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

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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Locations
Status
LocationsStatus
Locations

Hospital San Pedro de Alcántara

Cáceres, Spain, 10003

Status
Active, not recruiting
 
Locations

Corporació Sanitària Parc Taulí

Sabadell, Spain, 08208

Status
Completed
 
Locations

Hospital Fundació Puigvert

Barcelona, Spain, 08025

Status
Completed
 
Locations

Hospital Virgen de la Victoria

Málaga, Spain, 29010

Status
Active, not recruiting
 
Locations

Fundación Hospital Alcorcón

Alcorcón, Spain, 28922

Status
Active, not recruiting
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Completed
 
Locations

Canterbury Urology Research Trust

Christchurch, New Zealand, 8013

Status
Active, not recruiting
 
Locations

Tauranga Urology Research Limited

Tauranga, New Zealand, 3112

Status
Active, not recruiting
 
Locations

Urology Waikato

Hamilton, New Zealand, 3214

Status
Active, not recruiting
 
Locations

Waikato Hospital

Hamilton, New Zealand, 3200

Status
Active, not recruiting
 
Locations

Cape Town Oncology Trials

Cape Town, South Africa, 7570

Status
Active, not recruiting
 
Locations

Cancercare Langenhoven

Port Elizabeth, South Africa, 6045

Status
Active, not recruiting
 
Locations

University of Pretoria, Clinical Research Unit

Pretoria, South Africa, 0002

Status
Active, not recruiting
 
Locations

East Rand Medical Research Unit

Johannesburg, South Africa, 1475

Status
Not yet recruiting
 
Locations

Anhui Provincial Hospital

Hefei, China, 230001

Status
Active, not recruiting
 
Locations

Beijing Hospital

Beijing, China, 100730

Status
Active, not recruiting
 
Locations

Guangzhou First People's Hospital

Guangzhou, China, 510180

Status
Active, not recruiting
 
Locations

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

Nanjing, China, 210008

Status
Active, not recruiting
 
Locations

Peking University Third Hospital

Beijing, China, 100083

Status
Active, not recruiting
 
Locations

Liaoning Cancer Hospital and Institute

Shengyang, China, 110042

Status
Active, not recruiting
 
Locations

Sun Yat-sen University Cancer Center

Guangzhou, China, 510060

Status
Active, not recruiting
 
Locations

Hunan Cancer Hospital

Changsha, China, 410013

Status
Active, not recruiting
 
Locations

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

Wuhan, China, 430030

Status
Active, not recruiting
 
Locations

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China, 325000

Status
Active, not recruiting
 
Locations

Zhongnan hospital of Wuhan University

Wuhan, China, 430071

Status
Active, not recruiting
 
Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100021

Status
Active, not recruiting
 
Locations

Beijing Cancer Hospital

Beijing, China, 100142

Status
Not yet recruiting
 
Locations

The 1st Affiliated Hospital of Zhejiang University

Hangzhou, China, 310003

Status
Active, not recruiting
 
Locations

The 2nd Affiliated Hospital of Soochow University

Suzhou, China, 215004

Status
Active, not recruiting
 
Locations

SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos

Chengdu, China, 610072

Status
Active, not recruiting
 
Locations

Yantai Yuhuangding Hospital

Yantai, China, 264000

Status
Active, not recruiting
 
Locations

1st Hospital of Jilin University

Changchun, China, 130021

Status
Active, not recruiting
 
Locations

ZheJiang Provincial People's Hospital

Hangzhou, China, 310014

Status
Active, not recruiting
 
Locations

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China, 710061

Status
Active, not recruiting
 
Locations

Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen

Shenzhen, China, 518117

Status
Active, not recruiting
 
Locations

Hubei Cancer Hospital

Wuhan, China, 430079

Status
Active, not recruiting
 
Locations

Sichuan University West China Hospital

Chengdu, China

Status
Active, not recruiting
 
Locations

Ningbo First Hospital

Ningbo, China, 315010

Status
Active, not recruiting
 
Locations

Nantong tumor hospital

Nantong, China, 226361

Status
Active, not recruiting
 
Locations

G. Kenneth Jansz Medicine Professional Corporation

Burlington, Canada, L7N 3V2

Status
Completed
 
Locations

Centre de Recherche du CHUM

Montreal, Canada, H2X 0A9

Status
Active, not recruiting
 
Locations

Peninsula Oncology Centre

Frankston, Australia, 3199

Status
Active, not recruiting
 
Locations

Nepean Hospital

Sydney, Australia, 2751

Status
Active, not recruiting
 
Locations

Austin Health

Heidelberg, Australia

Status
Active, not recruiting
 
Locations

Northern Cancer Institute

St Leonards, Australia, 2065

Status
Active, not recruiting
 
Locations

Hospital Clínico de la Pontificia Univ. Católica de Chile

Santiago, Chile, 8330024

Status
Active, not recruiting
 
Locations

Centro de Investigación Clínica del Sur

Temuco, Chile, 4781156

Status
Active, not recruiting
 
Locations

UROMED

Santiago, Chile

Status
Active, not recruiting
 
Locations

Fundación Arturo López Perez

Santiago, Chile, 7500921

Status
Active, not recruiting
 
Locations

OncoCentro

Viña del Mar, Chile, 2520598

Status
Active, not recruiting
 
Locations

Hospital Mae de Deus

Porto Alegre, Brazil, 90880-480

Status
Active, not recruiting
 
Locations

IBCC - Instituto Brasileiro de Controle do Cancer

São Paulo, Brazil, 04014-002

Status
Active, not recruiting
 
Locations

Hosp. Araujo Jorge da Associação de Combate ao Câncer

Goiânia, Brazil, 74605-070

Status
Active, not recruiting
 
Locations

Liga Norte Riograndense Contra o Câncer

Natal, Brazil, 59075-740

Status
Active, not recruiting
 
Locations

Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

Curitiba, Brazil, 81520-060

Status
Active, not recruiting
 
Locations

Inst. de Assistência Médica ao Sérvidor Público Estadual

São Paulo, Brazil, 04039-004

Status
Active, not recruiting
 
Locations

Hospital de Base da Fundação F M S J Rio Preto

São José do Rio Preto, Brazil, 15090-000

Status
Active, not recruiting
 
Locations

Instituto COI de Educação e Pesquisa

Rio de Janeiro, Brazil, 22793-080

Status
Active, not recruiting
 
Locations

Hospital Nossa Senhora da Conceição

Porto Alegre, Brazil, 91350-200

Status
Active, not recruiting
 
Locations

Hospital da Universidade Federal de Minas Gerais

Belo Horizonte, Brazil, 30130-100

Status
Active, not recruiting
 
Locations

Urobrasil

São Paulo, Brazil, 01243-020

Status
Active, not recruiting
 
Locations

Cetus Oncologia Hospital Dia

Belo Horizonte, Brazil, 30150-270

Status
Active, not recruiting
 
Locations

Chelyabinsk Regional Oncology Dispensary

Chelyabinsk, Russia, 454087

Status
Active, not recruiting
 
Locations

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, Russia, 620102

Status
Active, not recruiting
 
Locations

Clinical Oncological Dispensary of Omsk Region

Omsk, Russia, 644013

Status
Active, not recruiting
 
Locations

Republican Clinical Oncology Dispensary Ufa

Ufa, Russia, 450054

Status
Active, not recruiting
 
Locations

AV Medical Group

St. Petersburg, Russia, 197082

Status
Active, not recruiting
 
Locations

Russian Scientific Radiology and Surgery Technologies Center

St. Petersburg, Russia, 197758

Status
Active, not recruiting
 
Locations

Volga District Med Center FMBA

Nizhny Novgorod, Russia, 603109

Status
Active, not recruiting
 
Locations

GBUZ RM "Republican Oncology Dispensary"

Saransk, Russia, 430032

Status
Active, not recruiting
 
Locations

Arkhangelsk Clinical Oncology Dispensary

Arkhangelsk, Russia, 163045

Status
Active, not recruiting
 
Locations

LLC Reafan

Novosibirsk, Russia, 630099

Status
Active, not recruiting
 
Locations

Multi-Field Clinical Medical Center "Medical City"

Tyumen, Russia, 625041

Status
Active, not recruiting
 
Locations

Vologda Regional Hospital

Vologda, Russia, 160022

Status
Active, not recruiting
 
Locations

Ivanovo Regional Oncology Dispensary

Ivanovo, Russia, 153040

Status
Active, not recruiting
 
Locations

Republican Clinical Oncology Dispensary Kazan

Kazan, Russia, 420029

Status
Active, not recruiting
 
Locations

Ltd "EVIMED"

Chelyabinsk, Russia, 454048

Status
Active, not recruiting
 
Locations

Medical Center "Avicenna"

Novosibirsk, Russia, 630007

Status
Active, not recruiting
 
Locations

Research Centre of X-ray and Radiology

Moscow, Russia, 117997

Status
Active, not recruiting
 
Locations

City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA

Dnipro, Ukraine, 49102

Status
Active, not recruiting
 
Locations

Kyiv City Hospital #3

Kyiv, Ukraine, 02660

Status
Active, not recruiting
 
Locations

Kyiv Regional Oncological Dispensary

Kyiv, Ukraine, 04107

Status
Active, not recruiting
 
Locations

Cherkasy Oncological Dispensary

Cherkasy, Ukraine, 18009

Status
Active, not recruiting
 
Locations

The Hospital of Lithuanian University of Health SciencesLUHS

Kaunas, Lithuania, LT-50009

Status
Active, not recruiting
 
Locations

National Cancer Institute

Vilnius, Lithuania, LT-08660

Status
Active, not recruiting
 
Locations

PI Klaipedos University Hospital

Klaipeda, Lithuania, LT-92288

Status
Completed
 
Locations

Taipei Veterans General Hospital

Taipei, Taiwan, China, 11217

Status
Completed
 
Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, China, 807

Status
Active, not recruiting
 
Locations

Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

Status
Active, not recruiting
 
Locations

Changhua Christian Hospital

Changhua, Taiwan, China, 50006

Status
Active, not recruiting
 
Locations

Aliada

San Isidro, Peru, 15036

Status
Active, not recruiting
 
Locations

Hospital Guillermo Almenara Irigoyen

La Victoria, Peru, 15033

Status
Active, not recruiting
 
Locations

Hospital Militar Luis Arias Schreiber

Lima, Peru, LIMA 11

Status
Active, not recruiting
 
Locations

Clínica El Golf

Lima, Peru, LIMA 27

Status
Active, not recruiting
 
Locations

Daugavpils Regional Hospital

Daugavpils, Latvia, LV-5417

Status
Active, not recruiting
 
Locations

URO Ltd.

Riga, Latvia, LV-1001

Status
Active, not recruiting
 
Locations

Vidzemes Hospital

Valmiera, Latvia, LV-4201

Status
Active, not recruiting
 
Locations

P. Stradins Clinical University Hospital

Riga, Latvia, LV-1002

Status
Active, not recruiting
 
Locations

RAKUS Hospital Gailezers

Riga, Latvia, 1038

Status
Active, not recruiting
 
Locations

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90050-170

Status
Active, not recruiting
 
Locations

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania, LT-08661

Status
Active, not recruiting
 
Locations

SMS Medical College & Attached Hospitals

Jaipur, India, 302004

Status
Active, not recruiting
 
Locations

Sparsh Hospital & Critical Care

Bhubaneswar, India, 751007

Status
Active, not recruiting
 
Locations

Tata Medical Center

Kolkata, India, 700156

Status
Active, not recruiting
 
Locations

Regional Cancer Centre - Thiruvananthapuram

Thiruvananthapuram, India, 695011

Status
Active, not recruiting
 
Locations

HCG Cancer Centre - Ahmedabad

Ahmedabad, India, 380060

Status
Not yet recruiting
 
Locations

Healthcare Global Enterprises Ltd

Bengaluru, India, 560027

Status
Active, not recruiting
 
Locations

Curie Manavata Cancer Centre

Nashik, India, 422004

Status
Active, not recruiting
 
Locations

Christian Medical Center & Hospital

Ludhiana, India, 141008

Status
Recruiting
 
Locations

Rajiv Gandhi Cancer Institute & Research Centre

New Delhi, India, 110 085

Status
Active, not recruiting
 
Locations

Cancer Care Clinic - Vadodara

Vadodara, India, 390007

Status
Recruiting
 
Locations

All India Institute of Medical Sciences

New Delhi, India, 110029

Status
Active, not recruiting
 
Locations

Jehangir Hospital

Pune, India, 411001

Status
Active, not recruiting
 
Locations

Macquarie University Hospital

Macquarie University, Australia, 2109

Status
Active, not recruiting
 
Locations

Cancer Research South Australia

South Terrace, Australia, 5000

Status
Active, not recruiting
 
Locations

Fundação Pio XII – Hospital de Câncer de Barretos

Barretos, Brazil, 14784-400

Status
Active, not recruiting
 
Locations

Unidade de Pesquisas Clinicas em Oncologia

Pelotas, Brazil, 96020-080

Status
Active, not recruiting
 
Locations

Assistência Multidisciplinar em Oncologia (AMO)

Salvador, Brazil, 41950-610

Status
Active, not recruiting
 
Locations

Mahatma Gandhi Cancer Hospital & Research Institute

Vishakapatnam, India, 530017

Status
Active, not recruiting
 
Locations

Centro de Estudios Clínicos SAGA SpA

Providencia, Chile

Status
Active, not recruiting
 
Locations

Oncovida

Santiago, Chile, 7510032

Status
Active, not recruiting
 
Locations

Meenakshi Mission Hospital & Research Centre

Madurai, India, 625107

Status
Active, not recruiting
 
Locations

KLES Dr. Prabhakar Kore Hospital & Medical Research Centre

Belagavi, India, 590010

Status
Active, not recruiting
 
Locations

National Cheng Kung University Hospital

Tainan, Taiwan, China, 704

Status
Active, not recruiting
 
Locations

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

St. Petersburg, Russia, 197758

Status
Active, not recruiting
 
Locations

Jaslok Hospital and Research Centre

Mumbai, India, 400 026

Status
Active, not recruiting
 
Locations

Amrita Institute of Medical Sciences

Kochi, India, 682026

Status
Active, not recruiting
 
Locations

The Gujarat Cancer & Research Institute

Ahmedabad, India, 380016

Status
Completed
 
Locations

Apollo Specialty Hospital- Teynampet

Chennai, India, 600035

Status
Active, not recruiting
 
Locations

Post Graduate Institute of Medical Education and Research

Chandigarh, India, 160012

Status
Active, not recruiting
 
Locations

Jawaharlal Institute Of Postgraduate Medical Education and R

Gorimedu, India, 605006

Status
Completed
 
Locations

Marathwada Regional Cancer Centre and Research Institute

Aurangabad, India, 431001

Status
Active, not recruiting
 

Trial Design