account_circleRecruiting

Biochemically recurrent prostate cancer

A study to compare darolutamide given with Androgen Deprivation Therapy (ADT) with ADT in men with hormone sensitive prostate cancer and raise of Prostate Specific Antigen (PSA) levels after local therapies

Trial purpose

Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer.

BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat.

In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments.

The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months.

To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells.

To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy.

During the study, the study team will:
•   take blood and urine samples.
•   measure PSA and testosterone levels in the blood samples
•   do physical examinations
•   check the participants’ overall health
•   examine heart health using electrocardiogram (ECG)
•   check vital signs
•   check cancer status using PSMA PET/CT scans, CT, MRI and bone scans
•   take tumor samples (if required)
•   ask the participants if they have medical problems

About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - Capable of giving signed informed consent as described which includes compliance with the requirements, restrictions listed in the informed consent form (ICF), and in this protocol.
    - Male ≥18 years of age at the time of signing the informed consent.
    - Histologically or cytologically confirmed adenocarcinoma of prostate.
    - Prostate cancer initially treated by: radical prostatectomy (RP) followed by adjuvant radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participants who are unfit for (or refused) ART or SRT, or primary radiotherapy (RT).
    - High-risk biochemical recurrence (BCR), defined as Prostate-specific antigen doubling time (PSADT) <12 months calculated using the formula provided by the Sponsor, and PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT (local or central values accepted), or PSA ≥2 ng/mL above the nadir after primary RT only (local or central values accepted).
    - Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 42-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by blinded independent central review (BICR) to identify at least one PSMA PET/CT lesion of prostate cancer.
    - Serum testosterone ≥150 ng/dL (5.2 nmol/L) (local assessment is allowed whenever central assessment cannot be done).
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    - Blood counts at screening: Hemoglobin ≥9.0 g/dL (participant must not have received blood transfusion within 7 days prior to sample being taken); Absolute neutrophil count (ANC) ≥1.5x10^9/L (participant must not have received any growth factor within 4 weeks prior to sample being taken); Platelet count ≥100x10^9/L.
    - Screening values of: Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤1.5 x ULN; Total bilirubin (TBL) ≤1.5 ULN, (except participants with a diagnosis of Gilbert’s disease); Estimated glomerular filtration rate (eGFR) >40 ml/min/1.73 m^2 calculated by the CKD-EPI formula.
    - Sexually active male participants must agree to use contraception as detailed in the protocol during the Treatment period and for at least 1 week after the last dose of study treatment, and refrain from donating sperm during this period.
  • - Pathological finding consistent with small cell, ductal or ≥50 % component of neuroendocrine carcinoma of the prostate.
    - History of bilateral orchiectomy.
    - Metastases or recurrent /new malignant lesions in prostate gland/bed seminal vesicles, lymph nodes below the CIA bifurcation on conventional imaging (CI) as assessed by BICR during screening.
    - Brain metastasis on PSMA PET /CT by BICR at screening.
    - High-risk BCR after primary radiotherapy with new loco-regional lesions on screening PSMA PET/CT who are eligible for curative salvage prostatectomy.
    Note: Participants treated with curative salvage prostatectomy after primary RT who meet the PSA criteria (inclusion criteria 5) may be considered for the study.
    - Prior treatment with second generation (e.g. enzalutamide, apalutamide) androgen receptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18 months prior to signing of the ICF.
    - Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization.
    - Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or salvage treatment completed within 8 weeks prior to signing of the ICF.
    - 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.
    - History of pelvic radiotherapy for other malignancy.

Trial summary

Enrollment Goal
750
Trial Dates
April 2023 - March 2030
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Darolutamide+ADT (BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für OnkologieWien, 1090, Austria
Recruiting
Ordensklinikum Linz GmbH ElisabethinenLinz, 4020, Austria
Recruiting
Krankenhaus der Barmherzigen BrüderVienna, 1020, Austria
Active, not recruiting
Dana-Farber Cancer InstituteBoston, 02215, United States
Recruiting
Carolina Urological Research CenterMyrtle Beach, 29579, United States
Recruiting
Colorado Urology - St. Anthony Hospital CampusLakewood, 80228, United States
Recruiting
Urology San Antonio, PA dba USA Clinical TrialsSan Antonio, 78229, United States
Not yet recruiting
White Plains HospitalWhite Plains, 10601, United States
Withdrawn
First Urology PSCJeffersonville, 47130, United States
Terminated
Tower Urology, IncLos Angeles, 90048, United States
Withdrawn
MidLantic Urology - Bala CynwydBala Cynwyd, 19004, United States
Recruiting
Alliance Urology SpecialistsGreensboro, 27403, United States
Withdrawn
Ohio State University Wexner Medical CenterColumbus, 43210, United States
Withdrawn
Arizona Institute of UrologyTucson, 85704, United States
Withdrawn
New Jersey Urology, LLCVoorhees, 08043, United States
Withdrawn
Associated Medical Professionals of NY, PLLCSyracuse, 13210, United States
Withdrawn
Urological Associates of LancasterLancaster, 17604, United States
Withdrawn
Bon Secours St. Francis HospitalGreenville, 29607, United States
Withdrawn
University of Florida - JacksonvilleJacksonville, 32209, United States
Recruiting
Barbara Ann Karmanos Cancer Institute - Detroit HeadquartersDetroit, 48201, United States
Recruiting
University of KansasKansas City, 66160, United States
Recruiting
University of Southern CaliforniaLos Angeles, 90033, United States
Recruiting
University of California, Los AngelesLos Angeles, 90095, United States
Withdrawn
Comprehensive Cancer CenterChicago, 60637, United States
Completed
NYU Langone HealthMineola, 11501, United States
Recruiting
University of Texas MD Anderson Cancer CenterHouston, 77030, United States
Withdrawn
Urology of Indiana, LLCGreenwood, 46143, United States
Recruiting
Sidney Kimmel Comprehensive Cancer Center - Johns HopkinsBaltimore, 21231, United States
Withdrawn
Urology Austin, PLLC (an affiliate of Urology America)Austin, 78745, United States
Withdrawn
Clermont Oncology CenterClermont, 34711, United States
Recruiting
Mayo Clinic HospitalPhoenix, 85054, United States
Withdrawn
Wake Forest Baptist HealthWinston Salem, 27157, United States
Withdrawn
Mid Florida Cancer CentersOrange City, 32763-8316, United States
Withdrawn
Jesse Brown VA Medical CenterChicago, 60612, United States
Withdrawn
University of PittsburghPittsburgh, 15232, United States
Withdrawn
The Urology GroupCincinnati, 45212, United States
Not yet recruiting
UCSF Med Center Helen Diller Family Comp Cancer CenterSan Francisco, 94143, United States
Recruiting
City of Hope - Duarte Cancer CenterDuarte, 91010, United States
Completed
Washington University School of Medicine - Center for Advanced Medicine (CAM)Saint Louis, 63110-1032, United States
Recruiting
Institut de Cancerologie de l'Ouest - Saint Herblain - Unite de therapie precoceSaint Herblain, 44800, France
Recruiting
Gustave Roussy - Departement Oncologie-RadiotherapieVillejuif, 94800, France
Recruiting
Hôpital Pellegrin - BordeauxBORDEAUX cedex, 33076, France
Withdrawn
Hopital Bichat - ParisParis, 75018, France
Recruiting
HCL - Centre Hospitalier Lyon SudPIERRE BENITE, 69495, France
Recruiting
Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied - Service UrologieClermont Ferrand, 63003, France
Recruiting
Hopital Claude Huriez - Lille - UrologieLille, 59000, France
Recruiting
Hôpital PontchaillouRENNES CEDEX, 35033, France
Recruiting
Uniklinikum Salzburg - LandeskrankenhausSalzburg, 5020, Austria
Recruiting
East and North Hertfordshire NHS Trust - Mount Vernon Hospital - Mount Vernon Cancer Centre (MVCC)Northwood, HA6 2RN, United Kingdom
Recruiting
Royal Marsden Hospital (London)London, SW3 6JJ, United Kingdom
Recruiting
Charing Cross HospitalLondon, W6 8RF, United Kingdom
Recruiting
University of Minnesota Medical CenterMinneapolis, 55455, United States
Withdrawn
University of California Irvine Medical CenterOrange, 92868-3201, United States
Recruiting
Northwestern University Feinberg School of Medicine - Department of UrologyChicago, 60611, United States
Withdrawn
Michigan Institute of Urology, PCTroy, 48084, United States
Recruiting
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Recruiting
Hospital Universitario Puerta del MarCadiz, 11009, Spain
Recruiting
MD Anderson International Espanya, S.A.Madrid, 28033, Spain
Recruiting
Hospital Universitario Virgen de la Victoria | Cardiology DepartmentMalaga, 29010, Spain
Recruiting
Hospital del MarBarcelona, 08003, Spain
Recruiting
Hospital Clínic i Provincial de BarcelonaBarcelona, 8036, Spain
Recruiting
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Recruiting
Hospital Fundació PuigvertBarcelona, 08025, Spain
Recruiting
Instituto Valenciano de OncologíaValencia, 46009, Spain
Recruiting
Hospital Universitari i Politècnic La FeValencia, 46009, Spain
Recruiting
Hospital Universitario Ramon y CajalMadrid, 28034, Spain
Recruiting
H. General Uiversitario Morales Meseguer - Department of UrologyMurcia, 30008, Spain
Recruiting
Centro Integral Oncológico Clara CampalMadrid, 28050, Spain
Recruiting
Princess Margaret Cancer Centre - UHNToronto, M5G 2M9, Canada
Recruiting
St. Joseph's Healthcare - HamiltonHamilton, L8N 4A6, Canada
Recruiting
Sir Mortimer B. Davis Jewish General Hospital - Radiation OncologyMontreal, H3T 1E2, Canada
Recruiting
Vancouver Prostate CentreVancouver, V5Z 1M9, Canada
Recruiting
Prostate Cancer CentreCalgary, T2V 1P9, Canada
Recruiting
Hopital Hotel-Dieu de LevisQuebec, G6V 3Z1, Canada
Recruiting
BC Cancer - VictoriaVictoria, V8R 6V5, Canada
Withdrawn
Rambam Health CorporationHaifa, 3109601, Israel
Withdrawn
Hadassah Hebrew University Hospital Ein KeremJerusalem, 9112001, Israel
Withdrawn
Rabin Medical Center | Beilinson Hospital - Internal Medicine C DepartmentPetah Tikva, 4941492, Israel
Withdrawn
Macquarie University HospitalMacquarie University, 2109, Australia
Withdrawn
GenesisCare NewcastleNewcastle, 2290, Australia
Not yet recruiting
Prince of Wales Hospital NSWSydney, 2031, Australia
Withdrawn
St Vincents Hospital SydneySydney, 2010, Australia
Recruiting
Austin HealthHeidelberg, 3084, Australia
Recruiting
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy CentreLiverpool, NSW 2170, Australia
Recruiting
Sydney Adventist HospitalWahroonga, 2076, Australia
Withdrawn
Port Macquarie Base HospitalPort Macquarie, 2444, Australia
Recruiting
Epworth HealthCareEast Melbourne, 3002, Australia
Withdrawn
Tasman Health CareSouthport, 4215, Australia
Recruiting
Instituto Portugues de Oncologia de Lisboa | Unidade de Investigacao Clinica - Departamento de UrologiaLisbon, 1099-023, Portugal
Not yet recruiting
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao ClinicaLisboa, 1500-650, Portugal
Recruiting
University College London Hospitals NHS Foundation TrustLondon, NW1 2PG, United Kingdom
Withdrawn
Bedford Hospital - Bedfordshire Hospitals NHS Foundation TruBedford, MK42 9DJ, United Kingdom
Recruiting
Canterbury Urology Research TrustChristchurch, 8013, New Zealand
Recruiting
Auckland City HosptialAuckland, 1023, New Zealand
Recruiting
Tauranga Urology Research LimitedTauranga, 3112, New Zealand
Recruiting
Assistência Multidisciplinar em Oncologia (AMO)Salvador, 41950-640, Brazil
Recruiting
Instituto do Cancer do Estado de Sao PauloSão Paulo, 01246-000, Brazil
Recruiting
Faculdade de Medicina do ABCSanto André, 09060-650, Brazil
Recruiting
Inst. de Assistência Médica ao Sérvidor Público EstadualSão Paulo, 04039-004, Brazil
Recruiting
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa ClínicaNatal, 59040-000, Brazil
Recruiting
Hospital Sirio LibanesSao Paulo, 01308-050, Brazil
Recruiting
Liga Paranaense de Combate ao Cancer-Hosp Erasto GaertnerCuritiba, 81520-060, Brazil
Not yet recruiting
Universitaetsklinikum MuensterMünster, 48149, Germany
Not yet recruiting
Klinikum rechts der IsarMünchen, 81675, Germany
Recruiting
Universitätsmedizin der Georg-August-Universität GöttingenGoettingen, 37075, Germany
Not yet recruiting
Universitätsklinikum KölnKöln, 50937, Germany
Recruiting
Klinikum der Universität WürzburgWurzburg, 97080, Germany
Recruiting
Städtisches Klinikum Braunschweig gGmbHBrunswick, 38126, Germany
Not yet recruiting
Medizinische Fakultät der Otto-von-Guericke UniversitätMagdeburg, 39120, Germany
Recruiting
Universitätsklinikum der Johann Wolfgang Goethe UniversitätFrankfurt, 60590, Germany
Recruiting
Studienpraxis UrologieNürtingen, 72622, Germany
Recruiting
ICANS - Institut de Cancerologie de Strasbourg EuropSTRASBOURG, 67033, France
Not yet recruiting
Hopital BretonneauTours, 37044, France
Recruiting
Institute of Science Tokyo HospitalBunkyo-ku, 113-8519, Japan
Recruiting
Kyoto University HospitalKyoto, 606-8507, Japan
Recruiting
Hokkaido University HospitalSapporo, 060-8648, Japan
Recruiting
Kanazawa University HospitalKanazawa, 920-8641, Japan
Recruiting
Osaka University HospitalSuita, 565-0871, Japan
Recruiting
Yokohama City University HospitalYokohama, 236-0004, Japan
Withdrawn
Kagoshima University HospitalKagoshima, 890-8520, Japan
Recruiting
Ospedale San Raffaele s.r.l - UrologiaMilano, 20132, Italy
Withdrawn
A.O.U.I. VeronaVerona, 37134, Italy
Withdrawn
A.O.U. Consorziale PoliclinicoBari, 70124, Italy
Recruiting
Azienda Ospedaliero Universitaria di Modena_Policlinico - OncologiaModena, 41124, Italy
Recruiting
Centro di Riferimento Oncologico di Aviano - Oncologia RadioterapicaAviano, 33081, Italy
Recruiting
A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Radioterapia OncologicaPerugia, 06129, Italy
Recruiting
IRCCS Ospedale Policlinico San Martino - Oncologia Medica 1Genova, 16132, Italy
Recruiting
Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia MedicaTrento, 38122, Italy
Recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Oncologia Clinica Sperimentale Uro-GinecologicaNapoli, 80131, Italy
Recruiting
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia ProvincialeReggio Emilia, 42123, Italy
Withdrawn
Fondazione IRCCS Istituto Nazionale dei TumoriMilano, 20133, Italy
Recruiting
A.O.U. Città della Salute e della Scienza di Torino_Molinette - Urologia UTorino, 10126, Italy
Recruiting
I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena - UrologiaRoma, 00128, Italy
Recruiting
Azienda Unita Sanitaria Locale Di Bologna_Ospedale Bellaria - Oncologia MedicaBologna, 40139, Italy
Recruiting
Virgen del Rocio University Hospital - Oncology DepartmentSevilla, 41013, Spain
Withdrawn
Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao ClinicaLisboa, 1400-038, Portugal
Recruiting
Hospital Santa Maria | Centro de Investigacao ClinicaLisboa, 1649-035, Portugal
Recruiting
Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research CenterLisboa, 1350-352, Portugal
Withdrawn
Centro Clinico Academico Braga | Braga, PortugalBraga, 4710-243, Portugal
Withdrawn
Hospital Israelita Albert Einstein | Morumbi - Clinical Research DepartmentSao Paulo, 05651-901, Brazil
Recruiting
Hospital Moinhos de Vento-Centro ClínicoPorto Alegre, 90035-001, Brazil
Withdrawn
Docrates KlinikkaHelsinki, 00180, Finland
Recruiting
Turun yliopistollinen keskussairaalaTurku, 20520, Finland
Recruiting
Oulun yliopistollinen sairaalaOulu, 90220, Finland
Recruiting
HUS, Meilahden sairaalaHelsinki, 00029, Finland
Recruiting
Tampereen yliopistollinen sairaalaTampere, 33520, Finland
Recruiting
Royal Surrey County HospitalGuildford, GU2 7XX, United Kingdom
Not yet recruiting
Institut Curie - Ulm - ParisPARIS cedex 5, 75248, France
Recruiting
Center Hospitalier Michallon - Grenoble - Service d Urologie et de la transplantation RenaleLa Tronche, 38700, France
Not yet recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti_Foggia - Oncologia Medica e Terapia Biomolecolare UniversitariaFoggia, 71122, Italy
Recruiting
Chris O'Brien LifehouseCamperdown, 2050, Australia
Recruiting
Eastern Clinical Research Unit - Box HillBox Hill, 3128, Australia
Withdrawn
Bundaberg Hospital, Genesis Cancer Care - BundabergBundaberg, 4670, Australia
Withdrawn
Wide Bay Hospital and Health Service - Hervey Bay HospitalPialba, 4655, Australia
Recruiting
Medizinische Universität InnsbruckInnsbruck, 6020, Austria
Withdrawn
Shaare Zedek Medical CenterJerusalem, 9372212, Israel
Withdrawn
Sheba Medical CenterTel Hashomer, 52621, Israel
Withdrawn
Sourasky Medical CenterTel-Aviv, 64239, Israel
Recruiting
The Urology PlaceSan Antonio, 78240, United States
Recruiting
Istituto Oncologico Veneto_Castelfranco Veneto - UOC Urologia OncologicaCastelfranco Veneto, 31033, Italy
Withdrawn
IRCCS Ospedale Sacro Cuore Don CalabriaVerona, 37024, Italy
Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - OncologiaBergamo, 24127, Italy
Recruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata - UOC RadioterapiaRoma, 00133, Italy
Recruiting
Klinikum Mannheim GmbHMannheim, 68135, Germany
Recruiting
Allegheny General HospitalPittsburgh, 15212, United States
Recruiting
Humanitas Mirasole S.p.A. - Oncologia Medica ed EmatologiaRozzano, 20089, Italy
Not yet recruiting
Vivantes Klinikum Am UrbanBerlin, 10967, Germany
Recruiting
Skane University Hospital - Department of UrologyMalmo, 20502, Sweden
Recruiting
Goteborgs UniversitetGothenburg, 413 45, Sweden
Recruiting
Rigshospitalet - KræftbehandlingKøbenhavn Ø, 2100, Denmark
Withdrawn
Charité Campus Benjamin Franklin (CBF)Berlin, 12203, Germany
Recruiting
Universitätsklinikum Carl Gustav Carus an der Technischen Universität DresdenDresden, 1307, Germany
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Degenza di Radioterapia OncologicaRoma, 00168, Italy
Recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UrologiaBologna, 40138, Italy
Recruiting
Aarhus UniversitetshospitalAarhus N, 8200, Denmark
Recruiting
Aalborg University HospitalAalborg, 9000, Denmark
Not yet recruiting
London Health Sciences Centre (LHSC) - London Regional Cancer Program (LRCP)London, N6A 5W9, Canada
Not yet recruiting
Cabrini MalvernMalvern, 3144, Australia
Recruiting
Fudan University Shanghai Cancer CenterShanghai, 200000, China
Recruiting
Peking Union Medical College Hospital (PUMCH) - East LocationBeijing, 100730, China
Recruiting
The 1st Affiliated Hospital of Zhejiang UniversityHangzhou, 310003, China
Withdrawn
New Jersey Urology (NJU)Saddle Brook, 07663-5227, United States
Recruiting
Nova Scotia Health AuthorityHalifax, B3H 2Y9, Canada
Recruiting
Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital FleurimontSherbrooke, J1H 5N4, Canada
Recruiting
Institut de Cancerologie Jean Godinot - Departement oncologie medicaleReims, 51056, France
Recruiting
Nanjing First HospitalNanjing, 210006, China
Recruiting
Marien-Krankenhaus Bergisch GladbachBergisch Gladbach, 51465, Germany
Recruiting
Chesapeake Urology Associates - TowsonBaltimore, 21204, United States
Withdrawn
Spokane Urology PSSpokane, 99202, United States
Recruiting
Urology Cancer Center, PCOmaha, 68130, United States
Withdrawn
UMass Memorial Medical Center - University CampusWorcester, 01655-0002, United States
Withdrawn
VA Pittsburgh Healthcare SystemPittsburgh, 15240, United States
Withdrawn
Westmead HospitalWestmead, 2145, Australia
Not yet recruiting
Universitaetsklinikum Jena - Klinik fuer UrologieJena, 7747, Germany
Not yet recruiting
Royal Melbourne HospitalParkville, 3050, Australia
Not yet recruiting
Institut Curie - Saint-CloudSaint-Cloud, 92210, France
Withdrawn
Uppsala University Hospital, Urology DepartmentUppsala, SE-751, Sweden
Recruiting
Hopital Maisonneuve-RosemontMontreal, H1T 2M4, Canada
Withdrawn
Ruijin Hosp. Shanghai Jiaotong Univ.School of MedicineShanghai, 200025, China
Recruiting
Zhongnan hospital ,Wuhan UniversityWuhan, 430071, China
Recruiting
West China Hospital,Sichuan UniversityChengdu, 610041, China
Recruiting
BC Cancer - AbbotsfordAbbotsford, V2S 0C2, Canada
Not yet recruiting
The Affiliated Hospital of Inner Mongolia Medical UniversityHohehot, 010030, China
Recruiting
Tianjin Cancer Hospital, Airport HospitalTianjin, 300308, China
Recruiting
Swietokrzyskie Centrum OnkologiiKielce, 25-734, Poland
Recruiting
Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical UniversityNanjing, 210029, China
Recruiting
Hunan Cancer HospitalChangsha, 410013, China
Recruiting
Sir Charles Gairdner HospitalNedlands, 6009, Australia
Recruiting
National Taiwan University HospitalTaipei, 100, Taiwan
Recruiting
HagaZiekenhuis van Den HaagThe Hague, 2545, Netherlands
Not yet recruiting
Albert Schweitzer Hospital | Internal Medicine - Oncology DepartmentDordrecht, 3300 AK, Netherlands
Withdrawn
Catharina ZiekenhuisEINDHOVEN, 5623 EJ, Netherlands
Recruiting
University Medical Center Groningen | Urology DepartmentGRONINGEN, 9713 GZ, Netherlands
Recruiting
St. Franciscus GasthuisRotterdam, 3045 PM, Netherlands
Recruiting
St. Antonius Ziekenhuis | Utrecht - R&D Interne GeneeskundeNieuwegein, 3435 CM, Netherlands
Not yet recruiting
Tergooi MC | Hilversum - WetenschapsbureauHilversum, 1213 VG, Netherlands
Recruiting
UZ Gent - department UrologyGent, 9000, Belgium
Withdrawn
Institut Jules Bordet/Jules Bordet InstituutBruxelles, 1070, Belgium
Recruiting
AZ Groeninge Campus Kennedylaan - UrologyKortrijk, 8500, Belgium
Not yet recruiting
Jessa Hospital | Campus Virga Jesse - Data Management Oncology and Hematology DepartmentHasselt, 3500, Belgium
Recruiting
Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Urology DepartmentLeuven, 3000, Belgium
Not yet recruiting
Maria Middelares General Hospital | Medical Oncology DepartmentGent, 9000, Belgium
Not yet recruiting
Northern HospitalEpping, 3076, Australia
Recruiting
Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)Brno, 602 00, Czech Republic
Recruiting
Koo Foundation Sun Yet-Sen Cancer CentreTaipei, 112019, Taiwan
Recruiting
Chang Gung Memorial Hospital at LinkouTaoyuan, 33305, Taiwan
Not yet recruiting
Tungs' Taichung MetroHarbor HospitalTaichung, 435403, Taiwan
Recruiting
Fakultni Nemocnice Olomouc (FNOL) - Onkologicka KlinikaOlomouc, 779 00, Czech Republic
Not yet recruiting
Royal Brisbane & Women's HospitalBrisbane, 4029, Australia
Recruiting
Western UrologyMaribyrnong, 3032, Australia
Recruiting
Centrum Medyczne iMed24Krakow, 31-864, Poland
Recruiting
Medrise Sp. z o.o. Centrum Badan KlinicznychLublin, 20-582, Poland
Recruiting
Vseobecna fakultni nemocnice - Urologicka klinika, PrahaPraha 2, 128 08, Czech Republic
Recruiting
Fakultni nemocnice u Sv. Anny, Onkologicko-chirurgicke oddeleniBrno, 602 00, Czech Republic
Withdrawn
Multiscan s.r.o., Department: Ambulance klinické onkologie Nemocnice HoroviceHorovice, 26801, Czech Republic
Recruiting
Universitätsklinikum Hamburg-Eppendorf - Martini-Klinik am UKE GmbHHamburg, 20246, Germany
Recruiting
Centrum Onkologii im. Prof. Franciszka LukaszczykaBydgoszcz, 85-796, Poland
Recruiting
Barwon HealthGeelong, 3220, Australia
Recruiting
Szpital Grochowski im. dr.med. Rafala MasztakaWarszawa, 04-073, Poland
Not yet recruiting
Semmelweis Egyetem, Altalanos Orvostudomanyi Kar, Urologiai KlinikaBudapest, 1082, Hungary
Not yet recruiting
Budapesti Jahn Ferenc Del-pesti Korhaz es RendelointezetBudapest, 1204, Hungary
Not yet recruiting
Orszagos Onkologiai IntezetBudapest, 1122, Hungary
Recruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato KorhazGyor, 9024, Hungary
Recruiting
Budapesti Uzsoki Utcai KórházBudapest, 1145, Hungary
Not yet recruiting
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras TagkorhazNyiregyhaza, 4400, Hungary
Recruiting
EMC Instytut Medyczny SAWroclaw, 54-144, Poland
Withdrawn
Centro Hospitalar Universitario do PortoPorto, 4099-001, Portugal
Not yet recruiting
Centro Hospitalar e Universitario de Coimbra EPE (CHUC)Coimbra, 3004-561, Portugal
Recruiting
Marienhospital Herne UniversitätsklinikHerne, 44625, Germany
Not yet recruiting
Johannes Gutenberg-Universität Mainz - UrologieMainz, 55131, Germany
Recruiting
Medizinische Universitaet Graz - Klinische Abteilung für Onkologie - Innere MedizinGraz, 8036, Austria
Recruiting
Clinique ClementvilleMontpellier, 34070, France
Recruiting
Centre Georges Francois Leclerc Dijon - service de radiotherapieDIJON, 21079, France
Recruiting
Centre d' Oncologie du Pays Basque Clinique Belharra - Bayonne - Oncologie medicaleBayonne, 64100, France
Recruiting
Institut de Cancérologie de Lorraine - Alexis VautrinVandoeuvre-les-Nancy, 54519, France
Not yet recruiting
Blacktown HospitalBlacktown, 2148, Australia
Not yet recruiting
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Henri Mondor (Hopital Henri-Mondor)Creteil, 94000, France
Not yet recruiting
AP-HM - Hopital de la TimoneMARSEILLE, 13005, France
Recruiting
Royal Adelaide HospitalAdelaide, 5000, Australia
Not yet recruiting
University of Texas Southwestern Medical Center-Harold C. Simmons Comprehensive Cancer CenterDallas, 75235, United States
Recruiting
Kaye Edmonton Clinic - Dianne and Irving Kipnes Urology CentreEdmonton, T6G 1Z1, Canada
Recruiting
CISSS de l'Outaouais - Hopital de Gatineau - Centre de cancerolgieGatineau, J8P 7H2, Canada
Recruiting
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec - Radio-oncologieTrois-rivieres, G8Z 3R9, Canada
Recruiting
Urology South Shore Research - Research DepartmentGreenfield Park, J4V 2H3, Canada
Recruiting
MidCentral District Health Board (MDHB) - Palmerston North Hospital (PNH)TBC, 4414, New Zealand
Not yet recruiting
Real e Benemérita Associação Portuguesa de BeneficênciaSão Paulo, 01323-001, Brazil
Recruiting
Universidade Estadual do Rio de JaneiroRio de Janeiro, 20551-030, Brazil
Not yet recruiting
Hospital do Cancer de Sao Paulo - A. C. CamargoSao Paulo, 01525-001, Brazil
Not yet recruiting
Hospital Alemao Oswaldo CruzSao Paulo, 01327-001, Brazil
Withdrawn
Hospital Sirio Libanês - Hospital Base de BrasiliaBrasilia, 70200-730, Brazil
Not yet recruiting
Oncocentro - FortalezaFortaleza, 60135-237, Brazil
Not yet recruiting
Hospital São RafaelSalvador, 41253-190, Brazil
Withdrawn
Real Hospital PortuguêsRecife, 50070-160, Brazil
Recruiting
Urologicum DuisburgDuisburg, 47169, Germany
Recruiting
Urologische Gemeinschaftspraxis WeselWesel, 46483, Germany
Recruiting
Hopital de La Louvière - Site Jolimont - Oncology departmentLa Louvière, 7100, Belgium
Recruiting
Fakultni nemocnice v Motole, Onkologicka klinika 2. LF UK a FN MotolPrague, 15006, Czech Republic
Not yet recruiting
Klinikum Stuttgart / Klinik für Urologie und TransplantationschirurgieStuttgart, 70174, Germany
Not yet recruiting
Universitätsklinikum Schleswig-Holstein/ Klinik für UrologieKiel, 24105, Germany
Not yet recruiting
Universitätsklinikum Aachen / Klinik und Poliklinik für Urologie und KinderurologieAachen, 52074, Germany
Recruiting
Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale BlancheBrest, 29609, France
Recruiting
Institut de Cancérologie de BourgogneDijon, 21000, France
Recruiting
Centre Bourgogne - Hôpital Privé Le BoisLILLE, 59000, France
Recruiting
Centre Hospitalier Regional et Universitaire (CHRU) de Besancon - L'Hopital Jean MinjozBesancon, 25000, France
Recruiting
UNICANCER - Centre Leon-Berard (CLB) - Medical oncologyLyon, 69008, France
Not yet recruiting
Institut Claudius Regaud - iUCT OncopoleTOULOUSE CEDEX 9, 31059, France
Recruiting
Cliniche Gavazzeni S.p.A - Dipartimento Area Chirurgia Unità Operativa di UrologiaBergamo, 24125, Italy
Not yet recruiting
Hospital Universitario "Marqués de Valdecilla"Santander, 39008, Spain
Recruiting
Sjællands University hospital NæstvedNæstved, 4700, Denmark
Recruiting
Thomayerova Nemocnice (TN) (Thomayers Hospital) - Onkologicka Klinika 1. LF UK A TNPrague, 140 59, Czech Republic
Not yet recruiting
Instituto D'Or Pesquisa e Ensino (IDOR) (D'Or Institute for Research & Education) - Rio de JaneiroRio de Janeiro, 22281-100, Brazil
Not yet recruiting
Hospital das Clínicas da Universidade de Campinas - UNICAMPSão Paulo, 13083-888, Brazil
Recruiting
Peking University First HospitalBeijing, 100034, China
Not yet recruiting
Hospital Evangélico de Cachoeiro de ItapemirimVitória, 29047-660, Brazil
Not yet recruiting
City of Hope - Phoenix Cancer CenterGoodyear, 85338, United States
Not yet recruiting
Hospital Mae de DeusPorto Alegre, 90850-170, Brazil
Not yet recruiting
NAIC - Instituto do CancerBauru, 17033-490, Brazil
Not yet recruiting
Icahn School of Medicine at Mount Sinai - OncologyNew York, 10029, United States
Not yet recruiting
Azienda Ospedaliera Santa Croce e Carle - OncologiaCuneo, 12100, Italy
Not yet recruiting
Australian Prostate CentreNorth Melbourne, 3051, Australia

Primary Outcome

  • Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)
    date_rangeTime Frame:
    After randomization to after last treatment, approximately 24 months

Secondary Outcome

  • Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR
    date_rangeTime Frame:
    After randomization to after last treatment, approximately 46 months
  • Time to Castration-resistant prostate cancer (CRPC) assessed by investigator
    date_rangeTime Frame:
    After randomization to after last treatment, approximately 46 months
  • Time to initiation of first subsequent systemic antineoplastic therapy
    date_rangeTime Frame:
    After randomization to after last treatment, approximately 46 months
  • Time to loco-regional progression by PSMA PET/CT
    date_rangeTime Frame:
    After randomization to after last treatment, approximately 46 months
  • Time to first Symptomatic skeletal event (SSE)
    date_rangeTime Frame:
    After randomization to after last treatment, approximately 46 months
  • Overall survival (OS)
    date_rangeTime Frame:
    After randomization to after last treatment, approximately 46 months
  • Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL)
    date_rangeTime Frame:
    After randomization to after last treatment, approximately 46 months
  • Time to deterioration in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score
    FACT-P is a multidimension, selfreport QoL instrument specifically designed for patients with prostate cancer. It consists of 39 questions items, made up by 2 parts: the 27 questions for functional assessment of cancer therapy general (FACT-G) and 12 prostate cancer subscale questions. It assesses 4 main domains which are: physical (n=7), social/family (n=7), emotional (n=6) and functional wellbeing (n=7).
    date_rangeTime Frame:
    After randomization to after last treatment, approximately 24 months
  • Time to symptomatic progression
    date_rangeTime Frame:
    After randomization to after last treatment, approximately 46 months
  • Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severity
    date_rangeTime Frame:
    After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months
  • Number of participants who discontinue study treatment due to a TEAE
    date_rangeTime Frame:
    After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months

Trial design

A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2