rio de Janeiro, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Abbotsford British Columbia, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Barrie, Ontario, Canada

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Brampton, Ontario, Canada

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London, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Toronto, Canada

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Concepción, Chile

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Temuco, Chile

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Beijing, China

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Beijing, China

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Beijing, China

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Changchun, China

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Changsha, China

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Chongqing, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Hangzhou, China

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Hangzhou, China

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Jinan, China

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Jinhua, China

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Lanzhou, China

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Nanchang, China

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Ningbo, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Shenyang, China

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Sichuan, China

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Suining, China

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Tianjin, China

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Wuhan, China

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Wuhan, China

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Wuhu, China

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Xiamen, China

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Yangzhou, China

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Zhuhai, China

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Helsinki, Finland

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Helsinki, Finland

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Kuopio, Finland

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Oulu, Finland

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Tampere, Finland

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Turku, Finland

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Angers, France

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Bordeaux, France

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Caen, France

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Clermont-Ferrand, France

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Le Mans, France

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Marseille, France

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Montpellier, France

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Montpellier, France

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Nice, France

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Nîmes, France

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Paris, France

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Paris, France

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Paris, France

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Pierre-Bénite, France

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Rennes, France

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Saint-Herblain, France

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Saint-Priest-en-Jarez, France

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Strasbourg, France

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Suresnes, France

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Tours, France

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Vandœuvre-lès-Nancy, France

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Villejuif, France

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Augsburg, Germany

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Berlin, Germany

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Braunschweig, Germany

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Cologne, Germany

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Dresden, Germany

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Duisburg, Germany

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Düsseldorf, Germany

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Essen, Germany

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Giessen, Germany

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Göttingen, Germany

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Hamburg, Germany

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Herne, Germany

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Kiel, Germany

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Lübeck, Germany

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Marburg, Germany

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Münster, Germany

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Nuremberg, Germany

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Nürtingen, Germany

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Regensburg, Germany

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Schwerin, Germany

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Trier, Germany

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Ulm, Germany

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Würzburg, Germany

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Debrecen, Hungary

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Győr, Hungary

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Gyula, Hungary

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Zalaegerszeg, Hungary

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Ansārinagar, India

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Babgalore, India

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Delhi, India

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Hyderabad, India

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Kannur, India

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Kanpur, India

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Mumbai, India

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Nagpur, India

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Varanasi, India

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Afula, Israel

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Beersheba, Israel

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Haifa, Israel

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Jerusalem, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Arezzo, Italy

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Bari, Italy

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Bergamo, Italy

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Bergamo, Italy

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Chieti, Italy

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Genoa, Italy

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Milan, Italy

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Milan, Italy

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Milan, Italy

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Naples, Italy

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Palermo, Italy

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Pisa, Italy

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Roma, Italy

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Roma, Italy

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Rozzano, Italy

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Torino, Italy

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Varese, Italy

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Verona, Italy

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Bunkyō City, Japan

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Fukuoka, Japan

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Kamakura-shi, Japan

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Kawagoe-shi, Japan

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Kawasaki-shi, Japan

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Kisarazu-shi, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Maebashi, Japan

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Miyazaki, Japan

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Ōta-ku, Japan

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Sagamihara-shi, Japan

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Shimotsuke-shi, Japan

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Yokohama, Japan

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Yokohama, Japan

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Batu Caves, Malaysia

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Kuala Lumpur, Malaysia

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Kuala Selangor, Malaysia

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Pulau Pinang, Malaysia

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Hilversum, Netherlands

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Hoofddorp, Netherlands

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Maastricht, Netherlands

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Nijmegen, Netherlands

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Roosendaal, Netherlands

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Trujillo, Peru

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Gdynia, Poland

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Gliwice, Poland

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Koszalin, Poland

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Krakow, Poland

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Piotrkow Trybunalski, Poland

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Poznan, Poland

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Rzeszów, Poland

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Warsaw, Poland

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Busan, South Korea

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Daegu, South Korea

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Goyang-si, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Barcelona, Spain

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Girona, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Majadahonda, Spain

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Málaga, Spain

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Málaga, Spain

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Oviedo, Spain

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Sabadell, Spain

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Santander, Spain

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Valencia, Spain

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Valencia, Spain

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Gothenburg, Sweden

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Malmö, Sweden

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Stockholm, Sweden

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Stockholm, Sweden

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Umeå, Sweden

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Uppsala, Sweden

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Khon Kaen, Thailand

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Muang, Thailand

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Pathum Thani, Thailand

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Songkhla, Thailand

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Cordaleo, Turkey (Türkiye)

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Diyarbakır, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Sakarya, Turkey (Türkiye)

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Şahinbey, Turkey (Türkiye)

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Aberdeen, United Kingdom

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Bristol, United Kingdom

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Cambridge, United Kingdom

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Edinburgh, United Kingdom

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Exeter, United Kingdom

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Glasgow, United Kingdom

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Greater London, United Kingdom

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Guildford, United Kingdom

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London, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Newcastle, United Kingdom

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Plymouth, United Kingdom

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Preston, United Kingdom

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Romford, United Kingdom

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NCT06952803


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