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Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE)

Primary Purpose

Prostatic Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Darolutamide (Nubeqa, BAY1841788)
Placebo
Androgen deprivation therapy (ADT)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Metastatic hormone-sensitive prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Northern Cancer Institute
  • Macquarie University Hospital
  • Nepean Hospital
  • Cancer Research South Australia
  • Peninsula Oncology Centre
  • Austin Health
  • Assistência Multidisciplinar em Oncologia (AMO)
  • Hosp. Araujo Jorge da Associação de Combate ao Câncer
  • Hospital da Universidade Federal de Minas Gerais
  • Cetus Oncologia Hospital Dia
  • Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
  • Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
  • Unidade de Pesquisas Clinicas em Oncologia
  • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Hospital Mae de Deus
  • Hospital Nossa Senhora da Conceição
  • Fundação Pio XII - Hospital de Câncer de Barretos
  • Hospital de Base da Fundação F M S J Rio Preto
  • IBCC - Instituto Brasileiro de Controle do Cancer
  • Urobrasil
  • Inst. de Assistência Médica ao Sérvidor Público Estadual
  • Instituto COI de Educação e Pesquisa
  • G. Kenneth Jansz Medicine Professional Corporation
  • Centre de Recherche du CHUM
  • Centro de Investigación Clínica del Sur
  • Centro de Estudios Clínicos SAGA SpA
  • OncoCentro
  • Fundación Arturo López Perez
  • Oncovida
  • Hospital Clínico de la Pontificia Univ. Católica de Chile
  • UROMED
  • Anhui Provincial Hospital
  • Sun Yat-sen University Cancer Center
  • Guangzhou First People's Hospital
  • Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen
  • Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
  • Zhongnan hospital of Wuhan University
  • Hubei Cancer Hospital
  • Hunan Cancer Hospital
  • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
  • Nantong tumor hospital
  • The 2nd Affiliated Hospital of Soochow University
  • 1st Hospital of Jilin University
  • Liaoning Cancer Hospital and Institute
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Yantai Yuhuangding Hospital
  • SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos
  • Sichuan University West China Hospital
  • The 1st Affiliated Hospital of Zhejiang University
  • ZheJiang Provincial People's Hospital
  • Ningbo First Hospital
  • The First Affiliated Hospital of Wenzhou Medical University
  • Cancer Hospital, Chinese Academy of Medical Sciences
  • Peking University Third Hospital
  • Beijing Cancer Hospital
  • Beijing Hospital
  • Mahatma Gandhi Cancer Hospital & Research Institute
  • All India Institute of Medical Sciences
  • The Gujarat Cancer & Research Institute
  • HCG Cancer Centre - Ahmedabad
  • Cancer Care Clinic - Vadodara
  • KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
  • Healthcare Global Enterprises Ltd
  • Amrita Institute of Medical Sciences
  • Regional Cancer Centre - Thiruvananthapuram
  • Marathwada Regional Cancer Centre and Research Institute
  • Jaslok Hospital and Research Centre
  • Curie Manavata Cancer Centre
  • Jehangir Hospital
  • Sparsh Hospital & Critical Care
  • Jawaharlal Institute Of Postgraduate Medical Education and R
  • Post Graduate Institute of Medical Education and Research
  • Christian Medical Center & Hospital
  • SMS Medical College & Attached Hospitals
  • Meenakshi Mission Hospital & Research Centre
  • Apollo Specialty Hospital- Teynampet
  • Tata Medical Center
  • Apex Wellness Hospital
  • Rajiv Gandhi Cancer Institute & Research Centre
  • Daugavpils Regional Hospital
  • RAKUS Hospital Gailezers
  • URO Ltd.
  • P. Stradins Clinical University Hospital
  • Vidzemes Hospital
  • The Hospital of Lithuanian University of Health SciencesLUHS
  • PI Klaipedos University Hospital
  • National Cancer Institute
  • Vilnius University Hospital Santaros Klinikos
  • Canterbury Urology Research Trust
  • Waikato Hospital
  • Urology Waikato
  • Tauranga Urology Research Limited
  • Hospital Guillermo Almenara Irigoyen
  • Aliada
  • Hospital Militar Luis Arias Schreiber
  • Clínica El Golf
  • Arkhangelsk Clinical Oncology Dispensary
  • Ltd "EVIMED"
  • Chelyabinsk Regional Oncology Dispensary
  • Ivanovo Regional Oncology Dispensary
  • Republican Clinical Oncology Dispensary Kazan
  • Research Centre of X-ray and Radiology
  • Volga District Med Center FMBA
  • Medical Center "Avicenna"
  • LLC Reafan
  • Clinical Oncological Dispensary of Omsk Region
  • GBUZ RM "Republican Oncology Dispensary"
  • AV Medical Group
  • Russian Scientific Radiology and Surgery Technologies Center
  • Scientific Research Instutute of Oncology n.a. N.N. Petrov
  • Multi-Field Clinical Medical Center "Medical City"
  • Republican Clinical Oncology Dispensary Ufa
  • Vologda Regional Hospital
  • Sverdlovsk Regional Clinical Hospital #1
  • Cancercare Langenhoven
  • East Rand Medical Research Unit
  • University of Pretoria, Clinical Research Unit
  • Cape Town Oncology Trials
  • Corporació Sanitària Parc Taulí
  • Fundación Hospital Alcorcón
  • Hospital Fundació Puigvert
  • Hospital San Pedro de Alcántara
  • Hospital Universitario Virgen de la Victoria | Cardiology Department
  • H Virgen del Rocio |Cardiology|AF|Stroke prevention
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Changhua Christian Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • Taipei Veterans General Hospital
  • City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA
  • Kyiv City Hospital #3
  • Kyiv Regional Oncological Dispensary
  • CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Darolutamide+ADT

Placebo+ADT

Arm Description

Participants will receive darolutamide 600 mg (2 tablets of 300 mg) twice daily with food and ADT of investigator's choice as standard therapy

Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy

Outcomes

Primary Outcome Measures

Radiological progression-free survival (rPFS)
Time from the date of randomization to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Overall survival (OS)
Time from the date of randomization to the date of death from any cause.
Time to castration-resistant prostate cancer (CRPC)
Time from the date of randomization to the date of first castration resistant event (radiological progression, PSA progression or symptomatic skeletal events, whichever occurs first).
Time to initiation of subsequent anti-cancer therapy
Time from the date of randomization to initiation of first subsequent anti-cancer therapy for prostate cancer.
Time to PSA progression
Time from the date of randomization to the date of first prostate-specific antigen (PSA) progression. PSA progression is defined as a ≥25% increase above the nadir (lowest Screening or baseline) value, which is confirmed by a second value 3 or more weeks later, and an increase in absolute value of ≥ 2 ng/mL above nadir, at least 12 weeks from baseline.
PSA undetectable rates (<0.2 ng/mL)
The percentage of participants with detectable PSA values (≥0.2 ng/mL) at baseline which become undetectable (<0.2 ng/mL) during the study treatment.
Time to pain progression
Time from the date of randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline. Pain to be assessed with a patient reported questionaire.
Number of participants with adverse events as a measure of safety

Full Information

First Posted
January 29, 2021
Last Updated
October 16, 2023
Sponsor
Bayer
Collaborators
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04736199
Brief Title
Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
Acronym
ARANOTE
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
September 26, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Orion Corporation, Orion Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Metastatic hormone-sensitive prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
662 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Darolutamide+ADT
Arm Type
Experimental
Arm Description
Participants will receive darolutamide 600 mg (2 tablets of 300 mg) twice daily with food and ADT of investigator's choice as standard therapy
Arm Title
Placebo+ADT
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy
Intervention Type
Drug
Intervention Name(s)
Darolutamide (Nubeqa, BAY1841788)
Intervention Description
Coated tablet, oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Coated tablet matching Darolutamide in appearance, oral administration
Intervention Type
Other
Intervention Name(s)
Androgen deprivation therapy (ADT)
Intervention Description
Luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or orchiectomy
Primary Outcome Measure Information:
Title
Radiological progression-free survival (rPFS)
Description
Time from the date of randomization to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Time from the date of randomization to the date of death from any cause.
Time Frame
Up to 55 months
Title
Time to castration-resistant prostate cancer (CRPC)
Description
Time from the date of randomization to the date of first castration resistant event (radiological progression, PSA progression or symptomatic skeletal events, whichever occurs first).
Time Frame
Up to 55 months
Title
Time to initiation of subsequent anti-cancer therapy
Description
Time from the date of randomization to initiation of first subsequent anti-cancer therapy for prostate cancer.
Time Frame
Up to 55 months
Title
Time to PSA progression
Description
Time from the date of randomization to the date of first prostate-specific antigen (PSA) progression. PSA progression is defined as a ≥25% increase above the nadir (lowest Screening or baseline) value, which is confirmed by a second value 3 or more weeks later, and an increase in absolute value of ≥ 2 ng/mL above nadir, at least 12 weeks from baseline.
Time Frame
Up to 55 months
Title
PSA undetectable rates (<0.2 ng/mL)
Description
The percentage of participants with detectable PSA values (≥0.2 ng/mL) at baseline which become undetectable (<0.2 ng/mL) during the study treatment.
Time Frame
Up to 55 months
Title
Time to pain progression
Description
Time from the date of randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline. Pain to be assessed with a patient reported questionaire.
Time Frame
Up to 55 months
Title
Number of participants with adverse events as a measure of safety
Time Frame
Up to 55 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Northern Cancer Institute
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Macquarie University Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Nepean Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Facility Name
Cancer Research South Australia
City
South Terrace
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Peninsula Oncology Centre
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Austin Health
City
Heidelberg
Country
Australia
Facility Name
Assistência Multidisciplinar em Oncologia (AMO)
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41950-610
Country
Brazil
Facility Name
Hosp. Araujo Jorge da Associação de Combate ao Câncer
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Hospital da Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Cetus Oncologia Hospital Dia
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-270
Country
Brazil
Facility Name
Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59040-000
Country
Brazil
Facility Name
Unidade de Pesquisas Clinicas em Oncologia
City
Pelotas
State/Province
Rio Grande Do Sul
ZIP/Postal Code
96020-080
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital Mae de Deus
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90880-480
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceição
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos
City
Barretos/SP
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital de Base da Fundação F M S J Rio Preto
City
São José do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
IBCC - Instituto Brasileiro de Controle do Cancer
City
São Paulo/SP
State/Province
Sao Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
Urobrasil
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01243-020
Country
Brazil
Facility Name
Inst. de Assistência Médica ao Sérvidor Público Estadual
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04039-004
Country
Brazil
Facility Name
Instituto COI de Educação e Pesquisa
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
G. Kenneth Jansz Medicine Professional Corporation
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Facility Name
Centre de Recherche du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Centro de Investigación Clínica del Sur
City
Temuco
State/Province
Araucanía
ZIP/Postal Code
4781156
Country
Chile
Facility Name
Centro de Estudios Clínicos SAGA SpA
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
OncoCentro
City
Viña del Mar
State/Province
Valparaíso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Fundación Arturo López Perez
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Oncovida
City
Santiago
ZIP/Postal Code
7510032
Country
Chile
Facility Name
Hospital Clínico de la Pontificia Univ. Católica de Chile
City
Santiago
ZIP/Postal Code
8330024
Country
Chile
Facility Name
UROMED
City
Santiago
Country
Chile
Facility Name
Anhui Provincial Hospital
City
Hefei City, Anhui Province
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518117
Country
China
Facility Name
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Zhongnan hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Nantong tumor hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226361
Country
China
Facility Name
The 2nd Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
1st Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Liaoning Cancer Hospital and Institute
City
Shengyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Facility Name
SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
Sichuan University West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
The 1st Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
ZheJiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Mahatma Gandhi Cancer Hospital & Research Institute
City
Vishakapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530017
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
The Gujarat Cancer & Research Institute
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
HCG Cancer Centre - Ahmedabad
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380060
Country
India
Facility Name
Cancer Care Clinic - Vadodara
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390007
Country
India
Facility Name
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
City
Belagavi
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Facility Name
Healthcare Global Enterprises Ltd
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
Facility Name
Amrita Institute of Medical Sciences
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682026
Country
India
Facility Name
Regional Cancer Centre - Thiruvananthapuram
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Marathwada Regional Cancer Centre and Research Institute
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431001
Country
India
Facility Name
Jaslok Hospital and Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 026
Country
India
Facility Name
Curie Manavata Cancer Centre
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422004
Country
India
Facility Name
Jehangir Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Sparsh Hospital & Critical Care
City
Bhubaneswar
State/Province
Orissa
ZIP/Postal Code
751007
Country
India
Facility Name
Jawaharlal Institute Of Postgraduate Medical Education and R
City
Gorimedu
State/Province
Pondicherry
ZIP/Postal Code
605006
Country
India
Facility Name
Post Graduate Institute of Medical Education and Research
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Facility Name
Christian Medical Center & Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Facility Name
SMS Medical College & Attached Hospitals
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
Meenakshi Mission Hospital & Research Centre
City
Madurai
State/Province
Tamil N?du
ZIP/Postal Code
625107
Country
India
Facility Name
Apollo Specialty Hospital- Teynampet
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600035
Country
India
Facility Name
Tata Medical Center
City
Kolkata
ZIP/Postal Code
700156
Country
India
Facility Name
Apex Wellness Hospital
City
Nashik
ZIP/Postal Code
422009
Country
India
Facility Name
Rajiv Gandhi Cancer Institute & Research Centre
City
New Delhi
ZIP/Postal Code
110 085
Country
India
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
RAKUS Hospital Gailezers
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
URO Ltd.
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Facility Name
P. Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Vidzemes Hospital
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
Facility Name
The Hospital of Lithuanian University of Health SciencesLUHS
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
PI Klaipedos University Hospital
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
National Cancer Institute
City
Vilnius
ZIP/Postal Code
LT-08660
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Canterbury Urology Research Trust
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3200
Country
New Zealand
Facility Name
Urology Waikato
City
Hamilton
ZIP/Postal Code
3214
Country
New Zealand
Facility Name
Tauranga Urology Research Limited
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Hospital Guillermo Almenara Irigoyen
City
La Victoria
State/Province
Lima
ZIP/Postal Code
15033
Country
Peru
Facility Name
Aliada
City
San Isidro
State/Province
Lima
ZIP/Postal Code
15036
Country
Peru
Facility Name
Hospital Militar Luis Arias Schreiber
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
Clínica El Golf
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
Facility Name
Arkhangelsk Clinical Oncology Dispensary
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Ltd "EVIMED"
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
Chelyabinsk Regional Oncology Dispensary
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary Kazan
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Research Centre of X-ray and Radiology
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Volga District Med Center FMBA
City
Nizhny Novgorod
ZIP/Postal Code
603109
Country
Russian Federation
Facility Name
Medical Center "Avicenna"
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
LLC Reafan
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Clinical Oncological Dispensary of Omsk Region
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
GBUZ RM "Republican Oncology Dispensary"
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
AV Medical Group
City
St. Petersburg
ZIP/Postal Code
196006
Country
Russian Federation
Facility Name
Russian Scientific Radiology and Surgery Technologies Center
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Scientific Research Instutute of Oncology n.a. N.N. Petrov
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Multi-Field Clinical Medical Center "Medical City"
City
Tyumen
ZIP/Postal Code
625041
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary Ufa
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Vologda Regional Hospital
City
Vologda
ZIP/Postal Code
160022
Country
Russian Federation
Facility Name
Sverdlovsk Regional Clinical Hospital #1
City
Yekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Cancercare Langenhoven
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6045
Country
South Africa
Facility Name
East Rand Medical Research Unit
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1475
Country
South Africa
Facility Name
University of Pretoria, Clinical Research Unit
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Cape Town Oncology Trials
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Fundación Hospital Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Fundació Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital San Pedro de Alcántara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria | Cardiology Department
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
H Virgen del Rocio |Cardiology|AF|Stroke prevention
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
State/Province
Kaohsiung
ZIP/Postal Code
807377
Country
Taiwan
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Kyiv City Hospital #3
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Kyiv Regional Oncological Dispensary
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"
City
Zaporizhia
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Links:
URL
https://clinicaltrials.bayer.com/study/21140
Description
Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

Learn more about this trial

Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

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