Trial Condition(s):

Biochemically recurrent prostate cancer

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 (ARASTEP)

Bayer Identifier:

21492

ClinicalTrials.gov Identifier:

NCT05794906

EudraCT Number:

Not Available

EU CT Number:

2022-501343-33-00

Recruiting

Trial Purpose

Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer.

BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat.

In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments.

The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months.

To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells.

To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy.

During the study, the study team will:
•    take blood and urine samples.
•    measure PSA and testosterone levels in the blood samples
•    do physical examinations
•    check the participants’ overall health
•    examine heart health using electrocardiogram (ECG)
•    check vital signs
•    check cancer status using PSMA PET/CT scans, CT, MRI and bone scans
•    take tumor samples (if required)
•    ask the participants if they have medical problems

About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.

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.

Trial Summary

Enrollment Goal
750
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Darolutamide+ADT (BAY1841788)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie

Wien, Austria, 1090

Status
Not yet recruiting
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Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria, 4020

Status
Recruiting
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Krankenhaus der Barmherzigen Brüder

Vienna, Austria, 1020

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Not yet recruiting
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Dana-Farber Cancer Institute

Boston, United States, 02115-6084

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Carolina Urological Research Center

Myrtle Beach, United States, 29579

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Recruiting
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Colorado Urology (Colorado Clinical Research)

Lakewood, United States, 80228

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Recruiting
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Urology San Antonio, PA dba USA Clinical Trials

San Antonio, United States, 78229

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Recruiting
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White Plains Hospital

White Plains, United States, 10601

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Not yet recruiting
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Tower Urology, Inc

Los Angeles, United States, 90048

Status
Recruiting
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MidLantic Urology - Bala Cynwyd

Bala Cynwyd, United States, 19004

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Alliance Urology Specialists

Greensboro, United States, 27403

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New Jersey Urology, LLC

Voorhees, United States, 08043

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Barbara Ann Karmanos Cancer Institute - Detroit

Detroit, United States, 48201

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University of Kansas

Kansas City, United States, 66160

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University of Southern California

Los Angeles, United States, 90033

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University of California, Los Angeles

Los Angeles, United States, 90095

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NYU Langone Health

New York, United States, 10016

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University of Texas MD Anderson Cancer Center

Houston, United States, 77030

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Johns Hopkins Univ School Med|Sidney Kimmel Comp Cancer Cntr

Baltimore, United States, 21231

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Urology Austin, PLLC (an affiliate of Urology America)

Austin, United States, 78745

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Mayo Clinic Hospital

Phoenix, United States, 85054

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The Urology Group

Cincinnati, United States, 45212

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UCSF Med Center Helen Diller Family Comp Cancer Center

San Francisco, United States, 94143

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City of Hope National Medical Center

Durate, United States, 91010

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Washington University School of Medicine

St. Louis, United States, 63110-1093

Status
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Institut de Cancérologie de l'Ouest - Saint Herblain

Saint-Herblain, France, 44800

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Institut Gustave Roussy - Département de Médecine Oncologique

VILLEJUIF CEDEX, France, 94805

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Hôpital Pellegrin - Bordeaux

BORDEAUX, France, 33000

Status
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Hopital Bichat - Paris

PARIS, France, 75018

Status
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Centre Hospitalier Lyon Sud

PIERRE BENITE, France, 69495

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Centre Jean Perrin

CLERMONT-FERRAND, France, 63011

Status
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Hôpital Claude Huriez - Lille

LILLE, France, 59037

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Hôpital Pontchaillou

RENNES CEDEX, France, 35033

Status
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Uniklinikum Salzburg - Landeskrankenhaus

Salzburg, Austria, 5020

Status
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Mount Vernon Cancer Centre

Northwood, United Kingdom, HA6 2RN

Status
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Royal Marsden Hospital (London)

London, United Kingdom, SW3 6JJ

Status
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Charing Cross Hospital

London, United Kingdom, W6 8RF

Status
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University of Minnesota Medical Center

Minneapolis, United States, 55455

Status
Not yet recruiting
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Northwestern University Feinberg School of Medicine - Department of Urology

Chicago, United States, 60611

Status
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Michigan Institute of Urology, PC

Troy, United States, 48084

Status
Not yet recruiting
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Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Status
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Hospital Universitario Puerta del Mar

Cadiz, Spain, 11009

Status
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MD Anderson International Espanya, S.A.

Madrid, Spain, 28033

Status
Not yet recruiting
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Hospital Universitario Virgen de la Victoria | Cardiology Department

Málaga, Spain, 29010

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Hospital del Mar

Barcelona, Spain, 08003

Status
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Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08023

Status
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Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
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Hospital Fundació Puigvert

Barcelona, Spain, 08025

Status
Not yet recruiting
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Instituto Valenciano de Oncología

Valencia, Spain, 46009

Status
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Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Recruiting
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Hospital Universitario Ramon y Cajal | Departamento de Medicina Interna

Madrid, Spain, 28034

Status
Not yet recruiting
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H. General Uiversitario Morales Meseguer - Department of Urology

Murcia, Spain, 30008

Status
Not yet recruiting
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Centro Integral Oncológico Clara Campal

Madrid, Spain, 28050

Status
Not yet recruiting
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Princess Margaret Cancer Centre - UHN

Toronto, Canada, M5G 2M9

Status
Not yet recruiting
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St. Joseph's Healthcare - Hamilton

Hamilton, Canada, L8P 3B6

Status
Recruiting
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Sir Mortimer B. Davis Jewish General Hospital - Radiation Oncology

Montreal, Canada, H3T 1E2

Status
Recruiting
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Vancouver Prostate Centre

Vancouver, Canada, V5Z 1M9

Status
Not yet recruiting
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Prostate Cancer Centre

Calgary, Canada, T2V 1P9

Status
Not yet recruiting
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Hopital Hotel-Dieu de Levis

Levis, Canada, G6V 3Z1

Status
Recruiting
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BCCA-Vancouver Island Centre

Victoria, Canada, V8R 6V5

Status
Recruiting
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Prince of Wales Hospital NSW

Randwick, Australia, 2031

Status
Not yet recruiting
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Austin Health

Heidelberg, Australia

Status
Not yet recruiting
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South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department

Liverpool, Australia, 2170

Status
Not yet recruiting
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Sydney Adventist Hospital

Wahroonga, Australia, 2076

Status
Not yet recruiting
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Epworth HealthCare

East Melbourne, Australia, 3002

Status
Not yet recruiting
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IPO Lisboa

Lisboa, Portugal, 1093 CODEX

Status
Not yet recruiting
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Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica

Lisboa, Portugal, 1500-650

Status
Not yet recruiting
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University College London Hospitals NHS Foundation Trust

London, United Kingdom, NW1 2PQ

Status
Recruiting
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Canterbury Urology Research Trust

Christchurch, New Zealand, 8013

Status
Not yet recruiting
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Auckland City Hosptial

Auckland, New Zealand, 1023

Status
Not yet recruiting
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Tauranga Urology Research Limited

Tauranga, New Zealand, 3112

Status
Not yet recruiting
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Assistência Multidisciplinar em Oncologia (AMO)

Salvador, Brazil, 41950-640

Status
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Instituto do Cancer do Estado de Sao Paulo

São Paulo, Brazil, 01246-000

Status
Not yet recruiting
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Faculdade de Medicina do ABC

Santo André, Brazil, 09060-650

Status
Not yet recruiting
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Inst. de Assistência Médica ao Sérvidor Público Estadual

São Paulo, Brazil, 04039-004

Status
Not yet recruiting
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Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

Natal, Brazil, 59062-000

Status
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Hospital Sirio Libanes

Sao Paulo, Brazil, 01308-050

Status
Not yet recruiting
Locations

Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

Curitiba, Brazil, 81520-060

Status
Recruiting
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Universitätsklinikum Münster (UKM)

Münster, Germany, 48149

Status
Not yet recruiting
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Klinikum rechts der Isar

München, Germany, 81675

Status
Not yet recruiting
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Universitätsmedizin der Georg-August-Universität Göttingen

Göttingen, Germany, 37075

Status
Not yet recruiting
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Universitätsklinikum Köln

Köln, Germany, 50937

Status
Not yet recruiting
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Klinikum der Universität Würzburg

Würzburg, Germany, 97080

Status
Not yet recruiting
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Städtisches Klinikum Braunschweig gGmbH

Braunschweig, Germany, 38126

Status
Not yet recruiting
Locations

Medizinische Fakultät der Otto-von-Guericke Universität

Magdeburg, Germany, 39120

Status
Not yet recruiting
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Universitätsklinikum der Johann Wolfgang Goethe Universität

Frankfurt, Germany, 60596

Status
Not yet recruiting
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Studienpraxis Urologie

Nürtingen, Germany, 72622

Status
Not yet recruiting
Locations

ICANS - Institut de Cancérologie de Strasbourg Europe

STRASBOURG, France, 67033

Status
Recruiting
Locations

Hôpital Bretonneau

TOURS, France, 37044

Status
Not yet recruiting
Locations

Tokyo Medical and Dental University Hospital

Bunkyo-ku, Japan, 113-8519

Status
Recruiting
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Kyoto University Hospital

Kyoto, Japan, 606-8507

Status
Not yet recruiting
Locations

Hokkaido University Hospital

Sapporo, Japan, 060-8648

Status
Not yet recruiting
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Kanazawa University Hospital

Kanazawa, Japan, 920-8641

Status
Not yet recruiting
Locations

Osaka University Hospital

Suita, Japan, 565-0871

Status
Recruiting
Locations

Yokohama City University Hospital

Yokohama, Japan, 236-0004

Status
Recruiting
Locations

Kagoshima University Hospital

Kagoshima, Japan, 890-8520

Status
Not yet recruiting
Locations

Ospedale San Raffaele s.r.l.

Milano, Italy, 20132

Status
Not yet recruiting
Locations

A.O.U. di Modena - Policlinico

Modena, Italy, 41124

Status
Not yet recruiting
Locations

IRCCS Centro di Riferimento Oncologico (CRO)

Pordenone, Italy, 33081

Status
Not yet recruiting
Locations

A.O. di Perugia - Ospedale Santa Maria della Misericordia - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA

Perugia, Italy, 06123

Status
Not yet recruiting
Locations

IRCCS Ist Nazionale Tumori GE - Oncologia Medica

Genova, Italy, 16132

Status
Recruiting
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Santa Chiara Hospital

Trento, Italy, 38122

Status
Not yet recruiting
Locations

Istituto Nazionale Tumori IRCCS Fondazione G.Pascale

Napoli, Italy, 80131

Status
Not yet recruiting
Locations

AUSL-IRCCS di Reggio Emilia

Reggio Emilia, Italy, 42123

Status
Not yet recruiting
Locations

Molinette Hospital University of Torino

Torino, Italy, 10126

Status
Recruiting
Locations

IRCCS Istituti Fisioterapici Ospitalieri - IFO

Roma, Italy, 00144

Status
Recruiting
Locations

AUSL di Bologna

Bologna, Italy, 40139

Status
Not yet recruiting
Locations

Virgen del Rocio University Hospital - Oncology Department

Sevilla, Spain, 41013

Status
Recruiting
Locations

CHULN - H. Sta.Maria (Centro de Investigacao Clinica)

Lisboa, Portugal, 1649-035

Status
Not yet recruiting
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Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research Center

Lisboa, Portugal, 1350-352

Status
Not yet recruiting
Locations

Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department

São Paulo, Brazil, 05651-901

Status
Not yet recruiting
Locations

Hospital Moinhos de Vento-Centro Clínico

Porto Alegre, Brazil, 90035-001

Status
Not yet recruiting
Locations

Turun yliopistollinen keskussairaala

Turku, Finland, FIN-20521

Status
Recruiting
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Oulun yliopistollinen sairaala

Oulu, Finland, 90220

Status
Not yet recruiting
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HUS, Meilahden sairaala

Helsinki, Finland, 29

Status
Not yet recruiting
Locations

Tampereen yliopistollinen sairaala, keskussairaala

Tampere, Finland, 33520

Status
Recruiting
Locations

Royal Surrey County Hospital

Guildford, United Kingdom, GU2 7XX

Status
Not yet recruiting
Locations

Institut Curie - Ulm - Paris

PARIS cedex 5, France, 75248

Status
Not yet recruiting
Locations

CHU GRENOBLE - Hopital Michallon

GRENOBLE, France, 38048

Status
Not yet recruiting
Locations

A.O.U. Ospedali Riuniti Foggia

Foggia, Italy, 71100

Status
Not yet recruiting
Locations

Royal Prince Alfred Hospital

Camperdown, Australia, 2050

Status
Not yet recruiting
Locations

Eastern Clinical Research Unit - Box Hill

Box Hill, Australia, 3128

Status
Not yet recruiting
Locations

Medizinische Universität Innsbruck

Innsbruck, Austria, 6020

Status
Recruiting
Locations

The Urology Place

San Antonio, United States, 78240

Status
Recruiting
Locations

Istituto Oncologico Veneto IRCCS (IOV)

Padova, Italy, 35128

Status
Not yet recruiting
Locations

ASST Papa Giovanni XXIII

Bergamo, Italy, 24127

Status
Recruiting
Locations

Fondazione PTV Policlinico Tor Vergata

Roma, Italy, 00133

Status
Not yet recruiting
Locations

Klinikum Mannheim GmbH

Mannheim, Germany, 68167

Status
Not yet recruiting
Locations

Allegheny General Hospital

Pittsburgh, United States, 15212

Status
Recruiting
Locations

Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

Milano, Italy, 20089

Status
Not yet recruiting
Locations

Vivantes Klinikum Am Urban

Berlin, Germany, 10967

Status
Not yet recruiting
Locations

Skane University Hospital - Department of Urology

Malmo, Sweden, 20502

Status
Recruiting
Locations

Goteborgs Universitet

Gothenburg, Sweden, 413 45

Status
Not yet recruiting
Locations

Rigshospitalet

Copenhagen, Denmark, 2100

Status
Recruiting
Locations

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany, 01307

Status
Not yet recruiting
Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 168

Status
Not yet recruiting
Locations

A.O.U. di Bologna Policlinico S.Orsola Malpighi

Bologna, Italy, 40138

Status
Not yet recruiting
Locations

Aarhus Universitetshospital

Aarhus N, Denmark, 8200

Status
Recruiting
Locations

Aalborg University Hospital

Aalborg, Denmark, 9000

Status
Recruiting
Locations

London Regional Cancer Program

London, Canada, N6A 4L6

Status
Not yet recruiting
Locations

Cabrini Medical Centre

Malvern, Australia, 3144

Status
Not yet recruiting
Locations

Fudan University Shanghai Cancer Center

Shanghai, China, 200030

Status
Not yet recruiting
Locations

Peking Union Medical College Hospital (PUMCH) - East Location

Beijing, China, 100730

Status
Recruiting
Locations

The 1st Affiliated Hospital of Zhejiang University

Hangzhou, China, 310000

Status
Not yet recruiting
Locations

Nova Scotia Health Authority

Halifax, Canada, B3H 2Y9

Status
Recruiting
Locations

Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont

Sherbrooke, Canada, J1H 5N4

Status
Recruiting
Locations

Institut de Cancérologie Jean Godinot

Reims, France, 51726

Status
Not yet recruiting
Locations

Nanjing First Hospital

Nanjing, China, 210006

Status
Not yet recruiting
Locations

Marien-Krankenhaus Bergisch Gladbach

Bergisch Gladbach, Germany, 51465

Status
Not yet recruiting
Locations

Chesapeake Urology Associates

Baltimore, United States, 21204

Status
Recruiting
Locations

Urology Cancer Center, PC

Omaha, United States, 68130-5606

Status
Recruiting
Locations

Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie

Jena, Germany, 07747

Status
Not yet recruiting
Locations

Royal Melbourne Hospital

Melbourne, Australia, 3052

Status
Not yet recruiting
Locations

Institue Curie - Saint-Cloud

SAINT-CLOUD, France, 92210

Status
Not yet recruiting
Locations

Hopital Maisonneuve-Rosemont

Montreal, Canada, H1T 2M4

Status
Not yet recruiting
Locations

Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine

Shanghai, China, 200025

Status
Not yet recruiting
Locations

Zhongnan hospital ,Wuhan University

Wuhan, China, 430033

Status
Recruiting
Locations

West China Hospital,Sichuan University

Chengdu, China, 610041

Status
Not yet recruiting
Locations

BC Cancer - Abbotsford Centre

Abbotsford, Canada, V2S 0C2

Status
Not yet recruiting
Locations

The Affiliated Hospital of Inner Mongolia Medical University

Hohehot, China, 10050

Status
Not yet recruiting
Locations

Tianjin Cancer Hospital, Airport Hospital

Tianjin, China, 300308

Status
Recruiting
Locations

Swietokrzyskie Centrum Onkologii

Kielce, Poland, 25-734

Status
Not yet recruiting
Locations

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

Nanjing, China, 210029

Status
Not yet recruiting
Locations

Hunan Cancer Hospital

Changsha, China, 410013

Status
Not yet recruiting
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Sir Charles Gairdner Hospital

Nedlands, Australia, 6009

Status
Not yet recruiting
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National Taiwan University Hospital

Taipei, Taiwan, China, 100

Status
Not yet recruiting
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HagaZiekenhuis van Den Haag

The Hague, Netherlands, 2545

Status
Not yet recruiting
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Albert Schweitzer Ziekenhuis - Dordwijk

Dordrecht, Netherlands, 3300 AK

Status
Not yet recruiting
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Catharina Ziekenhuis

EINDHOVEN, Netherlands, 5623 EJ

Status
Not yet recruiting
Locations

Universitair Medisch Centrum Groningen

GRONINGEN, Netherlands, 9713 GZ

Status
Not yet recruiting
Locations

St. Franciscus Gasthuis

ROTTERDAM, Netherlands, 3045 PM

Status
Not yet recruiting
Locations

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

NIEUWEGEIN, Netherlands, 3435 CM

Status
Not yet recruiting
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Tergooi MC | Hilversum - Wetenschapsbureau

HILVERSUM, Netherlands, 1213 XZ

Status
Not yet recruiting
Locations

UZ Gent - department Urology

Gent, Belgium, 9000

Status
Not yet recruiting
Locations

Institut Jules Bordet/Jules Bordet Instituut

Bruxelles, Belgium, 1070

Status
Not yet recruiting
Locations

AZ Groeninge Campus Kennedylaan - Urology

Kortrijk, Belgium, 8500

Status
Not yet recruiting
Locations

Jessa ziekenhuis - department Oncology

Hasselt, Belgium, 3500

Status
Not yet recruiting
Locations

UZ Leuven - department Uro-oncology

Leuven, Belgium, 3000

Status
Not yet recruiting
Locations

AZ Maria Middelares - Oncology

Gent, Belgium, 9000

Status
Not yet recruiting
Locations

Northern Hospital

Epping, Australia, 3076

Status
Not yet recruiting
Locations

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

Brno, Czech Republic, 602 00

Status
Not yet recruiting
Locations

Koo Foundation Sun Yet-Sen Cancer Centre

Taipei, Taiwan, China, TBC

Status
Not yet recruiting
Locations

Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, China, 33305

Status
Not yet recruiting
Locations

Tungs' Taichung MetroHarbor Hospital

Taichung, Taiwan, China, 435403

Status
Not yet recruiting
Locations

Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika

Olomouc, Czech Republic, 779 00

Status
Not yet recruiting
Locations

Royal Brisbane & Women's Hospital

Brisbane, Australia, 4029

Status
Not yet recruiting
Locations

Western Urology

Maribyrnong, Australia, 3032

Status
Not yet recruiting
Locations

Centrum Medyczne iMed24

Krakow, Poland, 31-864

Status
Not yet recruiting
Locations

Medrise Sp. z o.o. Centrum Badan Klinicznych

Lublin, Poland, 20-582

Status
Not yet recruiting
Locations

Vseobecna fakultni nemocnice - Urologicka klinika, Praha

Praha 2, Czech Republic, 128 08

Status
Not yet recruiting
Locations

Fakultni nemocnice u Sv. Anny, Onkologicko-chirurgicke oddeleni

Brno, Czech Republic, 602 00

Status
Not yet recruiting
Locations

Multiscan s.r.o., Department: Ambulance klinické onkologie Nemocnice Horovice

Horovice, Czech Republic, 26801

Status
Not yet recruiting
Locations

Martini-Klinik Hamburg

Hamburg, Germany, 20246

Status
Not yet recruiting
Locations

Centrum Onkologii im. Prof. Franciszka Lukaszczyka

Bydgoszcz, Poland, 85-796

Status
Not yet recruiting
Locations

Barwon Health

Geelong, Australia, 3220

Status
Not yet recruiting
Locations

Szpital Grochowski im. dr.med. Rafala Masztaka

Warszawa, Poland, 04-073

Status
Not yet recruiting
Locations

Semmelweis Egyetem, Altalanos Orvostudomanyi Kar, Urologiai Klinika

Budapest, Hungary, 1082

Status
Not yet recruiting
Locations

Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet

Budapest, Hungary, 1024

Status
Not yet recruiting
Locations

Orszagos Onkologiai Intezet

Budapest, Hungary, 1122

Status
Not yet recruiting
Locations

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

Gyor, Hungary, 9024

Status
Not yet recruiting
Locations

Budapesti Uzsoki Utcai Korhaz

Budapest, Hungary, 1145

Status
Not yet recruiting
Locations

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

Nyiregyhaza, Hungary, H-4400

Status
Not yet recruiting
Locations

EMC Instytut Medyczny SA

Wroclaw, Poland, 54-144

Status
Not yet recruiting
Locations

Centro Hospitalar e Universitario de Coimbra EPE (CHUC)

Coimbra, Portugal, 3004-561

Status
Not yet recruiting
Locations

Marienhospital Herne Universitätsklinik

Herne, Germany, 44625

Status
Not yet recruiting
Locations

Johannes Gutenberg-Universität Mainz - Urologie

Mainz, Germany, 55131

Status
Not yet recruiting
Locations

Medizinische Universitaet Graz - Klinische Abteilung für Onkologie - Innere Medizin

Graz, Austria, 8036

Status
Not yet recruiting
Locations

Clinique Clementville

Montpellier, France, 34070

Status
Not yet recruiting
Locations

Centre Georges Francois Leclerc Dijon

DIJON, France, 21079

Status
Not yet recruiting
Locations

Centre d'oncologie du Pays Basque

Bayonne, France, 64100

Status
Not yet recruiting
Locations

Institut de Cancérologie de Lorraine - Alexis Vautrin

Vandoeuvre-les-Nancy, France, 54519

Status
Not yet recruiting
Locations

Blacktown Hospital

Blacktownn, Australia, 2148

Status
Not yet recruiting
Locations

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Henri Mondor (Hopital Henri-Mondor)

Creteil, France, 94000

Status
Not yet recruiting
Locations

Hôpital de la Timone - Marseille

MARSEILLE, France, 13005

Status
Not yet recruiting
Locations

Royal Adelaide Hospital

Adelaide, Australia, 5000

Status
Not yet recruiting
Locations

University of Texas Southwestern Medical Center-Harold C. Simmons Comprehensive Cancer Center

Dallas, United States, 75235

Status
Not yet recruiting
Locations

Kaye Edmonton Clinic - Dianne and Irving Kipnes Urology Centre

Edmonton, Canada, T6G 1Z1

Status
Not yet recruiting
Locations

CISSS de l'Outaouais - Hopital de Gatineau - Centre de cancerolgie

Gatineau, Canada, J8P 7H2

Status
Not yet recruiting
Locations

Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec - Radio-oncologie

Trois-rivieres, Canada, G8Z 3R9

Status
Not yet recruiting
Locations

Urology South Shore Research - Research Department

Greenfield Park, Canada, J4V 2H3

Status
Not yet recruiting

Trial Design