Trial Condition(s):

Prostatic Neoplasms

Darolutamide in addition to ADT versus ADT in metastatic hormone-sensitive prostate cancer (ARANOTE)

Bayer Identifier:

21140

ClinicalTrials.gov Identifier:

NCT04736199

EudraCT Number:

2020-003093-48

EU CT Number:

Not Available

Recruitment Complete

Trial Purpose

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.

Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of prostate
- Metastatic disease 
- Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti–androgen, but not earlier than 12 weeks before randomization
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
- Adequate bone marrow, liver and renal function
Exclusion Criteria
- Prior treatment with: LHRH agonist/antagonists except neoadjuvant and /or adjuvant therapy; Second–generation androgen receptor (AR) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational AR inhibitors; Cytochrome P17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as anti-cancer treatment for prostate cancer; Chemotherapy including docetaxel or immunotherapy for prostate cancer; Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization; Radiopharmaceuticals; Any other anti-cancer treatment for prostate cancer, excluding local therapies and
ADT.
- Treatment with radiotherapy within 2 weeks before randomization
- Contraindication to iodinated CT and gadolinium chelate MRI intravenous contrast agent(s)
- Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
- Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
- A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
- Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization 
- Inability to swallow oral medications

Trial Summary

Enrollment Goal
662
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Darolutamide+ADT (BAY1841788)
Accepts Healthy Volunteers
No

Where to Participate

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Hospital San Pedro de Alcántara

Cáceres, Spain, 10003

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Corporació Sanitària Parc Taulí

Sabadell, Spain, 08208

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Hospital Fundació Puigvert

Barcelona, Spain, 08025

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Hospital Universitario Virgen de la Victoria | Cardiology Department

Málaga, Spain, 29010

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Fundación Hospital Alcorcón

Alcorcón, Spain, 28922

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H Virgen del Rocio |Cardiology|AF|Stroke prevention

Sevilla, Spain, 41013

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Canterbury Urology Research Trust

Christchurch, New Zealand, 8013

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Tauranga Urology Research Limited

Tauranga, New Zealand, 3112

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Urology Waikato

Hamilton, New Zealand, 3214

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Waikato Hospital

Hamilton, New Zealand, 3200

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Cape Town Oncology Trials

Cape Town, South Africa, 7570

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Cancercare Langenhoven

Port Elizabeth, South Africa, 6045

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University of Pretoria, Clinical Research Unit

Pretoria, South Africa, 0002

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East Rand Medical Research Unit

Johannesburg, South Africa, 1475

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Anhui Provincial Hospital

Hefei City, Anhui Province, China, 230031

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Beijing Hospital

Beijing, China, 100730

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Guangzhou First People Hospital

Guangzhou, China, 510180

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NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

Nanjing, China, 210008

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Peking University Third Hospital

Beijing, China, 100083

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Liaoning Cancer Hospital and Institute

Shengyang, China, 110042

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Sun Yat-sen University Cancer Center

Guangzhou, China, 510060

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Hunan Cancer Hospital

Changsha, China, 410013

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Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

Wuhan, China, 430030

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The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China, 325000

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Zhongnan hospital of Wuhan University

Wuhan, China, 430071

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Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100021

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Beijing Cancer Hospital

Beijing, China, 100142

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The 1st Affiliated Hospital of Zhejiang University

Hangzhou, China, 310000

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The 2nd Affiliated Hospital of Soochow University

Suzhou, China, 215004

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SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos

Chengdu, China, 610072

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Yantai Yuhuangding Hospital

Yantai, China, 264000

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1st Hospital of Jilin University

Changchun, China, 130021

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ZheJiang Provincial People's Hospital

Hangzhou, China, 310014

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The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China, 710061

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Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen

Shenzhen, China, 518117

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Hubei Cancer Hospital

Wuhan, China, 430079

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Sichuan University West China Hospital

Chengdu, China

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Ningbo First Hospital

Ningbo, China, 315010

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Nantong tumor hospital

Nantong, China, 226361

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G. Kenneth Jansz Medicine Professional Corporation

Burlington, Canada, L7N 3V2

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Centre de Recherche du CHUM

Montreal, Canada, H2X 0A9

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Peninsula Oncology Centre

Frankston, Australia, 3199

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Nepean Hospital

Sydney, Australia, 2751

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Austin Health

Heidelberg, Australia

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Northern Cancer Institute

St Leonards, Australia, 2065

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Hospital Clínico de la Pontificia Univ. Católica de Chile

Santiago, Chile, 8330024

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Centro de Investigación Clínica del Sur

Temuco, Chile, 4781156

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UROMED

Santiago, Chile

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Fundación Arturo López Perez

Santiago, Chile, 7500921

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OncoCentro

Viña del Mar, Chile, 2520598

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Hospital Mae de Deus

Porto Alegre, Brazil, 90880-480

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IBCC - Instituto Brasileiro de Controle do Cancer

São Paulo, Brazil, 03102-002

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Hosp. Araujo Jorge da Associação de Combate ao Câncer

Goiânia, Brazil, 74605-070

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Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

Natal, Brazil, 59040-000

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Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

Curitiba, Brazil, 81520-060

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Inst. de Assistência Médica ao Sérvidor Público Estadual

São Paulo, Brazil, 04039-004

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Hospital de Base | Integrated Research Center

São José do Rio Preto, Brazil, 15090-000

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Instituto COI de Educação e Pesquisa

Rio de Janeiro, Brazil, 22793-080

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Hospital Nossa Senhora da Conceição

Porto Alegre, Brazil, 91350-200

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Hospital da Universidade Federal de Minas Gerais

Belo Horizonte, Brazil, 30130-100

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Urobrasil

São Paulo, Brazil, 01243-020

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Cetus Oncologia Hospital Dia

Belo Horizonte, Brazil, 30150-270

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Chelyabinsk Regional Oncology Dispensary

Chelyabinsk, Russia, 454087

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Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, Russia, 620102

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Clinical Oncological Dispensary of Omsk Region

Omsk, Russia, 644013

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Republican Clinical Oncology Dispensary Ufa

Ufa, Russia, 450054

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AV Medical Group

St. Petersburg, Russia, 196006

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Russian Scientific Radiology and Surgery Technologies Center

St. Petersburg, Russia, 197758

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Volga District Med Center FMBA

Nizhny Novgorod, Russia, 603109

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GBUZ RM "Republican Oncology Dispensary"

Saransk, Russia, 430032

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Arkhangelsk Clinical Oncology Dispensary

Arkhangelsk, Russia, 163045

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LLC Reafan

Novosibirsk, Russia, 630099

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Multi-Field Clinical Medical Center "Medical City"

Tyumen, Russia, 625041

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Vologda Regional Hospital

Vologda, Russia, 160022

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Ivanovo Regional Oncology Dispensary

Ivanovo, Russia, 153040

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Republican Clinical Oncology Dispensary Kazan

Kazan, Russia, 420029

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Ltd "EVIMED"

Chelyabinsk, Russia, 454048

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Medical Center "Avicenna"

Novosibirsk, Russia, 630007

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Research Centre of X-ray and Radiology

Moscow, Russia, 117997

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City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA

Dnipro, Ukraine, 49102

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Kyiv City Hospital #3

Kyiv, Ukraine, 02660

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Kyiv Regional Oncological Dispensary

Kyiv, Ukraine, 04107

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CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"

Zaporizhia, Ukraine, 69600

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The Hospital of Lithuanian University of Health SciencesLUHS

Kaunas, Lithuania, LT-50009

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National Cancer Institute

Vilnius, Lithuania, LT-08660

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PI Klaipedos University Hospital

Klaipeda, Lithuania, LT-92288

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Taipei Veterans General Hospital

Taipei, Taiwan, China, 11217

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, China, 807377

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Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

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Changhua Christian Hospital

Changhua, Taiwan, China, 50006

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Aliada

San Isidro, Peru, 15036

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Hospital Guillermo Almenara Irigoyen

La Victoria, Peru, 15033

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Hospital Militar Luis Arias Schreiber

Lima, Peru, LIMA 11

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Clínica El Golf

Lima, Peru, LIMA 27

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Daugavpils Regional Hospital

Daugavpils, Latvia, LV-5417

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URO Ltd.

Riga, Latvia, LV-1001

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Vidzemes Hospital

Valmiera, Latvia, LV-4201

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P. Stradins Clinical University Hospital

Riga, Latvia, LV-1002

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RAKUS Hospital Gailezers

Riga, Latvia, 1038

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Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90020-090

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Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania, LT-08661

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SMS Medical College & Attached Hospitals

Jaipur, India, 302004

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Sparsh Hospital & Critical Care

Bhubaneswar, India, 751007

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Tata Medical Center

Kolkata, India, 700156

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Regional Cancer Centre - Thiruvananthapuram

Thiruvananthapuram, India, 695011

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HCG Cancer Centre - Ahmedabad

Ahmedabad, India, 380060

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Healthcare Global Enterprises Ltd

Bengaluru, India, 560027

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Curie Manavata Cancer Centre

Nashik, India, 422004

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Christian Medical Center & Hospital

Ludhiana, India, 141008

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Rajiv Gandhi Cancer Institute & Research Centre

New Delhi, India, 110 085

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Cancer Care Clinic - Vadodara

Vadodara, India, 390007

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All India Institute of Medical Sciences

Bhubaneswar, India, 751019

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Jehangir Hospital

Pune, India, 411001

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Macquarie University Hospital

Sydney, Australia, 2109

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Cancer Research South Australia

South Terrace, Australia, 5000

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Fundacao Pio XII – Hospital de Cancer de Barretos

Barretos/SP, Brazil, 14784-400

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Unidade de Pesquisas Clinicas em Oncologia

Pelotas, Brazil, 96020-080

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Assistência Multidisciplinar em Oncologia (AMO)

Salvador, Brazil, 41950-610

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Mahatma Gandhi Cancer Hospital & Research Institute

Vishakapatnam, India, 530017

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Centro de Estudios Clínicos SAGA SpA

Providencia, Chile

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Oncovida

Santiago, Chile, 7510032

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Meenakshi Mission Hospital & Research Centre

Madurai, India, 625107

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KLES Dr. Prabhakar Kore Hospital & Medical Research Centre

Belagavi, India, 590010

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National Cheng Kung University Hospital

Tainan, Taiwan, China, 704

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Scientific Research Instutute of Oncology n.a. N.N. Petrov

St. Petersburg, Russia, 197758

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Jaslok Hospital and Research Centre

Mumbai, India, 400 026

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Amrita Institute of Medical Sciences

Kochi, India, 682026

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The Gujarat Cancer & Research Institute

Ahmedabad, India, 380016

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Apollo Specialty Hospital- Teynampet

Chennai, India, 600035

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Post Graduate Institute of Medical Education and Research

Chandigarh, India, 160012

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Jawaharlal Institute Of Postgraduate Medical Education and R

Gorimedu, India, 605006

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Marathwada Regional Cancer Centre and Research Institute

Aurangabad, India, 431001

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Apex Wellness Hospital

Nashik, India, 422009

Trial Design