GVAX®-vaccine mod prostatacancer vs. Docetaxel & Prednison hos patienter med metastatisk hormonrefraktær prostatacancer
En fase III randomiseret, åben-label undersøgelse af CG1940 og CG8711 versus docetaxel og prednison hos patienter med metastatisk hormon-refraktær prostatacancer, som er kemoterapi-naive
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Antwerp, Belgien, B-2020
- ZNA Middelheim
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Bonheiden, Belgien, 2820
- Imelda Ziekenhuis
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Edegem, Belgien, 2650
- University Hospital Antwerp (UZA)
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Gent, Belgien, 9000
- UZ Gent
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Gent, Belgien, B-9000
- Unversity Hospial Gent
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Hasselt, Belgien, B-3500
- Virga Jesse Ziekenhuis
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Kortrijk, Belgien, B-8500
- AZ Groeninge
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Roeselare, Belgien, B-8800
- Heilig Hartziekenhuis Roeselare Men
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Sint-Truiden, Belgien, B-3800
- Regionaal Ziekenhuis Sint Trudo
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- CHUM Notre-Dam
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Montreal, Quebec, Canada, H2W1S6
- McGill University
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Pointe-Claire, Quebec, Canada, H9R 4S3
- Ultra Med Inc.
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Hopitalier Universitaire de Sherbrooke
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Cambridge, Det Forenede Kongerige, CB2 2QQ
- Addenbrooke's Hospital
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Glasgow, Det Forenede Kongerige, G11 6NT
- Beatson Oncology Centre
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Leeds, Det Forenede Kongerige, LS97TF
- St. James's University Hospital
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London, Det Forenede Kongerige, W12 0NN
- Hammersmith Hospital
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Middlesex, Det Forenede Kongerige, HA6 2RN
- Mount Vernon Hospital
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Newcastle upon Tyne, Det Forenede Kongerige, NE4 6BE
- Newcastle General Hospital
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Northampton, Det Forenede Kongerige, NN1 5BD
- Northampton General Hosptial
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Nottingham, Det Forenede Kongerige, NG5 1PB
- Nottingham City Hospital
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Oxford, Det Forenede Kongerige, OX3 7LT
- Oxford Cancer Centre, Churchill Hospital
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Scunthorpe, Det Forenede Kongerige, DN15 7BH
- Scunthorpe General Hospital
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Sheffield, Det Forenede Kongerige, S10 2JF
- Royal Hallamshire Hospital
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Wales, Det Forenede Kongerige, LL18 5UJ
- Glan Clwyd Hospital
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Alabama
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Alabaster, Alabama, Forenede Stater, 35007
- Central Alabama Oncology, LLC
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Alaska Clinical Research Center
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Arizona
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Glendale, Arizona, Forenede Stater, 85304
- Palo Verde Hematology/Oncology
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Scottsdale, Arizona, Forenede Stater, 85259
- Mayo Clinic Scottsdale
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Tuscon, Arizona, Forenede Stater, 85715
- ACRC/Arizona Clinical Res. Ctr. Inc.
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cancer Research Center
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California
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Corona, California, Forenede Stater, 92882
- Compassionate Cancer Care Medical Group, Inc.
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Fountain Valley, California, Forenede Stater, 92708
- Pacific Coast Hem Onc. Medical Group
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Greenbrae, California, Forenede Stater, 94904
- California Cancer Care
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La Mesa, California, Forenede Stater, 91942
- Center for Urological Research
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Montebello, California, Forenede Stater, 90640
- Oncology Care Medical Associates
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Orange, California, Forenede Stater, 92868
- UC Irvine Medical Center
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San Bernardino, California, Forenede Stater, 92404
- San Bernardino Urological Associates
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San Diego, California, Forenede Stater, 92123
- Sharp Healthcare
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San Francisco, California, Forenede Stater, 94115
- California Pacific Medical Center
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Soquel, California, Forenede Stater, 95073
- Cancer Research & Prevention Center
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Vista, California, Forenede Stater, 92081
- San Diego Cancer Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Univ. of Colorado Health Science Center
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Colorado Springs, Colorado, Forenede Stater, 80907
- Cancer Center of Colorado Springs
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Connecticut
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Bristol, Connecticut, Forenede Stater, 06010
- The Hope Clinic
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New Britain, Connecticut, Forenede Stater, 06052-1395
- Urology Center of Grove Hill
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Stamford, Connecticut, Forenede Stater, 06902
- Carl & Dorothy Bennett Cancer Center
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Florida
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Boca Raton, Florida, Forenede Stater, 33486
- Boca Raton Community Hospital, Inc.
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Fort Lauderdale, Florida, Forenede Stater, 33308
- Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
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Jacksonville, Florida, Forenede Stater, 32256
- Integrated Community Oncology Network
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Miami, Florida, Forenede Stater, 33176
- Oncology-Hematology Group of South Florida/Advanced Medical Specialists
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Ocoee, Florida, Forenede Stater, 34761
- Cancer Centers of Florida
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Port St. Lucie, Florida, Forenede Stater, 34952
- Hematology Oncology Associates of the Treasure Coast
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Safety Harbor, Florida, Forenede Stater, 34695
- Urology Consultants
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Winship Cancer Institute, Emory University
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Atlanta, Georgia, Forenede Stater, 30033
- Atlanta VAMC
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Atlanta, Georgia, Forenede Stater, 30084
- Georgia Cancer Specialists
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Atlanta, Georgia, Forenede Stater, 30309
- Peachtree Hematology Oncology Consultants, PC
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Macon, Georgia, Forenede Stater, 31201
- Central Georgia Cancer Care, P.C.
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Straub Clinic & Hospital
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois at Chicago
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Indiana
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Evansville, Indiana, Forenede Stater, 47713
- Welborn Clinic Research Center
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Fort Wayne, Indiana, Forenede Stater, 46815
- Fort Wayne Medical Oncology/Hematology Inc.
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Louisiana
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Lafayette, Louisiana, Forenede Stater, 70506
- Louisiana Oncology Associates
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Maryland
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Baltimore, Maryland, Forenede Stater, 21231
- Johns Hopkins University
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Frederick, Maryland, Forenede Stater, 21701
- Frederick Memorial Hospital Regional Cancer Therapy Center
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Michigan
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Free Soil, Michigan, Forenede Stater, 49411
- West Michigan Regional Cancer and Blood Center
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Royal Oak, Michigan, Forenede Stater, 48073-6706
- William Beaumont Hospital, Cancer Clinical Trials Office
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Southfield, Michigan, Forenede Stater, 48075
- Newland Medical Associates, P.C.
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Missouri
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St. Louis, Missouri, Forenede Stater, 63136
- Hematology Oncology Consultants, Inc.
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Montana
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Billings, Montana, Forenede Stater, 59101
- Deaconess Billings Clinic
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Billings, Montana, Forenede Stater, 59101
- Hematology/Oncology Centers of the Northern Rockies, P.C.
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68105
- Omaha VA Medical Center
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Omaha, Nebraska, Forenede Stater, 68198-7680
- Omaha VA Medical Center
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Cherry Hill, New Jersey, Forenede Stater, 08003
- The Center for Cancer & Hematologic Disease
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Morristown, New Jersey, Forenede Stater, 07962
- Hematology-Oncology Associates of Northern New Jersey
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Summit, New Jersey, Forenede Stater, 07901
- Summit Medical Group/Overlook Oncology Center
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New York
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Bronx, New York, Forenede Stater, 10461
- Jacobi Medical Center
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New York, New York, Forenede Stater, 10032
- Columbia University Medical Center
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Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Presbyterian Hospital/ Center for Cancer Research
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Hickory, North Carolina, Forenede Stater, 28602
- Northwestern Carolina Hematology Oncology, PA
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North Dakota
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Bismarck, North Dakota, Forenede Stater, 58501
- Medcenter One Cancer Care / Odyssey Research
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Fargo, North Dakota, Forenede Stater, 58103
- Dakota Cancer Institute
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Ohio
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Canton, Ohio, Forenede Stater, 44718
- Gabrail Cancer Center
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation, Taussig Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- Providence Portland Medical Center
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Pennsylvania
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Bala Cynwyd, Pennsylvania, Forenede Stater, 19004
- Urologic Surgery PC
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Kingston, Pennsylvania, Forenede Stater, 18704
- Medical Oncology Associates
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Lancaster, Pennsylvania, Forenede Stater, 17604
- Urological Associates of Lancaster
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Lancaster, Pennsylvania, Forenede Stater, 17601
- Lancaster Cancer Center, Ltd
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- University of Pittsburgh Cancer Center
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29403
- Charleston Hematology Oncology
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- Memorial Health Care System
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Memphis, Tennessee, Forenede Stater, 38120
- The West Clinic
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Texas
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Amarillo, Texas, Forenede Stater, 79106
- The Don and Sybil Harrington Cancer Center
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Dallas, Texas, Forenede Stater, 75201
- Mary Crowley Medical Research Center
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Dallas, Texas, Forenede Stater, 75230
- Center for Oncology Research and Treatment PA
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Dallas, Texas, Forenede Stater, 75231
- Urology Specialists and Associates, P.A.
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Houston, Texas, Forenede Stater, 77024
- Mobley Research Center
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San Antonio, Texas, Forenede Stater, 78229
- Urology San Antonio
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Tyler, Texas, Forenede Stater, 75702
- Tyler Cancer Center
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Vermont
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Bennington, Vermont, Forenede Stater, 05201
- Southwestern Oncology Research Department
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Virginia
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Norfolk, Virginia, Forenede Stater, 23502
- Virginia Oncology Associates
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Washington
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Seattle, Washington, Forenede Stater, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, Forenede Stater, 98101
- Virginia Mason Medical Center Urology
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Angers Cedex, Frankrig, 49033
- Centre Paul Papin
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Caen Cedex 5, Frankrig, 14076
- Centre François Baclesse
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Dijon Cedex, Frankrig, 77980
- Centre Georges François Leclerc
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Lyon Cedex, Frankrig, 08
- Centre Leon Berard Service de Cancerologie Medicale
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Marseille, Frankrig, 13009
- Institut Paoli-Calmettes
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Nantes-Saint Herblain, Frankrig, 44805
- Centre Rene Gauducheau
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Reims Cedex, Frankrig, 51056
- Institut Jean Godinot
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Vandoeuvre les Nancy Cedex, Frankrig, 54511
- Centre Alexis Vautrin
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Amsterdam, Holland, 1081 HV
- VU Medisch Centrum
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Groningen, Holland
- University Medical Centre Groningen
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Linkoping, Sverige
- University Hospital, Linköping
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Lund, Sverige
- University Hospital Lund
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Uppsala, Sverige, 85
- Akademiska University hospital
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Aachen, Tyskland, 52074
- Universitatsklinikum Aachen Urologie
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Dresden, Tyskland, 1307
- der Technischen Universitat Dresden
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Essen, Tyskland, 45122
- Universitatsklinik um Essen
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Homburg/Saar, Tyskland, 66421
- Universitatsklinik um des Saarlande
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- Bekræftet diagnose eller klinisk historie i overensstemmelse med adenocarcinom i prostata
- Metastaserende prostatacancer anses for at være uresponsiv eller refraktær over for hormonbehandling
- Påviselige metastaser
- Enhver Gleason-score
- ECOG ydeevne status 0-2
Ekskluderingskriterier:
- Forudgående behandling med kemoterapi
- Tidligere immunterapi
- Forudgående behandling med genterapi
- Betydelige kræftrelaterede smerter
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: BEHANDLING
- Tildeling: TILFÆLDIGT
- Interventionel model: PARALLEL
- Maskning: INGEN
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
ANDET: 2
Standard for pleje - kemoterapi
|
Kemoterapi (Taxotere og prednison)
|
|
EKSPERIMENTEL: 1
Immunterapi
|
Immunterapi med allogen prostatavaccine
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
|---|
|
Overlevelse
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
|---|
|
Knoglesmerter og knoglerelaterede hændelser
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (FAKTISKE)
Primær færdiggørelse
Studieafslutning (FAKTISKE)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (SKØN)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (SKØN)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Genitale neoplasmer, mandlige
- Prostatasygdomme
- Prostatiske neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Docetaxel
- Prednison
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- G-0029
- (VITAL-1)
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