do_not_disturb_altRecruitment Complete

Prostatic neoplasms

Bayer Identifier:
21140
ClinicalTrials.gov Identifier:
NCT04736199
EudraCT Number:
2020-003093-48
EU CT Number:
Not Available
Darolutamide in addition to ADT versus ADT in metastatic hormone-sensitive prostate cancer

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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
  • - 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
669
Trial Dates
February 2021 - January 2026
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Darolutamide+ADT (BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Hospital Universitario Puerta del MarCádiz, 11009, Spain
Active, not recruiting
Hospital San Pedro de Alcántara - OncologiaCáceres, 10003, Spain
Withdrawn
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Parc Tauli Hospital Universitari - OncologiaSabadell, 08208, Spain
Completed
Fundacio Puigvert - UrologiaBarcelona, 8025, Spain
Active, not recruiting
Hospital Universitario Virgen De La Victoria - UrologiaMalaga, 20910, Spain
Completed
Hospital Universitario Fundacion Alcorcon - UrologiaAlcorcón, 28922, Spain
Completed
Hospital Universitario Virgen Del Rocio S.L. - UrologiaSevilla, 41013, Spain
Active, not recruiting
Canterbury Urology Research TrustChristchurch, 8013, New Zealand
Active, not recruiting
Tauranga Urology Research LimitedTauranga, 3112, New Zealand
Active, not recruiting
Waikato HospitalHamilton, 3240, New Zealand
Active, not recruiting
Waikato HospitalHamilton, 3240, New Zealand
Active, not recruiting
Cape Town Oncology TrialsCape Town, 7570, South Africa
Active, not recruiting
Cancercare LangenhovenPort Elizabeth, 6045, South Africa
Withdrawn
Groote Schuur HospitalCape Town, 7925, South Africa
Active, not recruiting
University of Pretoria, Clinical Research UnitPretoria, 2, South Africa
Not yet recruiting
East Rand Medical Research UnitJohannesburg, 1475, South Africa
Completed
Anhui Provincial HospitalHefei City, Anhui Province, 230031, China
Withdrawn
Beijing Friendship Hospital, Capital Medical UniversityBeijing, 100050, China
Active, not recruiting
Beijing HospitalBeijing, 100730, China
Active, not recruiting
Guangzhou First People HospitalGuangzhou, 510180, China
Active, not recruiting
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med SchoolNanjing, 210008, China
Withdrawn
Huashan Hospital, Fudan UniversityShanghai, 200040, China
Withdrawn
The First Affiliated Hospital of Xiamen UniversityXiamen, 361003, China
Completed
Peking University Third HospitalBeijing, 100083, China
Active, not recruiting
Liaoning Cancer Hospital and InstituteShengyang, 110042, China
Active, not recruiting
Sun Yat-sen University Cancer CenterGuangzhou, 510000, China
Active, not recruiting
Hunan Cancer HospitalChangsha, 410013, China
Active, not recruiting
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.Wuhan, 430030, China
Active, not recruiting
The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, 325000, China
Active, not recruiting
Zhongnan hospital ,Wuhan UniversityWuhan, 430071, China
Withdrawn
Xinhua Hos Affiliated to SH Jiaotong Uni School of MedicineShanghai, 200092, China
Active, not recruiting
Cancer Hospital, Chinese Academy of Medical SciencesBeijing, 100000, China
Not yet recruiting
Beijing Cancer HospitalBeijing, 100142, China
Completed
The 1st Affiliated Hospital of Zhejiang UniversityHangzhou, 310000, China
Active, not recruiting
The 2nd Affiliated Hospital of Soochow UniversitySuzhou, 215004, China
Active, not recruiting
SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHosChengdu, 610072, China
Active, not recruiting
Yantai Yuhuangding HospitalYantai, 264000, China
Active, not recruiting
1st Hospital of Jilin UniversityChangchun, 130021, China
Active, not recruiting
ZheJiang Provincial People's HospitalHangzhou, 310014, China
Completed
The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, 710061, China
Active, not recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen CenterShenzhen, 518172, China
Active, not recruiting
Hubei Cancer HospitalWuhan, 430079, China
Active, not recruiting
Sichuan University West China HospitalChengdu, MISSING, China
Active, not recruiting
Ningbo First HospitalNingbo, 315010, China
Withdrawn
Yunnan Cancer HospitalKunming, 650118, China
Withdrawn
FuJian Medical University Union HospitalFuzhou, 350000, China
Withdrawn
Shanghai Fifth People's Hospital,Fudan UniversityShanghai, 200240, China
Active, not recruiting
Nantong tumor hospitalNantong, 226361, China
Withdrawn
CIUSSS de l’Estrie- Centre Haute-YamaskaGranby, J2G 1T7, Canada
Completed
G. Kenneth Jansz Medicine Professional CorporationBurlington, L7N 3V2, Canada
Completed
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)Montreal, H2X 0A9, Canada
Withdrawn
Centre integre de Sante et de Services Sociaux de IOutaouaisGatineau, J8O 7H2, Canada
Withdrawn
Exdeo Clinical Research Inc.Abbotsford, V2T 1X8, Canada
Active, not recruiting
Peninsula Oncology CentreFrankston, 3199, Australia
Active, not recruiting
Nepean HospitalKingswood, 2747, Australia
Active, not recruiting
Austin HealthHeidelberg, 3084, Australia
Active, not recruiting
Northern Cancer InstituteSt Leonards, 2065, Australia
Withdrawn
Sociedad Clinical Research Chile SpAValdivia, 5110683, Chile
Active, not recruiting
Hospital Clínico de la Pontificia Univ. Católica de ChileSantiago, TBC, Chile
Completed
Centro de Investigación Clínica del SurTemuco, 4781156, Chile
Completed
UROMEDSantiago, N/A, Chile
Active, not recruiting
Fundación Arturo López PerezSantiago, 7500921, Chile
Active, not recruiting
OncoCentroViña del Mar, 2520598, Chile
Withdrawn
Centro Oncológico del NorteAntofagasta, 1267348, Chile
Active, not recruiting
Hospital Mae de DeusPorto Alegre, 90850-170, Brazil
Active, not recruiting
IBCC - Instituto Brasileiro de Controle do CancerSão Paulo, 03102-002, Brazil
Active, not recruiting
Hosp. Araujo Jorge da Associação de Combate ao CâncerGoiânia, 74605-070, Brazil
Active, not recruiting
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa ClínicaNatal, 59040-000, Brazil
Active, not recruiting
Liga Paranaense de Combate ao Cancer-Hosp Erasto GaertnerCuritiba, 81520-060, Brazil
Active, not recruiting
Inst. de Assistência Médica ao Sérvidor Público EstadualSão Paulo, 04039-004, Brazil
Active, not recruiting
Hospital de Base | Integrated Research CenterSão José do Rio Preto, 15090-000, Brazil
Active, not recruiting
Instituto COI de Educação e PesquisaRio de Janeiro, 22793-080, Brazil
Active, not recruiting
FZ Pesquisa e Servicos em Cardiologia | Porto Alegre, BrazilPorto Alegre, 91350-280, Brazil
Withdrawn
Hospital de Clinicas de Porto Alegre | Clinical Research Center - Surgery Research CenterPorto Alegre, Brazil
Active, not recruiting
Hospital da Universidade Federal de Minas GeraisBelo Horizonte, 30130-100, Brazil
Withdrawn
Hospital Ernesto DornellesPorto Alegre, 90160-093, Brazil
Active, not recruiting
UrobrasilSão Paulo, 01243-020, Brazil
Active, not recruiting
Cetus Oncologia Hospital DiaBelo Horizonte, 30150-270, Brazil
Completed
Chelyabinsk Regional Oncology DispensaryChelyabinsk, 454087, Russia
Active, not recruiting
Sverdlovsk Regional Clinical Hospital #1Yekaterinburg, 620102, Russia
Withdrawn
St. Petersburg Clinical Hospital of RASSt. Petersburg, 194017, Russian Federation
Withdrawn
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMSMoscow, 115478, Russian Federation
Active, not recruiting
Clinical Oncological Dispensary of Omsk RegionOmsk, 644013, Russia
Active, not recruiting
Republican Clinical Oncology DispensaryUfa, 450054, Russia
Active, not recruiting
AV Medical GroupSt. Petersburg, 196006, Russia
Active, not recruiting
Russian Scientific Radiology and Surgery Technologies CenterSt. Petersburg, 197758, Russia
Completed
Volga District Med Center FMBANizhny Novgorod, 603109, Russia
Active, not recruiting
Republican Clinical Oncology DispensaryUfa, 450054, Russia
Active, not recruiting
Arkhangelsk Clinical Oncology DispensaryArkhangelsk, 163045, Russia
Completed
LLC ReafanNovosibirsk, 630099, Russia
Active, not recruiting
Multi-Field Clinical Medical Center "Medical City"Tyumen, 625041, Russia
Active, not recruiting
Vologda Regional HospitalVologda, 160022, Russia
Completed
Ivanovo Regional Oncology DispensaryIvanovo, 153040, Russia
Completed
Republican Clinical Oncology Dispensary KazanKazan, 420029, Russia
Active, not recruiting
Ltd "EVIMED"Chelyabinsk, 454048, Russia
Active, not recruiting
Medical Center "Avicenna"Novosibirsk, 630099, Russia
Active, not recruiting
Research Centre of X-ray and RadiologyMoscow, 117997, Russia
Active, not recruiting
City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMADnipro, 49102, Ukraine
Active, not recruiting
Kyiv City Hospital #3 - Department of UrologyKyiv, 02660, Ukraine
Completed
Kyiv Regional Oncological DispensaryKyiv, 4107, Ukraine
Active, not recruiting
CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"Cherkasy, 18009, Ukraine
Active, not recruiting
The Hospital of Lithuanian University of Health SciencesLUHSKaunas, LT-50009, Lithuania
Active, not recruiting
National Cancer InstituteVilnius, LT-08660, Lithuania
Completed
PI Klaipedos University HospitalKlaipeda, LT-92288, Lithuania
Withdrawn
Tampereen yliopistollinen sairaala, keskussairaalaTampere, 33520, Finland
Withdrawn
HUS, Meilahden sairaalaHelsinki, 00290, Finland
Withdrawn
Oulun yliopistollinen sairaalaOulu, 90220, Finland
Withdrawn
Seinäjoen keskussairaalaSeinäjoki, 60220, Finland
Withdrawn
Docrates KlinikkaHelsinki, 00180, Finland
Completed
Taipei Veterans General HospitalTaipei, 11217, Taiwan
Active, not recruiting
Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, 807377, Taiwan
Active, not recruiting
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Completed
Changhua Christian HospitalChanghua, 50006, Taiwan
Active, not recruiting
AliadaSan Isidro, 15036, Peru
Active, not recruiting
Hospital Guillermo Almenara IrigoyenSantiago de Surco, 15033, Peru
Active, not recruiting
Hospital Militar Luis Arias SchreiberLima, LIMA 11, Peru
Active, not recruiting
Clínica El GolfLima, LIMA 27, Peru
Active, not recruiting
Daugavpils Regional HospitalDaugavpils, LV-5417, Latvia
Completed
URO Ltd.Riga, LV-1001, Latvia
Active, not recruiting
Vidzemes HospitalValmiera, LV-4201, Latvia
Active, not recruiting
P. Stradins Clinical University HospitalRiga, LV-1002, Latvia
Active, not recruiting
RAKUS Hospital GailezersRiga, 1038, Latvia
Active, not recruiting
Irmandade da Santa Casa de Misericordia de Porto Alegre | Hospital Sao Francisco - Centro Medico Pesquisa Clinica CardiologiaPorto Alegre, 90020-090, Brazil
Active, not recruiting
Vilnius University Hospital Santaros KlinikosVilnius, LT-08661, Lithuania
Completed
Sawami Man Singh (SMS) Medical College & Attached HospitalsJaipur, 302017, India
Active, not recruiting
Sparsh Hospital & Critical CareBhubaneswar, 751007, India
Completed
Tata Medical CenterKolkata, 700156, India
Completed
Regional Cancer Centre - ThiruvananthapuramThiruvananthapuram, 695011, India
Not yet recruiting
HCG Cancer Centre - AhmedabadAhmedabad, 380060, India
Completed
Healthcare Global Enterprises LtdBengaluru, 560027, India
Active, not recruiting
Curie Manavata Cancer CentreNashik, 422004, India
Recruiting
Christian Medical Center & HospitalLudhiana, 141008, India
Active, not recruiting
Rajiv Gandhi Cancer Institute & Research CentreNew Delhi, 110 085, India
Recruiting
Cancer Care Clinic - VadodaraVadodara, 390007, India
Active, not recruiting
All India Institute of Medical SciencesBhubaneswar, 751019, India
Withdrawn
Sushrut Hospital & Research CentreMumbai, 400 071, India
Active, not recruiting
Jehangir HospitalPune, 411001, India
Withdrawn
Tata Memorial HospitalMumbai,, 400012, India
Active, not recruiting
Macquarie University HospitalSydney, 2109, Australia
Active, not recruiting
Cancer Research South AustraliaAdelaide, 5000, Australia
Active, not recruiting
Fundacao Pio XII – Hospital de Cancer de BarretosBarretos/SP, 14784-400, Brazil
Active, not recruiting
Unidade de Pesquisas Clinicas em OncologiaPelotas, 96020-080, Brazil
Active, not recruiting
Assistência Multidisciplinar em Oncologia (AMO)Salvador, 41950-640, Brazil
Active, not recruiting
Mahatma Gandhi Cancer Hospital & Research InstituteVishakapatnam, 530017, India
Active, not recruiting
Centro de Estudios Clínicos SAGA SpAProvidencia, 7500653, Chile
Active, not recruiting
OncovidaSantiago, 7510032, Chile
Completed
Meenakshi Mission Hospital & Research CentreMadurai, 625107, India
Active, not recruiting
K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research CentreBelgaum, 590010, India
Active, not recruiting
National Cheng Kung University HospitalTainan, 704, Taiwan
Active, not recruiting
Scientific Research Instutute of Oncology n.a. N.N. PetrovSt. Petersburg, 197758, Russia
Completed
Jaslok Hospital and Research CentreMumbai, 400026, India
Active, not recruiting
Amrita Institute of Medical SciencesKochi, 682 041, India
Completed
The Gujarat Cancer & Research InstituteAhmedabad, 380016, India
Active, not recruiting
Apollo Speciality HospitalsMadurai, 625020, India
Active, not recruiting
Post Graduate Institute of Medical Education and ResearchChandigarh, 160012, India
Completed
Jawaharlal Institute Of Postgraduate Medical Education and RGorimedu, 605006, India
Active, not recruiting
Marathwada Regional Cancer Centre and Research InstituteAurangabad, 431001, India
Completed
Apex Wellness HospitalNashik, 422009, India

Primary Outcome

  • Radiological progression-free survival (rPFS) assessed by central review
    rPFS used conventional imaging method (99mTc-phosphonate bone scan, CT/MRI scan). rPFS was defined as the time from the date of randomization to the date of progressive disease in malignant soft tissue lesions, progressive disease in malignant bone lesions, or death due to any cause, whichever occurs first. Malignant soft tissue lesions were assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and malignant bone lesions were assessed by Prostate Cancer Clinical Trials Working Group (PCWG3) criteria.
    date_rangeTime Frame:
    From randomization to the date when 222 rPFS events were observed, approximately 36 months

Secondary Outcome

  • Overall survival (OS)
    Time from the date of randomization to the date of death from any cause.
    date_rangeTime Frame:
    From randomization to the date when 222 rPFS events were observed, approximately 36 months
  • Time to castration–resistant prostate cancer (CRPC)
    Time from the date of randomization to the date of first castration resistant event (radiological progression, Prostate-specific antigen (PSA) progression or symptomatic skeletal events, whichever occurs first).
    date_rangeTime Frame:
    From randomization to the date when 222 rPFS events were observed, approximately 36 months
  • 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.
    date_rangeTime Frame:
    From randomization to the date when 222 rPFS events were observed, approximately 36 months
  • Time to PSA progression
    Time from the date of randomization to the date of first prostate-specific antigen (PSA) progression. PSA progression with serum testosterone being at castrate level <0.50 ng/mL, is defined as a ≥25% increase above the nadir (lowest at or after baseline) value and an increase in absolute value of ≥2 ng/mL above nadir, and is at least 12 weeks from randomization date, which is confirmed by a second value 3 or more weeks later. All PSA values between the initial assessment meeting the PSA progression criteria and confirmation assessment must be ≥2 ng/mL and ≥25% increase above nadir, serum testosterone at castrate levels <0.50 ng/mL is requested at initial assessment.
    date_rangeTime Frame:
    From randomization to the date when 222 rPFS events were observed, approximately 36 months
  • PSA undetectable rates (<0.2 ng/mL)
    Percentage of subjects with detectable PSA values of ≥0.2 ng/mL at baseline which became undetectable with any PSA values <0.2 ng/mL during the period between randomization and 30 days after last dose of study drug or start of new anti-cancer therapy whichever occurred earliest, based on the subjects had detectable PSA value at baseline.
    date_rangeTime Frame:
    From randomization to the date when 222 rPFS events were observed, approximately 36 months
  • Time to pain progression
    Pain progression was assessed by Question 3 (Q3) of the BPI–SF questionnaire related to the worst pain in the last 24 hours (worst pain subscale [WPS]) taken as an average for post baseline score, or initiation of short or long-acting opioids for malignant disease for ≥7 consecutive days after randomization. Pain progression was defined as: (1) for asymptomatic subjects with WPS=0 at baseline, an increase of 2 or more points in the WPS score from nadir observed at 2 consecutive evaluations ≥4 weeks apart, or initiation of short- or long-acting opioid use for malignant disease for ≥7 consecutive days after randomization; (2) for symptomatic subjects with WPS >0 at baseline, an increase of 2 or more points in the WPS score from nadir observed at 2 consecutive evaluations ≥4 weeks apart and a WPS ≥5, or initiation of short- or long-acting opioid use for malignant disease for ≥7 consecutive days after randomization.
    date_rangeTime Frame:
    From randomization to the date when 222 rPFS events were observed, approximately 36 months
  • Number of participants with adverse events as a measure of safety
    An AE is any untoward medical occurrence in a patient or clinical study participant, after providing written IC for participation in the study, may or may not be temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AE (TEAE) is defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug.
    date_rangeTime Frame:
    From start of study drug administration until 30 days after the last administration

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

Additional Information

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