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

Last updated: March 10, 2025
Sponsor: Bayer
Overall Status: Active - Recruiting

Phase

3

Condition

Urologic Cancer

Prostate Cancer

Prostate Cancer, Early, Recurrent

Treatment

Darolutamide (BAY1841788, Nubeqa)

Placebo matching darolutamide

ADT

Clinical Study ID

NCT05794906
21492
2022-501343-33-00
  • Ages > 18
  • Male

Study 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

Inclusion Criteria:

  • Capable of giving signed informed consent as described which includes compliancewith the requirements, restrictions listed in the informed consent form (ICF), andin 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 byadjuvant radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participantswho are unfit for (or refused) ART or SRT, or primary radiotherapy (RT).

  • High-risk biochemical recurrence (BCR), defined as Prostate-specific antigendoubling time (PSADT) <12 months calculated using the formula provided by theSponsor, and PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants whoare unfit for ART or SRT (local or central values accepted), or PSA ≥2 ng/mL abovethe nadir after primary RT only (local or central values accepted).

  • Participants must undergo prostate-specific membrane antigen positron emissiontomography/computed tomography (PSMA PET/CT) within the 42-day Screening periodusing either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessedby blinded independent central review (BICR) to identify at least one PSMA PET/CTlesion of prostate cancer.

  • Serum testosterone ≥150 ng/dL (5.2 nmol/L) (local assessment is allowed whenevercentral 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 receivedblood transfusion within 7 days prior to sample being taken); Absolute neutrophilcount (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 glomerularfiltration 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 theprotocol during the Treatment period and for at least 1 week after the last dose ofstudy treatment, and refrain from donating sperm during this period.

Exclusion

Exclusion Criteria:

  • Pathological finding consistent with small cell, ductal or ≥50 % component ofneuroendocrine carcinoma of the prostate.

  • History of bilateral orchiectomy.

  • Metastases or recurrent /new malignant lesions in prostate gland/bed seminalvesicles, lymph nodes below the CIA bifurcation on conventional imaging (CI) asassessed 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 screeningPSMA 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) androgenreceptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18months prior to signing of the ICF.

  • Prior treatments with PSMA-radiotherapeutics within 12 months prior torandomization.

  • Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant orsalvage treatment completed within 8 weeks prior to signing of the ICF.

  • Any prior malignancy (other than adequately treated basal cell or squamous cell skincancer, superficial bladder cancer, or any other cancer in situ currently incomplete remission) within 5 years.

  • History of pelvic radiotherapy for other malignancy.

Study Design

Total Participants: 750
Treatment Group(s): 3
Primary Treatment: Darolutamide (BAY1841788, Nubeqa)
Phase: 3
Study Start date:
April 03, 2023
Estimated Completion Date:
March 29, 2030

Connect with a study center

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    France

    Active - Recruiting

  • AP-HM - Hopital de la Timone

    Marseille, 13005
    France

    Site Not Available

  • Hôpital de la Timone - Marseille

    Marseille, 13005
    France

    Site Not Available

  • Clinique Clementville

    Montpellier, 34070
    France

    Active - Recruiting

  • Institut Curie - Ulm - Paris

    PARIS cedex 5, 75248
    France

    Site Not Available

  • Hopital Bichat - Paris

    Paris, 75018
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre Benite, 69495
    France

    Active - Recruiting

  • HCL - Centre Hospitalier Lyon Sud

    Pierre Benite, 69495
    France

    Active - Recruiting

  • Institut de Cancerologie Jean Godinot - Departement oncologie medicale

    Reims, 51056
    France

    Active - Recruiting

  • Institut de Cancérologie Jean Godinot

    Reims, 51726
    France

    Active - Recruiting

  • Hôpital Pontchaillou

    Rennes Cedex, 35033
    France

    Active - Recruiting

  • Institut de Cancerologie de l'Ouest - Saint Herblain - Unite de therapie precoce

    Saint Herblain, 44800
    France

    Active - Recruiting

  • Institue Curie - Saint-Cloud

    Saint-Cloud, 92210
    France

    Site Not Available

  • Institut Curie - Saint-Cloud

    Saint-Cloud, 92210
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest - Saint Herblain

    Saint-Herblain, 44800
    France

    Site Not Available

  • Institut de Cancerologie de Ouest - Saint Herblain

    St Herblain, 44805
    France

    Site Not Available

  • ICANS - Institut de Cancerologie de Strasbourg Europ

    Strasbourg, 67033
    France

    Active - Recruiting

  • ICANS - Institut de Cancérologie de Strasbourg Europe

    Strasbourg, 67033
    France

    Active - Recruiting

  • Institut Claudius Regaud - iUCT Oncopole

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Hopital Bretonneau

    Tours, 37044
    France

    Site Not Available

  • Hôpital Bretonneau

    Tours, 37044
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine - Alexis Vautrin

    Vandoeuvre-les-Nancy, 54519
    France

    Active - Recruiting

  • Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

    Villejuif, 94805
    France

    Site Not Available

  • Gustave Roussy - Departement Oncologie-Radiotherapie

    Villejuif, 94800
    France

    Active - Recruiting

  • Institut Gustave Roussy - Département de Médecine Oncologique

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Klinikum Mannheim GmbH

    Mannheim, Baden-Württemberg 68135
    Germany

    Active - Recruiting

  • Klinikum Mannheim GmbH Universitaetsklinikum

    Mannheim, Baden-Württemberg 68167
    Germany

    Site Not Available

  • Studienpraxis Urologie

    Nürtingen, Baden-Württemberg 72622
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar

    München, Bavaria 81675
    Germany

    Site Not Available

  • Klinikum der Universität Würzburg

    Wurzburg, Bayern 97080
    Germany

    Active - Recruiting

  • Klinikum der Universität Würzburg

    Würzburg, Bayern 97080
    Germany

    Site Not Available

  • Universitätsklinikum der Johann Wolfgang Goethe Universität

    Frankfurt, Hessen 60590
    Germany

    Active - Recruiting

  • Klinikum der Johann-Wolfgang-Goethe-Universitaet Frankfurt M

    Frankfurt a. M., Hessen 60590
    Germany

    Site Not Available

  • Städtisches Klinikum Braunschweig gGmbH

    Brunswick, Lower Saxony 38126
    Germany

    Active - Recruiting

  • Universitätsmedizin der Georg-August-Universität Göttingen

    Goettingen, Lower Saxony 37075
    Germany

    Active - Recruiting

  • Marienhospital Herne Universitätsklinik

    Herne, NRW 44625
    Germany

    Active - Recruiting

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, Niedersachsen 38126
    Germany

    Site Not Available

  • Universitätsmedizin der Georg-August-Universität Göttingen

    Göttingen, Niedersachsen 37075
    Germany

    Site Not Available

  • Urologicum Duisburg

    Duisburg, Nordrhein-Westfalen 47169
    Germany

    Active - Recruiting

  • Universitätsklinikum Köln

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitätsklinikum Münster (UKM)

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, Sachsen 1307
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, Sachsen 1307
    Germany

    Active - Recruiting

  • Medizinische Fakultät der Otto-von-Guericke Universität

    Magdeburg, Sachsen-Anhalt 39120
    Germany

    Site Not Available

  • Universitätsklinikum Aachen / Klinik und Poliklinik für Urologie und Kinderurologie

    Aachen, 52074
    Germany

    Site Not Available

  • Marien-Krankenhaus Bergisch Gladbach

    Bergisch Gladbach, 51465
    Germany

    Active - Recruiting

  • Charité Campus Benjamin Franklin (CBF)

    Berlin, 12203
    Germany

    Site Not Available

  • Vivantes Klinikum Am Urban

    Berlin, 10967
    Germany

    Site Not Available

  • Martini-Klinik Hamburg

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Universitätsklinikum Hamburg-Eppendorf - Martini-Klinik am UKE GmbH

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Universitaetsklinikum Jena - Klinik fuer Urologie

    Jena, 7747
    Germany

    Site Not Available

  • Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie

    Jena, 07747
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein/ Klinik für Urologie

    Kiel, 24105
    Germany

    Site Not Available

  • Johannes Gutenberg-Universität Mainz - Urologie

    Mainz, 55131
    Germany

    Site Not Available

  • Klinikum Stuttgart / Klinik für Urologie und Transplantationschirurgie

    Stuttgart, 70174
    Germany

    Site Not Available

  • Urologische Gemeinschaftspraxis Wesel

    Wesel, 46483
    Germany

    Active - Recruiting

  • Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet

    Budapest, 1204
    Hungary

    Site Not Available

  • Budapesti Uzsoki Utcai Korhaz

    Budapest, 1145
    Hungary

    Active - Recruiting

  • Budapesti Uzsoki Utcai Kórház

    Budapest, 1145
    Hungary

    Active - Recruiting

  • Orszagos Onkologiai Intezet

    Budapest, 1122
    Hungary

    Site Not Available

  • Semmelweis Egyetem, Altalanos Orvostudomanyi Kar, Urologiai Klinika

    Budapest, 1082
    Hungary

    Site Not Available

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    Gyor, 9024
    Hungary

    Active - Recruiting

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

    Nyiregyhaza, 4400
    Hungary

    Site Not Available

  • Rambam Health Corporation

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah Hebrew University Hospital Ein Kerem

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 9372212
    Israel

    Site Not Available

  • Clalit Health Services Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Sheba Medical Center

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Oncologia Clinica Sperimentale Uro-Ginecologica

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione G.Pascale

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Azienda Unita Sanitaria Locale Di Bologna_Ospedale Bellaria - Oncologia Medica

    Bologna, Emilia-Romagma 40139
    Italy

    Active - Recruiting

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

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • AUSL di Bologna

    Bologna, Emilia-Romagna 40139
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Urologia

    Bologna, Emilia-Romagna 40138
    Italy

    Active - Recruiting

  • A.O.U. di Modena - Policlinico

    Modena, Emilia-Romagna 41124
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia

    Modena, Emilia-Romagna 41124
    Italy

    Active - Recruiting

  • AUSL-IRCCS di Reggio Emilia

    Reggio Emilia, Emilia-Romagna 42123
    Italy

    Site Not Available

  • Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia

    Reggio Emilia, Emilia-Romagna 42123
    Italy

    Site Not Available

  • Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale

    Reggio Emilia, Emilia-Romagna 42123
    Italy

    Active - Recruiting

  • Centro di Riferimento Oncologico di Aviano - Oncologia Radioterapica

    Aviano, Friuli-Venezia Giulia 33081
    Italy

    Active - Recruiting

  • Centro di Riferimento Oncologico di Aviano - Oncologia Radioterapica

    Aviano (PN), Friuli-Venezia Giulia 33081
    Italy

    Site Not Available

  • IRCCS Centro di Riferimento Oncologico (CRO)

    Pordenone, Friuli-Venezia Giulia 33081
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Degenza di Radioterapia Oncologica

    Roma, Lazio 00168
    Italy

    Active - Recruiting

  • I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena - Urologia

    Roma, Lazio 00128
    Italy

    Active - Recruiting

  • IRCCS Istituti Fisioterapici Ospitalieri - IFO

    Roma, Lazio 00144
    Italy

    Active - Recruiting

  • Policlinico Gemelli

    Rome, Lazio 168
    Italy

    Site Not Available

  • IRCCS Ist Nazionale Tumori GE - Oncologia Medica

    Genova, Liguria 16132
    Italy

    Active - Recruiting

  • IRCCS Ospedale Policlinico San Martino - Oncologia Medica 1

    Genova, Liguria 16132
    Italy

    Active - Recruiting

  • ASST Papa Giovanni XXIII

    Bergamo, Lombardia 24127
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Oncologia

    Bergamo, Lombardia 24127
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, Lombardia 20133
    Italy

    Site Not Available

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

    Milano, Lombardia 20089
    Italy

    Site Not Available

  • Ospedale San Raffaele s.r.l - Urologia

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • Ospedale San Raffaele s.r.l.

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia

    Rozzano, Lombardia 20089
    Italy

    Active - Recruiting

  • A.O.U. Città della Salute e della Scienza di Torino - Urologia U

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • A.O.U. Città della Salute e della Scienza di Torino_Molinette - Urologia U

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • Molinette Hospital University of Torino

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • A.O.U. Consorziale Policlinico

    Bari, Puglia 70124
    Italy

    Site Not Available

  • A.O.U. Ospedali Riuniti Foggia

    Foggia, Puglia 71122
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali Riuniti_Foggia - Oncologia Medica e Terapia Biomolecolare Universitaria

    Foggia, Puglia 71122
    Italy

    Site Not Available

  • Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia Medica

    Trento, Trentino 38122
    Italy

    Active - Recruiting

  • Santa Chiara Hospital

    Trento, Trentino 38122
    Italy

    Site Not Available

  • A.O. di Perugia - Ospedale Santa Maria della Misericordia

    Perugia, Umbria 06129
    Italy

    Site Not Available

  • A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Radioterapia Oncologica

    Perugia, Umbria 06129
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto_Castelfranco Veneto - UOC Urologia Oncologica

    Castelfranco Veneto, Veneto 31033
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto IRCCS (IOV)

    Padova, Veneto 35128
    Italy

    Site Not Available

  • Azienda Ospedaliera Policlinico Universitario Tor Vergata - UOC Radioterapia

    Roma, Veneto 00133
    Italy

    Active - Recruiting

  • Fondazione PTV Policlinico Tor Vergata

    Roma, Veneto 00133
    Italy

    Site Not Available

  • A.O.U.I. Verona

    Verona, Veneto 37134
    Italy

    Site Not Available

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Verona, Veneto 37024
    Italy

    Site Not Available

  • Cliniche Gavazzeni S.p.A - Dipartimento Area Chirurgia Unità Operativa di Urologia

    Bergamo, 24125
    Italy

    Active - Recruiting

  • IOV Castelfranco Veneto

    Castelfranco Veneto, 31033
    Italy

    Site Not Available

  • Azienda Ospedaliera Santa Croce e Carle - Oncologia

    Cuneo, 12100
    Italy

    Site Not Available

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

    Perugia, 06123
    Italy

    Site Not Available

  • Policlinico Tor Vergata

    Roma, 00133
    Italy

    Site Not Available

  • IRCCS Ist Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa 920-8641
    Japan

    Active - Recruiting

  • Yokohama City University Hospital

    Yokohama, Kanagawa 236-0004
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita, Osaka 565-0871
    Japan

    Active - Recruiting

  • Institute of Science Tokyo Hospital

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Tokyo Medical and Dental University Hospital

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Site Not Available

  • Kagoshima University Hospital

    Kagoshima, 890-8520
    Japan

    Site Not Available

  • Kyoto University Hospital

    Kyoto, 606-8507
    Japan

    Active - Recruiting

  • Catharina Ziekenhuis

    Eindhoven, Noord-Brabant 5623 EJ
    Netherlands

    Site Not Available

  • Albert Schweitzer Hospital | Internal Medicine - Oncology Department

    Dordrecht, 3300 AK
    Netherlands

    Site Not Available

  • Albert Schweitzer Ziekenhuis - Dordwijk

    Dordrecht, 3300 AK
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • University Medical Center Groningen | Urology Department

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Tergooi MC | Hilversum - Wetenschapsbureau

    Hilversum, 1213 VG
    Netherlands

    Site Not Available

  • Tergooiziekenhuizen Hilversum

    Hilversum, 1213 XZ
    Netherlands

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435 CM
    Netherlands

    Site Not Available

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

    Nieuwegein, 3435 CM
    Netherlands

    Active - Recruiting

  • St. Franciscus Gasthuis

    Rotterdam, 3045 PM
    Netherlands

    Active - Recruiting

  • HagaZiekenhuis van Den Haag

    The Hague, 2545
    Netherlands

    Active - Recruiting

  • Canterbury Urology Research Trust

    Christchurch, Canterbury 8013
    New Zealand

    Active - Recruiting

  • Auckland City Hosptial

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • MidCentral District Health Board (MDHB) - Palmerston North Hospital (PNH)

    Palmerston North, 4414
    New Zealand

    Site Not Available

  • MidCentral District Health Board (MDHB) - Palmerston North Hospital (PNH)

    TBC, 4414
    New Zealand

    Active - Recruiting

  • Tauranga Urology Research Limited

    Tauranga, 3112
    New Zealand

    Active - Recruiting

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka

    Bydgoszcz, 85-796
    Poland

    Active - Recruiting

  • Swietokrzyskie Centrum Onkologii

    Kielce, 25-734
    Poland

    Active - Recruiting

  • Centrum Medyczne iMed24

    Krakow, 31-864
    Poland

    Active - Recruiting

  • Medrise Sp. z o.o. Centrum Badan Klinicznych

    Lublin, 20-582
    Poland

    Active - Recruiting

  • Szpital Grochowski im. dr.med. Rafala Masztaka

    Warszawa, 04-073
    Poland

    Active - Recruiting

  • EMC Instytut Medyczny SA

    Wroclaw, 54-144
    Poland

    Active - Recruiting

  • Instituto Portugues de Oncologia de Lisboa | Unidade de Investigacao Clinica - Departamento de Urologia

    Lisbon, Lisboa 1099-023
    Portugal

    Active - Recruiting

  • Centro Clinico Academico - Braga

    Braga, 4710-243
    Portugal

    Site Not Available

  • Centro Clinico Academico Braga | Braga, Portugal

    Braga, 4710-243
    Portugal

    Site Not Available

  • Centro Hospitalar e Universitario de Coimbra EPE (CHUC)

    Coimbra, 3004-561
    Portugal

    Site Not Available

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

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Centro Hospitalar Universitário de Lisboa Norte | Heart and Vessels Department

    Lisboa, 1649-028
    Portugal

    Site Not Available

  • Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research Center

    Lisboa, 1350-352
    Portugal

    Active - Recruiting

  • Fundacao Champalimaud

    Lisboa, 1400-038
    Portugal

    Site Not Available

  • Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica

    Lisboa, 1400-038
    Portugal

    Site Not Available

  • Hospital CUF Tejo

    Lisboa, 1350-352
    Portugal

    Site Not Available

  • Hospital Santa Maria | Centro de Investigacao Clinica

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Hospital da Luz - Lisboa

    Lisboa, 1500-650
    Portugal

    Site Not Available

  • IPO Lisboa

    Lisboa, 1093 CODEX
    Portugal

    Site Not Available

  • Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica

    Lisboa, 1500-650
    Portugal

    Site Not Available

  • Centro Hospitalar Universitario do Porto

    Porto, 4099-001
    Portugal

    Site Not Available

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña 15706
    Spain

    Active - Recruiting

  • Hospital Universitario "Marqués de Valdecilla"

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria | Cardiology Department

    Malaga, Málaga 29010
    Spain

    Active - Recruiting

  • Ciutat Sanitaria i Universitaria de la Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 8036
    Spain

    Active - Recruiting

  • Hospital Fundació Puigvert

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009
    Spain

    Active - Recruiting

  • Centro Integral Oncológico Clara Campal

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal | Departamento de Medicina Interna

    Madrid, 28034
    Spain

    Site Not Available

  • MD Anderson International Espanya, S.A.

    Madrid, 28033
    Spain

    Active - Recruiting

  • H. General Uiversitario Morales Meseguer - Department of Urology

    Murcia, 30008
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria | Cardiology Department

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Virgen del Rocio University Hospital - Oncology Department

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46009
    Spain

    Active - Recruiting

  • Instituto Valenciano de Oncología

    Valencia, 46009
    Spain

    Active - Recruiting

  • Goteborgs Universitet

    Gothenburg, 413 45
    Sweden

    Active - Recruiting

  • Skane University Hospital - Department of Urology

    Malmo, 20502
    Sweden

    Active - Recruiting

  • Akademiska sjukhuset (Uppsala University Hospital) - Njurkliniken

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Uppsala University Hospital, Urology Department

    Uppsala, SE-751
    Sweden

    Site Not Available

  • Tungs' Taichung MetroHarbor Hospital

    Taichung, 435403
    Taiwan

    Site Not Available

  • Koo Foundation Sun Yet-Sen Cancer Centre

    Taipei, 112019
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital (CGMH) - Linkou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, 33305
    Taiwan

    Active - Recruiting

  • Bedford Hospital - Bedfordshire Hospitals NHS Foundation Tru

    Bedford, Bedfordshire MK42 9DJ
    United Kingdom

    Site Not Available

  • East and North Hertfordshire NHS Trust - Mount Vernon Hospital - Mount Vernon Cancer Centre (MVCC)

    Northwood, Middlesex HA6 2RN
    United Kingdom

    Active - Recruiting

  • Mount Vernon Cancer Centre

    Northwood, Middlesex HA6 2RN
    United Kingdom

    Site Not Available

  • Royal Surrey County Hospital

    Guildford, Surrey GU2 7XX
    United Kingdom

    Active - Recruiting

  • Royal Surrey County Hospital NHS Foundation Trust

    Guildford, Surrey GU2 7WG
    United Kingdom

    Site Not Available

  • Royal Surrey County Hospital

    Manchester, Surrey M1 3DZ
    United Kingdom

    Site Not Available

  • Charing Cross Hospital

    London, W6 8RF
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital (London)

    London, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • City of Hope - Phoenix Cancer Center

    Goodyear, Arizona 85338
    United States

    Site Not Available

  • Mayo Clinic Hospital

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Arizona Institute of Urology

    Tucson, Arizona 85704
    United States

    Site Not Available

  • City of Hope - Duarte Cancer Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Tower Urology, Inc

    Los Angeles, California 90048
    United States

    Terminated

  • University of California, Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • University of California Irvine Medical Center

    Orange, California 92868-3201
    United States

    Site Not Available

  • UCSF Med Center Helen Diller Family Comp Cancer Center

    San Francisco, California 94143
    United States

    Site Not Available

  • Colorado Urology (Colorado Clinical Research)

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Colorado Urology - St. Anthony Hospital Campus

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Clermont Oncology Center

    Clermont, Florida 34711
    United States

    Site Not Available

  • University of Florida - Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Mid Florida Cancer Centers

    Orange City, Florida 32763-8316
    United States

    Site Not Available

  • Comprehensive Cancer Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Jesse Brown VA Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern University Feinberg School of Medicine - Department of Urology

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Urology of Indiana, LLC

    Greenwood, Indiana 46143
    United States

    Site Not Available

  • First Urology PSC

    Jeffersonville, Indiana 47130
    United States

    Site Not Available

  • University of Kansas

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Chesapeake Urology Associates

    Baltimore, Maryland 21204
    United States

    Active - Recruiting

  • Chesapeake Urology Associates - Towson

    Baltimore, Maryland 21204
    United States

    Active - Recruiting

  • Johns Hopkins Univ School Med|Sidney Kimmel Comp Cancer Cntr

    Baltimore, Maryland 21231
    United States

    Active - Recruiting

  • Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins

    Baltimore, Maryland 21231
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts 01655-0002
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute - Detroit

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute - Detroit Headquarters

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Michigan Institute of Urology, PC

    Troy, Michigan 48084
    United States

    Site Not Available

  • University of Minnesota Medical Center

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine - Center for Advanced Medicine (CAM)

    Saint Louis, Missouri 63110-1032
    United States

    Completed

  • Urology Cancer Center, PC

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • New Jersey Urology (NJU)

    Saddle Brook, New Jersey 07663-5227
    United States

    Site Not Available

  • New Jersey Urology, LLC

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • NYU Langone Health

    Mineola, New York 11501
    United States

    Completed

  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)

    New York, New York 10029-6500
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai - Oncology

    New York, New York 10029
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Associated Medical Professionals of NY, PLLC

    Syracuse, New York 13210
    United States

    Site Not Available

  • White Plains Hospital

    White Plains, New York 10601
    United States

    Site Not Available

  • Alliance Urology

    Greensboro, North Carolina 27403
    United States

    Active - Recruiting

  • Alliance Urology Specialists

    Greensboro, North Carolina 27403
    United States

    Active - Recruiting

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • The Urology Group

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • MidLantic Urology - Bala Cynwyd

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • Urological Associates of Lancaster

    Lancaster, Pennsylvania 17604
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania 15240
    United States

    Site Not Available

  • Bon Secours St. Francis Hospital

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Carolina Urological Research Center

    Myrtle Beach, South Carolina 29579
    United States

    Active - Recruiting

  • Urology Austin, PLLC (an affiliate of Urology America)

    Austin, Texas 78745
    United States

    Site Not Available

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

    Dallas, Texas 75235
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The Urology Place

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Urology San Antonio Research, PA

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Urology San Antonio, PA dba USA Clinical Trials

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Spokane Urology PS

    Spokane, Washington 99202
    United States

    Site Not Available

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