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Trial record 1 of 1 for:    NCT01322490
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A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer (Prospect)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bavarian Nordic, Inc.
Information provided by (Responsible Party):
Bavarian Nordic, Inc. Identifier:
First received: March 23, 2011
Last updated: October 21, 2014
Last verified: October 2014

The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.

Condition Intervention Phase
Prostate Cancer Metastatic
Biological: PROSTVAC-V
Biological: PROSTVAC-F
Drug: GM-CSF
Other: GM-CSF Placebo
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Bavarian Nordic, Inc.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Survival will be assessed over the life of the study ] [ Designated as safety issue: No ]
    Overall survival will be measured for all patients until the required number of events per comparison arm is reached.

Secondary Outcome Measures:
  • Proportion of event-free patients compared with placebo [ Time Frame: Events will be measured at baseline and 6 months ] [ Designated as safety issue: No ]
    This endpoint will measure the proportion of patients receiving PROSTVAC with or without GM-CSF who remain event-free (radiological progression, pain progression, initiation of chemotherapy, or death) at 6 months compared to placebo.

Estimated Enrollment: 1200
Study Start Date: November 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
  • GM-CSF
Biological: PROSTVAC-V Biological: PROSTVAC-F Drug: GM-CSF
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF placebo
  • GM-CSF placebo
Biological: PROSTVAC-V Biological: PROSTVAC-F Other: GM-CSF Placebo
Placebo Comparator: Placebo Control
PROSTVAC V/F Placebo + GM-CSF Placebo
Other: GM-CSF Placebo Biological: Placebo

Detailed Description:

BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and PROSTVAC without GM-CSF versus controls.

Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are:

  1. (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF
  2. (Arm V) PROSTVAC-V/F plus GM-CSF placebo
  3. (Arm P) Double placebo

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.

Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).

  1. Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer.


  2. PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).

Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated).

Exclusion Criteria:

Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed).

Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo.

Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F.

History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin.

Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.

History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01322490

Contact: Call Center 1-855-319-4021
Contact: Jeannie Giacchino

  Hide Study Locations
United States, Alaska
Alaska Clinical Research Center, Llc Recruiting
Anchorage, Alaska, United States, 99508
Contact    907-276-1455      
United States, Arizona
Scottsdale Healthcare Recruiting
Scottsdale, Arizona, United States, 85258
Contact    480-323-1073      
United States, California
Alta Bates Summit Medical Center Active, not recruiting
Berkeley, California, United States, 94704
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact    310-423-3713      
Prostate Oncology Specialists, Inc. Recruiting
Marina del Rey, California, United States, 90292
Contact    310-827-7707 ext 13      
Desert Hematology-Oncology Recruiting
Rancho Mirage, California, United States, 92270
Contact    760-568-3613 ext 111      
San Bernardino Urological Associates Recruiting
San Bernardino, California, United States, 92404
Contact    909-881-0555      
San Diego Clinical Trials Recruiting
San Diego, California, United States, 92120
Contact    619-287-6000      
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact    858-939-5062      
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Contact    858-552-8585 ext 7521      
Stanford Advanced Medical Center Recruiting
Stanford, California, United States, 94305
Contact    650-736-1252      
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact    720-848-0632      
The Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
Contact    303-421-5783      
United States, District of Columbia
Washington Cancer Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact    202-877-6998      
United States, Florida
South Florida Medical Research Recruiting
Aventura, Florida, United States, 33180
Contact    305-931-8080      
Manatee Medical Research Institute, LLC Recruiting
Bradenton, Florida, United States, 34205
Contact    941-792-0340 ext 1328      
Florida Urology Physicians Active, not recruiting
Fort Myers, Florida, United States, 33908
Lakeland Regional Cancer Center Recruiting
Lakeland, Florida, United States, 33805
Contact    863-904-1900      
Pinellas Urology, Inc. Recruiting
St. Petersberg, Florida, United States, 33710
Contact    727-341-1583      
James A Haley Veteran Affairs Medical Center Recruiting
Tampa, Florida, United States, 33612
Contact    813-972-2000 ext 7579      
Palm Beach Cancer Institute Recruiting
West Palm Beach, Florida, United States, 33401
Contact    561-366-4128      
United States, Idaho
North Idaho Urology Recruiting
Coeur d'Alene, Idaho, United States, 83814
Contact    208-667-0621      
United States, Illinois
Jesse Brown VA Recruiting
Chicago, Illinois, United States, 60612
Contact    847-363-8914      
United States, Indiana
First Urology PSC Recruiting
Jeffersonville, Indiana, United States, 47130
Contact    812-206-8128      
Northern Indiana Cancer Research Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact    937-395-8020      
United States, Iowa
The Iowa Clinic, PC Iowa Urology Recruiting
West Des Moines, Iowa, United States, 50266
Contact    515-875-9815      
United States, Louisiana
Ochsner Cancer Institute Recruiting
New Orleans, Louisiana, United States, 70121
Contact    504-842-3115      
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact    504-988-2735      
United States, Maryland
Union Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21218
Contact    410-261-8151      
Maryland Prostate Center Recruiting
Baltimore, Maryland, United States, 21201
Contact    410-328-7742      
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact    443-849-3592      
National Cancer Institute - Center for Cancer Research Recruiting
Bethesda, Maryland, United States, 20892
Contact    301-496-7224      
Walter Reed Army Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact    301-319-2923      
Myron Murdock M.D. LLC Recruiting
Greenbelt, Maryland, United States, 20770
Contact    301-477-2969      
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact    617-632-4126      
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact    617-632-9287      
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact    507-284-3369      
United States, Missouri
Kansas City VA Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Contact    816-861-4700 ext x57665      
United States, Nebraska
GU Research Network, LLC Recruiting
Omaha, Nebraska, United States, 68130
Contact    402-991-8468      
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
Contact    402-691-6971      
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact    702-952-3400      
VA Sierra Nevada HealthCare System Recruiting
Reno, Nevada, United States, 89502
Contact    775-328-1828      
United States, New Jersey
Delaware Valley Urology LLC - Westhampton Recruiting
Mt Laurel, New Jersey, United States, 08054
Contact    856-252-1000 ext 1031      
The Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact    732-235-4926      
United States, New York
Brooklyn Urology Research Group Recruiting
Brooklyn, New York, United States, 11215
Contact    718-230-1202      
University Urology Associates Recruiting
New York, New York, United States, 10016
Contact    212-686-9015      
Hudson Valley Urology, P.C. Recruiting
Poughkeepsie, New York, United States, 12601
Contact    845-437-5010      
United States, North Carolina
Presbyterian Hospital Center for Cancer Research Recruiting
Charlotte, North Carolina, United States, 28204
Contact    704-316-4185      
Northeast Urology Research Recruiting
Concord, North Carolina, United States, 28025
Contact    704-786-2931      
Durham VA Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact    919-286-0411 ext 7563      
Regional Cancer Care PA Recruiting
Durham, North Carolina, United States, 27704
Contact    919-477-0047      
W.G. (Bill) Hefner VA Medical Center Recruiting
Salisbury, North Carolina, United States, 28144
Contact    704-638-9000 ext x3273      
United States, North Dakota
St. Alexius Medical Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact    701-530-6955      
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Contact    330-492-3345 ext 213      
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact    513-558-4060      
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact    216-445-8492      
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact    216-844-5546      
Columbus Urology Research Recruiting
Columbus, Ohio, United States, 43221
Contact    614-457-6028      
United States, Oregon
Willamette Valley Cancer Center Recruiting
Springfield, Oregon, United States, 97477
Contact    541-681-4930      
United States, Pennsylvania
Urologic Consultants of Southeaster PA LLP Recruiting
Bala Cynwyd, Pennsylvania, United States, 19004
Contact    610-667-3020      
Urological Associates Of Lancaster Recruiting
Lancaster, Pennsylvania, United States, 17604
Contact    717-431-2285      
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact    215-728-3614      
UPMC Cancer Pavillion Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact    412-623-8962      
Mount Nittany Medical Center Recruiting
State College, Pennsylvania, United States, 16801
Contact    814-238-8418 ext 206      
United States, South Carolina
Ralph H Johnson VAMC Recruiting
Charleston, South Carolina, United States, 29401
Contact    843-789-7816      
WJB Dorn VA Medical Center Recruiting
Columbia, South Carolina, United States, 29209
Contact    803-776-4000 ext x4728      
Greenville Hospital System Recruiting
Greenville, South Carolina, United States, 29605
Contact    864-968-9060      
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact    843-449-1010 ext 241      
United States, Tennessee
University of TN Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact    865-305-9773      
The West Clinic, P.C. Recruiting
Memphis, Tennessee, United States, 38120
Contact    901-683-0055 ext 1236      
James H. Quillen Veterans Affairs Medical Center Recruiting
Mountain Home, Tennessee, United States, 37684
Contact    423-926-1171 ext x4412      
Urology Associates, PC Recruiting
Nashville, Tennessee, United States, 37209
Contact    615-250-9268      
United States, Texas
Mary Crowley Cancer Research Center Recruiting
Dallas, Texas, United States, 75230
Contact    214-658-1945      
Urology Clinics of North Texas Recruiting
Dallas, Texas, United States, 75225
Contact    214-580-1482      
Scott and White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact    254-724-0294      
Central Texas Veterans Health Care System Recruiting
Temple, Texas, United States, 76504
Contact    254-742-4984      
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact    801-585-0255      
United States, Vermont
White River Junction Veterans Affairs Medical Center Recruiting
White River Junction, Vermont, United States, 05009
Contact    802-295-9363 ext x5619      
United States, Virginia
Virginia Oncology Associates PC Recruiting
Norfolk, Virginia, United States, 23502
Contact    757-213-5813      
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact    206-341-0578      
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact    253-968-3891      
United States, West Virginia
The Schiffler Cancer Center Recruiting
Wheeling, West Virginia, United States, 26003
Contact    304-243-3490      
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact    414-805-0789      
Australia, New South Wales
Sydney Haematology and Oncology Clinic Recruiting
St Leonards, New South Wales, Australia, 2065
Contact    +612 94804353      
Calvary Mater Newcastle Recruiting
Waratah, New South Wales, Australia, 2298
Contact    +61 2 4014 3947      
Australia, Queensland
Redcliffe Hospital Recruiting
Redcliffe, Queensland, Australia, 4020
Contact    +61 7 3883 7851      
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact    +61882222689      
Australia, Victoria
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Contact    +61394963038      
Monash Medical Centre - Moorabbin Campus Recruiting
Bentleigh East, Australia, 3165
Contact    +61 3 9928 8253      
Barwon Health Recruiting
Geelong, Australia, 3220
Contact    +61 3 4215 2758      
St John of God Hospital Recruiting
Subiaco, Australia, 6008
Contact    +61 8 6465 9204      
Border Medical Oncology Recruiting
Wodonga, Australia, 3690
Contact    +61 2 6051 5317      
Princess Alexandra Hospital Recruiting
Woolloongabba, Australia, 4102
Contact    +61 7 3176 2217      
Ziekenhuisnetwerk Antwerpen - AZ Middelheim Recruiting
Antwerp, Belgium, 2020
Contact    +32 3 280 34 00      
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact    +322 764 35 46      
Institut Jules Bordet Recruiting
Bruxelles, Belgium, 1000
Contact    +32 2 541 32 28      
AZ Maria Middelares Recruiting
Gent, Belgium, 9000
Contact    +32 9 260 55 41      
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact    +32 16 34 83 45      
H.-Hartziekenhuis Roeselare-Menen vzw Recruiting
Roeselare, Belgium, 8800
Contact    +32 (0) 51 237511      
Canada, British Columbia
Southern Interior Medical Research Inc. Recruiting
Kelowna, British Columbia, Canada, V1Y 2H4
Contact    (250) 801-0681      
Canada, Nova Scotia
Capital District Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact    (902) 425-3940      
Canada, Ontario
Brantford Urology Research Recruiting
Brantford, Ontario, Canada, N3S 6T6
Contact    (519) 753-9221      
Cambridge Memorial Hospital Recruiting
Cambridge, Ontario, Canada, N1R3G2
Contact    (519) 621-2333 ext 2363      
St. Josephs Healthcare Hamilton Research Ethics Board Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact    905 522-4528      
Queen's University at Kingston Recruiting
Kingston, Ontario, Canada, K7L3J7
Contact    (613) 549-6666 ext X3848      
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact    (519) 685-8500 ext 57350      
The Female/Male Health Centres Recruiting
Oakville, Ontario, Canada, L6H 3P1
Contact    (905) 338-3130      
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact    (416) 946-4501      
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact    (514) 890-8000 ext 27466      
Centre Hospitalier Universitaire de Quebec Hotel Dieu Recruiting
Quebec, Canada, G1R 2J6
Contact    (418) 525-4444 ext 16730      
Aalborg Sygehus Recruiting
Aalborg, Denmark, 9100
Contact    +45 99321492      
Rigshospitalet Recruiting
Copenhagen, Denmark, 2200
Contact    +45 35 45 74 15      
Frederiksberg Hospital Recruiting
Frederiksberg, Denmark, DK-2000
Contact    +45 3816 3610      
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact    +45 3868 1507      
Holstebro Sygehus Recruiting
Holstebro, Denmark, 7500
Contact    +45 78439425      
Storstrømmens Sygehus Næstved Recruiting
Næstved, Denmark, DK-4700
Contact    +45 21 68 79 53      
Skejby Sygehus Recruiting
Århus N, Denmark, DK-8200
Contact    +45 7845 2636      
East Tallinn Central Hospital Recruiting
Tallinn, Estonia, EE-10138
Contact    +372 56 353 415      
North Estonia Medical Centre Foundation Recruiting
Tallinn, Estonia, EE-13419
Contact    +372 617 1621      
Tartu University Hospital Recruiting
Tartu, Estonia, EE-51014
Contact    +372 731 8251      
Centre Paul Papin Recruiting
Angers, France, 49933
Contact    +33 2 41 35 27 34      
Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries Recruiting
La Roche Sur Yon, France, 85925
Contact    +33 2 51 44 61 61      
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes Recruiting
Lyon, France, 69373
Contact    +33 469856034      
Centre d'Oncologie de Gentilly Recruiting
Nancy, France, 54000
Contact    +33383935005      
Fondation Hôpital Saint-Joseph Active, not recruiting
Paris, France, 75014
HIA du Val de Grâce Recruiting
Paris, France, 75005
Contact    +33140514584      
Institut Curie Recruiting
Paris, France, 75005
Contact    +33156245648      
Institut Mutualiste Montsouris Recruiting
Paris, France, 75014
Contact    +331 56 61 63 71      
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69495
Contact    +33 4 78 86 43 24      
Institut Jean Godinot - Centre de lutte contre le cancer Recruiting
Reims, France, 51056
Contact    +33 3 26 50 41 84      
Clinique Armoricaine de Radiologie Recruiting
Saint Brieuc, France, 22000
Contact    +33 2 96 75 22 16      
Hôpital Bretonneau Recruiting
Tours, France, 37044
Contact    +33247478625      
Centre Alexis Vautrin - Centre Régional de lutte contre le cancer de Lorraine Recruiting
Vandoeuvre les Nancy, France, 54511
Contact    +33 383598604      
Stadtisches Klinikum Muchen GmbH Recruiting
Munich, Bavaria, Germany, 81737
Contact    0049 89 6794 2747      
Universitätsklinikum Essen Recruiting
Essen, Germany, 45147
Contact    +49 201 7233213      
Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt am Main Recruiting
Frankfurt, Germany, 60590
Contact    +0049 69 6301 84778      
Chirurgische Universitätsklinik Freiburg Recruiting
Freiburg, Germany, 79106
Contact    0049 761 27028920      
Martini-Klinik am UKE GmbH Recruiting
Hamburg, Germany, 20246
Contact    +4940741051311      
Klinikum der Friedrich-Schiller-Universität Jena Recruiting
Jena, Germany, 07743
Contact    +0049 3641 935 206      
Klinikum der Philipps-Universität Marburg Recruiting
Marburg, Germany, 35043
Contact    0049 6421 5863695      
Studienpraxis Urologie Recruiting
Reutlingen, Germany, 72766
Contact    +49 170 3809223      
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Contact    0049 7071 2987235      
Universitatsklinikum Ulm Recruiting
Ulm, Germany, 89075
Contact    + 0049 731 50058000      
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89075
Contact    +4973150058000      
Universitätsklinikum Würzburg Recruiting
Würzburg, Germany, 97080
Contact    0049 931 20140414      
Landspitali University Hospital Recruiting
Reykjavik, Iceland, IS-101
Contact    +3545436130      
Soroka University Medical Center Recruiting
Beer Sheva, Israel, 84101
Contact    +972-8-6244127      
Bnei Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact    +972-4-8359700      
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact    +972-04-8543811      
Edith Wolfson Medical Center Recruiting
Holon, Israel, 58100
Contact    +972- 3-5028408      
Hadassah University Hospital Ein Kerem Recruiting
Jerusalem, Israel, 91120
Contact    +972-2-6776760      
The Chaim Sheba Medical Center Recruiting
Ramat-Gan, Israel, 52621
Contact    +972-3-5302413      
The Chaim Sheba Medical Center Recruiting
Ramat-Gan, Israel, 52621
Contact    +972-3-5302191      
Assaf Harofe Medical Center Recruiting
Tzrifin, Israel, 70300
Contact    +972 8 9778003      
Radboudumc Recruiting
Nijmegen, Netherlands, 6525 GA
Contact    +243540788      
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015CE
Contact    +31107035527      
AMEDS CENTRUM Sp. z o.o. Recruiting
Grodzisk Mazowiecki, Poland, 05-827
Contact    +48 608 260 405      
Urologica Praktyka Lekarska Adam Marcheluk Recruiting
Siedlce, Poland, 08-110
Contact    +48(60) 648 53 50      
Szpital sw Elzbiety - Mokotowskie Centrum Medyczne Sp. z o. o. Recruiting
Warsaw, Poland, 02-616
Contact    +48 605 254 245      
Miedzyleski Szpital Specjalistyczny w Warszawie Recruiting
Warsaw, Poland, 04-749
Contact    +48 602 499 225      
Klinika Urologii i Onkologii Urologicznej, Uniwersytecki Szpital Kliniczny we Wrocławiu Recruiting
Wroclaw, Poland, 50-556
Contact    +48660442252      
Puerto Rico
Ponce School of Medicine Recruiting
Ponce, Puerto Rico, 00716
Contact    (787) 840-2575 ext 2292      
Alliance for Research and Knowledge Active, not recruiting
San Juan, Puerto Rico, 00910
Russian Federation
Arkhangelsk Regional Clinical Oncology Dispensary Recruiting
Arkhangelsk, Russian Federation, 163045
Contact    (909) 556-5735      
Chelyabinsk Regional Clinical Oncology Dispensary Recruiting
Chelyabinsk, Russian Federation, 454087
Contact    +7-351-232-93-76      
Kazan State Medical University Recruiting
Kazan, Russian Federation, 420111
Contact    (917) 260-4011      
Moscow Research Oncology Institute n.a. P.A.Gertsen Recruiting
Moscow, Russian Federation, 125248
Contact    (905) 786-4103      
Clinical Oncology Dispensary Recruiting
Omsk, Russian Federation, 644013
Contact    (913) 604-3222      
Orel Oncology Center Recruiting
Orel, Russian Federation, 302020
Contact    +7-906-570-55-53      
Orenburg Regional Clinical Oncology Center Recruiting
Orenburg, Russian Federation, 460021
Contact    (908) 322-2291      
City Hospital #15 Recruiting
St. Petersburg, Russian Federation, 198205
Contact    +7 921 992 45 06      
"Orkli" LLC Recruiting
St. Petersburg, Russian Federation, 199178
Contact    (921) 962-2189      
St. Petersburg Medical Academy of Postgraduate Education Recruiting
St. Petersburg, Russian Federation, 191015
Contact    (921) 420-9097      
St. Petersburg State Medical University n.a. I.P. Pavlov Recruiting
St. Petersburg, Russian Federation, 197022
Contact    +7 921 958 4 958      
"Clinic Andros" LLC Recruiting
St.Petersburg, Russian Federation, 197136
Contact    +7 812 235 69 88      
Stavropol Regional Clinical Oncology Dispensary Recruiting
Stavropol, Russian Federation, 355047
Contact    +7 865 238 49 83      
Regional Clinical Oncology Center Recruiting
Vladimir, Russian Federation, 600020
Contact    +7 (4) 922 53 50 49      
Regional Clinical Oncology Hospital Recruiting
Yaroslavl, Russian Federation, 150040
Contact    +7 903 824 31 11      
Complejo Hospitalario de Santiago de Compostela Recruiting
Santiago de Compostela (A Coruña), Galicia, Spain, 15706
Contact    +34 981 950 511      
Hospital 12 de Octubre Recruiting
Madrid, Madrid, Communidad de, Spain, 28041
Contact    +34 65 912 95 81      
Hospital Nuestra Señora de Sonsoles Recruiting
Avila, Spain, 05004
Contact    +34920358519      
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08041
Contact    + 34 93 553 71 34      
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact    +34932483609      
Hospital Vall D´Hebron Recruiting
Barcelona, Spain, 08035
Contact    +34934894375      
Hospital Universitario Reina Sofia Recruiting
Córdoba, Spain, 14004
Contact    +34957012408      
Hospital General Universitario de Elche Recruiting
Elche, Spain, 03203
Contact    +34966679250      
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact    +34914269392      
MD Anderson International Espana Recruiting
Madrid, Spain, 28033
Contact    +3491078708600 ext 2882      
Centro Integral Oncológico Clara Campal Recruiting
Madrid, Spain, 28050
Contact    +34917567984      
Hospital Universitario Puerta de Hierro Recruiting
Majadahonda, Spain, 28222
Contact    +34911917913      
Althaia: Xarxa Assistencial de Manresa Recruiting
Manresa, Spain, 08243
Contact    +34938742112      
Hospital General Carlos Haya Recruiting
Málaga, Spain, 29010
Contact    +34951291425      
Hospital Son Espases Recruiting
Palma de Mallorca, Spain, 07010
Contact    +34 871206130      
Fundación Hospital Manacor Recruiting
Palma de Mallorca, Spain, 07198
Contact    +3497 847142      
Clinica Universitaria de Navarra Recruiting
Pamplona, Spain, 31008
Contact    +34948255400 ext 5866      
Corporació Sanitaria Parc Taulí Recruiting
Sabadell, Spain, 08208
Contact    +34937242759      
Hospital Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Contact    +34955013068      
Hospital Mutua de Terrassa Recruiting
Terrassa, Spain, 08221
Contact    +34937365050 ext 2300      
Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain, 50009
Contact    +34976765500 ext 3825      
United Kingdom
Bristol Haematology & Oncology Centre Recruiting
Bristol, UK, United Kingdom, BS2 8ED
Contact    +44 0117 342 4263      
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B15 2TH
Contact    +44 0121 204 1602      
Velindre Hospital Recruiting
Cardiff, United Kingdom, CF14 2TL
Contact    +44(0) 2920 316986      
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom, G12 0YN
Contact    +44 (0) 141 301 7221      
University of Surrey Recruiting
Guildford, United Kingdom, GU2 7XP
Contact    +44 1483 686074      
St James's Institute of Clinical Oncology Recruiting
Leeds, United Kingdom, LS9 7TF
Contact    +44 (0)1132068360      
St Bartholomews Hospital Recruiting
London, United Kingdom, EC1M 6BQ
Contact    +44 (0)20 7882 5958      
St Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
Contact    +44 203 31 22493      
The Royal Marsden Recruiting
London, United Kingdom, SW3 6JJ
Contact    +44 20 7811 8116      
Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Contact    +44 0161 918 7345      
Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact    +441752431960      
University of Southampton Recruiting
Southampton, United Kingdom, SO16 6YD
Contact    +44 2380 798785      
Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM2 5PT
Contact    +44(0) 208 661 3434      
The Clatterbridge Cancer Centre NHS Foundation Trust Recruiting
Wirral, United Kingdom, CH63 4JY
Contact    +441513341155 ext 5731      
Sponsors and Collaborators
Bavarian Nordic, Inc.
Principal Investigator: James L. Gulley, MD National Cancer Institute (NCI)
Principal Investigator: Philip Kantoff, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Bavarian Nordic, Inc. Identifier: NCT01322490     History of Changes
Other Study ID Numbers: BNIT-PRV-301
Study First Received: March 23, 2011
Last Updated: October 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bavarian Nordic, Inc.:
prostate cancer
Phase 3

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on November 27, 2014