AzTrials
AzTrials

Biochemically Recurrent Prostate CancerPhase 3ARASTEPNCT05794906

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

A Phase 3 study testing Darolutamide (BAY1841788, Nubeqa) and ADT in people with Biochemically Recurrent Prostate Cancer, run by Bayer at 226 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Biochemically Recurrent Prostate Cancer
What is being tested?
Darolutamide (BAY1841788, Nubeqa) and ADT
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
985 participants
Where
226 sitesin 23 countries
Study dates
3 Apr 2023to 29 Mar 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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 locations and contacts

226 sites in 23 countries.

226 sites in 23 countries

United States25 sites

  • Chesapeake Urology Associates - Towson

    Baltimore, Maryland, 21204

  • Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins

    Baltimore, Maryland, 21231

  • Dana-Farber Cancer Institute - Oncology Department

    Boston, Massachusetts, 02215

  • Northwestern Medicine - Urology

    Chicago, Illinois, 60611

  • University Hospital Simmons Cancer Center Genitourinary Clinic

    Dallas, Texas, 75235

  • Barbara Ann Karmanos Cancer Institute - Detroit Headquarters

    Detroit, Michigan, 48201

  • City of Hope - Duarte Cancer Center

    Duarte, California, 91010

  • Alliance Urology Specialists

    Greensboro, North Carolina, 27403

  • The University of Texas MD Anderson Cancer Center - Texas Medical Center

    Houston, Texas, 77030

  • The University of Kansas Cancer Center - Richard and Annette Bloch Radiation Oncology Pavilion

    Kansas City, Missouri, 66160

  • Colorado Urology - St. Anthony Hospital Campus

    Lakewood, Colorado, 80228

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Tower Urology

    Los Angeles, California, 90048

  • UCLA Clark Urology Center

    Los Angeles, California, 90095

  • NYU Langone Health

    Mineola, New York, 11501

  • M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center

    Minneapolis, Minnesota, 55455

  • Carolina Urological Research Center

    Myrtle Beach, South Carolina, 29579

  • Icahn School of Medicine at Mount Sinai - Oncology

    New York, New York, 10029

  • XCancer Omaha

    Omaha, Nebraska, 68130

  • Mayo Clinic Hospital - Phoenix - Cardiology

    Phoenix, Arizona, 85054

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • USA Clinical Trials

    San Antonio, Texas, 78229

  • The Urology Place

    San Antonio, Texas, 78240

  • UCSF Bakar Precision Cancer Medicine Building - Genitourinary

    San Francisco, California, 94143

  • Washington University School of Medicine - Center for Advanced Medicine (CAM)

    St Louis, Missouri, 63110-1032

Other trials in United States

France22 sites

  • Centre d' Oncologie du Pays Basque Clinique Belharra - Bayonne - Oncologie medicale

    Bayonne, New Aquitaine, 64100

  • CHRU Besancon - Hopital Jean Minjoz

    Besançon, Bourgogne-Franche-Comté, 25000

  • CHU Bordeaux - Hopital Pellegrin - Service urologie

    Bordeaux, New Aquitaine, 33000

  • Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie

    Brest, Brittany Region, 29200

  • Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied - Service Urologie

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000

  • APHP - Hopital Henri Mondor - Departement Urologie

    Créteil, Île-de-France Region, 94000

  • Institut de cancerologie de Bourgogne - Departement radiotherapie

    Dijon, Bourgogne-Franche-Comté, 21000

  • Centre Georges Francois Leclerc Dijon - service de radiotherapie

    Dijon, Bourgogne-Franche-Comté, 21079

  • Center Hospitalier Michallon - Grenoble - Service d Urologie et de la transplantation Renale

    La Tronche, Auvergne-Rhône-Alpes, 38700

  • Hopital Claude Huriez - Lille - Urologie

    Lille, Hauts-de-France, 59000

  • Hopital Prive Le Bois - Centre Bourgogne - Service radiotherapie oncologie

    Lille, Hauts-de-France, 59000

  • UNICANCER - Centre Leon-Berard (CLB) - Medical oncology

    Lyon, Auvergne-Rhône-Alpes, 69373

  • Clinique Clementville

    Montpellier, Occitanie, 34070

  • HCL - Centre Hospitalier Lyon Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Institut de Cancerologie Jean Godinot - Departement oncologie medicale

    Reims, Grand Est, 51056

  • CHU Rennes - Hopital Pontchaillou - Urologie

    Rennes, Brittany Region, 35000

  • Institut Curie - Saint-Cloud

    Saint-Cloud, Île-de-France Region, 92210

  • Institut de Cancerologie de l'Ouest - Saint Herblain - Unite de therapie precoce

    Saint-Herblain, Pays de la Loire Region, 44800

  • ICANS - Institut de Cancerologie de Strasbourg Europe

    Strasbourg, Grand Est, 67033

  • Institut Claudius Regaud - iUCT Oncopole - Service oncologie

    Toulouse, Occitanie, 31100

  • Institut de Cancérologie de Lorraine - Alexis Vautrin

    Vandœuvre-lès-Nancy, Grand Est, 54519

  • Gustave Roussy - Departement Oncologie-Radiotherapie

    Villejuif, Île-de-France Region, 94800

Other trials in France

Germany20 sites

  • Universitätsklinikum Aachen / Klinik und Poliklinik für Urologie und Kinderurologie

    Aachen, North Rhine-Westphalia, 52074

  • Marien-Krankenhaus Bergisch Gladbach

    Bergisch Gladbach, North Rhine-Westphalia, 51465

  • Vivantes Klinikum Am Urban

    Berlin, 10967

  • Städtisches Klinikum Braunschweig GmbH

    Braunschweig, Lower Saxony, 38126

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden AöR

    Dresden, Saxony, 1307

  • Urologicum Duisburg

    Duisburg, North Rhine-Westphalia, 47169

  • Universitätsklinikum der Johann Wolfgang Goethe Universität

    Frankfurt am Main, Hesse, 60590

  • Universitätsmedizin der Georg-August-Universität Göttingen

    Göttingen, Lower Saxony, 37075

  • Universitätsklinikum Hamburg-Eppendorf - Martini-Klinik am UKE GmbH

    Hamburg, 20246

  • Marienhospital Herne Universitätsklinik

    Herne, North Rhine-Westphalia, 44625

  • Universitaetsklinikum Jena - Klinik fuer Urologie

    Jena, Thuringia, 7747

  • Universitätsklinikum Schleswig-Holstein/ Klinik für Urologie

    Kiel, Schleswig-Holstein, 24105

  • Medizinische Fakultät der Otto-von-Guericke Universität

    Magdeburg, Saxony-Anhalt, 39120

  • Johannes Gutenberg-Universität Mainz - Urologie

    Mainz, Rhineland-Palatinate, 55131

  • Klinikum Mannheim GmbH

    Mannheim, Baden-Wurttemberg, 68135

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622

  • Klinikum Stuttgart / Klinik für Urologie und Transplantationschirurgie

    Stuttgart, Baden-Wurttemberg, 70174

  • Urologische Gemeinschaftspraxis Wesel

    Wesel, North Rhine-Westphalia, 46483

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

Italy20 sites

  • Centro di Riferimento Oncologico di Aviano - Oncologia Radioterapica

    Aviano, Friuli Venezia Giulia, 33081

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Oncologia

    Bergamo, Lombardy, 24127

  • Cliniche Gavazzeni S.p.A - Dipartimento Area Chirurgia Unità Operativa di Urologia

    Bergamo, 24125

  • Azienda Unita Sanitaria Locale Di Bologna_Ospedale Bellaria - Oncologia Medica

    Bologna, Emilia-Romagma, 40139

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Urologia

    Bologna, Emilia-Romagna, 40138

  • Istituto Oncologico Veneto_Castelfranco Veneto - UOC Urologia Oncologica

    Castelfranco Veneto, Veneto, 31033

  • Azienda Ospedaliera Santa Croce e Carle - Oncologia

    Cuneo, 12100

  • Azienda Ospedaliero Universitaria Ospedali Riuniti_Foggia - Oncologia Medica e Terapia Biomolecolare Universitaria

    Foggia, Apulia, 71122

  • IRCCS Ospedale Policlinico San Martino - Oncologia Medica 1

    Genoa, Liguria, 16132

  • Ospedale San Raffaele s.r.l - Urologia

    Milan, Lombardy, 20132

  • Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia

    Modena, Emilia-Romagna, 41124

  • IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Oncologia Clinica Sperimentale Uro-Ginecologica

    Naples, Campania, 80131

  • A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Radioterapia Oncologica

    Perugia, Umbria, 06129

  • Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale

    Reggio Emilia, Emilia-Romagna, 42123

  • Azienda Ospedaliera Policlinico Universitario Tor Vergata - UOC Radioterapia

    Roma, Veneto, 00133

  • I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena - Urologia

    Rome, Lazio, 00128

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Degenza di Radioterapia Oncologica

    Rome, Lazio, 00168

  • Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia

    Rozzano, Lombardy, 20089

  • Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia Medica

    Trento, Trentino-Alto Adige, 38122

  • A.O.U. Città della Salute e della Scienza di Torino_Molinette - Urologia U

    Turin, Piedmont, 10126

Other trials in Italy

Brazil17 sites

  • Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Oncocentro - Fortaleza

    Fortaleza, Ceará, 60135-237

  • Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

    Natal, Rio Grande do Norte, 59040-000

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90850-170

  • Universidade Estadual do Rio de Janeiro

    Rio de Janeiro, 20551-030

  • Instituto D'Or Pesquisa e Ensino (IDOR) (D'Or Institute for Research & Education) - Rio de Janeiro

    Rio de Janeiro, 22281-100

  • Assistência Multidisciplinar em Oncologia (AMO)

    Salvador, Estado de Bahia, 41950-640

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650

  • Instituto do Cancer do Estado de Sao Paulo

    São Paulo, São Paulo, 01246-000

  • Hospital Sirio Libanes

    São Paulo, São Paulo, 01308-050

  • Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, São Paulo, 01323-001

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01327-001

  • Hospital do Cancer de Sao Paulo - A. C. Camargo

    São Paulo, São Paulo, 01525-001

  • Inst. de Assistência Médica ao Sérvidor Público Estadual

    São Paulo, São Paulo, 04039-004

  • Hospital das Clínicas da Universidade de Campinas - UNICAMP

    São Paulo, São Paulo, 13083-888

  • Hospital São Rafael

    São Paulo, São Paulo, 41253-190

  • Hospital Moinhos de Vento-Centro Clínico

    Uberlândia, Minas Gerais, 90035-001

Other trials in Brazil

Canada16 sites

  • BC Cancer | Abbotsford

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9

  • Kaye Edmonton Clinic | Dianne and Irving Kipnes Urology Centre

    Edmonton, Alberta, T6G 1Z1

  • Hopital de Gatineau | Oncology

    Gatineau, Quebec, J8P 7H2

  • Urology South Shore Research - Research Department

    Greenfield Park, Quebec, J4V 2H3

  • Queen Elizabeth II Health Sciences Centre | Oncology

    Halifax, Nova Scotia, B3H 2Y9

  • St Joseph's Healthcare Hamilton | Cardiology

    Hamilton, Ontario, L8N 4A6

  • Victoria Hospital | Oncology

    London, Ontario, N6A 4L6

  • Hôpital Maisonneuve-Rosemont | Oncology

    Montreal, Quebec, H1T 2M4

  • Jewish General Hospital | Radiation Oncology

    Montreal, Quebec, H3T 1E2

  • L'Hôtel-Dieu de Lévis | Urology

    Québec, G6V 3Z1

  • Centre hospitalier universitaire de Sherbrooke (CHUS) | Oncology

    Sherbrooke, Quebec, J1H 5N4

  • Princess Margaret Cancer Centre - Oncology Department

    Toronto, Ontario, M5G 2M9

  • Hôpital du Centre-de-la-Mauricie | Radio-oncologie

    Trois-Rivières, Quebec, G8Z 3R9

  • Vancouver Prostate Centre

    Vancouver, British Columbia, V5Z 1M9

  • BC Cancer | Victoria

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Spain15 sites

  • Hospital del Mar | Urologia

    Barcelona, 08003

  • Fundacio Puigvert | Urologia

    Barcelona, 08025

  • Hospital Universitari Vall D Hebron | Oncologia Radioterapica

    Barcelona, 08035

  • Hospital Clinic De Barcelona | Urologia

    Barcelona, 8036

  • Hospital Universitario Puerta Del Mar | Urologia

    Cadiz, 11009

  • MD Anderson Cancer Center | Oncologia Radioterapica

    Madrid, 28033

  • Hospital Universitario Ramon Y Cajal | Oncologia Radioterapica

    Madrid, 28034

  • Hospital Universitario Hm Sanchinarro | Oncologia

    Madrid, 28050

  • Hospital Universitario Virgen De La Victoria | Urologia

    Málaga, 20910

  • Hospital General Universitario Morales Meseguer | Urologia

    Murcia, 30008

  • Hospital Universitario Marques De Valdecilla - Urologia

    Santander, Cantabria, 39008

  • Complexo Hospitalario Universitario De Santiago | Oncologia Radioterapica

    Santiago de Compostela, A Coruña, 15706

  • Hospital Universitario Virgen Del Rocio S.L. | Urologia

    Seville, 41013

  • Fundacion Instituto Valenciano De Oncologia | Urologia

    Valencia, 46009

  • Hospital Universitario Y Politecnico La Fe | Oncologia Radioterapica

    Valencia, 46009

Other trials in Spain

Australia11 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Eastern Clinical Research Unit - Box Hill

    Box Hill, Victoria, 3128

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Epworth HealthCare

    East Melbourne, Victoria, 3002

  • Northern Hospital

    Epping, New South Wales, 3076

  • Barwon Health

    Geelong, Victoria, 3220

  • Austin Health

    Heidelberg, Victoria, 3084

  • University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre

    Liverpool, New South Wales, 2170

  • Western Urology

    Maribyrnong, Victoria, 3032

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

Other trials in Australia

China10 sites

  • Peking University First Hospital - Oncology Department

    Beijing, Beijing Municipality, 100034

  • Peking Union Medical College Hospital (PUMCH) - East Location

    Beijing, Beijing Municipality, 100730

  • Hunan Cancer Hospital - Oncology Department

    Changsha, Hunan, 410013

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, 610041

  • The 1st Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Fudan University Shanghai Cancer Center - Oncology Department

    Shanghai, Shanghai Municipality, 200000

  • Tianjin Cancer Hospital, Airport Hospital

    Tianjin, Tianjin Municipality, 300308

  • Zhongnan hospital ,Wuhan University

    Wuhan, Hubei, 430071

Other trials in China

Austria6 sites

  • Medizinische Universität Innsbruck, Tirol Kliniken

    Innsbruck, Tyrol, 6020

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, Upper Austria, 4020

  • Medizinische Universitaet Graz - Klinische Abteilung für Onkologie - Innere Medizin

    Salzburg, Styria, 5020

  • Medizinische Universität Wien- Universitätsklinik für Urologie

    Vienna, State of Vienna, 1090

  • Uniklinikum Salzburg - Landeskrankenhaus

    Vienna, State of Vienna, 1090

  • Krankenhaus der Barmherzigen Brüder Wien

    Vienna, Upper Austria, 4020

Other trials in Austria

Belgium6 sites

  • Maria Middelares General Hospital | Medical Oncology Department

    Ghent, East Flanders, 9000

  • UZ Gent - department Urology

    Ghent, East Flanders, 9000

  • Jessa Hospital | Campus Virga Jesse - Data Management Oncology and Hematology Department

    Hasselt, Limburg, 3500

  • AZ Groeninge Campus Kennedylaan - Urology

    Kortrijk, West Flanders, 8500

  • Hopital de La Louvière - Site Jolimont - Oncology department

    La Louvière, Hainaut, 7100

  • Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Urology Department

    Leuven, Flemish Brabant, 3000

Other trials in Belgium

Czechia6 sites

  • Fakultni nemocnice u Sv. Anny, Onkologicko-chirurgicke oddeleni

    Brno, South Moravian, 602 00

  • Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)

    Brno, South Moravian, 602 00

  • Fakultní nemocnice Olomouc - Onkologická klinika

    Olomouc, Olomouc Region, 779 00

  • Všeobecná fakultní nemocnice v Praze - Urologická klinika

    Prague, Prague, 128 08

  • Thomayerova Nemocnice (TN) (Thomayers Hospital) - Onkologicka Klinika 1. LF UK A TN

    Prague, Prague, 140 59

  • Fakultní nemocnice Motol a Homolka, Pracovište MOTOL - Onkologická klinika 2. LF UK a FNMH

    Prague, Prague, 150 06

Other trials in Czechia

Hungary6 sites

  • Semmelweis Egyetem, Altalanos Orvostudomanyi Kar, Urologiai Klinika

    Budapest, 1082

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Budapesti Uzsoki Utcai Kórház

    Budapest, 1145

  • Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet

    Budapest, 1204

  • Gyor-Moson-Sopron Vármegyei Petz Aladár Oktató Kórház

    Győr, Győr-Moson-Sopron, 9024

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

Other trials in Hungary

Japan6 sites

  • Institute of Science Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8519

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • The University of Osaka Hospital

    Suita, Osaka, 565-0871

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Netherlands6 sites

  • Albert Schweitzer Hospital | Internal Medicine - Oncology Department

    Dordrecht, South Holland, 3300 AK

  • University Medical Center Groningen | Urology Department

    Groningen, 9713 GZ

  • Tergooi MC | Hilversum - Wetenschapsbureau

    Hilversum, North Holland, 1213 VG

  • St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde

    Nieuwegein, Utrecht, 3435 CM

  • St. Franciscus Gasthuis

    Rotterdam, South Holland, 3045 PM

  • HagaZiekenhuis van Den Haag

    The Hague, South Holland, 2545 AA

Other trials in Netherlands

Poland6 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka

    Bydgoszcz, 85-796

  • Swietokrzyskie Centrum Onkologii

    Kielce, 25-734

  • Comarch Healthcare SA Centrum Medyczne iMed24

    Krakow, 31-864

  • Medrise Sp. z o.o. Centrum Badan Klinicznych

    Lublin, 20-582

  • Szpital Grochowski im. dr.med. Rafala Masztaka

    Warsaw, 04-073

  • EMC Instytut Medyczny SA - Penta Hospitals Przychodnie, Wroclaw Wejherowska

    Wroclaw, 54-239

Other trials in Poland

Portugal5 sites

  • Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Urologia

    Coimbra, 3004-561

  • Instituto Portugues de Oncologia de Lisboa | Unidade de Investigacao Clinica - Departamento de Urologia

    Lisbon, 1099-023

  • Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research Center

    Lisbon, 1350-352

  • Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica

    Lisbon, 1500-650

  • Hospital Santa Maria | Centro de Investigacao Clinica

    Lisbon, 1649-035

Other trials in Portugal

United Kingdom5 sites

  • Royal Surrey NHS Foundation Trust | Royal Surrey County Hospital - Cancer Centre

    Guildford, Surrey, GU2 7XX

  • University College London Hospitals NHS Foundation Trust | University College Hospital (UCLH) - Cancer Clinical Trials Unit

    London, Greater London, NW1 2PG

  • The Royal Marsden NHS Foundation Trust | The Royal Marsden Hospital - The Royal Marsden Clinical Trials Unit (CTU)

    London, Greater London, SW3 6JJ

  • Imperial College Healthcare NHS Trust | Charing Cross Hospital - Cancer Services

    London, Greater London, W68RF

  • East and North Hertfordshire NHS Trust - Mount Vernon Hospital - Mount Vernon Cancer Centre (MVCC)

    Northwood, Middlesex, HA6 2RN

Other trials in United Kingdom

Denmark4 sites

  • Aalborg University Hospital

    Aalborg, North Denmark, 9000

  • Aarhus Universitetshospital

    Aarhus N, Central Jutland, 8200

  • Rigshospitalet Copenhagen University Hospital | Oncology Department

    København Ø, 2100

  • Sjællands University hospital Næstved

    Næstved, Region Sjælland, 4700

Other trials in Denmark

Finland4 sites

  • HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Urologia

    Helsinki, Uusimaa, 00029

  • Oulu University Hospital, Oulun yliopistollinen sairaala (OYS)

    Oulu, North Ostrobothnia, 90220

  • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)

    Tampere, Pirkanmaa, 33520

  • Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Urologia

    Turku, Southwest Finland, 20540

Other trials in Finland

New Zealand4 sites

  • Auckland City Hospital

    Auckland, 1023

  • Canterbury Urology Research Trust

    Christchurch, Canterbury, 8013

  • MidCentral District Health Board (MDHB) - Palmerston North Hospital (PNH)

    Palmerston North, Manawatu-Wanganui, 4442

  • Tauranga Urology Research Limited

    Tauranga, Bay of Plenty, 3112

Other trials in New Zealand

Taiwan4 sites

  • Tungs' Taichung MetroHarbor Hospital

    Taichung, 435403

  • National Taiwan University Hospital

    Taipei, 100

  • Koo Foundation Sun Yet-Sen Cancer Centre

    Taipei, 112019

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, 33305

Other trials in Taiwan

Sweden2 sites

  • Sahlgrenska Universitetssjukhuset - Sahlgrenska Sjukhuset - Urologi

    Gothenburg, Västra Götaland County, 413 45

  • Skånes Universitetssjukhus - Malmö - Urologi

    Malmö, Skåne County, 214 28

Other trials in Sweden

About this study

Official title: 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

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.

Read more

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.

Being tested
Darolutamide (BAY1841788, Nubeqa), Placebo matching darolutamide, ADT
Keywords
darolutamide, high risk BCR, PSMA PET imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Darolutamide (BAY1841788, Nubeqa)Drug

    Coated tablet, 300 mg / tablet, oral.

  • Placebo matching darolutamideOther

    Coated tablet, oral

  • ADTOther

    Luteinizing hormone-releasing hormone [LHRH] agonist/antagonists

Study groups in NCT05794906
Study groupRoleWhat they receive
Darolutamide+ADTExperimentalParticipants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months.
Receives: Drug: Darolutamide (BAY1841788, Nubeqa); Other: ADT
Placebo+ADTPlacebo comparatorParticipants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months.
Receives: Other: Placebo matching darolutamide; Other: ADT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: After randomization to after last treatment, approximately 24 months

Secondary outcomes (11)

  1. Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR

    Measured: After randomization to after last treatment, approximately 46 months

  2. Time to Castration-resistant prostate cancer (CRPC)

    Measured: After randomization to after last treatment, approximately 46 months

  3. Time to initiation of first subsequent systemic antineoplastic therapy

    Measured: After randomization to after last treatment, approximately 46 months

  4. Time to loco-regional progression by PSMA PET/CT

    Measured: After randomization to after last treatment, approximately 46 months

  5. Time to first Symptomatic skeletal event (SSE)

    Measured: After randomization to after last treatment, approximately 46 months

  6. Overall survival (OS)

    Measured: After randomization to after last treatment, approximately 46 months

  7. Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL)

    Measured: After randomization to after last treatment, approximately 46 months

  8. 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).

    Measured: After randomization to after last treatment, approximately 24 months

  9. Time to symptomatic progression

    Measured: After randomization to after last treatment, approximately 46 months

  10. Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severity

    Measured: After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months

  11. Number of participants who discontinue study treatment due to a TEAE

    Measured: After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start3 Apr 2023
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion29 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
985 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05794906
Sponsor's protocol ID
21492
Other IDs
2022-501343-33-00
Acronym
ARASTEP
Status last verified
Jul 2026
First submitted
21 Mar 2023
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 41216639

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darolutamide (BAY1841788, Nubeqa) and ADT in people with Biochemically Recurrent Prostate Cancer, run by Bayer at 226 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, France, Germany, Italy, Brazil and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: After randomization to after last treatment, approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05794906, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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