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JOURNAL ONKOLOGIE – STUDIE
ARASTEP

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

Rekrutierend

NCT-Nummer:
NCT05794906

Studienbeginn:
April 2023

Letztes Update:
30.04.2024

Wirkstoff:
Darolutamide (BAY1841788, Nubeqa)

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Bayer

Collaborator:
-

Kontakt

Bayer Clinical Trials Contact
Kontakt:
Phone: (+)1-888-84 22937
E-Mail: clinical-trials-contact@bayer.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 259)

Brustzentrum Regio im Comprehensive Cancer Center Marburg
Baldingerstraße 1
35043 Marburg
DeutschlandZurückgezogen» Google-Maps
Darmzentrum am Krankenhaus der Barmherzigen Brüder Trier
Nordallee 1
54292 Trier
DeutschlandNoch nicht rekrutierend» Google-Maps
Klinikum Mannheim GmbH
68167 Mannheim
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Studienpraxis Urologie
72622 Nürtingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Pankreaskrebszentrum am Klinikum rechts der Isar
Ismaninger Straße 22
81675 München
DeutschlandNoch nicht rekrutierend» Google-Maps
Klinikum der Universität Würzburg
97080 Würzburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsklinikum der Johann Wolfgang Goethe Universität
60596 Frankfurt
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Städtisches Klinikum Braunschweig gGmbH
38126 Braunschweig
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsmedizin der Georg-August-Universität Göttingen
37075 Göttingen
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Marienhospital Herne Universitätsklinik
44625 Herne
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsklinikum Köln
50937 Köln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsklinikum Münster (UKM)
48149 Münster
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Medizinische Fakultät der Otto-von-Guericke Universität
39120 Magdeburg
(Sachsen-Anhalt)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsklinikum Carl Gustav Carus Dresden
01307 Dresden
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Marien-Krankenhaus Bergisch Gladbach
51465 Bergisch Gladbach
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Vivantes Klinikum Am Urban
10967 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Charité Campus Benjamin Franklin (CBF)
12203 Berlin
(Berlin)
GermanyZurückgezogen» Google-Maps
Martini-Klinik Hamburg
20246 Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie
07747 Jena
(Thüringen)
GermanyNoch nicht rekrutierend» Google-Maps
Johannes Gutenberg-Universität Mainz - Urologie
55131 Mainz
(Rheinland-Pfalz)
GermanyNoch nicht rekrutierend» Google-Maps
Mayo Clinic Hospital
85054 Phoenix
United StatesNoch nicht rekrutierend» Google-Maps
Arizona Institute of Urology
85704 Tucson
United StatesZurückgezogen» Google-Maps
City of Hope National Medical Center
91010 Duarte
United StatesRekrutierend» Google-Maps
University of Southern California
90033 Los Angeles
United StatesNoch nicht rekrutierend» Google-Maps
Tower Urology, Inc
90048 Los Angeles
United StatesRekrutierend» Google-Maps
University of California, Los Angeles
90095 Los Angeles
United StatesNoch nicht rekrutierend» Google-Maps
University of California Irvine Medical Center
92868-3201 Orange
United StatesZurückgezogen» Google-Maps
UCSF Med Center Helen Diller Family Comp Cancer Center
94143 San Francisco
United StatesNoch nicht rekrutierend» Google-Maps
Colorado Urology (Colorado Clinical Research)
80228 Lakewood
United StatesRekrutierend» Google-Maps
Clermont Oncology Center
34711 Clermont
United StatesZurückgezogen» Google-Maps
University of Florida - Jacksonville
32209 Jacksonville
United StatesZurückgezogen» Google-Maps
Mid Florida Cancer Centers
32763-8316 Orange City
United StatesZurückgezogen» Google-Maps
Northwestern University Feinberg School of Medicine - Department of Urology
60611 Chicago
United StatesRekrutierend» Google-Maps
Jesse Brown VA Medical Center
60612 Chicago
United StatesZurückgezogen» Google-Maps
Urology of Indiana, LLC
46143 Greenwood
United StatesZurückgezogen» Google-Maps
First Urology PSC
47130 Jeffersonville
United StatesZurückgezogen» Google-Maps
University of Kansas
66160 Kansas City
United StatesNoch nicht rekrutierend» Google-Maps
Chesapeake Urology Associates
21204 Baltimore
United StatesRekrutierend» Google-Maps
Johns Hopkins Univ School Med|Sidney Kimmel Comp Cancer Cntr
21231 Baltimore
United StatesNoch nicht rekrutierend» Google-Maps
Dana-Farber Cancer Institute
02115-6084 Boston
United StatesNoch nicht rekrutierend» Google-Maps
UMass Memorial Medical Center - University Campus
01655-0002 Worcester
United StatesZurückgezogen» Google-Maps
Barbara Ann Karmanos Cancer Institute - Detroit
48201 Detroit
United StatesRekrutierend» Google-Maps
Michigan Institute of Urology, PC
48084 Troy
United StatesNoch nicht rekrutierend» Google-Maps
University of Minnesota Medical Center
55455 Minneapolis
United StatesNoch nicht rekrutierend» Google-Maps
Washington University School of Medicine
63110-1093 Saint Louis
United StatesNoch nicht rekrutierend» Google-Maps
Urology Cancer Center, PC
68130-5606 Omaha
United StatesRekrutierend» Google-Maps
New Jersey Urology (NJU)
07663-5227 Saddle Brook
United StatesZurückgezogen» Google-Maps
New Jersey Urology, LLC
08043 Voorhees
United StatesNoch nicht rekrutierend» Google-Maps
NYU Langone Health
10016 New York
United StatesNoch nicht rekrutierend» Google-Maps
Associated Medical Professionals of NY, PLLC
13210 Syracuse
United StatesZurückgezogen» Google-Maps
White Plains Hospital
10601 White Plains
United StatesNoch nicht rekrutierend» Google-Maps
Wake Forest Baptist Health
27157 Winston-Salem
United StatesZurückgezogen» Google-Maps
The Urology Group
45212 Cincinnati
United StatesNoch nicht rekrutierend» Google-Maps
Ohio State University Wexner Medical Center
43210 Columbus
United StatesZurückgezogen» Google-Maps
MidLantic Urology - Bala Cynwyd
19004 Bala-Cynwyd
United StatesNoch nicht rekrutierend» Google-Maps
Urological Associates of Lancaster
17604 Lancaster
United StatesZurückgezogen» Google-Maps
Allegheny General Hospital
15212 Pittsburgh
United StatesNoch nicht rekrutierend» Google-Maps
University of Pittsburgh
15232 Pittsburgh
United StatesZurückgezogen» Google-Maps
VA Pittsburgh Healthcare System
15240 Pittsburgh
United StatesZurückgezogen» Google-Maps
Bon Secours St. Francis Hospital
29607 Greenville
United StatesZurückgezogen» Google-Maps
Carolina Urological Research Center
29579 Myrtle Beach
United StatesRekrutierend» Google-Maps
Urology Austin, PLLC (an affiliate of Urology America)
78745 Austin
United StatesNoch nicht rekrutierend» Google-Maps
University of Texas MD Anderson Cancer Center
77030 Houston
United StatesNoch nicht rekrutierend» Google-Maps
Urology San Antonio, PA dba USA Clinical Trials
78229 San Antonio
United StatesRekrutierend» Google-Maps
Blacktown Hospital
2148 Blacktownn
AustraliaNoch nicht rekrutierend» Google-Maps
Royal Prince Alfred Hospital
2050 Camperdown
AustraliaNoch nicht rekrutierend» Google-Maps
South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department
2170 Liverpool
AustraliaNoch nicht rekrutierend» Google-Maps
Macquarie University Hospital
2109 Macquarie University
AustraliaZurückgezogen» Google-Maps
Port Macquarie Base Hospital
2444 Port Macquarie
AustraliaZurückgezogen» Google-Maps
St Vincents Hospital Sydney
2010 Sydney
AustraliaZurückgezogen» Google-Maps
Sydney Adventist Hospital
2076 Wahroonga
AustraliaNoch nicht rekrutierend» Google-Maps
Royal Brisbane & Women's Hospital
4029 Brisbane
AustraliaNoch nicht rekrutierend» Google-Maps
Bundaberg Hospital, Genesis Cancer Care - Bundaberg
4670 Bundaberg
AustraliaZurückgezogen» Google-Maps
Wide Bay Hospital and Health Service - Hervey Bay Hospital
4655 Pialba
AustraliaZurückgezogen» Google-Maps
Royal Adelaide Hospital
5000 Adelaide
AustraliaNoch nicht rekrutierend» Google-Maps
Eastern Clinical Research Unit - Box Hill
3128 Box Hill
AustraliaNoch nicht rekrutierend» Google-Maps
Epworth HealthCare
3002 East Melbourne
AustraliaNoch nicht rekrutierend» Google-Maps
Cabrini Medical Centre
3144 Malvern
AustraliaNoch nicht rekrutierend» Google-Maps
Royal Melbourne Hospital
3052 Melbourne
AustraliaNoch nicht rekrutierend» Google-Maps
Sir Charles Gairdner Hospital
6009 Nedlands
AustraliaNoch nicht rekrutierend» Google-Maps
Northern Hospital
3076 Epping
AustraliaNoch nicht rekrutierend» Google-Maps
Western Urology
3032 Maribyrnong
AustraliaNoch nicht rekrutierend» Google-Maps
Prince of Wales Hospital NSW
2031 Randwick
AustraliaNoch nicht rekrutierend» Google-Maps
Ordensklinikum Linz GmbH Elisabethinen
4020 Linz
AustriaNoch nicht rekrutierend» Google-Maps
Medizinische Universitaet Graz - Klinische Abteilung für Onkologie - Innere Medizin
8036 Graz
AustriaNoch nicht rekrutierend» Google-Maps
Medizinische Universität Innsbruck
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Uniklinikum Salzburg - Landeskrankenhaus
5020 Salzburg
AustriaNoch nicht rekrutierend» Google-Maps
Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie
1090 Wien
AustriaNoch nicht rekrutierend» Google-Maps
Institut Jules Bordet/Jules Bordet Instituut
1070 Bruxelles
BelgiumNoch nicht rekrutierend» Google-Maps
AZ Maria Middelares - Oncology
9000 Gent
BelgiumNoch nicht rekrutierend» Google-Maps
UZ Gent - department Urology
9000 Gent
BelgiumNoch nicht rekrutierend» Google-Maps
Jessa ziekenhuis - department Oncology
3500 Hasselt
BelgiumNoch nicht rekrutierend» Google-Maps
AZ Groeninge Campus Kennedylaan - Urology
8500 Kortrijk
BelgiumNoch nicht rekrutierend» Google-Maps
UZ Leuven - department Uro-oncology
3000 Leuven
BelgiumNoch nicht rekrutierend» Google-Maps
Assistência Multidisciplinar em Oncologia (AMO)
41950-640 Salvador
BrazilNoch nicht rekrutierend» Google-Maps
Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
81520-060 Curitiba
BrazilRekrutierend» Google-Maps
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
59062-000 Natal
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Moinhos de Vento-Centro Clínico
90035-001 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Faculdade de Medicina do ABC
09060-650 Santo André
BrazilNoch nicht rekrutierend» Google-Maps
Instituto do Cancer do Estado de Sao Paulo
01246-000 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Inst. de Assistência Médica ao Sérvidor Público Estadual
04039-004 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
05651-901 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Sirio Libanes
01308-050 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Prostate Cancer Centre
T2V 1P9 Calgary
CanadaNoch nicht rekrutierend» Google-Maps
Vancouver Prostate Centre
V5Z 1M9 Vancouver
CanadaNoch nicht rekrutierend» Google-Maps
BCCA-Vancouver Island Centre
V8R 6V5 Victoria
CanadaRekrutierend» Google-Maps
Nova Scotia Health Authority
B3H 2Y9 Halifax
CanadaNoch nicht rekrutierend» Google-Maps
St. Joseph's Healthcare - Hamilton
L8P 3B6 Hamilton
CanadaNoch nicht rekrutierend» Google-Maps
London Regional Cancer Program
N6A 4L6 London
CanadaNoch nicht rekrutierend» Google-Maps
Princess Margaret Cancer Centre - UHN
M5G 2M9 Toronto
CanadaNoch nicht rekrutierend» Google-Maps
Hopital Maisonneuve-Rosemont
H1T 2M4 Montreal
CanadaNoch nicht rekrutierend» Google-Maps
Sir Mortimer B. Davis Jewish General Hospital
H3T 1E2 Montreal
CanadaRekrutierend» Google-Maps
BC Cancer - Abbotsford Centre
V2S 0C2 Abbotsford
CanadaNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont
J1H 5N4 Sherbrooke
CanadaRekrutierend» Google-Maps
Zhongnan hospital ,Wuhan University
430033 Wuhan
ChinaNoch nicht rekrutierend» Google-Maps
Hunan Cancer Hospital
410013 Changsha
ChinaNoch nicht rekrutierend» Google-Maps
Affiliated Hospital of Inner Mongolia Medical University
010050 Hohehot
ChinaNoch nicht rekrutierend» Google-Maps
Nanjing First Hospital
210006 Nanjing
ChinaNoch nicht rekrutierend» Google-Maps
Fudan University Shanghai Cancer Center
200030 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
West China Hospital,Sichuan University
610041 Chengdu
ChinaNoch nicht rekrutierend» Google-Maps
The 1st Affiliated Hospital of Zhejiang University
310000 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Peking Union Medical College Hospital (PUMCH) - East Location
100730 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
210029 Nanjing
ChinaNoch nicht rekrutierend» Google-Maps
Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine
200025 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Tianjin Cancer Hospital, Airport Hospital
300308 Tianjin
ChinaNoch nicht rekrutierend» Google-Maps
Fakultni nemocnice u Sv. Anny, Onkologicko-chirurgicke oddeleni
602 00 Brno
CzechiaNoch nicht rekrutierend» Google-Maps
Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
602 00 Brno
CzechiaNoch nicht rekrutierend» Google-Maps
Multiscan s.r.o., Department: Ambulance klinické onkologie Nemocnice Horovice
26801 Horovice
CzechiaNoch nicht rekrutierend» Google-Maps
Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika
779 00 Olomouc
CzechiaNoch nicht rekrutierend» Google-Maps
Vseobecna fakultni nemocnice - Urologicka klinika, Praha
128 08 Praha 2
CzechiaNoch nicht rekrutierend» Google-Maps
Aarhus Universitetshospital
8200 Aarhus N
DenmarkNoch nicht rekrutierend» Google-Maps
HUS, Meilahden sairaala
29 Helsinki
FinlandNoch nicht rekrutierend» Google-Maps
Oulun yliopistollinen sairaala
90220 Oulu
FinlandNoch nicht rekrutierend» Google-Maps
Tampereen yliopistollinen sairaala, keskussairaala
33520 Tampere
FinlandRekrutierend» Google-Maps
Turun yliopistollinen keskussairaala
FIN-20521 Turku
FinlandRekrutierend» Google-Maps
Centre d'oncologie du Pays Basque
64100 Bayonne
FranceNoch nicht rekrutierend» Google-Maps
Hôpital Pellegrin - Bordeaux
33000 Bordeaux
FranceNoch nicht rekrutierend» Google-Maps
Centre Jean Perrin
63011 Clermont-ferrand
FranceNoch nicht rekrutierend» Google-Maps
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Henri Mondor (Hopital Henri-Mondor)
94000 Creteil
FranceNoch nicht rekrutierend» Google-Maps
Centre Georges Francois Leclerc Dijon
21079 Dijon
FranceNoch nicht rekrutierend» Google-Maps
CHU GRENOBLE - Hopital Michallon
38048 Grenoble
FranceNoch nicht rekrutierend» Google-Maps
Hôpital Claude Huriez - Lille
59037 Lille
FranceNoch nicht rekrutierend» Google-Maps
Hôpital de la Timone - Marseille
13005 Marseille
FranceNoch nicht rekrutierend» Google-Maps
Clinique Clementville
34070 Montpellier
FranceNoch nicht rekrutierend» Google-Maps
Institut Curie - Ulm - Paris
75248 PARIS cedex 5
FranceNoch nicht rekrutierend» Google-Maps
Hopital Bichat - Paris
75018 Paris
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Lyon Sud
69495 Pierre Benite
FranceNoch nicht rekrutierend» Google-Maps
Institut de Cancérologie Jean Godinot
51726 Reims
FranceNoch nicht rekrutierend» Google-Maps
Institue Curie - Saint-Cloud
92210 Saint-cloud
FranceNoch nicht rekrutierend» Google-Maps
Institut de Cancérologie de l'Ouest - Saint Herblain
44800 Saint-Herblain
FranceRekrutierend» Google-Maps
ICANS - Institut de Cancérologie de Strasbourg Europe
67033 Strasbourg
FranceRekrutierend» Google-Maps
Institut de Cancérologie de Lorraine - Alexis Vautrin
54519 Vandoeuvre-les-Nancy
FranceNoch nicht rekrutierend» Google-Maps
Institut Gustave Roussy - Département de Médecine Oncologique
94805 Villejuif Cedex
FranceRekrutierend» Google-Maps
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
1024 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Semmelweis Egyetem, Altalanos Orvostudomanyi Kar, Urologiai Klinika
1082 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Orszagos Onkologiai Intezet
1122 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Budapesti Uzsoki Utcai Korhaz
1145 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
9024 Gyor
HungaryNoch nicht rekrutierend» Google-Maps
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
H-4400 Nyiregyhaza
HungaryNoch nicht rekrutierend» Google-Maps
Hadassah Hebrew University Hospital Ein Kerem
9112001 Jerusalem
IsraelZurückgezogen» Google-Maps
Shaare Zedek Medical Center
9372212 Jerusalem
IsraelZurückgezogen» Google-Maps
Clalit Health Services Rabin Medical Center-Beilinson Campus
4941492 Petah Tikva
IsraelZurückgezogen» Google-Maps
Istituto Nazionale Tumori IRCCS Fondazione G.Pascale
80131 Napoli
ItalyNoch nicht rekrutierend» Google-Maps
A.O.U. di Bologna Policlinico S.Orsola Malpighi
40138 Bologna
ItalyNoch nicht rekrutierend» Google-Maps
A.O.U. di Modena - Policlinico
41124 Modena
ItalyNoch nicht rekrutierend» Google-Maps
AUSL-IRCCS di Reggio Emilia
42123 Reggio Emilia
ItalyNoch nicht rekrutierend» Google-Maps
IRCCS Centro di Riferimento Oncologico (CRO)
33081 Pordenone
ItalyNoch nicht rekrutierend» Google-Maps
Fondazione PTV Policlinico Tor Vergata
00133 Roma
ItalyNoch nicht rekrutierend» Google-Maps
IRCCS Istituti Fisioterapici Ospitalieri - IFO
00144 Roma
ItalyNoch nicht rekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
168 Roma
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
20089 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Ospedale San Raffaele s.r.l.
20132 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
ItalyZurückgezogen» Google-Maps
Molinette Hospital University of Torino
10126 Torino
ItalyRekrutierend» Google-Maps
A.O.U. Consorziale Policlinico
70124 Bari
ItalyNoch nicht rekrutierend» Google-Maps
A.O.U. Ospedali Riuniti Foggia
71100 Foggia
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Oncologico Veneto IRCCS (IOV)
35128 Padova
ItalyNoch nicht rekrutierend» Google-Maps
IRCCS Ospedale Sacro Cuore Don Calabria
37024 Verona
ItalyZurückgezogen» Google-Maps
IRCCS Ist Nazionale Tumori GE - Oncologia Medica
16132 Genova
ItalyRekrutierend» Google-Maps
A.O. di Perugia - Ospedale Santa Maria della Misericordia - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA
06123 Perugia
ItalyNoch nicht rekrutierend» Google-Maps
Santa Chiara Hospital
38122 Trento
ItalyNoch nicht rekrutierend» Google-Maps
Hokkaido University Hospital
060-8648 Sapporo
JapanNoch nicht rekrutierend» Google-Maps
Kanazawa University Hospital
920-8641 Kanazawa
JapanNoch nicht rekrutierend» Google-Maps
Yokohama City University Hospital
236-0004 Yokohama
JapanNoch nicht rekrutierend» Google-Maps
Osaka University Hospital
565-0871 Suita
JapanNoch nicht rekrutierend» Google-Maps
Tokyo Medical and Dental University Hospital
113-8519 Bunkyo-ku
JapanRekrutierend» Google-Maps
Kagoshima University Hospital
890-8520 Kagoshima
JapanNoch nicht rekrutierend» Google-Maps
Kyoto University Hospital
606-8507 Kyoto
JapanNoch nicht rekrutierend» Google-Maps
Albert Schweitzer Ziekenhuis - Dordwijk
3300 AK Dordrecht
NetherlandsNoch nicht rekrutierend» Google-Maps
Catharina Ziekenhuis
5623 EJ Eindhoven
NetherlandsNoch nicht rekrutierend» Google-Maps
Universitair Medisch Centrum Groningen
9713 GZ Groningen
NetherlandsNoch nicht rekrutierend» Google-Maps
Tergooiziekenhuizen Hilversum
1213 XZ Hilversum
NetherlandsNoch nicht rekrutierend» Google-Maps
St. Antonius Ziekenhuis
3435 CM Nieuwegein
NetherlandsNoch nicht rekrutierend» Google-Maps
St. Franciscus Gasthuis
3045 PM Rotterdam
NetherlandsNoch nicht rekrutierend» Google-Maps
HagaZiekenhuis van Den Haag
2545 The Hague
NetherlandsNoch nicht rekrutierend» Google-Maps
Auckland City Hosptial
1023 Auckland
New ZealandNoch nicht rekrutierend» Google-Maps
Canterbury Urology Research Trust
8013 Christchurch
New ZealandNoch nicht rekrutierend» Google-Maps
Tauranga Urology Research Limited
3112 Tauranga
New ZealandNoch nicht rekrutierend» Google-Maps
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
85-796 Bydgoszcz
PolandNoch nicht rekrutierend» Google-Maps
Swietokrzyskie Centrum Onkologii
25-734 Kielce
PolandNoch nicht rekrutierend» Google-Maps
Centrum Medyczne iMed24
31-864 Krakow
PolandNoch nicht rekrutierend» Google-Maps
Medrise Sp. z o.o. Centrum Badan Klinicznych
20-582 Lublin
PolandNoch nicht rekrutierend» Google-Maps
Szpital Grochowski im. dr.med. Rafala Masztaka
04-073 Warszawa
PolandNoch nicht rekrutierend» Google-Maps
EMC Instytut Medyczny SA
54-144 Wroclaw
PolandNoch nicht rekrutierend» Google-Maps
Centro Clinico Academico Braga | Braga, Portugal
4710-243 Braga
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Centro Hospitalar e Universitario de Coimbra EPE (CHUC)
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Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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

(or refused) for 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 or central values accepted).

- 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.

Exclusion Criteria:

- Pathological finding consistent with small cell, ductal or ≥50 % component of

neuroendocrine carcinoma of the prostate.

- History of bilateral orchiectomy.

- Metastases or recurrent /new malignant lesions in prostate gland/bed seminal vesicles,

lymph nodes below the CIA bifurcation on conventional imaging (CI) as assessed by BICR

during screening.

- Brain metastasis on PSMA PET /CT by BICR at screening.

- High-risk BCR after primary radiotherapy with new loco-regional lesions on screening

PSMA PET/CT who are eligible for curative salvage prostatectomy.

Note: Participants treated with curative salvage prostatectomy after primary RT who meet

the PSA criteria (inclusion criteria 5) may be considered for the study.

- Prior treatment with second generation (e.g. enzalutamide, apalutamide) androgen

receptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18 months

prior to signing of the ICF.

- Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization.

- Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or

salvage treatment completed within 8 weeks prior to signing of the ICF.

- Any prior malignancy (other than adequately treated basal cell or squamous cell skin

cancer, superficial bladder cancer, or any other cancer in situ currently in complete

remission) within 5 years.

- History of pelvic radiotherapy for other malignancy.

Studien-Rationale

Primary outcome:

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) (Time Frame - After randomization to after last treatment, approximately 24 months)



Secondary outcome:

1. Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR (Time Frame - After randomization to after last treatment, approximately 46 months)

2. Time to Castration-resistant prostate cancer (CRPC) assessed by investigator (Time Frame - After randomization to after last treatment, approximately 46 months)

3. Time to initiation of first subsequent systemic antineoplastic therapy (Time Frame - After randomization to after last treatment, approximately 46 months)

4. Time to loco-regional progression by PSMA PET/CT (Time Frame - After randomization to after last treatment, approximately 46 months)

5. Time to first Symptomatic skeletal event (SSE) (Time Frame - After randomization to after last treatment, approximately 46 months)

6. Overall survival (OS) (Time Frame - After randomization to after last treatment, approximately 46 months)

7. Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL) (Time Frame - 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 (Time Frame - After randomization to after last treatment, approximately 24 months):
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).

9. Time to symptomatic progression (Time Frame - 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 (Time Frame - 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 (Time Frame - After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months)

Studien-Arme

  • Experimental: Darolutamide+ADT
    Participants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months.
  • Placebo Comparator: Placebo+ADT
    Participants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months.

Geprüfte Regime

  • Darolutamide (BAY1841788, Nubeqa):
    Coated tablet, 300 mg / tablet, oral.
  • Placebo matching darolutamide:
    Coated tablet, oral
  • ADT:
    Luteinizing hormone-releasing hormone [LHRH] agonist/antagonists

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"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"

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