Clinical trial NCT05794906: 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
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Biochemically Recurrent Prostate Cancer
Keywords: darolutamide
high risk BCR
PSMA PET imaging
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 970
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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.

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.

Primary outcomes:
measure: Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)
timeFrame: After randomization to after last treatment, approximately 24 months
Secondary outcomes:
measure: Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR
timeFrame: After randomization to after last treatment, approximately 46 months
measure: Time to Castration-resistant prostate cancer (CRPC)
timeFrame: After randomization to after last treatment, approximately 46 months
measure: Time to initiation of first subsequent systemic antineoplastic therapy
timeFrame: After randomization to after last treatment, approximately 46 months
measure: Time to loco-regional progression by PSMA PET/CT
timeFrame: After randomization to after last treatment, approximately 46 months
measure: Time to first Symptomatic skeletal event (SSE)
timeFrame: After randomization to after last treatment, approximately 46 months
measure: Overall survival (OS)
timeFrame: After randomization to after last treatment, approximately 46 months
measure: Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL)
timeFrame: After randomization to after last treatment, approximately 46 months
measure: Time to deterioration in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score
timeFrame: After randomization to after last treatment, approximately 24 months
measure: Time to symptomatic progression
timeFrame: After randomization to after last treatment, approximately 46 months
measure: Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severity
timeFrame: After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months
measure: Number of participants who discontinue study treatment due to a TEAE
timeFrame: After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: City of Hope - Phoenix Cancer Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Hospital - Phoenix - Cardiology
state: Arizona
city: Tucson
country: United States
facility: Arizona Institute of Urology
state: Arizona
city: Duarte
country: United States
facility: City of Hope - Duarte Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Tower Urology, Inc
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Med Center Helen Diller Family Comp Cancer Center
state: California
city: Lakewood
country: United States
facility: Colorado Urology - St. Anthony Hospital Campus
state: Colorado
city: Clermont
country: United States
facility: Clermont Oncology Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida - Jacksonville
state: Florida
city: Orange City
country: United States
facility: Mid Florida Cancer Centers
state: Florida
city: Chicago
country: United States
facility: Northwestern Medicine - Urology
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Chicago
country: United States
facility: Comprehensive Cancer Center
state: Illinois
city: Greenwood
country: United States
facility: Urology of Indiana, LLC
state: Indiana
city: Jeffersonville
country: United States
facility: First Urology PSC
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Baltimore
country: United States
facility: Chesapeake Urology Associates - Towson
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center - University Campus
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute - Detroit Headquarters
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology - Troy - Town Center Building
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Center for Advanced Medicine (CAM)
state: Missouri
city: Omaha
country: United States
facility: Urology Cancer Center, PC
state: Nebraska
city: Saddle Brook
country: United States
facility: New Jersey Urology (NJU)
state: New Jersey
city: Voorhees
country: United States
facility: New Jersey Urology - Voorhees
state: New Jersey
city: Mineola
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai - Oncology
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY, PLLC
state: New York
city: White Plains
country: United States
facility: White Plains Hospital
state: New York
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology - Bala Cynwyd
state: Pennsylvania
city: Lancaster
country: United States
facility: Urological Associates of Lancaster
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Greenville
country: United States
facility: Bon Secours St. Francis Hospital
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urological Research Center
state: South Carolina
city: Austin
country: United States
facility: Urology Austin, PLLC (an affiliate of Urology America)
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center-Harold C. Simmons Comprehensive Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio, PA dba USA Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: The Urology Place
state: Texas
city: Spokane
country: United States
facility: Spokane Urology PS
state: Washington
city: Blacktown
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Liverpool
country: Australia
facility: University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
state: New South Wales
city: Newcastle
country: Australia
facility: GenesisCare Newcastle
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St Vincents Hospital Sydney
state: New South Wales
city: Sydney
country: Australia
facility: Prince of Wales Hospital NSW
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Bundaberg
country: Australia
facility: Bundaberg Hospital, Genesis Cancer Care - Bundaberg
state: Queensland
city: Pialba
country: Australia
facility: Wide Bay Hospital and Health Service - Hervey Bay Hospital
state: Queensland
city: Southport
country: Australia
facility: Tasman Health Care
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Eastern Clinical Research Unit - Box Hill
state: Victoria
city: East Melbourne
country: Australia
facility: Epworth HealthCare
state: Victoria
city: Epping
country: Australia
facility: Northern Hospital
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Malvern
state: Victoria
city: Maribyrnong
country: Australia
facility: Western Urology
state: Victoria
city: North Melbourne
country: Australia
facility: Australian Prostate Centre
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
state: Oberösterreich
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
state: Tirol
city: Vienna
country: Austria
facility: Krankenhaus der Barmherzigen Brüder
state: Wien
city: Graz
country: Austria
facility: Medizinische Universitaet Graz - Klinische Abteilung für Onkologie - Innere Medizin
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg - Landeskrankenhaus
city: Wien
country: Austria
facility: Medizinische Universität Wien- Universitätsklinik für Urologie
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet/Jules Bordet Instituut
city: Gent
country: Belgium
facility: Maria Middelares General Hospital | Medical Oncology Department
city: Gent
country: Belgium
facility: UZ Gent - department Urology
city: Hasselt
country: Belgium
facility: Jessa Hospital | Campus Virga Jesse - Data Management Oncology and Hematology Department
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Kennedylaan - Urology
city: La Louvière
country: Belgium
facility: Hopital de La Louvière - Site Jolimont - Oncology department
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Urology Department
city: Salvador
country: Brazil
facility: Hospital São Rafael
state: Bahia
city: Salvador
country: Brazil
facility: Assistência Multidisciplinar em Oncologia (AMO)
state: Bahia
city: Fortaleza
country: Brazil
facility: Oncocentro - Fortaleza
state: Ceará
city: Vitória
country: Brazil
facility: Hospital Evangélico de Cachoeiro de Itapemirim
state: Espírito Santo
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
state: Parana
city: Recife
country: Brazil
facility: Real Hospital Português
state: Pernambuco
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento-Centro Clínico
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Instituto D'Or Pesquisa e Ensino (IDOR) (D'Or Institute for Research & Education) - Rio de Janeiro
state: RJ
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Real e Benemérita Associação Portuguesa de Beneficência
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Inst. de Assistência Médica ao Sérvidor Público Estadual
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Universidade de Campinas - UNICAMP
state: Sao Paulo
city: Bauru
country: Brazil
facility: NAIC - Instituto do Cancer
city: Brasilia
country: Brazil
facility: Hospital Sirio Libanês - Hospital Base de Brasilia
city: Rio de Janeiro
country: Brazil
facility: Universidade Estadual do Rio de Janeiro
city: Sao Paulo
country: Brazil
facility: Hospital Sirio Libanes
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: Sao Paulo
country: Brazil
facility: Hospital do Cancer de Sao Paulo - A. C. Camargo
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
city: Calgary
country: Canada
facility: Prostate Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Kaye Edmonton Clinic - Dianne and Irving Kipnes Urology Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre
state: British Columbia
city: Victoria
country: Canada
facility: BC Cancer - Victoria
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare - Hamilton
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre (LHSC) - London Regional Cancer Program (LRCP)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre - UHN
state: Ontario
city: Gatineau
country: Canada
facility: CISSS de l'Outaouais - Hopital de Gatineau - Centre de cancerolgie
state: Quebec
city: Greenfield Park
country: Canada
facility: Urology South Shore Research - Research Department
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital - Radiation Oncology
state: Quebec
city: Trois-rivieres
country: Canada
facility: Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec - Radio-oncologie
state: Quebec
city: Abbotsford
country: Canada
facility: BC Cancer - Abbotsford
city: Quebec
country: Canada
facility: Hôtel-Dieu de Lévis - Urology
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Wuhan
country: China
facility: Zhongnan hospital ,Wuhan University
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Hohehot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Jiangsu
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The 1st Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Peking Union Medical College Hospital (PUMCH) - East Location
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
city: Shanghai
country: China
facility: Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine
city: Tianjin
country: China
facility: Tianjin Cancer Hospital, Airport Hospital
city: Brno
country: Czechia
facility: Fakultni nemocnice u Sv. Anny, Onkologicko-chirurgicke oddeleni
city: Brno
country: Czechia
facility: Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)
city: Horovice
country: Czechia
facility: Multiscan s.r.o., Department: Ambulance klinické onkologie Nemocnice Horovice
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika
city: Prague
country: Czechia
facility: Thomayerova Nemocnice (TN) (Thomayers Hospital) - Onkologicka Klinika 1. LF UK A TN
city: Prague
country: Czechia
facility: Fakultni nemocnice v Motole, Onkologicka klinika 2. LF UK a FN Motol
city: Praha 2
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze - Urologická klinika
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
city: København Ø
country: Denmark
facility: Rigshospitalet - Kræftbehandling
city: Næstved
country: Denmark
facility: Sjællands University hospital Næstved
city: Helsinki
country: Finland
facility: HUS, Meilahden sairaala
state: Uusimaa
city: Helsinki
country: Finland
facility: Docrates Klinikka
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala
city: La Tronche
country: France
facility: Center Hospitalier Michallon - Grenoble - Service d Urologie et de la transplantation Renale
state: Grenoble Cedex 9
city: Bayonne
country: France
facility: Centre d' Oncologie du Pays Basque Clinique Belharra - Bayonne - Oncologie medicale
city: Besancon
country: France
facility: CHRU Besancon - Hopital Jean Minjoz
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital Pellegrin - Service urologie
city: Brest
country: France
facility: Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie
city: Clermont- Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied - Service Urologie
city: Creteil
country: France
facility: APHP - Hopital Henri Mondor - Departement Urologie
city: Dijon
country: France
facility: Institut de cancerologie de Bourgogne - Departement radiotherapie
city: Dijon
country: France
facility: Centre Georges Francois Leclerc Dijon - service de radiotherapie
city: Lille
country: France
facility: Hopital Claude Huriez - Lille - Urologie
city: Lille
country: France
facility: Hopital Prive Le Bois - Centre Bourgogne - Service radiotherapie oncologie
city: Lyon
country: France
facility: UNICANCER - Centre Leon-Berard (CLB) - Medical oncology
city: Marseille
country: France
facility: AP-HM - Hopital de la Timone
city: Montpellier
country: France
facility: Clinique Clementville
city: Paris
country: France
facility: Institut Curie - Paris - Oncologie Radiotherapie
city: Paris
country: France
facility: Hopital Bichat - Paris
city: Pierre Benite
country: France
facility: HCL - Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: Institut de Cancerologie Jean Godinot - Departement oncologie medicale
city: Rennes Cedex
country: France
facility: CHU Rennes - Hopital Pontchaillou
city: Saint Herblain
country: France
facility: Institut de Cancerologie de l'Ouest - Saint Herblain - Unite de therapie precoce
city: Saint-Cloud
country: France
facility: Institut Curie - Saint-Cloud
city: Strasbourg
country: France
facility: ICANS - Institut de Cancerologie de Strasbourg Europe
city: Toulouse
country: France
facility: Institut Claudius Regaud - iUCT Oncopole - Service oncologie
city: Tours
country: France
facility: Hopital Bretonneau
city: Vandoeuvre-les-Nancy
country: France
facility: Institut de Cancérologie de Lorraine - Alexis Vautrin
city: Villejuif
country: France
facility: Gustave Roussy - Departement Oncologie-Radiotherapie
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH
state: Baden-Württemberg
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
city: Wurzburg
country: Germany
facility: Klinikum der Universität Würzburg
state: Bayern
city: Frankfurt
country: Germany
facility: Universitätsklinikum der Johann Wolfgang Goethe Universität
state: Hessen
city: Brunswick
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH
state: Lower Saxony
city: Göttingen
country: Germany
facility: Universitätsmedizin der Georg-August-Universität Göttingen
state: Lower Saxony
city: Duisburg
country: Germany
facility: Urologicum Duisburg
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Universitätsklinikum Köln
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitaetsklinikum Muenster
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: Marienhospital Herne Universitätsklinik
state: NRW
city: Magdeburg
country: Germany
facility: Medizinische Fakultät der Otto-von-Guericke Universität
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
state: Sachsen
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen / Klinik und Poliklinik für Urologie und Kinderurologie
city: Bergisch Gladbach
country: Germany
facility: Marien-Krankenhaus Bergisch Gladbach
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin (CBF)
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf - Martini-Klinik am UKE GmbH
city: Jena
country: Germany
facility: Universitaetsklinikum Jena - Klinik fuer Urologie
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein/ Klinik für Urologie
city: Mainz
country: Germany
facility: Johannes Gutenberg-Universität Mainz - Urologie
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart / Klinik für Urologie und Transplantationschirurgie
city: Wesel
country: Germany
facility: Urologische Gemeinschaftspraxis Wesel
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Altalanos Orvostudomanyi Kar, Urologiai Klinika
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Budapest
country: Hungary
facility: Budapesti Uzsoki Utcai Kórház
city: Budapest
country: Hungary
facility: Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
city: Haifa
country: Israel
facility: Rambam Health Corporation
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Hospital Ein Kerem
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Napoli
country: Italy
facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Oncologia Clinica Sperimentale Uro-Ginecologica
state: Campania
city: Bologna
country: Italy
facility: Azienda Unita Sanitaria Locale Di Bologna_Ospedale Bellaria - Oncologia Medica
state: Emilia-Romagma
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Urologia
state: Emilia-Romagna
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano - Oncologia Radioterapica
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena - Urologia
state: Lazio
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Degenza di Radioterapia Oncologica
state: Lazio
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino - Oncologia Medica 1
state: Liguria
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Oncologia
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele s.r.l - Urologia
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
city: Rozzano
country: Italy
facility: Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
state: Lombardia
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino_Molinette - Urologia U
state: Piemonte
city: Bari
country: Italy
facility: Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
state: Puglia
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti_Foggia - Oncologia Medica e Terapia Biomolecolare Universitaria
state: Puglia
city: Trento
country: Italy
facility: Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia Medica
state: Trentino
city: Perugia
country: Italy
facility: A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Radioterapia Oncologica
state: Umbria
city: Castelfranco Veneto
country: Italy
facility: Istituto Oncologico Veneto_Castelfranco Veneto - UOC Urologia Oncologica
state: Veneto
city: Roma
country: Italy
facility: Azienda Ospedaliera Policlinico Universitario Tor Vergata - UOC Radioterapia
state: Veneto
city: Verona
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria
state: Veneto
city: Verona
country: Italy
facility: A.O.U.I. Verona
state: Veneto
city: Bergamo
country: Italy
facility: Cliniche Gavazzeni S.p.A - Dipartimento Area Chirurgia Unità Operativa di Urologia
city: Cuneo
country: Italy
facility: Azienda Ospedaliera Santa Croce e Carle - Oncologia
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Suita
country: Japan
facility: The University of Osaka Hospital
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Institute of Science Tokyo Hospital
state: Tokyo
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital | Internal Medicine - Oncology Department
city: Groningen
country: Netherlands
facility: University Medical Center Groningen | Urology Department
city: Hilversum
country: Netherlands
facility: Tergooi MC | Hilversum - Wetenschapsbureau
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde
city: Rotterdam
country: Netherlands
facility: St. Franciscus Gasthuis
city: The Hague
country: Netherlands
facility: HagaZiekenhuis van Den Haag
city: Christchurch
country: New Zealand
facility: Canterbury Urology Research Trust
state: Canterbury
city: Auckland
country: New Zealand
facility: Auckland City Hosptial
city: Palmerston North
country: New Zealand
facility: MidCentral District Health Board (MDHB) - Palmerston North Hospital (PNH)
city: Tauranga
country: New Zealand
facility: Tauranga Urology Research Limited
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii
city: Krakow
country: Poland
facility: Centrum Medyczne iMed24
city: Lublin
country: Poland
facility: Medrise Sp. z o.o. Centrum Badan Klinicznych
city: Warszawa
country: Poland
facility: Szpital Grochowski im. dr.med. Rafala Masztaka
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny SA
city: Lisbon
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa | Unidade de Investigacao Clinica - Departamento de Urologia
state: Lisboa
city: Braga
country: Portugal
facility: Centro Clinico Academico Braga | Braga, Portugal
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra EPE (CHUC)
city: Lisboa
country: Portugal
facility: Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research Center
city: Lisboa
country: Portugal
facility: Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
city: Lisboa
country: Portugal
facility: Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
city: Lisboa
country: Portugal
facility: Hospital Santa Maria | Centro de Investigacao Clinica
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
city: Santander
country: Spain
facility: Hospital Universitario Marques De Valdecilla - Urologia
state: Cantabria
city: Malaga
country: Spain
facility: Hospital Universitario Virgen De La Victoria - Urologia
state: Málaga
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Fundacio Puigvert - Urologia
city: Barcelona
country: Spain
facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar - Urologia
city: Madrid
country: Spain
facility: MD Anderson International Espanya, S.A. - Oncologia Radioterapica
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal - Oncologia Radioterapica
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer - Urologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio S.L. - Urologia
city: Valencia
country: Spain
facility: Hospital Universitario Y Politecnico La Fe - Oncologia Radioterapica
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Gothenburg
country: Sweden
facility: Goteborgs Universitet
city: Malmo
country: Sweden
facility: Skane University Hospital - Department of Urology
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Urology Department
city: Taichung
country: Taiwan
facility: Tungs' Taichung MetroHarbor Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yet-Sen Cancer Centre
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital at Linkou
city: Bedford
country: United Kingdom
facility: Bedford Hospital - Bedfordshire Hospitals NHS Foundation Tru
state: Bedfordshire
city: Northwood
country: United Kingdom
facility: East and North Hertfordshire NHS Trust - Mount Vernon Hospital - Mount Vernon Cancer Centre (MVCC)
state: Middlesex
city: Guildford
country: United Kingdom
facility: Royal Surrey NHS Foundation Trust | Royal Surrey County Hospital - Cancer Centre
state: Surrey
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust | University College Hospital (UCLH) - Cancer Clinical Trials Unit
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust | The Royal Marsden Hospital - The Royal Marsden Clinical Trials Unit (CTU)
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust | Charing Cross Hospital - Cancer Services
Study officials:
References: