ARASTEP: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Nonmetastatic Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies
Study Details
Study Description
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 for prostate cancer development. This may mean that the cancer has come back even though no cancer or cancer spreading is yet detectable using conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans. 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 men with a stage of prostate cancer where the PSA levels raised to a certain limit within a specified 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. Next generation androgen receptor inhibitors (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 and ADT given for 24 months. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
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 will 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:
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take blood and urine samples.
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measure PSA and testosterone levels in the blood samples
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do physical examinations
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check the participants' overall health
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examine heart health using electrocardiogram (ECG)
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check vital signs
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check cancer status using PSMA PET/CT scans, CT, MRI and bone scans
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take tumor samples (if required)
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Darolutamide+ADT Participants will receive darolutamide plus ADT twice daily with food for a maximum treatment duration of 24 months. |
Drug: Darolutamide (BAY1841788, Nubeqa)
Coated tablet, 300 mg / tablet, oral.
Other: ADT
Luteinizing hormone-releasing hormone [LHRH] agonist/antagonists
|
| Placebo Comparator: Placebo+ADT Participants will receive Placebo plus ADT twice daily with food for a maximum treatment duration of 24 months. |
Other: Placebo matching darolutamide
Coated tablet, oral
Other: ADT
Luteinizing hormone-releasing hormone [LHRH] agonist/antagonists
|
Outcome Measures
Primary Outcome Measures
- Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR) [After randomization to after last treatment, approximately 24 months]
Secondary Outcome Measures
- Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR [After randomization to after last treatment, approximately 46 months]
- Time to Castration-resistant prostate cancer (CRPC) assessed by investigator [After randomization to after last treatment, approximately 46 months]
- Time to initiation of first subsequent systemic antineoplastic therapy [After randomization to after last treatment, approximately 46 months]
- Time to loco-regional progression by PSMA PET/CT [After randomization to after last treatment, approximately 46 months]
- Time to first Symptomatic skeletal event (SSE) [After randomization to after last treatment, approximately 46 months]
- Overall survival (OS) [After randomization to after last treatment, approximately 46 months]
- Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL) [After randomization to after last treatment, approximately 46 months]
- Time to deterioration in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score [After randomization to after last treatment, approximately 24 months]
FACT-P is a multidimension, selfreport QoL instrument specifically designed for patients with prostate cancer. It consists of 39 questions items, made up by 2 parts: the 27 questions for functional assessment of cancer therapy general (FACT-G) and 12 prostate cancer subscale questions. It assesses 4 main domains which are: physical (n=7), social/family (n=7), emotional (n=6) and functional wellbeing (n=7).
- Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severity [After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months]
- Number of participants who discontinue study treatment due to a TEAE [After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Male ≥18 years of age at the time of signing the informed consent.
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Histologically or cytologically confirmed adenocarcinoma of prostate.
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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 ART or SRT, or primary radiotherapy (RT).
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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, or PSA ≥2 ng/mL above the nadir after primary RT only.
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Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 30-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by BICR.
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Serum testosterone ≥150 ng/dL (5.2 nmol/L).
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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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) ≥1.5x109/L (participant must not have received any growth factor within 4 weeks prior to sample being taken); Platelet count ≥100x109/L.
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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.
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Sexually active male participants must agree to use contraception as detailed in the protocol during the Treatment period and for at least 3 months after the last dose of study treatment, and refrain from donating sperm during this period.
Exclusion Criteria:
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Pathological finding consistent with small cell, ductal or ≥50 % component of neuroendocrine carcinoma of the prostate.
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History of bilateral orchiectomy.
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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.
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Brain metastasis on PSMA PET /CT by BICR at screening.
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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.
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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.
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Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization.
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Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or salvage treatment completed within 8 weeks prior to signing of the ICF.
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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.
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History of pelvic radiotherapy for other malignancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic Hospital | Phoenix | Arizona | United States | 85054 |
| 2 | Arizona Institute of Urology | Tucson | Arizona | United States | 85704 |
| 3 | City of Hope National Medical Center | Duarte | California | United States | 91010 |
| 4 | University of Southern California | Los Angeles | California | United States | 90033 |
| 5 | Tower Urology, Inc | Los Angeles | California | United States | 90048 |
| 6 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
| 7 | University of California Irvine Medical Center | Orange | California | United States | 92868-3201 |
| 8 | UCSF Med Center Helen Diller Family Comp Cancer Center | San Francisco | California | United States | 94143 |
| 9 | Colorado Urology (Colorado Clinical Research) | Lakewood | Colorado | United States | 80228 |
| 10 | Clermont Oncology Center | Clermont | Florida | United States | 34711 |
| 11 | University of Florida - Jacksonville | Jacksonville | Florida | United States | 32209 |
| 12 | Mid Florida Cancer Centers | Orange City | Florida | United States | 32763-8316 |
| 13 | Northwestern University Feinberg School of Medicine | Chicago | Illinois | United States | 60611 |
| 14 | Jesse Brown VA Medical Center | Chicago | Illinois | United States | 60612 |
| 15 | Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 16 | Urology of Indiana, LLC | Greenwood | Indiana | United States | 46143 |
| 17 | First Urology PSC | Jeffersonville | Indiana | United States | 47130 |
| 18 | University of Kansas | Kansas City | Kansas | United States | 66160 |
| 19 | Johns Hopkins Univ School Med|Sidney Kimmel Comp Cancer Cntr | Baltimore | Maryland | United States | 21231 |
| 20 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115-6084 |
| 21 | Barbara Ann Karmanos Cancer Institute - Detroit | Detroit | Michigan | United States | 48201 |
| 22 | Michigan Institute of Urology, PC | Troy | Michigan | United States | 48084 |
| 23 | University of Minnesota Medical Center | Minneapolis | Minnesota | United States | 55455 |
| 24 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110-1093 |
| 25 | New Jersey Urology (NJU) | Saddle Brook | New Jersey | United States | 07663-5227 |
| 26 | New Jersey Urology, LLC | Voorhees | New Jersey | United States | 08043 |
| 27 | NYU Langone Health | New York | New York | United States | 10016 |
| 28 | Associated Medical Professionals of NY, PLLC | Syracuse | New York | United States | 13210 |
| 29 | White Plains Hospital | White Plains | New York | United States | 10601 |
| 30 | Alliance Urology | Greensboro | North Carolina | United States | 27403 |
| 31 | Wake Forest Baptist Health | Winston-Salem | North Carolina | United States | 27157 |
| 32 | The Urology Group | Cincinnati | Ohio | United States | 45212 |
| 33 | Ohio State University Wexner Medical Center | Columbus | Ohio | United States | 43210 |
| 34 | MidLantic Urology | Bala-Cynwyd | Pennsylvania | United States | 19004 |
| 35 | Urological Associates of Lancaster | Lancaster | Pennsylvania | United States | 17604 |
| 36 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 37 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15232 |
| 38 | Bon Secours St. Francis Hospital | Greenville | South Carolina | United States | 29607 |
| 39 | Carolina Urological Research Center | Myrtle Beach | South Carolina | United States | 29579 |
| 40 | Urology Austin, PLLC (an affiliate of Urology America) | Austin | Texas | United States | 78759 |
| 41 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 42 | Urology San Antonio Research, PA | San Antonio | Texas | United States | 78229 |
| 43 | The Urology Place | San Antonio | Texas | United States | 78257 |
| 44 | Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia | 2050 |
| 45 | Liverpool Hospital | Liverpool | New South Wales | Australia | 2170 |
| 46 | Macquarie University Hospital | Macquarie University | New South Wales | Australia | 2109 |
| 47 | GenesisCare Newcastle | Newcastle | New South Wales | Australia | 2290 |
| 48 | Port Macquarie Base Hospital | Port Macquarie | New South Wales | Australia | 2444 |
| 49 | St Vincents Hospital Sydney | Sydney | New South Wales | Australia | 2010 |
| 50 | Sydney Adventist Hospital | Wahroonga | New South Wales | Australia | 2076 |
| 51 | Bundaberg Hospital, Genesis Cancer Care - Bundaberg | Bundaberg | Queensland | Australia | 4670 |
| 52 | Wide Bay Hospital and Health Service - Hervey Bay Hospital | Pialba | Queensland | Australia | 4655 |
| 53 | Tasman Health Care | Southport | Queensland | Australia | 4215 |
| 54 | Eastern Clinical Research Unit - Box Hill | Box Hill | Victoria | Australia | 3128 |
| 55 | Epworth HealthCare | East Melbourne | Victoria | Australia | 3002 |
| 56 | Cabrini Medical Centre | Malvern | Victoria | Australia | 3144 |
| 57 | Austin Health | Heidelberg | Australia | ||
| 58 | Prince of Wales Hospital NSW | Randwick | Australia | 2031 | |
| 59 | Ordensklinikum Linz GmbH Elisabethinen | Linz | Oberösterreich | Austria | 4020 |
| 60 | Medizinische Universität Innsbruck | Innsbruck | Austria | 6020 | |
| 61 | Uniklinikum Salzburg - Landeskrankenhaus | Salzburg | Austria | 5020 | |
| 62 | Krankenhaus der Barmherzigen Brüder | Wien | Austria | 1020 | |
| 63 | Universitätsklinikum AKH Wien | Wien | Austria | 1090 | |
| 64 | Assistência Multidisciplinar em Oncologia (AMO) | Salvador | Bahia | Brazil | 41950-640 |
| 65 | Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner | Curitiba | Parana | Brazil | 81520-060 |
| 66 | Liga Norte Riograndense Contra o Câncer | Natal | Rio Grande Do Norte | Brazil | 59062-000 |
| 67 | Hospital Moinhos de Vento-Centro Clínico | Porto Alegre | Rio Grande Do Sul | Brazil | 90035-001 |
| 68 | Faculdade de Medicina do ABC | Santo André | Sao Paulo | Brazil | 09060-650 |
| 69 | Instituto do Câncer do Estado de São Paulo | São Paulo | Sao Paulo | Brazil | 01246-000 |
| 70 | Inst. de Assistência Médica ao Sérvidor Público Estadual | São Paulo | Sao Paulo | Brazil | 04039-004 |
| 71 | Hospital Israelita Albert Einstein | São Paulo | Sao Paulo | Brazil | 05651-901 |
| 72 | Hospital Sirio Libanes | Sao Paulo | Brazil | 01308-050 | |
| 73 | Prostate Cancer Centre | Calgary | Alberta | Canada | T2V 1P9 |
| 74 | Vancouver General Hospital | Vancouver | British Columbia | Canada | V6H 3Z6 |
| 75 | BCCA-Vancouver Island Centre | Victoria | British Columbia | Canada | V8R 6V5 |
| 76 | Nova Scotia Health Authority | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 77 | Hamilton Health Sciences-Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
| 78 | London Regional Cancer Program | London | Ontario | Canada | N6A 4L6 |
| 79 | Princess Margaret Cancer Centre - UHN | Toronto | Ontario | Canada | M5G 2M9 |
| 80 | Hopital Hotel-Dieu de Levis | Levis | Quebec | Canada | G6V 3Z1 |
| 81 | Sir Mortimer B. Davis Jewish General Hospital | Montreal | Quebec | Canada | H3T 1E2 |
| 82 | Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont | Sherbrooke | Canada | J1H 5N4 | |
| 83 | Nanjing First Hospital | Nanjing | Jiangsu | China | 210006 |
| 84 | The 1st Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | China | 310000 |
| 85 | Peking Union Medical College Hospital (PUMCH) - East Location | Beijing | China | 100730 | |
| 86 | Aalborg University Hospital | Aalborg | Denmark | 9000 | |
| 87 | Aarhus Universitetshospital | Aarhus N | Denmark | 8200 | |
| 88 | Rigshospitalet | Copenhagen | Denmark | 2100 | |
| 89 | Docrates Klinikka | Helsinki | Finland | 00180 | |
| 90 | HUS, Meilahden sairaala | Helsinki | Finland | 00290 | |
| 91 | Oulun yliopistollinen sairaala | Oulu | Finland | 90220 | |
| 92 | Tampereen yliopistollinen sairaala, keskussairaala | Tampere | Finland | 33520 | |
| 93 | Turun yliopistollinen keskussairaala | Turku | Finland | FIN-20521 | |
| 94 | Hôpital Pellegrin - Bordeaux | Bordeaux | France | 33000 | |
| 95 | Centre Jean Perrin | Clermont-ferrand | France | 63011 | |
| 96 | CHU GRENOBLE - Hopital Michallon | Grenoble | France | 38048 | |
| 97 | Hôpital Claude Huriez - Lille | Lille | France | 59037 | |
| 98 | Institut Curie - Ulm - Paris | PARIS cedex 5 | France | 75248 | |
| 99 | Hopital Bichat - Paris | Paris | France | 75018 | |
| 100 | Centre Hospitalier Lyon Sud | Pierre Benite | France | 69495 | |
| 101 | Hôpital Pontchaillou | Rennes Cedex | France | 35033 | |
| 102 | Institut de Cancerologie de Ouest - Saint Herblain | St Herblain | France | 44805 | |
| 103 | ICANS - Institut de Cancérologie de Strasbourg Europe | Strasbourg | France | 67033 | |
| 104 | Hôpital Bretonneau | Tours | France | 37044 | |
| 105 | Gustave Roussy (Institut de Cancerologie Gustave-Roussy) | Villejuif | France | 94805 | |
| 106 | Klinikum Mannheim GmbH Universitaetsklinikum | Mannheim | Baden-Württemberg | Germany | 68167 |
| 107 | Studienpraxis Urologie | Nürtingen | Baden-Württemberg | Germany | 72622 |
| 108 | Klinikum rechts der Isar | München | Bayern | Germany | 81675 |
| 109 | Klinikum der Universität Würzburg | Würzburg | Bayern | Germany | 97080 |
| 110 | Klinikum der Johann-Wolfgang-Goethe-Universitaet Frankfurt M | Frankfurt a. M. | Hessen | Germany | 60590 |
| 111 | Städtisches Klinikum Braunschweig gGmbH | Braunschweig | Niedersachsen | Germany | 38126 |
| 112 | Universitätsmedizin der Georg-August-Universität Göttingen | Göttingen | Niedersachsen | Germany | 37075 |
| 113 | Universitätsklinikum Köln | Köln | Nordrhein-Westfalen | Germany | 50937 |
| 114 | Universitätsklinikum Münster (UKM) | Münster | Nordrhein-Westfalen | Germany | 48149 |
| 115 | Medizinische Fakultät der Otto-von-Guericke Universität | Magdeburg | Sachsen-Anhalt | Germany | 39120 |
| 116 | Universitätsklinikum Carl Gustav Carus Dresden | Dresden | Sachsen | Germany | 01307 |
| 117 | Vivantes Klinikum Am Urban | Berlin | Germany | 10967 | |
| 118 | Charité Campus Benjamin Franklin (CBF) | Berlin | Germany | 12203 | |
| 119 | Rambam Health Corporation | Haifa | Israel | 3109601 | |
| 120 | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem | Israel | 9112001 | |
| 121 | Shaare Zedek Medical Center | Jerusalem | Israel | 9372212 | |
| 122 | Clalit Health Services Rabin Medical Center-Beilinson Campus | Petah Tikva | Israel | 4941492 | |
| 123 | Sheba Medical Center | Tel Hashomer | Israel | 52621 | |
| 124 | Sourasky Medical Center | Tel-Aviv | Israel | 64239 | |
| 125 | Istituto Nazionale Tumori IRCCS Fondazione G.Pascale | Napoli | Campania | Italy | 80131 |
| 126 | A.O.U. di Bologna Policlinico S.Orsola Malpighi | Bologna | Emilia-Romagna | Italy | 40138 |
| 127 | AUSL di Bologna | Bologna | Emilia-Romagna | Italy | 40139 |
| 128 | A.O.U. di Modena - Policlinico | Modena | Emilia-Romagna | Italy | 41124 |
| 129 | AUSL-IRCCS di Reggio Emilia | Reggio Emilia | Emilia-Romagna | Italy | 42123 |
| 130 | IRCCS Centro di Riferimento Oncologico (CRO) | Pordenone | Friuli-Venezia Giulia | Italy | 33081 |
| 131 | IRCCS Istituti Fisioterapici Ospitalieri - IFO | Roma | Lazio | Italy | 00144 |
| 132 | Policlinico Gemelli | Rome | Lazio | Italy | 168 |
| 133 | ASST Papa Giovanni XXIII | Bergamo | Lombardia | Italy | 24127 |
| 134 | Ospedale San Raffaele s.r.l. | Milano | Lombardia | Italy | 20132 |
| 135 | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano | Lombardia | Italy | 20133 |
| 136 | Molinette Hospital University of Torino | Torino | Piemonte | Italy | 10126 |
| 137 | A.O.U. Consorziale Policlinico | Bari | Puglia | Italy | 70124 |
| 138 | A.O.U. Ospedali Riuniti Foggia | Foggia | Puglia | Italy | 71100 |
| 139 | IRCCS Ospedale Sacro Cuore Don Calabria | Verona | Veneto | Italy | 37024 |
| 140 | A.O.U.I. Verona | Verona | Veneto | Italy | 37126 |
| 141 | IOV Castelfranco Veneto | Castelfranco Veneto | Italy | 31033 | |
| 142 | IRCCS Ist Nazionale Tumori GE - Oncologia Medica | Genova | Italy | 16132 | |
| 143 | A.O. di Perugia - Ospedale Santa Maria della Misericordia - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA | Perugia | Italy | 06123 | |
| 144 | Policlinico Tor Vergata | Roma | Italy | 00133 | |
| 145 | IRCCS Ist Clinico Humanitas | Rozzano | Italy | 20089 | |
| 146 | Santa Chiara Hospital | Trento | Italy | 38122 | |
| 147 | Hokkaido University Hospital | Sapporo | Hokkaido | Japan | 060-8648 |
| 148 | Kanazawa University Hospital | Kanazawa | Ishikawa | Japan | 920-8641 |
| 149 | Yokohama City University Hospital | Yokohama | Kanagawa | Japan | 236-0004 |
| 150 | Osaka University Hospital | Suita | Osaka | Japan | 565-0871 |
| 151 | Tokyo Medical and Dental University Hospital | Bunkyo-ku | Tokyo | Japan | 113-8519 |
| 152 | Kagoshima University Hospital | Kagoshima | Japan | 890-8520 | |
| 153 | Kyoto University Hospital | Kyoto | Japan | 606-8507 | |
| 154 | Auckland City Hosptial | Auckland | New Zealand | ||
| 155 | Canterbury Urology Research Trust | Christchurch | New Zealand | 8013 | |
| 156 | Tauranga Urology Research Limited | Tauranga | New Zealand | 3112 | |
| 157 | Centro Clinico Academico - Braga | Braga | Portugal | 4710-243 | |
| 158 | IPO Lisboa | Lisboa | Portugal | 1099-023 | |
| 159 | Hospital CUF Tejo | Lisboa | Portugal | 1350-352 | |
| 160 | Fundacao Champalimaud | Lisboa | Portugal | 1400-038 | |
| 161 | Hospital da Luz - Lisboa | Lisboa | Portugal | 1500-650 | |
| 162 | Centro Hospitalar Universitário de Lisboa Norte | Heart and Vessels Department | Lisboa | Portugal | 1649-028 | |
| 163 | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | A Coruña | Spain | 15706 |
| 164 | Hospital del Mar | Barcelona | Spain | 08003 | |
| 165 | Hospital Clínic i Provincial de Barcelona | Barcelona | Spain | 08023 | |
| 166 | Hospital Fundació Puigvert | Barcelona | Spain | 08025 | |
| 167 | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona | Spain | 08035 | |
| 168 | Hospital Universitario Puerta del Mar | Cadiz | Spain | 11009 | |
| 169 | MD Anderson International Espanya, S.A. | Madrid | Spain | 28033 | |
| 170 | Hospital Ramón y Cajal | Madrid | Spain | 28034 | |
| 171 | Hospital Madrid Norte Sanchinarro | Madrid | Spain | 28050 | |
| 172 | H. General Uiversitario Morales Meseguer - Department of Urology | Murcia | Spain | 30008 | |
| 173 | Hospital Virgen de la Victoria | Málaga | Spain | 29010 | |
| 174 | Virgen del Rocio University Hospital - Oncology Department | Sevilla | Spain | 41013 | |
| 175 | Instituto Valenciano de Oncología | Valencia | Spain | 46009 | |
| 176 | Hospital Universitari i Politècnic La Fe | Valencia | Spain | 46026 | |
| 177 | Goteborgs Universitet | Gothenburg | Sweden | 413 45 | |
| 178 | Skane University Hospital - Department of Urology | Malmo | Sweden | 20502 | |
| 179 | Bedford Hospital - Bedfordshire Hospitals NHS Foundation Tru | Bedford | Bedfordshire | United Kingdom | MK42 9DJ |
| 180 | Mount Vernon Cancer Centre | Northwood | Middlesex | United Kingdom | HA6 2RN |
| 181 | Royal Surrey County Hospital NHS Foundation Trust | Guildford | Surrey | United Kingdom | GU2 7WG |
| 182 | University College London Hospitals NHS Foundation Trust | London | United Kingdom | NW1 2PQ | |
| 183 | Royal Marsden Hospital (London) | London | United Kingdom | SW3 6JJ | |
| 184 | Charing Cross Hospital | London | United Kingdom | W6 8RF |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21492
- 2022-501343-33-00