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
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Locations Hospital San Pedro de Alcántara Cáceres, Spain, 10003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Corporació Sanitària Parc Taulí Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Fundació Puigvert Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de la Victoria | Cardiology Department Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundación Hospital Alcorcón Alcorcón, Spain, 28922 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations H Virgen del Rocio |Cardiology|AF|Stroke prevention Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Canterbury Urology Research Trust Christchurch, New Zealand, 8013 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tauranga Urology Research Limited Tauranga, New Zealand, 3112 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urology Waikato Hamilton, New Zealand, 3214 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Waikato Hospital Hamilton, New Zealand, 3200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cape Town Oncology Trials Cape Town, South Africa, 7570 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancercare Langenhoven Port Elizabeth, South Africa, 6045 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Pretoria, Clinical Research Unit Pretoria, South Africa, 0002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations East Rand Medical Research Unit Johannesburg, South Africa, 1475 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Anhui Provincial Hospital Hefei City, Anhui Province, China, 230031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Hospital Beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Guangzhou First People Hospital Guangzhou, China, 510180 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Peking University Third Hospital Beijing, China, 100083 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liaoning Cancer Hospital and Institute Shengyang, China, 110042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sun Yat-sen University Cancer Center Guangzhou, China, 510000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hunan Cancer Hospital Changsha, China, 410013 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Affiliated Hospital of Wenzhou Medical University Wenzhou, China, 325000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhongnan hospital of Wuhan University Wuhan, China, 430071 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancer Hospital, Chinese Academy of Medical Sciences Beijing, China, 100000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Cancer Hospital Beijing, China, 100142 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 1st Affiliated Hospital of Zhejiang University Hangzhou, China, 310000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 2nd Affiliated Hospital of Soochow University Suzhou, China, 215004 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos Chengdu, China, 610072 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yantai Yuhuangding Hospital Yantai, China, 264000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations 1st Hospital of Jilin University Changchun, China, 130021 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ZheJiang Provincial People's Hospital Hangzhou, China, 310014 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Shenzhen, China, 518117 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hubei Cancer Hospital Wuhan, China, 430079 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sichuan University West China Hospital Chengdu, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ningbo First Hospital Ningbo, China, 315010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nantong tumor hospital Nantong, China, 226361 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations G. Kenneth Jansz Medicine Professional Corporation Burlington, Canada, L7N 3V2 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre de Recherche du CHUM Montreal, Canada, H2X 0A9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Peninsula Oncology Centre Frankston, Australia, 3199 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nepean Hospital Sydney, Australia, 2751 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Austin Health Heidelberg, Australia | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northern Cancer Institute St Leonards, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico de la Pontificia Univ. Católica de Chile Santiago, Chile, 8330024 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Investigación Clínica del Sur Temuco, Chile, 4781156 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UROMED Santiago, Chile | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundación Arturo López Perez Santiago, Chile, 7500921 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations OncoCentro Viña del Mar, Chile, 2520598 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Mae de Deus Porto Alegre, Brazil, 90880-480 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IBCC - Instituto Brasileiro de Controle do Cancer São Paulo, Brazil, 03102-002 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica Natal, Brazil, 59040-000 | 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 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de Base | Integrated Research Center São José do Rio Preto, Brazil, 15090-000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto COI de Educação e Pesquisa Rio de Janeiro, Brazil, 22793-080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Nossa Senhora da Conceição Porto Alegre, Brazil, 91350-200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital da Universidade Federal de Minas Gerais Belo Horizonte, Brazil, 30130-100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urobrasil São Paulo, Brazil, 01243-020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cetus Oncologia Hospital Dia Belo Horizonte, Brazil, 30150-270 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chelyabinsk Regional Oncology Dispensary Chelyabinsk, Russia, 454087 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sverdlovsk Regional Clinical Hospital #1 Yekaterinburg, Russia, 620102 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Oncological Dispensary of Omsk Region Omsk, Russia, 644013 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Republican Clinical Oncology Dispensary Ufa Ufa, Russia, 450054 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AV Medical Group St. Petersburg, Russia, 196006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Russian Scientific Radiology and Surgery Technologies Center St. Petersburg, Russia, 197758 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Volga District Med Center FMBA Nizhny Novgorod, Russia, 603109 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GBUZ RM "Republican Oncology Dispensary" Saransk, Russia, 430032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Arkhangelsk Clinical Oncology Dispensary Arkhangelsk, Russia, 163045 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Reafan Novosibirsk, Russia, 630099 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multi-Field Clinical Medical Center "Medical City" Tyumen, Russia, 625041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vologda Regional Hospital Vologda, Russia, 160022 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ivanovo Regional Oncology Dispensary Ivanovo, Russia, 153040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Republican Clinical Oncology Dispensary Kazan Kazan, Russia, 420029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ltd "EVIMED" Chelyabinsk, Russia, 454048 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Center "Avicenna" Novosibirsk, Russia, 630007 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Research Centre of X-ray and Radiology Moscow, Russia, 117997 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA Dnipro, Ukraine, 49102 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyiv City Hospital #3 Kyiv, Ukraine, 02660 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyiv Regional Oncological Dispensary Kyiv, Ukraine, 04107 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council" Zaporizhia, Ukraine, 69600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Hospital of Lithuanian University of Health SciencesLUHS Kaunas, Lithuania, LT-50009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Institute Vilnius, Lithuania, LT-08660 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PI Klaipedos University Hospital Klaipeda, Lithuania, LT-92288 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, Taiwan, China, 807377 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 50006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aliada San Isidro, Peru, 15036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Guillermo Almenara Irigoyen La Victoria, Peru, 15033 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Militar Luis Arias Schreiber Lima, Peru, LIMA 11 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clínica El Golf Lima, Peru, LIMA 27 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Daugavpils Regional Hospital Daugavpils, Latvia, LV-5417 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations URO Ltd. Riga, Latvia, LV-1001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vidzemes Hospital Valmiera, Latvia, LV-4201 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations P. Stradins Clinical University Hospital Riga, Latvia, LV-1002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations RAKUS Hospital Gailezers Riga, Latvia, 1038 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vilnius University Hospital Santaros Klinikos Vilnius, Lithuania, LT-08661 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SMS Medical College & Attached Hospitals Jaipur, India, 302004 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sparsh Hospital & Critical Care Bhubaneswar, India, 751007 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tata Medical Center Kolkata, India, 700156 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regional Cancer Centre - Thiruvananthapuram Thiruvananthapuram, India, 695011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HCG Cancer Centre - Ahmedabad Ahmedabad, India, 380060 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Healthcare Global Enterprises Ltd Bengaluru, India, 560027 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Curie Manavata Cancer Centre Nashik, India, 422004 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Christian Medical Center & Hospital Ludhiana, India, 141008 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rajiv Gandhi Cancer Institute & Research Centre New Delhi, India, 110 085 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancer Care Clinic - Vadodara Vadodara, India, 390007 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations All India Institute of Medical Sciences Bhubaneswar, India, 751019 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jehangir Hospital Pune, India, 411001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Macquarie University Hospital Sydney, Australia, 2109 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancer Research South Australia South Terrace, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundacao Pio XII Hospital de Cancer de Barretos Barretos/SP, Brazil, 14784-400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Unidade de Pesquisas Clinicas em Oncologia Pelotas, Brazil, 96020-080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Assistência Multidisciplinar em Oncologia (AMO) Salvador, Brazil, 41950-610 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mahatma Gandhi Cancer Hospital & Research Institute Vishakapatnam, India, 530017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Estudios Clínicos SAGA SpA Providencia, Chile | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oncovida Santiago, Chile, 7510032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meenakshi Mission Hospital & Research Centre Madurai, India, 625107 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations KLES Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi, India, 590010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cheng Kung University Hospital Tainan, Taiwan, China, 704 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jaslok Hospital and Research Centre Mumbai, India, 400 026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Amrita Institute of Medical Sciences Kochi, India, 682026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Gujarat Cancer & Research Institute Ahmedabad, India, 380016 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Apollo Specialty Hospital- Teynampet Chennai, India, 600035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Post Graduate Institute of Medical Education and Research Chandigarh, India, 160012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jawaharlal Institute Of Postgraduate Medical Education and R Gorimedu, India, 605006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Marathwada Regional Cancer Centre and Research Institute Aurangabad, India, 431001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Apex Wellness Hospital Nashik, India, 422009 | 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
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