Spots Global Cancer Trial Database for Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
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Trial Identification
Brief Title: Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
Official Title: A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN Deficiency.
Study ID: NCT04493853
Conditions
Study Description
Brief Summary: This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Research Site, Tucson, Arizona, United States
Research Site, Tucson, Arizona, United States
Research Site, La Jolla, California, United States
Research Site, Orange, California, United States
Research Site, San Diego, California, United States
Research Site, Denver, Colorado, United States
Research Site, Lakewood, Colorado, United States
Research Site, Norwich, Connecticut, United States
Research Site, Fort Myers, Florida, United States
Research Site, West Palm Beach, Florida, United States
Research Site, Chicago, Illinois, United States
Research Site, Geneva, Illinois, United States
Research Site, Lisle, Illinois, United States
Research Site, Baltimore, Maryland, United States
Research Site, Detroit, Michigan, United States
Research Site, Grand Rapids, Michigan, United States
Research Site, Troy, Michigan, United States
Research Site, Bronx, New York, United States
Research Site, Syracuse, New York, United States
Research Site, Asheville, North Carolina, United States
Research Site, Durham, North Carolina, United States
Research Site, Columbus, Ohio, United States
Research Site, Lancaster, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Charleston, South Carolina, United States
Research Site, Myrtle Beach, South Carolina, United States
Research Site, Chattanooga, Tennessee, United States
Research Site, Houston, Texas, United States
Research Site, Norfolk, Virginia, United States
Research Site, Roanoke, Virginia, United States
Research Site, Seattle, Washington, United States
Research Site, Madison, Wisconsin, United States
Research Site, Berazategui, , Argentina
Research Site, Buenos Aires, , Argentina
Research Site, Buenos Aires, , Argentina
Research Site, Caba, , Argentina
Research Site, Caba, , Argentina
Research Site, Caba, , Argentina
Research Site, La Plata, , Argentina
Research Site, Mendoza, , Argentina
Research Site, Rosario, , Argentina
Research Site, San Salvador de Jujuy, , Argentina
Research Site, Birtinya, , Australia
Research Site, Darlinghurst, , Australia
Research Site, Kingswood, , Australia
Research Site, Orange, , Australia
Research Site, South Brisbane, , Australia
Research Site, Graz, , Austria
Research Site, Linz, , Austria
Research Site, Salzburg, , Austria
Research Site, Anderlecht, , Belgium
Research Site, Gent, , Belgium
Research Site, Kortrijk, , Belgium
Research Site, Liège, , Belgium
Research Site, Belem, , Brazil
Research Site, Belo Horizonte, , Brazil
Research Site, Florianópolis, , Brazil
Research Site, Fortaleza, , Brazil
Research Site, Jaú, , Brazil
Research Site, Joinville, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Ribeirão Preto, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Santa Maria, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São José do Rio Preto, , Brazil
Research Site, Tres Lagoas, , Brazil
Research Site, Pleven, , Bulgaria
Research Site, Plovdiv, , Bulgaria
Research Site, Plovdiv, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Varna, , Bulgaria
Research Site, Calgary, Alberta, Canada
Research Site, Edmonton, Alberta, Canada
Research Site, Kelowna, British Columbia, Canada
Research Site, Vancouver, British Columbia, Canada
Research Site, Toronto, CA, Canada
Research Site, Brampton, Ontario, Canada
Research Site, Oshawa, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, , Canada
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Temuco, , Chile
Research Site, Viña del Mar, , Chile
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Chengdu, , China
Research Site, Chongqing, , China
Research Site, Chongqing, , China
Research Site, Fuzhou, , China
Research Site, Fuzhou, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Guiyang, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Kunming, , China
Research Site, Nanchang, , China
Research Site, Nanjing, , China
Research Site, Nanjing, , China
Research Site, Nantong, , China
Research Site, Ningbo, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shanghai, , China
Research Site, Shengyang, , China
Research Site, Tianjin, , China
Research Site, Wenzhou, , China
Research Site, Wuhan, , China
Research Site, Xi'an, , China
Research Site, Yantai, , China
Research Site, Zhengzhou City, , China
Research Site, Zhengzhou, , China
Research Site, Brno, , Czechia
Research Site, Horovice, , Czechia
Research Site, Hradec Kralove, , Czechia
Research Site, Praha 10, , Czechia
Research Site, Praha 8, , Czechia
Research Site, Praha, , Czechia
Research Site, Besançon Cedex, , France
Research Site, Bordeaux, , France
Research Site, Marseille, , France
Research Site, Montpellier, , France
Research Site, Nice, , France
Research Site, Paris Cedex 14, , France
Research Site, Pierre Benite, , France
Research Site, Quimper Cedex, , France
Research Site, Rennes Cedex 9, , France
Research Site, Strasbourg, , France
Research Site, Suresnes Cedex, , France
Research Site, Villejuif Cedex, , France
Research Site, Berlin, , Germany
Research Site, Duisburg, , Germany
Research Site, Hamburg, , Germany
Research Site, Herne, , Germany
Research Site, Mettmann, , Germany
Research Site, Münster, , Germany
Research Site, Nürnberg, , Germany
Research Site, Nürtingen, , Germany
Research Site, Wesel, , Germany
Research Site, Hong Kong, , Hong Kong
Research Site, HongKong, , Hong Kong
Research Site, Lai Chi Kok, , Hong Kong
Research Site, Ahmedabad, , India
Research Site, Bangalore, , India
Research Site, Bangalore, , India
Research Site, Delhi, , India
Research Site, Faridabad, , India
Research Site, Kanpur, , India
Research Site, Kolkata, , India
Research Site, Madurai, , India
Research Site, Manipal, , India
Research Site, Meerut, , India
Research Site, Mohali, , India
Research Site, Nagpur, , India
Research Site, New Delhi, , India
Research Site, New Delhi, , India
Research Site, Thiruvananthapuram, , India
Research Site, Varanasi, , India
Research Site, Haifa, , Israel
Research Site, Jerusalem, , Israel
Research Site, Kfar Saba, , Israel
Research Site, Petach-Tikva, , Israel
Research Site, Ramat Gan, , Israel
Research Site, Zerifin, , Israel
Research Site, Bunkyo-ku, , Japan
Research Site, Chiba-shi, , Japan
Research Site, Chuo-ku, , Japan
Research Site, Fukuoka, , Japan
Research Site, Hamamatsu-shi, , Japan
Research Site, Hirakata-shi, , Japan
Research Site, Hirosaki-shi, , Japan
Research Site, Isehara-shi, , Japan
Research Site, Kanazawa-shi, , Japan
Research Site, Kashihara-shi, , Japan
Research Site, Kawagoe-shi, , Japan
Research Site, Kisarazu-shi, , Japan
Research Site, Kita-gun, , Japan
Research Site, Kobe-shi, , Japan
Research Site, Kumamoto-shi, , Japan
Research Site, Kyoto-shi, , Japan
Research Site, Miyazaki-city, , Japan
Research Site, Morioka-shi, , Japan
Research Site, Nagano-shi,, , Japan
Research Site, Nagasaki-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Natori-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Osakasayama-shi, , Japan
Research Site, Ota Shi, , Japan
Research Site, Sagamihara-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Shinjuku-ku, , Japan
Research Site, Toon-shi, , Japan
Research Site, Tsu-shi, , Japan
Research Site, Ube-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Yokosuka-shi, , Japan
Research Site, Yufu-shi, , Japan
Research Site, Daegu, , Korea, Republic of
Research Site, Goyang-si, , Korea, Republic of
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Culiacan, , Mexico
Research Site, Culiacan, , Mexico
Research Site, Guadalajara, , Mexico
Research Site, Mexico City, , Mexico
Research Site, Monterrey, , Mexico
Research Site, Nuevo Leon, , Mexico
Research Site, Amsterdam, , Netherlands
Research Site, Den Haag, , Netherlands
Research Site, Hilversum, , Netherlands
Research Site, Roosendaal, , Netherlands
Research Site, Tilburg, , Netherlands
Research Site, Utrecht, , Netherlands
Research Site, Callao, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, San Isidro, , Peru
Research Site, Baguio City, , Philippines
Research Site, Cebu City, , Philippines
Research Site, Davao City, , Philippines
Research Site, Iloilo City, , Philippines
Research Site, Quezon City, , Philippines
Research Site, Quezon City, , Philippines
Research Site, San Juan, , Philippines
Research Site, Bydgoszcz, , Poland
Research Site, Gdańsk, , Poland
Research Site, Koszalin, , Poland
Research Site, Olsztyn, , Poland
Research Site, Poznań, , Poland
Research Site, Rzeszow, , Poland
Research Site, Toruń, , Poland
Research Site, Warszawa, , Poland
Research Site, Warszawa, , Poland
Research Site, Łódź, , Poland
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Novisibirsk, , Russian Federation
Research Site, Novosibirsk, , Russian Federation
Research Site, Saint-Petersburg, , Russian Federation
Research Site, St.Petersburg, , Russian Federation
Research Site, Yaroslavl, , Russian Federation
Research Site, Bratislava, , Slovakia
Research Site, Bratislava, , Slovakia
Research Site, Martin, , Slovakia
Research Site, Nitra, , Slovakia
Research Site, Presov, , Slovakia
Research Site, Sala, , Slovakia
Research Site, Trenčín, , Slovakia
Research Site, Johannesburg, , South Africa
Research Site, Johannesburg, , South Africa
Research Site, Kraaifontein, , South Africa
Research Site, Parow, , South Africa
Research Site, Port Elizabeth, , South Africa
Research Site, Pretoria, , South Africa
Research Site, Badalona (Barcelona), , Spain
Research Site, Barcelona, , Spain
Research Site, Las Palmas de Gran Canaria, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Oviedo, , Spain
Research Site, Santander, , Spain
Research Site, Sevilla, , Spain
Research Site, Kaohsiung, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan City, , Taiwan
Research Site, Bangkok, , Thailand
Research Site, Bangkok, , Thailand
Research Site, Bangkok, , Thailand
Research Site, Chiang Mai, , Thailand
Research Site, Hat Yai, , Thailand
Research Site, Lampang, , Thailand
Research Site, Muang, , Thailand
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Antalya, , Turkey
Research Site, Eskisehir, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Izmir, , Turkey
Research Site, Izmir, , Turkey
Research Site, Kayseri, , Turkey
Research Site, Cambridge, , United Kingdom
Research Site, Guildford, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Plymouth, , United Kingdom
Research Site, Sutton, , United Kingdom
Research Site, Whitchurch, , United Kingdom
Research Site, Ha Noi, , Vietnam
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Contact Details
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