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
- Conditions
- Biochemically Recurrent Prostate Cancer
- Interventions
- Registration Number
- NCT05794906
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 970
- Capable of giving signed informed consent as described which includes compliance with the requirements, restrictions listed in the informed consent form (ICF), and in this protocol.
- Male ≥18 years of age at the time of signing the informed consent.
- Histologically or cytologically confirmed adenocarcinoma of prostate.
- Prostate cancer initially treated by: radical prostatectomy (RP) followed by adjuvant radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participants who are unfit for (or refused) ART or SRT, or primary radiotherapy (RT).
- High-risk biochemical recurrence (BCR), defined as Prostate-specific antigen doubling time (PSADT) <12 months calculated using the formula provided by the Sponsor, and PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT (local or central values accepted), or PSA ≥2 ng/mL above the nadir after primary RT only (local or central values accepted).
- Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 42-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by blinded independent central review (BICR) to identify at least one PSMA PET/CT lesion of prostate cancer.
- Serum testosterone ≥150 ng/dL (5.2 nmol/L) (local assessment is allowed whenever central assessment cannot be done).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Blood counts at screening: Hemoglobin ≥9.0 g/dL (participant must not have received blood transfusion within 7 days prior to sample being taken); Absolute neutrophil count (ANC) ≥1.5x10^9/L (participant must not have received any growth factor within 4 weeks prior to sample being taken); Platelet count ≥100x10^9/L.
- Screening values of: Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤1.5 x ULN; Total bilirubin (TBL) ≤1.5 ULN, (except participants with a diagnosis of Gilbert's disease); Estimated glomerular filtration rate (eGFR) >40 ml/min/1.73 m^2 calculated by the CKD-EPI formula.
- Sexually active male participants must agree to use contraception as detailed in the protocol during the Treatment period and for at least 1 week after the last dose of study treatment, and refrain from donating sperm during this period.
- Pathological finding consistent with small cell, ductal or ≥50 % component of neuroendocrine carcinoma of the prostate.
- History of bilateral orchiectomy.
- Metastases or recurrent /new malignant lesions in prostate gland/bed seminal vesicles, lymph nodes below the CIA bifurcation on conventional imaging (CI) as assessed by BICR during screening.
- Brain metastasis on PSMA PET /CT by BICR at screening.
- High-risk BCR after primary radiotherapy with new loco-regional lesions on screening PSMA PET/CT who are eligible for curative salvage prostatectomy.
Note: Participants treated with curative salvage prostatectomy after primary RT who meet the PSA criteria (inclusion criteria 5) may be considered for the study.
- Prior treatment with second generation (e.g. enzalutamide, apalutamide) androgen receptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18 months prior to signing of the ICF.
- Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization.
- Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or salvage treatment completed within 8 weeks prior to signing of the ICF.
- Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years.
- History of pelvic radiotherapy for other malignancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Darolutamide+ADT Darolutamide (BAY1841788, Nubeqa) Participants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months. Darolutamide+ADT ADT Participants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months. Placebo+ADT ADT Participants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months. Placebo+ADT Placebo matching darolutamide Participants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months.
- Primary Outcome Measures
Name Time Method Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR) After randomization to after last treatment, approximately 24 months
- Secondary Outcome Measures
Name Time Method Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR After randomization to after last treatment, approximately 46 months Time to Castration-resistant prostate cancer (CRPC) After randomization to after last treatment, approximately 46 months Time to initiation of first subsequent systemic antineoplastic therapy After randomization to after last treatment, approximately 46 months Time to loco-regional progression by PSMA PET/CT After randomization to after last treatment, approximately 46 months Time to first Symptomatic skeletal event (SSE) After randomization to after last treatment, approximately 46 months Overall survival (OS) After randomization to after last treatment, approximately 46 months Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL) After randomization to after last treatment, approximately 46 months Time to symptomatic progression After randomization to after last treatment, approximately 46 months Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severity After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months Number of participants who discontinue study treatment due to a TEAE After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months Time to deterioration in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score 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).
Trial Locations
- Locations (300)
Hospital Fundació Puigvert
🇪🇸Barcelona, Spain
Centrum Medyczne iMed24
🇵🇱Krakow, Poland
Medrise Sp. z o.o. Centrum Badan Klinicznych
🇵🇱Lublin, Poland
City of Hope - Phoenix Cancer Center
🇺🇸Goodyear, Arizona, United States
Mayo Clinic Hospital - Phoenix - Cardiology
🇺🇸Phoenix, Arizona, United States
Arizona Institute of Urology
🇺🇸Tucson, Arizona, United States
City of Hope - Duarte Cancer Center
🇺🇸Duarte, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Tower Urology, Inc
🇺🇸Los Angeles, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
University of California Irvine Medical Center
🇺🇸Orange, California, United States
UCSF Med Center Helen Diller Family Comp Cancer Center
🇺🇸San Francisco, California, United States
Colorado Urology - St. Anthony Hospital Campus
🇺🇸Lakewood, Colorado, United States
Clermont Oncology Center
🇺🇸Clermont, Florida, United States
University of Florida - Jacksonville
🇺🇸Jacksonville, Florida, United States
Mid Florida Cancer Centers
🇺🇸Orange City, Florida, United States
Northwestern Medicine - Urology
🇺🇸Chicago, Illinois, United States
Jesse Brown VA Medical Center
🇺🇸Chicago, Illinois, United States
Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Urology of Indiana, LLC
🇺🇸Greenwood, Indiana, United States
First Urology PSC
🇺🇸Jeffersonville, Indiana, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
Chesapeake Urology Associates - Towson
🇺🇸Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
UMass Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute - Detroit Headquarters
🇺🇸Detroit, Michigan, United States
Michigan Institute of Urology - Troy - Town Center Building
🇺🇸Troy, Michigan, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Washington University School of Medicine - Center for Advanced Medicine (CAM)
🇺🇸Saint Louis, Missouri, United States
Urology Cancer Center, PC
🇺🇸Omaha, Nebraska, United States
New Jersey Urology (NJU)
🇺🇸Saddle Brook, New Jersey, United States
New Jersey Urology - Voorhees
🇺🇸Voorhees, New Jersey, United States
NYU Langone Health
🇺🇸Mineola, New York, United States
Icahn School of Medicine at Mount Sinai - Oncology
🇺🇸New York, New York, United States
Associated Medical Professionals of NY, PLLC
🇺🇸Syracuse, New York, United States
White Plains Hospital
🇺🇸White Plains, New York, United States
Alliance Urology Specialists
🇺🇸Greensboro, North Carolina, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
MidLantic Urology - Bala Cynwyd
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Urological Associates of Lancaster
🇺🇸Lancaster, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
VA Pittsburgh Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States
Bon Secours St. Francis Hospital
🇺🇸Greenville, South Carolina, United States
Carolina Urological Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Urology Austin, PLLC (an affiliate of Urology America)
🇺🇸Austin, Texas, United States
University of Texas Southwestern Medical Center-Harold C. Simmons Comprehensive Cancer Center
🇺🇸Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Urology San Antonio, PA dba USA Clinical Trials
🇺🇸San Antonio, Texas, United States
The Urology Place
🇺🇸San Antonio, Texas, United States
Spokane Urology PS
🇺🇸Spokane, Washington, United States
Blacktown Hospital
🇦🇺Blacktown, New South Wales, Australia
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
🇦🇺Liverpool, New South Wales, Australia
Zhongnan hospital ,Wuhan University
🇨🇳Wuhan, Hubei, China
GenesisCare Newcastle
🇦🇺Newcastle, New South Wales, Australia
Port Macquarie Base Hospital
🇦🇺Port Macquarie, New South Wales, Australia
St Vincents Hospital Sydney
🇦🇺Sydney, New South Wales, Australia
Prince of Wales Hospital NSW
🇦🇺Sydney, New South Wales, Australia
Macquarie University Hospital
🇦🇺Sydney, New South Wales, Australia
Sydney Adventist Hospital
🇦🇺Wahroonga, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Royal Brisbane & Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Bundaberg Hospital, Genesis Cancer Care - Bundaberg
🇦🇺Bundaberg, Queensland, Australia
Wide Bay Hospital and Health Service - Hervey Bay Hospital
🇦🇺Pialba, Queensland, Australia
Tasman Health Care
🇦🇺Southport, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Eastern Clinical Research Unit - Box Hill
🇦🇺Box Hill, Victoria, Australia
Epworth HealthCare
🇦🇺East Melbourne, Victoria, Australia
Northern Hospital
🇦🇺Epping, Victoria, Australia
Barwon Health
🇦🇺Geelong, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Cabrini Malvern
🇦🇺Malvern, Victoria, Australia
Western Urology
🇦🇺Maribyrnong, Victoria, Australia
Australian Prostate Centre
🇦🇺North Melbourne, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen
🇦🇹Linz, Oberösterreich, Austria
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Tirol, Austria
Krankenhaus der Barmherzigen Brüder
🇦🇹Vienna, Wien, Austria
Medizinische Universitaet Graz - Klinische Abteilung für Onkologie - Innere Medizin
🇦🇹Graz, Austria
Uniklinikum Salzburg - Landeskrankenhaus
🇦🇹Salzburg, Austria
Medizinische Universität Wien- Universitätsklinik für Urologie
🇦🇹Wien, Austria
Institut Jules Bordet/Jules Bordet Instituut
🇧🇪Bruxelles, Belgium
Maria Middelares General Hospital | Medical Oncology Department
🇧🇪Gent, Belgium
UZ Gent - department Urology
🇧🇪Gent, Belgium
Jessa Hospital | Campus Virga Jesse - Data Management Oncology and Hematology Department
🇧🇪Hasselt, Belgium
AZ Groeninge Campus Kennedylaan - Urology
🇧🇪Kortrijk, Belgium
Hopital de La Louvière - Site Jolimont - Oncology department
🇧🇪La Louvière, Belgium
Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Urology Department
🇧🇪Leuven, Belgium
Hospital São Rafael
🇧🇷Salvador, Bahia, Brazil
Assistência Multidisciplinar em Oncologia (AMO)
🇧🇷Salvador, Bahia, Brazil
Oncocentro - Fortaleza
🇧🇷Fortaleza, Ceará, Brazil
Hospital Evangélico de Cachoeiro de Itapemirim
🇧🇷Vitória, Espírito Santo, Brazil
Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
🇧🇷Curitiba, Parana, Brazil
Real Hospital Português
🇧🇷Recife, Pernambuco, Brazil
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
🇧🇷Natal, Rio Grande Do Norte, Brazil
Hospital Moinhos de Vento-Centro Clínico
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Mae de Deus
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Instituto D'Or Pesquisa e Ensino (IDOR) (D'Or Institute for Research & Education) - Rio de Janeiro
🇧🇷Rio de Janeiro, RJ, Brazil
Faculdade de Medicina do ABC
🇧🇷Santo André, Sao Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo
🇧🇷São Paulo, Sao Paulo, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
🇧🇷São Paulo, Sao Paulo, Brazil
Inst. de Assistência Médica ao Sérvidor Público Estadual
🇧🇷São Paulo, Sao Paulo, Brazil
Hospital das Clínicas da Universidade de Campinas - UNICAMP
🇧🇷São Paulo, Sao Paulo, Brazil
NAIC - Instituto do Cancer
🇧🇷Bauru, Brazil
Hospital Sirio Libanês - Hospital Base de Brasilia
🇧🇷Brasilia, Brazil
Universidade Estadual do Rio de Janeiro
🇧🇷Rio de Janeiro, Brazil
Hospital Sirio Libanes
🇧🇷Sao Paulo, Brazil
Hospital Alemao Oswaldo Cruz
🇧🇷Sao Paulo, Brazil
Hospital do Cancer de Sao Paulo - A. C. Camargo
🇧🇷Sao Paulo, Brazil
Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
🇧🇷Sao Paulo, Brazil
Prostate Cancer Centre
🇨🇦Calgary, Alberta, Canada
Kaye Edmonton Clinic - Dianne and Irving Kipnes Urology Centre
🇨🇦Edmonton, Alberta, Canada
Vancouver Prostate Centre
🇨🇦Vancouver, British Columbia, Canada
BC Cancer - Victoria
🇨🇦Victoria, British Columbia, Canada
Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
St. Joseph's Healthcare - Hamilton
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Centre (LHSC) - London Regional Cancer Program (LRCP)
🇨🇦London, Ontario, Canada
Princess Margaret Cancer Centre - UHN
🇨🇦Toronto, Ontario, Canada
CISSS de l'Outaouais - Hopital de Gatineau - Centre de cancerolgie
🇨🇦Gatineau, Quebec, Canada
Urology South Shore Research - Research Department
🇨🇦Greenfield Park, Quebec, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Sir Mortimer B. Davis Jewish General Hospital - Radiation Oncology
🇨🇦Montreal, Quebec, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec - Radio-oncologie
🇨🇦Trois-rivieres, Quebec, Canada
BC Cancer - Abbotsford
🇨🇦Abbotsford, Canada
Hôtel-Dieu de Lévis - Urology
🇨🇦Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont
🇨🇦Sherbrooke, Canada
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohehot, Inner Mongolia, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Jiangsu, China
West China Hospital,Sichuan University
🇨🇳Chengdu, Sichuan, China
The 1st Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Peking Union Medical College Hospital (PUMCH) - East Location
🇨🇳Beijing, China
Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, China
Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine
🇨🇳Shanghai, China
Tianjin Cancer Hospital, Airport Hospital
🇨🇳Tianjin, China
Fakultni nemocnice u Sv. Anny, Onkologicko-chirurgicke oddeleni
🇨🇿Brno, Czechia
Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
🇨🇿Brno, Czechia
Multiscan s.r.o., Department: Ambulance klinické onkologie Nemocnice Horovice
🇨🇿Horovice, Czechia
Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika
🇨🇿Olomouc, Czechia
Thomayerova Nemocnice (TN) (Thomayers Hospital) - Onkologicka Klinika 1. LF UK A TN
🇨🇿Prague, Czechia
Fakultni nemocnice v Motole, Onkologicka klinika 2. LF UK a FN Motol
🇨🇿Prague, Czechia
Vseobecna fakultni nemocnice - Urologicka klinika, Praha
🇨🇿Praha 2, Czechia
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Aarhus Universitetshospital
🇩🇰Aarhus N, Denmark
Rigshospitalet - Kræftbehandling
🇩🇰København Ø, Denmark
Sjællands University hospital Næstved
🇩🇰Næstved, Denmark
HUS, Meilahden sairaala
🇫🇮Helsinki, Uusimaa, Finland
Docrates Klinikka
🇫🇮Helsinki, Finland
Oulun yliopistollinen sairaala
🇫🇮Oulu, Finland
Tampereen yliopistollinen sairaala
🇫🇮Tampere, Finland
Turun yliopistollinen keskussairaala
🇫🇮Turku, Finland
Center Hospitalier Michallon - Grenoble - Service d Urologie et de la transplantation Renale
🇫🇷La Tronche, Grenoble Cedex 9, France
Centre d' Oncologie du Pays Basque Clinique Belharra - Bayonne - Oncologie medicale
🇫🇷Bayonne, France
CHRU Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
CHU Bordeaux - Hopital Pellegrin - Service urologie
🇫🇷Bordeaux, France
Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie
🇫🇷Brest, France
Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied - Service Urologie
🇫🇷Clermont- Ferrand, France
APHP - Hopital Henri Mondor - Departement Urologie
🇫🇷Creteil, France
Institut de cancerologie de Bourgogne - Departement radiotherapie
🇫🇷Dijon, France
Centre Georges Francois Leclerc Dijon - service de radiotherapie
🇫🇷Dijon, France
Hopital Claude Huriez - Lille - Urologie
🇫🇷Lille, France
Hopital Prive Le Bois - Centre Bourgogne - Service radiotherapie oncologie
🇫🇷Lille, France
UNICANCER - Centre Leon-Berard (CLB) - Medical oncology
🇫🇷Lyon, France
AP-HM - Hopital de la Timone
🇫🇷Marseille, France
Clinique Clementville
🇫🇷Montpellier, France
Institut Curie - Paris - Oncologie Radiotherapie
🇫🇷Paris, France
Hopital Bichat - Paris
🇫🇷Paris, France
HCL - Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Institut de Cancerologie Jean Godinot - Departement oncologie medicale
🇫🇷Reims, France
CHU Rennes - Hopital Pontchaillou
🇫🇷Rennes Cedex, France
Institut de Cancerologie de l'Ouest - Saint Herblain - Unite de therapie precoce
🇫🇷Saint Herblain, France
Institut Curie - Saint-Cloud
🇫🇷Saint-Cloud, France
ICANS - Institut de Cancerologie de Strasbourg Europe
🇫🇷Strasbourg, France
Institut Claudius Regaud - iUCT Oncopole - Service oncologie
🇫🇷Toulouse, France
Hopital Bretonneau
🇫🇷Tours, France
Institut de Cancérologie de Lorraine - Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Gustave Roussy - Departement Oncologie-Radiotherapie
🇫🇷Villejuif, France
Klinikum Mannheim GmbH
🇩🇪Mannheim, Baden-Württemberg, Germany
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
🇭🇺Gyor, Hungary
Swietokrzyskie Centrum Onkologii
🇵🇱Kielce, Poland
Studienpraxis Urologie
🇩🇪Nürtingen, Baden-Württemberg, Germany
Klinikum rechts der Isar
🇩🇪München, Bavaria, Germany
Klinikum der Universität Würzburg
🇩🇪Wurzburg, Bayern, Germany
Universitätsklinikum der Johann Wolfgang Goethe Universität
🇩🇪Frankfurt, Hessen, Germany
Städtisches Klinikum Braunschweig gGmbH
🇩🇪Brunswick, Lower Saxony, Germany
Universitätsmedizin der Georg-August-Universität Göttingen
🇩🇪Goettingen, Lower Saxony, Germany
Urologicum Duisburg
🇩🇪Duisburg, Nordrhein-Westfalen, Germany
Universitätsklinikum Köln
🇩🇪Köln, Nordrhein-Westfalen, Germany
Universitaetsklinikum Muenster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Marienhospital Herne Universitätsklinik
🇩🇪Herne, NRW, Germany
Medizinische Fakultät der Otto-von-Guericke Universität
🇩🇪Magdeburg, Sachsen-Anhalt, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
🇩🇪Dresden, Sachsen, Germany
Universitätsklinikum Aachen / Klinik und Poliklinik für Urologie und Kinderurologie
🇩🇪Aachen, Germany
Marien-Krankenhaus Bergisch Gladbach
🇩🇪Bergisch Gladbach, Germany
Vivantes Klinikum Am Urban
🇩🇪Berlin, Germany
Charité Campus Benjamin Franklin (CBF)
🇩🇪Berlin, Germany
Universitätsklinikum Hamburg-Eppendorf - Martini-Klinik am UKE GmbH
🇩🇪Hamburg, Germany
Universitaetsklinikum Jena - Klinik fuer Urologie
🇩🇪Jena, Germany
Universitätsklinikum Schleswig-Holstein/ Klinik für Urologie
🇩🇪Kiel, Germany
Johannes Gutenberg-Universität Mainz - Urologie
🇩🇪Mainz, Germany
Klinikum Stuttgart / Klinik für Urologie und Transplantationschirurgie
🇩🇪Stuttgart, Germany
Urologische Gemeinschaftspraxis Wesel
🇩🇪Wesel, Germany
Semmelweis Egyetem, Altalanos Orvostudomanyi Kar, Urologiai Klinika
🇭🇺Budapest, Hungary
Orszagos Onkologiai Intezet
🇭🇺Budapest, Hungary
Budapesti Uzsoki Utcai Kórház
🇭🇺Budapest, Hungary
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
🇭🇺Budapest, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
🇭🇺Nyiregyhaza, Hungary
Rambam Health Corporation
🇮🇱Haifa, Israel
Hadassah Hebrew University Hospital Ein Kerem
🇮🇱Jerusalem, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
🇮🇱Petah Tikva, Israel
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Oncologia Clinica Sperimentale Uro-Ginecologica
🇮🇹Napoli, Campania, Italy
Azienda Unita Sanitaria Locale Di Bologna_Ospedale Bellaria - Oncologia Medica
🇮🇹Bologna, Emilia-Romagma, Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Urologia
🇮🇹Bologna, Emilia-Romagna, Italy
Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia
🇮🇹Modena, Emilia-Romagna, Italy
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
🇮🇹Reggio Emilia, Emilia-Romagna, Italy
Centro di Riferimento Oncologico di Aviano - Oncologia Radioterapica
🇮🇹Aviano, Friuli-Venezia Giulia, Italy
I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena - Urologia
🇮🇹Roma, Lazio, Italy
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
🇪🇸Barcelona, Spain
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Degenza di Radioterapia Oncologica
🇮🇹Roma, Lazio, Italy
IRCCS Ospedale Policlinico San Martino - Oncologia Medica 1
🇮🇹Genova, Liguria, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Oncologia
🇮🇹Bergamo, Lombardia, Italy
Ospedale San Raffaele s.r.l - Urologia
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Lombardia, Italy
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
🇮🇹Rozzano, Lombardia, Italy
A.O.U. Città della Salute e della Scienza di Torino_Molinette - Urologia U
🇮🇹Torino, Piemonte, Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
🇮🇹Bari, Puglia, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti_Foggia - Oncologia Medica e Terapia Biomolecolare Universitaria
🇮🇹Foggia, Puglia, Italy
Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia Medica
🇮🇹Trento, Trentino, Italy
A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Radioterapia Oncologica
🇮🇹Perugia, Umbria, Italy
Istituto Oncologico Veneto_Castelfranco Veneto - UOC Urologia Oncologica
🇮🇹Castelfranco Veneto, Veneto, Italy
Azienda Ospedaliera Policlinico Universitario Tor Vergata - UOC Radioterapia
🇮🇹Roma, Veneto, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
🇮🇹Verona, Veneto, Italy
A.O.U.I. Verona
🇮🇹Verona, Veneto, Italy
Cliniche Gavazzeni S.p.A - Dipartimento Area Chirurgia Unità Operativa di Urologia
🇮🇹Bergamo, Italy
Azienda Ospedaliera Santa Croce e Carle - Oncologia
🇮🇹Cuneo, Italy
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
The University of Osaka Hospital
🇯🇵Suita, Osaka, Japan
Institute of Science Tokyo Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Catharina Ziekenhuis
🇳🇱Eindhoven, Noord-Brabant, Netherlands
Albert Schweitzer Hospital | Internal Medicine - Oncology Department
🇳🇱Dordrecht, Netherlands
University Medical Center Groningen | Urology Department
🇳🇱Groningen, Netherlands
Tergooi MC | Hilversum - Wetenschapsbureau
🇳🇱Hilversum, Netherlands
St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde
🇳🇱Nieuwegein, Netherlands
St. Franciscus Gasthuis
🇳🇱Rotterdam, Netherlands
HagaZiekenhuis van Den Haag
🇳🇱The Hague, Netherlands
Canterbury Urology Research Trust
🇳🇿Christchurch, Canterbury, New Zealand
Auckland City Hosptial
🇳🇿Auckland, New Zealand
MidCentral District Health Board (MDHB) - Palmerston North Hospital (PNH)
🇳🇿Palmerson North, New Zealand
Tauranga Urology Research Limited
🇳🇿Tauranga, New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
🇵🇱Bydgoszcz, Poland
Szpital Grochowski im. dr.med. Rafala Masztaka
🇵🇱Warszawa, Poland
EMC Instytut Medyczny SA
🇵🇱Wroclaw, Poland
Instituto Portugues de Oncologia de Lisboa | Unidade de Investigacao Clinica - Departamento de Urologia
🇵🇹Lisbon, Lisboa, Portugal
Centro Clinico Academico Braga | Braga, Portugal
🇵🇹Braga, Portugal
Centro Hospitalar e Universitario de Coimbra EPE (CHUC)
🇵🇹Coimbra, Portugal
Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research Center
🇵🇹Lisboa, Portugal
Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
🇵🇹Lisboa, Portugal
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
🇵🇹Lisboa, Portugal
Hospital Santa Maria | Centro de Investigacao Clinica
🇵🇹Lisboa, Portugal
Centro Hospitalar Universitario do Porto
🇵🇹Porto, Portugal
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Universitario "Marqués de Valdecilla"
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Virgen de la Victoria | Cardiology Department
🇪🇸Malaga, Málaga, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Clínic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario Puerta del Mar
🇪🇸Cadiz, Spain
MD Anderson International Espanya, S.A.
🇪🇸Madrid, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Centro Integral Oncológico Clara Campal
🇪🇸Madrid, Spain
H. General Uiversitario Morales Meseguer - Department of Urology
🇪🇸Murcia, Spain
Virgen del Rocio University Hospital - Oncology Department
🇪🇸Sevilla, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Goteborgs Universitet
🇸🇪Gothenburg, Sweden
Skane University Hospital - Department of Urology
🇸🇪Malmo, Sweden
Uppsala University Hospital, Urology Department
🇸🇪Uppsala, Sweden
Tungs' Taichung MetroHarbor Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Koo Foundation Sun Yet-Sen Cancer Centre
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital at Linkou
🇨🇳Taoyuan, Taiwan
Bedford Hospital - Bedfordshire Hospitals NHS Foundation Tru
🇬🇧Bedford, Bedfordshire, United Kingdom
East and North Hertfordshire NHS Trust - Mount Vernon Hospital - Mount Vernon Cancer Centre (MVCC)
🇬🇧Northwood, Middlesex, United Kingdom
Royal Surrey NHS Foundation Trust | Royal Surrey County Hospital - Cancer Centre
🇬🇧Guildford, Surrey, United Kingdom
University College London Hospitals NHS Foundation Trust | University College Hospital (UCLH) - Cancer Clinical Trials Unit
🇬🇧London, United Kingdom
The Royal Marsden NHS Foundation Trust | The Royal Marsden Hospital - The Royal Marsden Clinical Trials Unit (CTU)
🇬🇧London, United Kingdom
Imperial College Healthcare NHS Trust | Charing Cross Hospital - Cancer Services
🇬🇧London, United Kingdom