Spots Global Cancer Trial Database for Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
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Trial Identification
Brief Title: Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Study ID: NCT04736199
Conditions
Study Description
Brief Summary: The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Northern Cancer Institute, St Leonards, New South Wales, Australia
Macquarie University Hospital, Sydney, New South Wales, Australia
Nepean Hospital, Sydney, New South Wales, Australia
Cancer Research South Australia, South Terrace, South Australia, Australia
Peninsula Oncology Centre, Frankston, Victoria, Australia
Austin Health, Heidelberg, , Australia
Assistência Multidisciplinar em Oncologia (AMO), Salvador, Bahia, Brazil
Hosp. Araujo Jorge da Associação de Combate ao Câncer, Goiânia, Goiás, Brazil
Hospital da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
Cetus Oncologia Hospital Dia, Belo Horizonte, Minas Gerais, Brazil
Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner, Curitiba, Parana, Brazil
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica, Natal, Rio Grande Do Norte, Brazil
Unidade de Pesquisas Clinicas em Oncologia, Pelotas, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre | Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Mae de Deus, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora da Conceição, Porto Alegre, Rio Grande Do Sul, Brazil
Fundacao Pio XII Hospital de Cancer de Barretos, Barretos/SP, Sao Paulo, Brazil
Hospital de Base | Integrated Research Center, São José do Rio Preto, Sao Paulo, Brazil
Urobrasil, São Paulo, Sao Paulo, Brazil
IBCC - Instituto Brasileiro de Controle do Cancer, São Paulo, Sao Paulo, Brazil
Inst. de Assistência Médica ao Sérvidor Público Estadual, São Paulo, Sao Paulo, Brazil
Instituto COI de Educação e Pesquisa, Rio de Janeiro, , Brazil
G. Kenneth Jansz Medicine Professional Corporation, Burlington, Ontario, Canada
Centre de Recherche du CHUM, Montreal, Quebec, Canada
Centro de Investigación Clínica del Sur, Temuco, Araucanía, Chile
Centro de Estudios Clínicos SAGA SpA, Providencia, Santiago, Chile
OncoCentro, Viña del Mar, Valparaíso, Chile
Fundación Arturo López Perez, Santiago, , Chile
Oncovida, Santiago, , Chile
Hospital Clínico de la Pontificia Univ. Católica de Chile, Santiago, , Chile
UROMED, Santiago, , Chile
Anhui Provincial Hospital, Hefei City, Anhui Province, Anhui, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Guangzhou First People Hospital, Guangzhou, Guangdong, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, Guangdong, China
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech., Wuhan, Hubei, China
Zhongnan hospital ,Wuhan University, Wuhan, Hubei, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School, Nanjing, Jiangsu, China
Nantong tumor hospital, Nantong, Jiangsu, China
The 2nd Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
1st Hospital of Jilin University, Changchun, Jilin, China
Liaoning Cancer Hospital and Institute, Shengyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Yantai Yuhuangding Hospital, Yantai, Shandong, China
SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos, Chengdu, Sichuan, China
Sichuan University West China Hospital, Chengdu, Sichuan, China
The 1st Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China
ZheJiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Ningbo First Hospital, Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, , China
Peking University Third Hospital, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
Beijing Hospital, Beijing, , China
Mahatma Gandhi Cancer Hospital & Research Institute, Vishakapatnam, Andhra Pradesh, India
All India Institute of Medical Sciences, Bhubaneswar, Delhi, India
The Gujarat Cancer & Research Institute, Ahmedabad, Gujarat, India
HCG Cancer Centre - Ahmedabad, Ahmedabad, Gujarat, India
Cancer Care Clinic - Vadodara, Vadodara, Gujarat, India
K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre, Belgaum, Karnataka, India
Healthcare Global Enterprises Ltd, Bengaluru, Karnataka, India
Amrita Institute of Medical Sciences, Kochi, Kerala, India
Regional Cancer Centre - Thiruvananthapuram, Thiruvananthapuram, Kerala, India
Marathwada Regional Cancer Centre and Research Institute, Aurangabad, Maharashtra, India
Jaslok Hospital and Research Centre, Mumbai, Maharashtra, India
Curie Manavata Cancer Centre, Nashik, Maharashtra, India
Jehangir Hospital, Pune, Maharashtra, India
Sparsh Hospital & Critical Care, Bhubaneswar, Orissa, India
Jawaharlal Institute Of Postgraduate Medical Education and R, Gorimedu, Pondicherry, India
Post Graduate Institute of Medical Education and Research, Chandigarh, Punjab, India
Christian Medical Center & Hospital, Ludhiana, Punjab, India
Sawami Man Singh (SMS) Medical College & Attached Hospitals, Jaipur, Rajasthan, India
Apollo Speciality Hospitals, Madurai, Tamil N?du, India
Meenakshi Mission Hospital & Research Centre, Madurai, Tamil N?du, India
Tata Medical Center, Kolkata, , India
Apex Wellness Hospital, Nashik, , India
Rajiv Gandhi Cancer Institute & Research Centre, New Delhi, , India
Daugavpils Regional Hospital, Daugavpils, , Latvia
RAKUS Hospital Gailezers, Riga, , Latvia
URO Ltd., Riga, , Latvia
P. Stradins Clinical University Hospital, Riga, , Latvia
Vidzemes Hospital, Valmiera, , Latvia
The Hospital of Lithuanian University of Health SciencesLUHS, Kaunas, , Lithuania
PI Klaipedos University Hospital, Klaipeda, , Lithuania
National Cancer Institute, Vilnius, , Lithuania
Vilnius University Hospital Santaros Klinikos, Vilnius, , Lithuania
Canterbury Urology Research Trust, Christchurch, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Tauranga Urology Research Limited, Tauranga, , New Zealand
Aliada, San Isidro, Lima, Peru
Hospital Guillermo Almenara Irigoyen, Santiago de Surco, Lima, Peru
Hospital Militar Luis Arias Schreiber, Lima, , Peru
Clínica El Golf, Lima, , Peru
Arkhangelsk Clinical Oncology Dispensary, Arkhangelsk, , Russian Federation
Ltd "EVIMED", Chelyabinsk, , Russian Federation
Chelyabinsk Regional Oncology Dispensary, Chelyabinsk, , Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
Republican Clinical Oncology Dispensary Kazan, Kazan, , Russian Federation
Research Centre of X-ray and Radiology, Moscow, , Russian Federation
Volga District Med Center FMBA, Nizhny Novgorod, , Russian Federation
Medical Center "Avicenna", Novosibirsk, , Russian Federation
LLC Reafan, Novosibirsk, , Russian Federation
Clinical Oncological Dispensary of Omsk Region, Omsk, , Russian Federation
AV Medical Group, St. Petersburg, , Russian Federation
Russian Scientific Radiology and Surgery Technologies Center, St. Petersburg, , Russian Federation
Scientific Research Instutute of Oncology n.a. N.N. Petrov, St. Petersburg, , Russian Federation
Multi-Field Clinical Medical Center "Medical City", Tyumen, , Russian Federation
Republican Clinical Oncology Dispensary Ufa, Ufa, , Russian Federation
Vologda Regional Hospital, Vologda, , Russian Federation
Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg, , Russian Federation
Cancercare Langenhoven, Port Elizabeth, Eastern Cape, South Africa
East Rand Medical Research Unit, Johannesburg, Gauteng, South Africa
University of Pretoria, Clinical Research Unit, Pretoria, Gauteng, South Africa
Cape Town Oncology Trials, Cape Town, , South Africa
Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain
Fundación Hospital Alcorcón, Alcorcón, Madrid, Spain
Hospital Fundació Puigvert, Barcelona, , Spain
Hospital San Pedro de Alcántara, Cáceres, , Spain
Hospital Universitario Virgen de la Victoria | Cardiology Department, Málaga, , Spain
H Virgen del Rocio |Cardiology|AF|Stroke prevention, Sevilla, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Kaohsiung, Taiwan
Changhua Christian Hospital, Changhua, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA, Dnipro, , Ukraine
Kyiv City Hospital #3, Kyiv, , Ukraine
Kyiv Regional Oncological Dispensary, Kyiv, , Ukraine
CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council", Zaporizhia, , Ukraine
Contact Details
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