Clinical trial NCT04736199: Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostatic Neoplasms
Keywords: Metastatic hormone-sensitive prostate cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2021-02-03
Enrollment: 669
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Radiological progression-free survival (rPFS)
timeFrame: 36 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 55 months
measure: Time to castration-resistant prostate cancer (CRPC)
timeFrame: Up to 55 months
measure: Time to initiation of subsequent anti-cancer therapy
timeFrame: Up to 55 months
measure: Time to PSA progression
timeFrame: Up to 55 months
measure: PSA undetectable rates (<0.2 ng/mL)
timeFrame: Up to 55 months
measure: Time to pain progression
timeFrame: Up to 55 months
measure: Number of participants with adverse events as a measure of safety
timeFrame: Up to 55 months
Other outcomes:
Locations:
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Northern Cancer Institute
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Cancer Research South Australia
state: South Australia
city: Frankston
country: Australia
facility: Peninsula Oncology Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Salvador
country: Brazil
facility: Assistência Multidisciplinar em Oncologia (AMO)
state: Bahia
city: Goiânia
country: Brazil
facility: Hosp. Araujo Jorge da Associação de Combate ao Câncer
state: Goiás
city: Belo Horizonte
country: Brazil
facility: Hospital da Universidade Federal de Minas Gerais
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Cetus Oncologia Hospital Dia
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
state: Parana
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
state: Rio Grande Do Norte
city: Pelotas
country: Brazil
facility: Unidade de Pesquisas Clinicas em Oncologia
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre | Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: FZ Pesquisa e Servicos em Cardiologia | Porto Alegre, Brazil
state: Rio Grande Do Sul
city: Barretos/SP
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base | Integrated Research Center
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Urobrasil
state: Sao Paulo
city: São Paulo
country: Brazil
facility: IBCC - Instituto Brasileiro de Controle do Cancer
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Inst. de Assistência Médica ao Sérvidor Público Estadual
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto COI de Educação e Pesquisa
city: Burlington
country: Canada
facility: G. Kenneth Jansz Medicine Professional Corporation
state: Ontario
city: Montreal
country: Canada
facility: Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
state: Quebec
city: Temuco
country: Chile
facility: Centro de Investigación Clínica del Sur
state: Araucanía
city: Providencia
country: Chile
facility: Centro de Estudios Clínicos SAGA SpA
state: Santiago
city: Viña del Mar
country: Chile
facility: OncoCentro
state: Valparaíso
city: Santiago
country: Chile
facility: Fundación Arturo López Perez
city: Santiago
country: Chile
facility: Oncovida
city: Santiago
country: Chile
facility: Hospital Clínico de la Pontificia Univ. Católica de Chile
city: Santiago
country: Chile
facility: UROMED
city: Hefei City, Anhui Province
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
state: Hubei
city: Wuhan
country: China
facility: Zhongnan hospital ,Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
state: Jiangsu
city: Nantong
country: China
facility: Nantong tumor hospital
state: Jiangsu
city: Suzhou
country: China
facility: The 2nd Affiliated Hospital of Soochow University
state: Jiangsu
city: Changchun
country: China
facility: 1st Hospital of Jilin University
state: Jilin
city: Shengyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos
state: Sichuan
city: Chengdu
country: China
facility: Sichuan University West China Hospital
state: Sichuan
city: Hangzhou
country: China
facility: The 1st Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: ZheJiang Provincial People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Vishakapatnam
country: India
facility: Mahatma Gandhi Cancer Hospital & Research Institute
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: The Gujarat Cancer & Research Institute
state: Gujarat
city: Ahmedabad
country: India
facility: HCG Cancer Centre - Ahmedabad
state: Gujarat
city: Vadodara
country: India
facility: Cancer Care Clinic - Vadodara
state: Gujarat
city: Belgaum
country: India
facility: K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre
state: Karnataka
city: Bengaluru
country: India
facility: Healthcare Global Enterprises Ltd
state: Karnataka
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences
state: Kerala
city: Thiruvananthapuram
country: India
facility: Regional Cancer Centre - Thiruvananthapuram
state: Kerala
city: Aurangabad
country: India
facility: Marathwada Regional Cancer Centre and Research Institute
state: Maharashtra
city: Mumbai
country: India
facility: Jaslok Hospital and Research Centre
state: Maharashtra
city: Nashik
country: India
facility: Curie Manavata Cancer Centre
state: Maharashtra
city: Pune
country: India
facility: Jehangir Hospital
state: Maharashtra
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences
state: Odisha
city: Bhubaneswar
country: India
facility: Sparsh Hospital & Critical Care
state: Orissa
city: Gorimedu
country: India
facility: Jawaharlal Institute Of Postgraduate Medical Education and R
state: Pondicherry
city: Ludhiana
country: India
facility: Christian Medical Center & Hospital
state: Punjab
city: Jaipur
country: India
facility: Sawami Man Singh (SMS) Medical College & Attached Hospitals
state: Rajasthan
city: Madurai
country: India
facility: Apollo Speciality Hospitals
state: Tamil Nadu
city: Madurai
country: India
facility: Meenakshi Mission Hospital & Research Centre
state: Tamil Nadu
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
city: Kolkata
country: India
facility: Tata Medical Center
city: Nashik
country: India
facility: Apex Wellness Hospital
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research Centre
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Riga
country: Latvia
facility: RAKUS Hospital Gailezers
city: Riga
country: Latvia
facility: URO Ltd.
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital
city: Valmiera
country: Latvia
facility: Vidzemes Hospital
city: Kaunas
country: Lithuania
facility: The Hospital of Lithuanian University of Health SciencesLUHS
city: Klaipeda
country: Lithuania
facility: PI Klaipedos University Hospital
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Christchurch
country: New Zealand
facility: Canterbury Urology Research Trust
state: Canterbury
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Urology Research Limited
city: San Isidro
country: Peru
facility: Aliada
state: Lima
city: Santiago de Surco
country: Peru
facility: Hospital Guillermo Almenara Irigoyen
state: Lima
city: Lima
country: Peru
facility: Hospital Militar Luis Arias Schreiber
city: Lima
country: Peru
facility: Clínica El Golf
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncology Dispensary
city: Chelyabinsk
country: Russian Federation
facility: Ltd "EVIMED"
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Oncology Dispensary
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary Kazan
city: Moscow
country: Russian Federation
facility: Research Centre of X-ray and Radiology
city: Nizhny Novgorod
country: Russian Federation
facility: Volga District Med Center FMBA
city: Novosibirsk
country: Russian Federation
facility: LLC Reafan
city: Novosibirsk
country: Russian Federation
facility: Medical Center "Avicenna"
city: Omsk
country: Russian Federation
facility: Clinical Oncological Dispensary of Omsk Region
city: St. Petersburg
country: Russian Federation
facility: AV Medical Group
city: St. Petersburg
country: Russian Federation
facility: Russian Scientific Radiology and Surgery Technologies Center
city: St. Petersburg
country: Russian Federation
facility: Scientific Research Instutute of Oncology n.a. N.N. Petrov
city: Tyumen
country: Russian Federation
facility: Multi-Field Clinical Medical Center "Medical City"
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary
city: Vologda
country: Russian Federation
facility: Vologda Regional Hospital
city: Yekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Hospital #1
city: Port Elizabeth
country: South Africa
facility: Cancercare Langenhoven
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: East Rand Medical Research Unit
state: Gauteng
city: Pretoria
country: South Africa
facility: University of Pretoria, Clinical Research Unit
state: Gauteng
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Alcorcón
country: Spain
facility: Fundación Hospital Alcorcón
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Fundació Puigvert
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria | Cardiology Department
city: Sevilla
country: Spain
facility: H Virgen del Rocio |Cardiology|AF|Stroke prevention
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
state: Kaohsiung
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Cherkasy
country: Ukraine
facility: CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"
city: Dnipro
country: Ukraine
facility: City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA
city: Kyiv
country: Ukraine
facility: Kyiv City Hospital #3 - Department of Urology
city: Kyiv
country: Ukraine
facility: Kyiv Regional Oncological Dispensary
Study officials:
References: