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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Hospital San Pedro de Alcántara Cáceres, Spain, 10003 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Corporació Sanitària Parc Taulí Sabadell, Spain, 08208 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Fundació Puigvert Barcelona, Spain, 08025 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundación Hospital Alcorcón Alcorcón, Spain, 28922 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Canterbury Urology Research Trust Christchurch, New Zealand, 8013 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tauranga Urology Research Limited Tauranga, New Zealand, 3112 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urology Waikato Hamilton, New Zealand, 3214 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Waikato Hospital Hamilton, New Zealand, 3200 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cape Town Oncology Trials Cape Town, South Africa, 7570 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancercare Langenhoven Port Elizabeth, South Africa, 6045 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Pretoria, Clinical Research Unit Pretoria, South Africa, 0002 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations East Rand Medical Research Unit Johannesburg, South Africa, 1475 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Anhui Provincial Hospital Hefei, China, 230001 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Hospital Beijing, China, 100730 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Guangzhou First People's Hospital Guangzhou, China, 510180 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School Nanjing, China, 210008 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Peking University Third Hospital Beijing, China, 100083 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liaoning Cancer Hospital and Institute Shengyang, China, 110042 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sun Yat-sen University Cancer Center Guangzhou, China, 510060 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hunan Cancer Hospital Changsha, China, 410013 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech. Wuhan, China, 430030 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Affiliated Hospital of Wenzhou Medical University Wenzhou, China, 325000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhongnan hospital of Wuhan University Wuhan, China, 430071 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancer Hospital, Chinese Academy of Medical Sciences Beijing, China, 100021 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Cancer Hospital Beijing, China, 100142 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 1st Affiliated Hospital of Zhejiang University Hangzhou, China, 310000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 2nd Affiliated Hospital of Soochow University Suzhou, China, 215004 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos Chengdu, China, 610072 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yantai Yuhuangding Hospital Yantai, China, 264000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations 1st Hospital of Jilin University Changchun, China, 130021 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ZheJiang Provincial People's Hospital Hangzhou, China, 310014 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Affiliated Hospital of Xi'an Jiaotong University Xi'an, China, 710061 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Shenzhen, China, 518117 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hubei Cancer Hospital Wuhan, China, 430079 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sichuan University West China Hospital Chengdu, China | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ningbo First Hospital Ningbo, China, 315010 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nantong tumor hospital Nantong, China, 226361 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations G. Kenneth Jansz Medicine Professional Corporation Burlington, Canada, L7N 3V2 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre de Recherche du CHUM Montreal, Canada, H2X 0A9 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Peninsula Oncology Centre Frankston, Australia, 3199 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nepean Hospital Sydney, Australia, 2751 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Austin Health Heidelberg, Australia | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northern Cancer Institute St Leonards, Australia, 2065 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico de la Pontificia Univ. Católica de Chile Santiago, Chile, 8330024 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Investigación Clínica del Sur Temuco, Chile, 4781156 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UROMED Santiago, Chile | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundación Arturo López Perez Santiago, Chile, 7500921 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations OncoCentro Viña del Mar, Chile, 2520598 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Mae de Deus Porto Alegre, Brazil, 90880-480 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IBCC - Instituto Brasileiro de Controle do Cancer São Paulo/SP, Brazil, 04014-002 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hosp. Araujo Jorge da Associação de Combate ao Câncer Goiânia, Brazil, 74605-070 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liga Norte Riograndense Contra o Câncer Natal, Brazil, 59040-000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner Curitiba, Brazil, 81520-060 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inst. de Assistência Médica ao Sérvidor Público Estadual São Paulo, Brazil, 04039-004 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de Base da Fundação F M S J Rio Preto São José do Rio Preto, Brazil, 15090-000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto COI de Educação e Pesquisa Rio de Janeiro, Brazil, 22793-080 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Nossa Senhora da Conceição Porto Alegre, Brazil, 91350-200 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital da Universidade Federal de Minas Gerais Belo Horizonte, Brazil, 30130-100 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urobrasil São Paulo, Brazil, 01243-020 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cetus Oncologia Hospital Dia Belo Horizonte, Brazil, 30150-270 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chelyabinsk Regional Oncology Dispensary Chelyabinsk, Russia, 454087 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sverdlovsk Regional Clinical Hospital #1 Yekaterinburg, Russia, 620102 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Oncological Dispensary of Omsk Region Omsk, Russia, 644013 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Republican Clinical Oncology Dispensary Ufa Ufa, Russia, 450054 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AV Medical Group St. Petersburg, Russia, 196006 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Russian Scientific Radiology and Surgery Technologies Center St. Petersburg, Russia, 197758 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Volga District Med Center FMBA Nizhny Novgorod, Russia, 603109 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GBUZ RM "Republican Oncology Dispensary" Saransk, Russia, 430032 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Arkhangelsk Clinical Oncology Dispensary Arkhangelsk, Russia, 163045 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Reafan Novosibirsk, Russia, 630099 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multi-Field Clinical Medical Center "Medical City" Tyumen, Russia, 625041 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vologda Regional Hospital Vologda, Russia, 160022 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ivanovo Regional Oncology Dispensary Ivanovo, Russia, 153040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Republican Clinical Oncology Dispensary Kazan Kazan, Russia, 420029 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ltd "EVIMED" Chelyabinsk, Russia, 454048 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Center "Avicenna" Novosibirsk, Russia, 630007 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Research Centre of X-ray and Radiology Moscow, Russia, 117997 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA Dnipro, Ukraine, 49102 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyiv City Hospital #3 Kyiv, Ukraine, 02660 | Status Active, not recruiting | Contact Us: E-mail: [email protected]om Phone: (+)1-888-84 22937 |
Locations Kyiv Regional Oncological Dispensary Kyiv, Ukraine, 04107 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cherkasy Oncological Dispensary Cherkasy, Ukraine, 18009 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Hospital of Lithuanian University of Health SciencesLUHS Kaunas, Lithuania, LT-50009 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Institute Vilnius, Lithuania, LT-08660 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PI Klaipedos University Hospital Klaipeda, Lithuania, LT-92288 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung, Taiwan, China, 807 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 50006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aliada San Isidro, Peru, 15036 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Guillermo Almenara Irigoyen La Victoria, Peru, 15033 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Militar Luis Arias Schreiber Lima, Peru, LIMA 11 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clínica El Golf Lima, Peru, LIMA 27 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Daugavpils Regional Hospital Daugavpils, Latvia, LV-5417 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations URO Ltd. Riga, Latvia, LV-1001 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vidzemes Hospital Valmiera, Latvia, LV-4201 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations P. Stradins Clinical University Hospital Riga, Latvia, LV-1002 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations RAKUS Hospital Gailezers Riga, Latvia, 1038 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre, Brazil, 90020-090 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vilnius University Hospital Santaros Klinikos Vilnius, Lithuania, LT-08661 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SMS Medical College & Attached Hospitals Jaipur, India, 302004 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sparsh Hospital & Critical Care Bhubaneswar, India, 751007 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tata Medical Center Kolkata, India, 700156 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regional Cancer Centre - Thiruvananthapuram Thiruvananthapuram, India, 695011 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HCG Cancer Centre - Ahmedabad Ahmedabad, India, 380060 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Healthcare Global Enterprises Ltd Bengaluru, India, 560027 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Curie Manavata Cancer Centre Nashik, India, 422004 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Christian Medical Center & Hospital Ludhiana, India, 141008 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rajiv Gandhi Cancer Institute & Research Centre New Delhi, India, 110 085 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancer Care Clinic - Vadodara Vadodara, India, 390007 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations All India Institute of Medical Sciences New Delhi, India, 110029 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jehangir Hospital Pune, India, 411001 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Macquarie University Hospital Macquarie University, Australia, 2109 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancer Research South Australia South Terrace, Australia, 5000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundação Pio XII – Hospital de Câncer de Barretos Barretos/SP, Brazil, 14784-400 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Unidade de Pesquisas Clinicas em Oncologia Pelotas, Brazil, 96020-080 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Assistência Multidisciplinar em Oncologia (AMO) Salvador, Brazil, 41950-610 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mahatma Gandhi Cancer Hospital & Research Institute Vishakapatnam, India, 530017 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Estudios Clínicos SAGA SpA Providencia, Chile | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oncovida Santiago, Chile, 7510032 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meenakshi Mission Hospital & Research Centre Madurai, India, 625107 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations KLES Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi, India, 590010 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cheng Kung University Hospital Tainan, Taiwan, China, 704 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Scientific Research Instutute of Oncology n.a. N.N. Petrov St. Petersburg, Russia, 197758 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jaslok Hospital and Research Centre Mumbai, India, 400 026 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Amrita Institute of Medical Sciences Kochi, India, 682026 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Gujarat Cancer & Research Institute Ahmedabad, India, 380016 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Apollo Specialty Hospital- Teynampet Chennai, India, 600035 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Post Graduate Institute of Medical Education and Research Chandigarh, India, 160012 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jawaharlal Institute Of Postgraduate Medical Education and R Gorimedu, India, 605006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Marathwada Regional Cancer Centre and Research Institute Aurangabad, India, 431001 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- 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.Timeframe: 36 months
Secondary Outcome
- Overall survival (OS)Time from the date of randomization to the date of death from any cause.Timeframe: Up to 55 months
- 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).Timeframe: Up to 55 months
- Time to initiation of subsequent anti-cancer therapyTime from the date of randomization to initiation of first subsequent anti-cancer therapy for prostate cancer.Timeframe: Up to 55 months
- Time to PSA progressionTime 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.Timeframe: Up to 55 months
- 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.Timeframe: Up to 55 months
- Time to pain progressionTime 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.Timeframe: Up to 55 months
- Number of participants with adverse events as a measure of safetyTimeframe: Up to 55 months
Additional Information
Not Available
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