A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies
ARASTEP
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
2 other identifiers
interventional
985
22 countries
220
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2023
Longer than P75 for phase_3
220 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 29, 2030
April 17, 2026
April 1, 2026
4.3 years
March 21, 2023
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
After randomization to after last treatment, approximately 24 months
Secondary Outcomes (11)
Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR
After randomization to after last treatment, approximately 46 months
Time to Castration-resistant prostate cancer (CRPC)
After randomization to after last treatment, approximately 46 months
Time to initiation of first subsequent systemic antineoplastic therapy
After randomization to after last treatment, approximately 46 months
Time to loco-regional progression by PSMA PET/CT
After randomization to after last treatment, approximately 46 months
Time to first Symptomatic skeletal event (SSE)
After randomization to after last treatment, approximately 46 months
- +6 more secondary outcomes
Study Arms (2)
Darolutamide+ADT
EXPERIMENTALParticipants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months.
Placebo+ADT
PLACEBO COMPARATORParticipants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months.
Interventions
Luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonists
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (226)
Mayo Clinic Hospital - Phoenix - Cardiology
Phoenix, Arizona, 85054, United States
City of Hope - Duarte Cancer Center
Duarte, California, 91010, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Tower Urology
Los Angeles, California, 90048, United States
UCLA Clark Urology Center
Los Angeles, California, 90095, United States
UCSF Bakar Precision Cancer Medicine Building - Genitourinary
San Francisco, California, 94143, United States
Colorado Urology - St. Anthony Hospital Campus
Lakewood, Colorado, 80228, United States
Northwestern Medicine - Urology
Chicago, Illinois, 60611, United States
The University of Kansas Cancer Center - Richard and Annette Bloch Radiation Oncology Pavilion
Kansas City, Kansas, 66160, United States
Chesapeake Urology Associates - Towson
Baltimore, Maryland, 21204, United States
Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins
Baltimore, Maryland, 21231, United States
Dana-Farber Cancer Institute - Oncology Department
Boston, Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute - Detroit Headquarters
Detroit, Michigan, 48201, United States
M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine - Center for Advanced Medicine (CAM)
St Louis, Missouri, 63110-1032, United States
XCancer Omaha
Omaha, Nebraska, 68130, United States
NYU Langone Health
Mineola, New York, 11501, United States
Icahn School of Medicine at Mount Sinai - Oncology
New York, New York, 10029, United States
Alliance Urology Specialists
Greensboro, North Carolina, 27403, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Carolina Urological Research Center
Myrtle Beach, South Carolina, 29579, United States
University Hospital Simmons Cancer Center Genitourinary Clinic
Dallas, Texas, 75235, United States
The University of Texas MD Anderson Cancer Center - Texas Medical Center
Houston, Texas, 77030, United States
USA Clinical Trials
San Antonio, Texas, 78229, United States
The Urology Place
San Antonio, Texas, 78240, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Northern Hospital
Epping, New South Wales, 3076, Australia
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
Liverpool, New South Wales, 2170, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Eastern Clinical Research Unit - Box Hill
Box Hill, Victoria, 3128, Australia
Epworth HealthCare
East Melbourne, Victoria, 3002, Australia
Barwon Health
Geelong, Victoria, 3220, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Western Urology
Maribyrnong, Victoria, 3032, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Medizinische Universität Wien- Universitätsklinik für Urologie
Vienna, State of Vienna, 1090, Austria
Uniklinikum Salzburg - Landeskrankenhaus
Vienna, State of Vienna, 1090, Austria
Medizinische Universitaet Graz - Klinische Abteilung für Onkologie - Innere Medizin
Salzburg, Styria, 5020, Austria
Medizinische Universität Innsbruck
Innsbruck, Tyrol, 6020, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020, Austria
Krankenhaus der Barmherzigen Brüder
Vienna, Upper Austria, 4020, Austria
Maria Middelares General Hospital | Medical Oncology Department
Ghent, 9000, Belgium
UZ Gent - department Urology
Ghent, 9000, Belgium
Jessa Hospital | Campus Virga Jesse - Data Management Oncology and Hematology Department
Hasselt, 3500, Belgium
AZ Groeninge Campus Kennedylaan - Urology
Kortrijk, 8500, Belgium
Hopital de La Louvière - Site Jolimont - Oncology department
La Louvière, 7100, Belgium
Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Urology Department
Leuven, 3000, Belgium
Oncocentro - Fortaleza
Fortaleza, Ceará, 60135-237, Brazil
Assistência Multidisciplinar em Oncologia (AMO)
Salvador, Estado de Bahia, 41950-640, Brazil
Hospital Moinhos de Vento-Centro Clínico
Uberlândia, Minas Gerais, 90035-001, Brazil
Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
Natal, Rio Grande do Norte, 59040-000, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90850-170, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, 01246-000, Brazil
Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, São Paulo, 01323-001, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01327-001, Brazil
Hospital do Cancer de Sao Paulo - A. C. Camargo
São Paulo, São Paulo, 01525-001, Brazil
Inst. de Assistência Médica ao Sérvidor Público Estadual
São Paulo, São Paulo, 04039-004, Brazil
Hospital das Clínicas da Universidade de Campinas - UNICAMP
São Paulo, São Paulo, 13083-888, Brazil
Hospital São Rafael
São Paulo, São Paulo, 41253-190, Brazil
Universidade Estadual do Rio de Janeiro
Rio de Janeiro, 20551-030, Brazil
Instituto D'Or Pesquisa e Ensino (IDOR) (D'Or Institute for Research & Education) - Rio de Janeiro
Rio de Janeiro, 22281-100, Brazil
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9, Canada
Kaye Edmonton Clinic - Dianne and Irving Kipnes Urology Centre
Edmonton, Alberta, T6G 1Z1, Canada
BC Cancer | Abbotsford
Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9, Canada
BC Cancer | Victoria
Victoria, British Columbia, V8R 6V5, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
St. Joseph's Healthcare - Hamilton
Hamilton, Ontario, L8N 4A6, Canada
London Health Sciences Centre (LHSC) - London Regional Cancer Program (LRCP)
London, Ontario, N6A 5W9, Canada
Princess Margaret Cancer Centre - Oncology Department
Toronto, Ontario, M5G 2M9, Canada
Hôtel-Dieu de Lévis - Urology
Québec, Province, G6V 3Z1, Canada
CISSS de l'Outaouais - Hopital de Gatineau - Centre de cancerolgie
Gatineau, Quebec, J8P 7H2, Canada
Urology South Shore Research - Research Department
Greenfield Park, Quebec, J4V 2H3, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Sir Mortimer B. Davis Jewish General Hospital - Radiation Oncology
Montreal, Quebec, H3T 1E2, Canada
Centre hospitalier universitaire de Sherbrooke (CHUS) | Oncology
Sherbrooke, Quebec, J1H 5N4, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec - Radio-oncologie
Trois-Rivières, Quebec, G8Z 3R9, Canada
Peking University First Hospital - Oncology Department
Beijing, Beijing Municipality, 100034, China
Zhongnan hospital ,Wuhan University
Wuhan, Hubei, 430071, China
Hunan Cancer Hospital - Oncology Department
Changsha, Hunan, 410013, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Fudan University Shanghai Cancer Center - Oncology Department
Shanghai, Jiangsu, 200000, China
West China Hospital,Sichuan University
Chengdu, Sichuan, 610041, China
The 1st Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003, China
Peking Union Medical College Hospital (PUMCH) - East Location
Beijing, 100730, China
Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
Nanjing, 210029, China
Tianjin Cancer Hospital, Airport Hospital
Tianjin, 300308, China
Fakultni nemocnice u Sv. Anny, Onkologicko-chirurgicke oddeleni
Brno, 602 00, Czechia
Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
Brno, 602 00, Czechia
Fakultní nemocnice Olomouc - Onkologická klinika
Olomouc, 779 00, Czechia
Všeobecná fakultní nemocnice v Praze - Urologická klinika
Prague, 128 08, Czechia
Thomayerova Nemocnice (TN) (Thomayers Hospital) - Onkologicka Klinika 1. LF UK A TN
Prague, 140 59, Czechia
Fakultní nemocnice Motol a Homolka, Pracovište MOTOL - Onkologická klinika 2. LF UK a FNMH
Prague, 15006, Czechia
Aarhus Universitetshospital
Aarhus N, Central Jutland, 8200, Denmark
Aalborg University Hospital
Aalborg, North Denmark, 9000, Denmark
Sjællands University hospital Næstved
Næstved, Region Sjælland, 4700, Denmark
Rigshospitalet - Kræftbehandling
København Ø, 2100, Denmark
Oulu University Hospital, Oulun yliopistollinen sairaala (OYS)
Oulu, North Ostrobothnia, 90220, Finland
Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)
Tampere, Pirkanmaa, 33520, Finland
Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Urologia
Turku, Southwest Finland, 20540, Finland
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Urologia
Helsinki, Uusimaa, 00029, Finland
Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied - Service Urologie
Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France
Center Hospitalier Michallon - Grenoble - Service d Urologie et de la transplantation Renale
La Tronche, Auvergne-Rhône-Alpes, 38700, France
UNICANCER - Centre Leon-Berard (CLB) - Medical oncology
Lyon, Auvergne-Rhône-Alpes, 69373, France
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
CHRU Besancon - Hopital Jean Minjoz
Besançon, Bourgogne-Franche-Comté, 25000, France
Institut de cancerologie de Bourgogne - Departement radiotherapie
Dijon, Bourgogne-Franche-Comté, 21000, France
Centre Georges Francois Leclerc Dijon - service de radiotherapie
Dijon, Bourgogne-Franche-Comté, 21079, France
Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie
Brest, Brittany Region, 29200, France
CHU Rennes - Hopital Pontchaillou
Rennes, Brittany Region, 35033, France
Institut de Cancerologie Jean Godinot - Departement oncologie medicale
Reims, Grand Est, 51056, France
ICANS - Institut de Cancerologie de Strasbourg Europe
Strasbourg, Grand Est, 67033, France
Institut de Cancérologie de Lorraine - Alexis Vautrin
Vandœuvre-lès-Nancy, Grand Est, 54519, France
Hopital Claude Huriez - Lille - Urologie
Lille, Hauts-de-France, 59000, France
Hopital Prive Le Bois - Centre Bourgogne - Service radiotherapie oncologie
Lille, Hauts-de-France, 59000, France
Centre d' Oncologie du Pays Basque Clinique Belharra - Bayonne - Oncologie medicale
Bayonne, New Aquitaine, 64100, France
CHU Bordeaux - Hopital Pellegrin - Service urologie
Bordeaux, New Aquitaine, 33000, France
Clinique Clementville
Montpellier, Occitanie, 34070, France
Institut Claudius Regaud - iUCT Oncopole - Service oncologie
Toulouse, Occitanie, 31100, France
Institut de Cancerologie de l'Ouest - Saint Herblain - Unite de therapie precoce
Saint-Herblain, Pays de la Loire Region, 44800, France
APHP - Hopital Henri Mondor - Departement Urologie
Créteil, Île-de-France Region, 94000, France
Institut Curie - Saint-Cloud
Saint-Cloud, Île-de-France Region, 92210, France
Gustave Roussy - Departement Oncologie-Radiotherapie
Villejuif, Île-de-France Region, 94800, France
Klinikum Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68135, Germany
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, 72622, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080, Germany
Universitätsklinikum der Johann Wolfgang Goethe Universität
Frankfurt am Main, Hesse, 60590, Germany
Städtisches Klinikum Braunschweig GmbH
Braunschweig, Lower Saxony, 38126, Germany
Universitätsmedizin der Georg-August-Universität Göttingen
Göttingen, Lower Saxony, 37075, Germany
Urologicum Duisburg
Duisburg, North Rhine-Westphalia, 47169, Germany
Marienhospital Herne Universitätsklinik
Herne, North Rhine-Westphalia, 44625, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, 1307, Germany
Medizinische Fakultät der Otto-von-Guericke Universität
Magdeburg, Saxony-Anhalt, 39120, Germany
Universitätsklinikum Aachen / Klinik und Poliklinik für Urologie und Kinderurologie
Aachen, 52074, Germany
Marien-Krankenhaus Bergisch Gladbach
Bergisch Gladbach, 51465, Germany
Vivantes Klinikum Am Urban
Berlin, 10967, Germany
Universitätsklinikum Hamburg-Eppendorf - Martini-Klinik am UKE GmbH
Hamburg, 20246, Germany
Universitaetsklinikum Jena - Klinik fuer Urologie
Jena, 7747, Germany
Universitätsklinikum Schleswig-Holstein/ Klinik für Urologie
Kiel, 24105, Germany
Johannes Gutenberg-Universität Mainz - Urologie
Mainz, 55131, Germany
Klinikum Stuttgart / Klinik für Urologie und Transplantationschirurgie
Stuttgart, 70174, Germany
Urologische Gemeinschaftspraxis Wesel
Wesel, 46483, Germany
Semmelweis Egyetem, Altalanos Orvostudomanyi Kar, Urologiai Klinika
Budapest, 1082, Hungary
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Budapesti Uzsoki Utcai Kórház
Budapest, 1145, Hungary
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, 1204, Hungary
Gyor-Moson-Sopron Vármegyei Petz Aladár Oktató Kórház
Győr, 9024, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
Nyíregyháza, 4400, Hungary
Azienda Ospedaliero Universitaria Ospedali Riuniti_Foggia - Oncologia Medica e Terapia Biomolecolare Universitaria
Foggia, Apulia, 71122, Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Oncologia Clinica Sperimentale Uro-Ginecologica
Naples, Campania, 80131, Italy
Azienda Unita Sanitaria Locale Di Bologna_Ospedale Bellaria - Oncologia Medica
Bologna, Emilia-Romagma, 40139, Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Urologia
Bologna, Emilia-Romagna, 40138, Italy
Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia
Modena, Emilia-Romagna, 41124, Italy
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
Reggio Emilia, Emilia-Romagna, 42123, Italy
Centro di Riferimento Oncologico di Aviano - Oncologia Radioterapica
Aviano, Friuli Venezia Giulia, 33081, Italy
I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena - Urologia
Rome, Lazio, 00128, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Degenza di Radioterapia Oncologica
Rome, Lazio, 00168, Italy
IRCCS Ospedale Policlinico San Martino - Oncologia Medica 1
Genoa, Liguria, 16132, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Oncologia
Bergamo, Lombardy, 24127, Italy
Ospedale San Raffaele s.r.l - Urologia
Milan, Lombardy, 20132, Italy
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
Rozzano, Lombardy, 20089, Italy
A.O.U. Città della Salute e della Scienza di Torino_Molinette - Urologia U
Turin, Piedmont, 10126, Italy
Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia Medica
Trento, Trentino-Alto Adige, 38122, Italy
A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Radioterapia Oncologica
Perugia, Umbria, 06129, Italy
Istituto Oncologico Veneto_Castelfranco Veneto - UOC Urologia Oncologica
Castelfranco Veneto, Veneto, 31033, Italy
Azienda Ospedaliera Policlinico Universitario Tor Vergata - UOC Radioterapia
Roma, Veneto, 00133, Italy
Cliniche Gavazzeni S.p.A - Dipartimento Area Chirurgia Unità Operativa di Urologia
Bergamo, 24125, Italy
Azienda Ospedaliera Santa Croce e Carle - Oncologia
Cuneo, 12100, Italy
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
The University of Osaka Hospital
Suita, Osaka, 565-0871, Japan
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8519, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Tergooi MC | Hilversum - Wetenschapsbureau
Hilversum, North Holland, 1213 VG, Netherlands
Albert Schweitzer Hospital | Internal Medicine - Oncology Department
Dordrecht, South Holland, 3300 AK, Netherlands
St. Franciscus Gasthuis
Rotterdam, South Holland, 3045 PM, Netherlands
HagaZiekenhuis van Den Haag
The Hague, South Holland, 2545 AA, Netherlands
St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde
Nieuwegein, Utrecht, 3435 CM, Netherlands
University Medical Center Groningen | Urology Department
Groningen, 9713 GZ, Netherlands
Tauranga Urology Research Limited
Tauranga, Bay of Plenty, 3112, New Zealand
Canterbury Urology Research Trust
Christchurch, Canterbury, 8013, New Zealand
MidCentral District Health Board (MDHB) - Palmerston North Hospital (PNH)
Palmerston North, Manawatu-Wanganui, 4442, New Zealand
Auckland City Hospital
Auckland, 1023, New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, 85-796, Poland
Swietokrzyskie Centrum Onkologii
Kielce, 25-734, Poland
Centrum Medyczne iMed24
Krakow, 31-864, Poland
Medrise Sp. z o.o. Centrum Badan Klinicznych
Lublin, 20-582, Poland
Szpital Grochowski im. dr.med. Rafala Masztaka
Warsaw, 04-073, Poland
EMC Instytut Medyczny SA - Penta Hospitals Przychodnie, Wroclaw Wejherowska
Wroclaw, 54-239, Poland
Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Urologia
Coimbra, 3004-561, Portugal
Instituto Portugues de Oncologia de Lisboa | Unidade de Investigacao Clinica - Departamento de Urologia
Lisbon, 1099-023, Portugal
Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research Center
Lisbon, 1350-352, Portugal
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
Lisbon, 1500-650, Portugal
Hospital Santa Maria | Centro de Investigacao Clinica
Lisbon, 1649-035, Portugal
Complexo Hospitalario Universitario De Santiago | Oncologia Radioterapica
Santiago de Compostela, A Coruña, 15706, Spain
Hospital Universitario Marques De Valdecilla - Urologia
Santander, Cantabria, 39008, Spain
Hospital del Mar I Urologia
Barcelona, 08003, Spain
Fundacio Puigvert | Urologia
Barcelona, 08025, Spain
Hospital Universitari Vall D Hebron | Oncologia Radioterapica
Barcelona, 08035, Spain
Hospital Clinic De Barcelona | Urologia
Barcelona, 8036, Spain
Hospital Universitario Puerta Del Mar | Urologia
Cadiz, 11009, Spain
MD Anderson Cancer Center | Oncologia Radioterapica
Madrid, 28033, Spain
Hospital Universitario Ramon Y Cajal | Oncologia Radioterapica
Madrid, 28034, Spain
Hospital Universitario Hm Sanchinarro | Oncologia
Madrid, 28050, Spain
Hospital Universitario Virgen De La Victoria | Urologia
Málaga, 20910, Spain
Hospital General Universitario Morales Meseguer | Urologia
Murcia, 30008, Spain
Hospital Universitario Virgen Del Rocio S.L. | Urologia
Seville, 41013, Spain
Fundacion Instituto Valenciano De Oncologia | Urologia
Valencia, 46009, Spain
Hospital Universitario Y Politecnico La Fe | Oncologia Radioterapica
Valencia, 46009, Spain
Skane University Hospital - Department of Urology
Malmo, Skåne County, 214 28, Sweden
Goteborgs Universitet
Gothenburg, Västra Götaland County, 413 45, Sweden
Tungs' Taichung MetroHarbor Hospital
Taichung, 435403, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Koo Foundation Sun Yet-Sen Cancer Centre
Taipei, 112019, Taiwan
Chang Gung Memorial Hospital at Linkou
Taoyuan District, 33305, Taiwan
University College London Hospitals NHS Foundation Trust | University College Hospital (UCLH) - Cancer Clinical Trials Unit
London, Greater London, NW1 2PG, United Kingdom
The Royal Marsden NHS Foundation Trust | The Royal Marsden Hospital - The Royal Marsden Clinical Trials Unit (CTU)
London, Greater London, SW3 6JJ, United Kingdom
Imperial College Healthcare NHS Trust | Charing Cross Hospital - Cancer Services
London, Greater London, W68RF, United Kingdom
East and North Hertfordshire NHS Trust - Mount Vernon Hospital - Mount Vernon Cancer Centre (MVCC)
Northwood, Middlesex, HA6 2RN, United Kingdom
Royal Surrey NHS Foundation Trust | Royal Surrey County Hospital - Cancer Centre
Guildford, Surrey, GU2 7XX, United Kingdom
Related Publications (1)
Morgans AK, Chehrazi-Raffle A, Niazi T, Shore ND, Ross AE, Roder A, Gomes AJ, Supiot S, Barthelemy P, Hatano K, Ruiz CBC, Yoshida S, Herrera-Imbroda B, Gratton M, Gschwend JE, Hope TA, Joensuu H, Kuss I, Le Berre MA, Dimova-Dobreva M, Fizazi K. Darolutamide plus androgen-deprivation therapy in high-risk biochemical recurrence of prostate cancer (ARASTEP). Future Oncol. 2025 Nov;21(27):3491-3498. doi: 10.1080/14796694.2025.2577633. Epub 2025 Nov 11.
PMID: 41216639DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2023
First Posted
April 3, 2023
Study Start
April 3, 2023
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
March 29, 2030
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.