account_circleRecruiting
Biochemically recurrent prostate cancer
Bayer Identifier:
21492
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2022-501343-33-00
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.
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
MaleAge
18 - N/ATrial summary
Enrollment Goal
750Trial Dates
April 2023 - March 2030Phase
Phase 3Could I Receive a placebo
YesProducts
Darolutamide+ADT (BAY1841788)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie | Wien, 1090, Austria |
Recruiting | Ordensklinikum Linz GmbH Elisabethinen | Linz, 4020, Austria |
Recruiting | Krankenhaus der Barmherzigen Brüder | Vienna, 1020, Austria |
Active, not recruiting | Dana-Farber Cancer Institute | Boston, 02215, United States |
Recruiting | Carolina Urological Research Center | Myrtle Beach, 29579, United States |
Recruiting | Colorado Urology - St. Anthony Hospital Campus | Lakewood, 80228, United States |
Recruiting | Urology San Antonio, PA dba USA Clinical Trials | San Antonio, 78229, United States |
Not yet recruiting | White Plains Hospital | White Plains, 10601, United States |
Withdrawn | First Urology PSC | Jeffersonville, 47130, United States |
Terminated | Tower Urology, Inc | Los Angeles, 90048, United States |
Withdrawn | MidLantic Urology - Bala Cynwyd | Bala Cynwyd, 19004, United States |
Recruiting | Alliance Urology Specialists | Greensboro, 27403, United States |
Withdrawn | Ohio State University Wexner Medical Center | Columbus, 43210, United States |
Withdrawn | Arizona Institute of Urology | Tucson, 85704, United States |
Withdrawn | New Jersey Urology, LLC | Voorhees, 08043, United States |
Withdrawn | Associated Medical Professionals of NY, PLLC | Syracuse, 13210, United States |
Withdrawn | Urological Associates of Lancaster | Lancaster, 17604, United States |
Withdrawn | Bon Secours St. Francis Hospital | Greenville, 29607, United States |
Withdrawn | University of Florida - Jacksonville | Jacksonville, 32209, United States |
Recruiting | Barbara Ann Karmanos Cancer Institute - Detroit Headquarters | Detroit, 48201, United States |
Recruiting | University of Kansas | Kansas City, 66160, United States |
Recruiting | University of Southern California | Los Angeles, 90033, United States |
Recruiting | University of California, Los Angeles | Los Angeles, 90095, United States |
Withdrawn | Comprehensive Cancer Center | Chicago, 60637, United States |
Completed | NYU Langone Health | Mineola, 11501, United States |
Recruiting | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Withdrawn | Urology of Indiana, LLC | Greenwood, 46143, United States |
Recruiting | Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins | Baltimore, 21231, United States |
Withdrawn | Urology Austin, PLLC (an affiliate of Urology America) | Austin, 78745, United States |
Withdrawn | Clermont Oncology Center | Clermont, 34711, United States |
Recruiting | Mayo Clinic Hospital | Phoenix, 85054, United States |
Withdrawn | Wake Forest Baptist Health | Winston Salem, 27157, United States |
Withdrawn | Mid Florida Cancer Centers | Orange City, 32763-8316, United States |
Withdrawn | Jesse Brown VA Medical Center | Chicago, 60612, United States |
Withdrawn | University of Pittsburgh | Pittsburgh, 15232, United States |
Withdrawn | The Urology Group | Cincinnati, 45212, United States |
Not yet recruiting | UCSF Med Center Helen Diller Family Comp Cancer Center | San Francisco, 94143, United States |
Recruiting | City of Hope - Duarte Cancer Center | Duarte, 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 precoce | Saint Herblain, 44800, France |
Recruiting | Gustave Roussy - Departement Oncologie-Radiotherapie | Villejuif, 94800, France |
Recruiting | Hôpital Pellegrin - Bordeaux | BORDEAUX cedex, 33076, France |
Withdrawn | Hopital Bichat - Paris | Paris, 75018, France |
Recruiting | HCL - Centre Hospitalier Lyon Sud | PIERRE BENITE, 69495, France |
Recruiting | Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied - Service Urologie | Clermont Ferrand, 63003, France |
Recruiting | Hopital Claude Huriez - Lille - Urologie | Lille, 59000, France |
Recruiting | Hôpital Pontchaillou | RENNES CEDEX, 35033, France |
Recruiting | Uniklinikum Salzburg - Landeskrankenhaus | Salzburg, 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 Hospital | London, W6 8RF, United Kingdom |
Recruiting | University of Minnesota Medical Center | Minneapolis, 55455, United States |
Withdrawn | University of California Irvine Medical Center | Orange, 92868-3201, United States |
Recruiting | Northwestern University Feinberg School of Medicine - Department of Urology | Chicago, 60611, United States |
Withdrawn | Michigan Institute of Urology, PC | Troy, 48084, United States |
Recruiting | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela, 15706, Spain |
Recruiting | Hospital Universitario Puerta del Mar | Cadiz, 11009, Spain |
Recruiting | MD Anderson International Espanya, S.A. | Madrid, 28033, Spain |
Recruiting | Hospital Universitario Virgen de la Victoria | Cardiology Department | Malaga, 29010, Spain |
Recruiting | Hospital del Mar | Barcelona, 08003, Spain |
Recruiting | Hospital Clínic i Provincial de Barcelona | Barcelona, 8036, Spain |
Recruiting | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Recruiting | Hospital Fundació Puigvert | Barcelona, 08025, Spain |
Recruiting | Instituto Valenciano de Oncología | Valencia, 46009, Spain |
Recruiting | Hospital Universitari i Politècnic La Fe | Valencia, 46009, Spain |
Recruiting | Hospital Universitario Ramon y Cajal | Madrid, 28034, Spain |
Recruiting | H. General Uiversitario Morales Meseguer - Department of Urology | Murcia, 30008, Spain |
Recruiting | Centro Integral Oncológico Clara Campal | Madrid, 28050, Spain |
Recruiting | Princess Margaret Cancer Centre - UHN | Toronto, M5G 2M9, Canada |
Recruiting | St. Joseph's Healthcare - Hamilton | Hamilton, L8N 4A6, Canada |
Recruiting | Sir Mortimer B. Davis Jewish General Hospital - Radiation Oncology | Montreal, H3T 1E2, Canada |
Recruiting | Vancouver Prostate Centre | Vancouver, V5Z 1M9, Canada |
Recruiting | Prostate Cancer Centre | Calgary, T2V 1P9, Canada |
Recruiting | Hopital Hotel-Dieu de Levis | Quebec, G6V 3Z1, Canada |
Recruiting | BC Cancer - Victoria | Victoria, V8R 6V5, Canada |
Withdrawn | Rambam Health Corporation | Haifa, 3109601, Israel |
Withdrawn | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem, 9112001, Israel |
Withdrawn | Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department | Petah Tikva, 4941492, Israel |
Withdrawn | Macquarie University Hospital | Macquarie University, 2109, Australia |
Withdrawn | GenesisCare Newcastle | Newcastle, 2290, Australia |
Not yet recruiting | Prince of Wales Hospital NSW | Sydney, 2031, Australia |
Withdrawn | St Vincents Hospital Sydney | Sydney, 2010, Australia |
Recruiting | Austin Health | Heidelberg, 3084, Australia |
Recruiting | University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre | Liverpool, NSW 2170, Australia |
Recruiting | Sydney Adventist Hospital | Wahroonga, 2076, Australia |
Withdrawn | Port Macquarie Base Hospital | Port Macquarie, 2444, Australia |
Recruiting | Epworth HealthCare | East Melbourne, 3002, Australia |
Withdrawn | Tasman Health Care | Southport, 4215, Australia |
Recruiting | Instituto Portugues de Oncologia de Lisboa | Unidade de Investigacao Clinica - Departamento de Urologia | Lisbon, 1099-023, Portugal |
Not yet recruiting | Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica | Lisboa, 1500-650, Portugal |
Recruiting | University College London Hospitals NHS Foundation Trust | London, NW1 2PG, United Kingdom |
Withdrawn | Bedford Hospital - Bedfordshire Hospitals NHS Foundation Tru | Bedford, MK42 9DJ, United Kingdom |
Recruiting | Canterbury Urology Research Trust | Christchurch, 8013, New Zealand |
Recruiting | Auckland City Hosptial | Auckland, 1023, New Zealand |
Recruiting | Tauranga Urology Research Limited | Tauranga, 3112, New Zealand |
Recruiting | Assistência Multidisciplinar em Oncologia (AMO) | Salvador, 41950-640, Brazil |
Recruiting | Instituto do Cancer do Estado de Sao Paulo | São Paulo, 01246-000, Brazil |
Recruiting | Faculdade de Medicina do ABC | Santo André, 09060-650, Brazil |
Recruiting | Inst. de Assistência Médica ao Sérvidor Público Estadual | São Paulo, 04039-004, Brazil |
Recruiting | Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica | Natal, 59040-000, Brazil |
Recruiting | Hospital Sirio Libanes | Sao Paulo, 01308-050, Brazil |
Recruiting | Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner | Curitiba, 81520-060, Brazil |
Not yet recruiting | Universitaetsklinikum Muenster | Münster, 48149, Germany |
Not yet recruiting | Klinikum rechts der Isar | München, 81675, Germany |
Recruiting | Universitätsmedizin der Georg-August-Universität Göttingen | Goettingen, 37075, Germany |
Not yet recruiting | Universitätsklinikum Köln | Köln, 50937, Germany |
Recruiting | Klinikum der Universität Würzburg | Wurzburg, 97080, Germany |
Recruiting | Städtisches Klinikum Braunschweig gGmbH | Brunswick, 38126, Germany |
Not yet recruiting | Medizinische Fakultät der Otto-von-Guericke Universität | Magdeburg, 39120, Germany |
Recruiting | Universitätsklinikum der Johann Wolfgang Goethe Universität | Frankfurt, 60590, Germany |
Recruiting | Studienpraxis Urologie | Nürtingen, 72622, Germany |
Recruiting | ICANS - Institut de Cancerologie de Strasbourg Europ | STRASBOURG, 67033, France |
Not yet recruiting | Hopital Bretonneau | Tours, 37044, France |
Recruiting | Institute of Science Tokyo Hospital | Bunkyo-ku, 113-8519, Japan |
Recruiting | Kyoto University Hospital | Kyoto, 606-8507, Japan |
Recruiting | Hokkaido University Hospital | Sapporo, 060-8648, Japan |
Recruiting | Kanazawa University Hospital | Kanazawa, 920-8641, Japan |
Recruiting | Osaka University Hospital | Suita, 565-0871, Japan |
Recruiting | Yokohama City University Hospital | Yokohama, 236-0004, Japan |
Withdrawn | Kagoshima University Hospital | Kagoshima, 890-8520, Japan |
Recruiting | Ospedale San Raffaele s.r.l - Urologia | Milano, 20132, Italy |
Withdrawn | A.O.U.I. Verona | Verona, 37134, Italy |
Withdrawn | A.O.U. Consorziale Policlinico | Bari, 70124, Italy |
Recruiting | Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia | Modena, 41124, Italy |
Recruiting | Centro di Riferimento Oncologico di Aviano - Oncologia Radioterapica | Aviano, 33081, Italy |
Recruiting | A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Radioterapia Oncologica | Perugia, 06129, Italy |
Recruiting | IRCCS Ospedale Policlinico San Martino - Oncologia Medica 1 | Genova, 16132, Italy |
Recruiting | Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia Medica | Trento, 38122, Italy |
Recruiting | IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Oncologia Clinica Sperimentale Uro-Ginecologica | Napoli, 80131, Italy |
Recruiting | Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale | Reggio Emilia, 42123, Italy |
Withdrawn | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano, 20133, Italy |
Recruiting | A.O.U. Città della Salute e della Scienza di Torino_Molinette - Urologia U | Torino, 10126, Italy |
Recruiting | I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena - Urologia | Roma, 00128, Italy |
Recruiting | Azienda Unita Sanitaria Locale Di Bologna_Ospedale Bellaria - Oncologia Medica | Bologna, 40139, Italy |
Recruiting | Virgen del Rocio University Hospital - Oncology Department | Sevilla, 41013, Spain |
Withdrawn | Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica | Lisboa, 1400-038, Portugal |
Recruiting | Hospital Santa Maria | Centro de Investigacao Clinica | Lisboa, 1649-035, Portugal |
Recruiting | Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research Center | Lisboa, 1350-352, Portugal |
Withdrawn | Centro Clinico Academico Braga | Braga, Portugal | Braga, 4710-243, Portugal |
Withdrawn | Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department | Sao Paulo, 05651-901, Brazil |
Recruiting | Hospital Moinhos de Vento-Centro Clínico | Porto Alegre, 90035-001, Brazil |
Withdrawn | Docrates Klinikka | Helsinki, 00180, Finland |
Recruiting | Turun yliopistollinen keskussairaala | Turku, 20520, Finland |
Recruiting | Oulun yliopistollinen sairaala | Oulu, 90220, Finland |
Recruiting | HUS, Meilahden sairaala | Helsinki, 00029, Finland |
Recruiting | Tampereen yliopistollinen sairaala | Tampere, 33520, Finland |
Recruiting | Royal Surrey County Hospital | Guildford, GU2 7XX, United Kingdom |
Not yet recruiting | Institut Curie - Ulm - Paris | PARIS cedex 5, 75248, France |
Recruiting | Center Hospitalier Michallon - Grenoble - Service d Urologie et de la transplantation Renale | La Tronche, 38700, France |
Not yet recruiting | Azienda Ospedaliero Universitaria Ospedali Riuniti_Foggia - Oncologia Medica e Terapia Biomolecolare Universitaria | Foggia, 71122, Italy |
Recruiting | Chris O'Brien Lifehouse | Camperdown, 2050, Australia |
Recruiting | Eastern Clinical Research Unit - Box Hill | Box Hill, 3128, Australia |
Withdrawn | Bundaberg Hospital, Genesis Cancer Care - Bundaberg | Bundaberg, 4670, Australia |
Withdrawn | Wide Bay Hospital and Health Service - Hervey Bay Hospital | Pialba, 4655, Australia |
Recruiting | Medizinische Universität Innsbruck | Innsbruck, 6020, Austria |
Withdrawn | Shaare Zedek Medical Center | Jerusalem, 9372212, Israel |
Withdrawn | Sheba Medical Center | Tel Hashomer, 52621, Israel |
Withdrawn | Sourasky Medical Center | Tel-Aviv, 64239, Israel |
Recruiting | The Urology Place | San Antonio, 78240, United States |
Recruiting | Istituto Oncologico Veneto_Castelfranco Veneto - UOC Urologia Oncologica | Castelfranco Veneto, 31033, Italy |
Withdrawn | IRCCS Ospedale Sacro Cuore Don Calabria | Verona, 37024, Italy |
Recruiting | Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Oncologia | Bergamo, 24127, Italy |
Recruiting | Azienda Ospedaliera Policlinico Universitario Tor Vergata - UOC Radioterapia | Roma, 00133, Italy |
Recruiting | Klinikum Mannheim GmbH | Mannheim, 68135, Germany |
Recruiting | Allegheny General Hospital | Pittsburgh, 15212, United States |
Recruiting | Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia | Rozzano, 20089, Italy |
Not yet recruiting | Vivantes Klinikum Am Urban | Berlin, 10967, Germany |
Recruiting | Skane University Hospital - Department of Urology | Malmo, 20502, Sweden |
Recruiting | Goteborgs Universitet | Gothenburg, 413 45, Sweden |
Recruiting | Rigshospitalet - Kræftbehandling | København Ø, 2100, Denmark |
Withdrawn | Charité Campus Benjamin Franklin (CBF) | Berlin, 12203, Germany |
Recruiting | Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden | Dresden, 1307, Germany |
Recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Degenza di Radioterapia Oncologica | Roma, 00168, Italy |
Recruiting | Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Urologia | Bologna, 40138, Italy |
Recruiting | Aarhus Universitetshospital | Aarhus N, 8200, Denmark |
Recruiting | Aalborg University Hospital | Aalborg, 9000, Denmark |
Not yet recruiting | London Health Sciences Centre (LHSC) - London Regional Cancer Program (LRCP) | London, N6A 5W9, Canada |
Not yet recruiting | Cabrini Malvern | Malvern, 3144, Australia |
Recruiting | Fudan University Shanghai Cancer Center | Shanghai, 200000, China |
Recruiting | Peking Union Medical College Hospital (PUMCH) - East Location | Beijing, 100730, China |
Recruiting | The 1st Affiliated Hospital of Zhejiang University | Hangzhou, 310003, China |
Withdrawn | New Jersey Urology (NJU) | Saddle Brook, 07663-5227, United States |
Recruiting | Nova Scotia Health Authority | Halifax, B3H 2Y9, Canada |
Recruiting | Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont | Sherbrooke, J1H 5N4, Canada |
Recruiting | Institut de Cancerologie Jean Godinot - Departement oncologie medicale | Reims, 51056, France |
Recruiting | Nanjing First Hospital | Nanjing, 210006, China |
Recruiting | Marien-Krankenhaus Bergisch Gladbach | Bergisch Gladbach, 51465, Germany |
Recruiting | Chesapeake Urology Associates - Towson | Baltimore, 21204, United States |
Withdrawn | Spokane Urology PS | Spokane, 99202, United States |
Recruiting | Urology Cancer Center, PC | Omaha, 68130, United States |
Withdrawn | UMass Memorial Medical Center - University Campus | Worcester, 01655-0002, United States |
Withdrawn | VA Pittsburgh Healthcare System | Pittsburgh, 15240, United States |
Withdrawn | Westmead Hospital | Westmead, 2145, Australia |
Not yet recruiting | Universitaetsklinikum Jena - Klinik fuer Urologie | Jena, 7747, Germany |
Not yet recruiting | Royal Melbourne Hospital | Parkville, 3050, Australia |
Not yet recruiting | Institut Curie - Saint-Cloud | Saint-Cloud, 92210, France |
Withdrawn | Uppsala University Hospital, Urology Department | Uppsala, SE-751, Sweden |
Recruiting | Hopital Maisonneuve-Rosemont | Montreal, H1T 2M4, Canada |
Withdrawn | Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine | Shanghai, 200025, China |
Recruiting | Zhongnan hospital ,Wuhan University | Wuhan, 430071, China |
Recruiting | West China Hospital,Sichuan University | Chengdu, 610041, China |
Recruiting | BC Cancer - Abbotsford | Abbotsford, V2S 0C2, Canada |
Not yet recruiting | The Affiliated Hospital of Inner Mongolia Medical University | Hohehot, 010030, China |
Recruiting | Tianjin Cancer Hospital, Airport Hospital | Tianjin, 300308, China |
Recruiting | Swietokrzyskie Centrum Onkologii | Kielce, 25-734, Poland |
Recruiting | Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University | Nanjing, 210029, China |
Recruiting | Hunan Cancer Hospital | Changsha, 410013, China |
Recruiting | Sir Charles Gairdner Hospital | Nedlands, 6009, Australia |
Recruiting | National Taiwan University Hospital | Taipei, 100, Taiwan |
Recruiting | HagaZiekenhuis van Den Haag | The Hague, 2545, Netherlands |
Not yet recruiting | Albert Schweitzer Hospital | Internal Medicine - Oncology Department | Dordrecht, 3300 AK, Netherlands |
Withdrawn | Catharina Ziekenhuis | EINDHOVEN, 5623 EJ, Netherlands |
Recruiting | University Medical Center Groningen | Urology Department | GRONINGEN, 9713 GZ, Netherlands |
Recruiting | St. Franciscus Gasthuis | Rotterdam, 3045 PM, Netherlands |
Recruiting | St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde | Nieuwegein, 3435 CM, Netherlands |
Not yet recruiting | Tergooi MC | Hilversum - Wetenschapsbureau | Hilversum, 1213 VG, Netherlands |
Recruiting | UZ Gent - department Urology | Gent, 9000, Belgium |
Withdrawn | Institut Jules Bordet/Jules Bordet Instituut | Bruxelles, 1070, Belgium |
Recruiting | AZ Groeninge Campus Kennedylaan - Urology | Kortrijk, 8500, Belgium |
Not yet recruiting | Jessa Hospital | Campus Virga Jesse - Data Management Oncology and Hematology Department | Hasselt, 3500, Belgium |
Recruiting | Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Urology Department | Leuven, 3000, Belgium |
Not yet recruiting | Maria Middelares General Hospital | Medical Oncology Department | Gent, 9000, Belgium |
Not yet recruiting | Northern Hospital | Epping, 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 Centre | Taipei, 112019, Taiwan |
Recruiting | Chang Gung Memorial Hospital at Linkou | Taoyuan, 33305, Taiwan |
Not yet recruiting | Tungs' Taichung MetroHarbor Hospital | Taichung, 435403, Taiwan |
Recruiting | Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika | Olomouc, 779 00, Czech Republic |
Not yet recruiting | Royal Brisbane & Women's Hospital | Brisbane, 4029, Australia |
Recruiting | Western Urology | Maribyrnong, 3032, Australia |
Recruiting | Centrum Medyczne iMed24 | Krakow, 31-864, Poland |
Recruiting | Medrise Sp. z o.o. Centrum Badan Klinicznych | Lublin, 20-582, Poland |
Recruiting | Vseobecna fakultni nemocnice - Urologicka klinika, Praha | Praha 2, 128 08, Czech Republic |
Recruiting | Fakultni nemocnice u Sv. Anny, Onkologicko-chirurgicke oddeleni | Brno, 602 00, Czech Republic |
Withdrawn | Multiscan s.r.o., Department: Ambulance klinické onkologie Nemocnice Horovice | Horovice, 26801, Czech Republic |
Recruiting | Universitätsklinikum Hamburg-Eppendorf - Martini-Klinik am UKE GmbH | Hamburg, 20246, Germany |
Recruiting | Centrum Onkologii im. Prof. Franciszka Lukaszczyka | Bydgoszcz, 85-796, Poland |
Recruiting | Barwon Health | Geelong, 3220, Australia |
Recruiting | Szpital Grochowski im. dr.med. Rafala Masztaka | Warszawa, 04-073, Poland |
Not yet recruiting | Semmelweis Egyetem, Altalanos Orvostudomanyi Kar, Urologiai Klinika | Budapest, 1082, Hungary |
Not yet recruiting | Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet | Budapest, 1204, Hungary |
Not yet recruiting | Orszagos Onkologiai Intezet | Budapest, 1122, Hungary |
Recruiting | Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz | Gyor, 9024, Hungary |
Recruiting | Budapesti Uzsoki Utcai Kórház | Budapest, 1145, Hungary |
Not yet recruiting | Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz | Nyiregyhaza, 4400, Hungary |
Recruiting | EMC Instytut Medyczny SA | Wroclaw, 54-144, Poland |
Withdrawn | Centro Hospitalar Universitario do Porto | Porto, 4099-001, Portugal |
Not yet recruiting | Centro Hospitalar e Universitario de Coimbra EPE (CHUC) | Coimbra, 3004-561, Portugal |
Recruiting | Marienhospital Herne Universitätsklinik | Herne, 44625, Germany |
Not yet recruiting | Johannes Gutenberg-Universität Mainz - Urologie | Mainz, 55131, Germany |
Recruiting | Medizinische Universitaet Graz - Klinische Abteilung für Onkologie - Innere Medizin | Graz, 8036, Austria |
Recruiting | Clinique Clementville | Montpellier, 34070, France |
Recruiting | Centre Georges Francois Leclerc Dijon - service de radiotherapie | DIJON, 21079, France |
Recruiting | Centre d' Oncologie du Pays Basque Clinique Belharra - Bayonne - Oncologie medicale | Bayonne, 64100, France |
Recruiting | Institut de Cancérologie de Lorraine - Alexis Vautrin | Vandoeuvre-les-Nancy, 54519, France |
Not yet recruiting | Blacktown Hospital | Blacktown, 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 Timone | MARSEILLE, 13005, France |
Recruiting | Royal Adelaide Hospital | Adelaide, 5000, Australia |
Not yet recruiting | University of Texas Southwestern Medical Center-Harold C. Simmons Comprehensive Cancer Center | Dallas, 75235, United States |
Recruiting | Kaye Edmonton Clinic - Dianne and Irving Kipnes Urology Centre | Edmonton, T6G 1Z1, Canada |
Recruiting | CISSS de l'Outaouais - Hopital de Gatineau - Centre de cancerolgie | Gatineau, J8P 7H2, Canada |
Recruiting | Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec - Radio-oncologie | Trois-rivieres, G8Z 3R9, Canada |
Recruiting | Urology South Shore Research - Research Department | Greenfield 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 Beneficência | São Paulo, 01323-001, Brazil |
Recruiting | Universidade Estadual do Rio de Janeiro | Rio de Janeiro, 20551-030, Brazil |
Not yet recruiting | Hospital do Cancer de Sao Paulo - A. C. Camargo | Sao Paulo, 01525-001, Brazil |
Not yet recruiting | Hospital Alemao Oswaldo Cruz | Sao Paulo, 01327-001, Brazil |
Withdrawn | Hospital Sirio Libanês - Hospital Base de Brasilia | Brasilia, 70200-730, Brazil |
Not yet recruiting | Oncocentro - Fortaleza | Fortaleza, 60135-237, Brazil |
Not yet recruiting | Hospital São Rafael | Salvador, 41253-190, Brazil |
Withdrawn | Real Hospital Português | Recife, 50070-160, Brazil |
Recruiting | Urologicum Duisburg | Duisburg, 47169, Germany |
Recruiting | Urologische Gemeinschaftspraxis Wesel | Wesel, 46483, Germany |
Recruiting | Hopital de La Louvière - Site Jolimont - Oncology department | La Louvière, 7100, Belgium |
Recruiting | Fakultni nemocnice v Motole, Onkologicka klinika 2. LF UK a FN Motol | Prague, 15006, Czech Republic |
Not yet recruiting | Klinikum Stuttgart / Klinik für Urologie und Transplantationschirurgie | Stuttgart, 70174, Germany |
Not yet recruiting | Universitätsklinikum Schleswig-Holstein/ Klinik für Urologie | Kiel, 24105, Germany |
Not yet recruiting | Universitätsklinikum Aachen / Klinik und Poliklinik für Urologie und Kinderurologie | Aachen, 52074, Germany |
Recruiting | Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche | Brest, 29609, France |
Recruiting | Institut de Cancérologie de Bourgogne | Dijon, 21000, France |
Recruiting | Centre Bourgogne - Hôpital Privé Le Bois | LILLE, 59000, France |
Recruiting | Centre Hospitalier Regional et Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz | Besancon, 25000, France |
Recruiting | UNICANCER - Centre Leon-Berard (CLB) - Medical oncology | Lyon, 69008, France |
Not yet recruiting | Institut Claudius Regaud - iUCT Oncopole | TOULOUSE CEDEX 9, 31059, France |
Recruiting | Cliniche Gavazzeni S.p.A - Dipartimento Area Chirurgia Unità Operativa di Urologia | Bergamo, 24125, Italy |
Not yet recruiting | Hospital Universitario "Marqués de Valdecilla" | Santander, 39008, Spain |
Recruiting | Sjællands University hospital Næstved | Næstved, 4700, Denmark |
Recruiting | Thomayerova Nemocnice (TN) (Thomayers Hospital) - Onkologicka Klinika 1. LF UK A TN | Prague, 140 59, Czech Republic |
Not yet recruiting | Instituto D'Or Pesquisa e Ensino (IDOR) (D'Or Institute for Research & Education) - Rio de Janeiro | Rio de Janeiro, 22281-100, Brazil |
Not yet recruiting | Hospital das Clínicas da Universidade de Campinas - UNICAMP | São Paulo, 13083-888, Brazil |
Recruiting | Peking University First Hospital | Beijing, 100034, China |
Not yet recruiting | Hospital Evangélico de Cachoeiro de Itapemirim | Vitória, 29047-660, Brazil |
Not yet recruiting | City of Hope - Phoenix Cancer Center | Goodyear, 85338, United States |
Not yet recruiting | Hospital Mae de Deus | Porto Alegre, 90850-170, Brazil |
Not yet recruiting | NAIC - Instituto do Cancer | Bauru, 17033-490, Brazil |
Not yet recruiting | Icahn School of Medicine at Mount Sinai - Oncology | New York, 10029, United States |
Not yet recruiting | Azienda Ospedaliera Santa Croce e Carle - Oncologia | Cuneo, 12100, Italy |
Not yet recruiting | Australian Prostate Centre | North 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 BICRdate_rangeTime Frame:After randomization to after last treatment, approximately 46 months
- Time to Castration-resistant prostate cancer (CRPC) assessed by investigatordate_rangeTime Frame:After randomization to after last treatment, approximately 46 months
- Time to initiation of first subsequent systemic antineoplastic therapydate_rangeTime Frame:After randomization to after last treatment, approximately 46 months
- Time to loco-regional progression by PSMA PET/CTdate_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 scoreFACT-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 progressiondate_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 severitydate_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 TEAEdate_rangeTime Frame:After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2