Working… Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01322490
Recruitment Status : Completed
First Posted : March 24, 2011
Results First Posted : August 8, 2019
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
Bavarian Nordic

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Metastatic Biological: PROSTVAC-V Biological: PROSTVAC-F Drug: GM-CSF Other: GM-CSF Placebo Biological: Placebo Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : November 28, 2011
Actual Primary Completion Date : September 25, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
  • 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

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study. ]
    The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.

Secondary Outcome Measures :
  1. Number of Subjects Alive Without Event at 6 Months [ Time Frame: Randomization through Week 25/End of Treatment visit. ]

    A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such.

    Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01322490

  Hide Study Locations
Layout table for location information
United States, Alaska
Alaska Clinical Research Center, Llc
Anchorage, Alaska, United States, 99508
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, California
Alta Bates Summit Medical Center
Berkeley, California, United States, 94704
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Prostate Oncology Specialists, Inc.
Marina Del Rey, California, United States, 90292
Desert Hematology-Oncology
Rancho Mirage, California, United States, 92270
San Bernardino Urological Associates
San Bernardino, California, United States, 92404
San Diego Clinical Trials
San Diego, California, United States, 92120
Sharp Memorial Hospital
San Diego, California, United States, 92123
VA San Diego Healthcare System
San Diego, California, United States, 92161
Stanford Advanced Medical Center
Stanford, California, United States, 94305
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Manatee Medical Research Institute, LLC
Bradenton, Florida, United States, 34205
Florida Urology Physicians
Fort Myers, Florida, United States, 33908
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
Pinellas Urology, Inc.
Saint Petersburg, Florida, United States, 33710
James A Haley Veteran Affairs Medical Center
Tampa, Florida, United States, 33612
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Idaho
North Idaho Urology
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Jesse Brown VA
Chicago, Illinois, United States, 60612
United States, Indiana
First Urology PSC
Jeffersonville, Indiana, United States, 47130
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
The Iowa Clinic, PC Iowa Urology
West Des Moines, Iowa, United States, 50266
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
Ochsner Cancer Institute
New Orleans, Louisiana, United States, 70121
United States, Maryland
Maryland Prostate Center
Baltimore, Maryland, United States, 21201
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Walter Reed Army Medical Center
Bethesda, Maryland, United States, 20889
National Cancer Institute - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Myron Murdock M.D. LLC
Greenbelt, Maryland, United States, 20770
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
United States, Nebraska
GU Research Network, LLC
Omaha, Nebraska, United States, 68130
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
VA Sierra Nevada HealthCare System
Reno, Nevada, United States, 89502
United States, New Jersey
Delaware Valley Urology LLC - Westhampton
Mount Laurel, New Jersey, United States, 08054
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Brooklyn Urology Research Group
Brooklyn, New York, United States, 11215
University Urology Associates
New York, New York, United States, 10016
Hudson Valley Urology, P.C.
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Presbyterian Hospital Center for Cancer Research
Charlotte, North Carolina, United States, 28204
Northeast Urology Research
Concord, North Carolina, United States, 28025
Regional Cancer Care PA
Durham, North Carolina, United States, 27704
Durham VA Medical Center
Durham, North Carolina, United States, 27705
W.G. (Bill) Hefner VA Medical Center
Salisbury, North Carolina, United States, 28144
United States, North Dakota
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Columbus Urology Research
Columbus, Ohio, United States, 43221
United States, Oregon
Willamette Valley Cancer Center
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Urologic Consultants of Southeaster PA LLP
Bala-Cynwyd, Pennsylvania, United States, 19004
Urological Associates Of Lancaster
Lancaster, Pennsylvania, United States, 17604
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, United States, 15232
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16801
United States, South Carolina
Ralph H Johnson VAMC
Charleston, South Carolina, United States, 29401
WJB Dorn VA Medical Center
Columbia, South Carolina, United States, 29209
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
University of TN Medical Center
Knoxville, Tennessee, United States, 37920
The West Clinic, P.C.
Memphis, Tennessee, United States, 38120
James H. Quillen Veterans Affairs Medical Center
Mountain Home, Tennessee, United States, 37684
Urology Associates, PC
Nashville, Tennessee, United States, 37209
United States, Texas
Urology Clinics of North Texas
Dallas, Texas, United States, 75225
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 75230
Central Texas Veterans Health Care System
Temple, Texas, United States, 76504
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84107
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Vermont
White River Junction Veterans Affairs Medical Center
White River Junction, Vermont, United States, 05009
United States, Virginia
Virginia Oncology Associates PC
Norfolk, Virginia, United States, 23502
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
United States, West Virginia
The Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Sydney Haematology and Oncology Clinic
St Leonards, New South Wales, Australia, 2065
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Redcliffe Hospital
Redcliffe, Queensland, Australia, 4020
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Monash Medical Centre - Moorabbin Campus
Bentleigh East, Australia, 3165
Barwon Health
Geelong, Australia, 3220
St John of God Hospital
Subiaco, Australia, 6008
Border Medical Oncology
Wodonga, Australia, 3690
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Ziekenhuisnetwerk Antwerpen - AZ Middelheim
Antwerp, Belgium, 2020
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Institut Jules Bordet
Bruxelles, Belgium, 1000
AZ Maria Middelares
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
H.-Hartziekenhuis Roeselare-Menen vzw
Roeselare, Belgium, 8800
Canada, British Columbia
Southern Interior Medical Research Inc.
Kelowna, British Columbia, Canada, V1Y 2H4
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Brantford Urology Research
Brantford, Ontario, Canada, N3S 6T6
Cambridge Memorial Hospital
Cambridge, Ontario, Canada, N1R3G2
St. Josephs Healthcare Hamilton Research Ethics Board
Hamilton, Ontario, Canada, L8N 4A6
Queen's University at Kingston
Kingston, Ontario, Canada, K7L3J7
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
The Female/Male Health Centres
Oakville, Ontario, Canada, L6H 3P1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L 4M1
Centre Hospitalier Universitaire de Quebec Hotel Dieu
Quebec, Canada, G1R 2J6
Aalborg Sygehus
Aalborg, Denmark, 9100
Copenhagen, Denmark, 2200
Frederiksberg Hospital
Frederiksberg, Denmark, DK-2000
Herlev Hospital
Herlev, Denmark, 2730
Holstebro Sygehus
Holstebro, Denmark, 7500
Storstrømmens Sygehus Næstved
Næstved, Denmark, DK-4700
Skejby Sygehus
Århus N, Denmark, DK-8200
East Tallinn Central Hospital
Tallinn, Estonia, EE-10138
North Estonia Medical Centre Foundation
Tallinn, Estonia, EE-13419
Tartu University Hospital
Tartu, Estonia, EE-51014
Centre Paul Papin
Angers, France, 49933
Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries
La Roche Sur Yon, France, 85925
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
Lyon, France, 69373
Centre d'Oncologie de Gentilly
Nancy, France, 54000
HIA du Val de Grâce
Paris, France, 75005
Institut Curie
Paris, France, 75005
Fondation Hôpital Saint-Joseph
Paris, France, 75014
Institut Mutualiste Montsouris
Paris, France, 75014
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Institut Jean Godinot - Centre de lutte contre le cancer
Reims, France, 51056
Clinique Armoricaine de Radiologie
Saint Brieuc, France, 22000
Hôpital Bretonneau
Tours, France, 37044
Centre Alexis Vautrin - Centre Régional de lutte contre le cancer de Lorraine
Vandoeuvre les Nancy, France, 54511
Stadtisches Klinikum Muchen GmbH
Munich, Bavaria, Germany, 81737
Universitätsklinikum Bonn
Bonn, Germany, 53127
Universitätsklinikum Essen
Essen, Germany, 45147
Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
Frankfurt, Germany, 60590
Chirurgische Universitätsklinik Freiburg
Freiburg, Germany, 79106
Martini-Klinik am UKE GmbH
Hamburg, Germany, 20246
Klinikum der Friedrich-Schiller-Universität Jena
Jena, Germany, 07743
Universitätsmedizin der JGU Mainz
Mainz, Germany, 55131
Klinikum der Philipps-Universität Marburg
Marburg, Germany, 35043
Studienpraxis Urologie
Reutlingen, Germany, 72766
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Universitatsklinikum Ulm
Ulm, Germany, 89075
Universitätsklinikum Ulm
Ulm, Germany, 89075
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Landspitali University Hospital
Reykjavik, Iceland, IS-101
Soroka University Medical Center
Beer Sheva, Israel, 84101
Bnei Zion Medical Center
Haifa, Israel, 31048
Rambam Medical Center
Haifa, Israel, 31096
Edith Wolfson Medical Center
Holon, Israel, 58100
Hadassah University Hospital Ein Kerem
Jerusalem, Israel, 91120
The Chaim Sheba Medical Center
Ramat-Gan, Israel, 52621
Assaf Harofe Medical Center
Tzrifin, Israel, 70300
Amsterdam, Netherlands, 1066 CX
Amsterdam, Netherlands, 1081 HV
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6229 HX
Nijmegen, Netherlands, 6525 GA
Erasmus MC
Rotterdam, Netherlands, 3015CE
Grodzisk Mazowiecki, Poland, 05-827
Urologica Praktyka Lekarska Adam Marcheluk
Siedlce, Poland, 08-110
Szpital sw Elzbiety - Mokotowskie Centrum Medyczne Sp. z o. o.
Warsaw, Poland, 02-616
Miedzyleski Szpital Specjalistyczny w Warszawie
Warsaw, Poland, 04-749
Klinika Urologii i Onkologii Urologicznej, Uniwersytecki Szpital Kliniczny we Wrocławiu
Wroclaw, Poland, 50-556
Puerto Rico
Ponce School of Medicine
Ponce, Puerto Rico, 00716
Alliance for Research and Knowledge
San Juan, Puerto Rico, 00910
Russian Federation
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Russian Federation, 163045
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, Russian Federation, 454087
Kazan State Medical University
Kazan, Russian Federation, 420111
Moscow Research Oncology Institute n.a. P.A.Gertsen
Moscow, Russian Federation, 125248
Clinical Oncology Dispensary
Omsk, Russian Federation, 644013
Orel Oncology Center
Orel, Russian Federation, 302020
Orenburg Regional Clinical Oncology Center
Orenburg, Russian Federation, 460021
St. Petersburg Medical Academy of Postgraduate Education
St. Petersburg, Russian Federation, 191015
St. Petersburg State Medical University n.a. I.P. Pavlov
St. Petersburg, Russian Federation, 197022
City Hospital #15
St. Petersburg, Russian Federation, 198205
"Orkli" LLC
St. Petersburg, Russian Federation, 199178
"Clinic Andros" LLC
St.Petersburg, Russian Federation, 197136
Stavropol Regional Clinical Oncology Dispensary
Stavropol, Russian Federation, 355047
Regional Clinical Oncology Center
Vladimir, Russian Federation, 600020
Regional Clinical Oncology Hospital
Yaroslavl, Russian Federation, 150040
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, Spain, 15706
Hospital 12 de Octubre
Madrid, Madrid, Communidad De, Spain, 28041
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Nuestra Señora de Sonsoles
Avila, Spain, 05004
Hospital del Mar
Barcelona, Spain, 08003
Hospital Vall D´Hebron
Barcelona, Spain, 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Hospital General Universitario de Elche
Elche, Spain, 03203
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
MD Anderson International Espana
Madrid, Spain, 28033
Centro Integral Oncológico Clara Campal
Madrid, Spain, 28050
Hospital Universitario Fundación Alcorcón
Madrid, Spain, 28922
Hospital Universitario Puerta de Hierro
Majadahonda, Spain, 28222
Althaia: Xarxa Assistencial de Manresa
Manresa, Spain, 08243
Hospital General Carlos Haya
Málaga, Spain, 29010
Hospital Son Espases
Palma de Mallorca, Spain, 07010
Fundación Hospital Manacor
Palma de Mallorca, Spain, 07198
Clinica Universitaria de Navarra
Pamplona, Spain, 31008
Corporació Sanitaria Parc Taulí
Sabadell, Spain, 08208
Hospital Virgen del Rocio
Sevilla, Spain, 41013
Hospital Mutua de Terrassa
Terrassa, Spain, 08221
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
United Kingdom
Bristol Haematology & Oncology Centre
Bristol, UK, United Kingdom, BS2 8ED
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Velindre Hospital
Cardiff, United Kingdom, CF14 2TL
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
University of Surrey
Guildford, United Kingdom, GU2 7XP
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds, United Kingdom, LS9 7TF
St Bartholomews Hospital
London, United Kingdom, EC1M 6BQ
The Royal Marsden
London, United Kingdom, SW3 6JJ
St Mary's Hospital
London, United Kingdom, W2 1NY
Christie Hospital
Manchester, United Kingdom, M20 4BX
Plymouth Hospitals NHS Trust, Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
University of Southampton
Southampton, United Kingdom, SO16 6YD
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
The Clatterbridge Cancer Centre NHS Foundation Trust
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Bavarian Nordic
Layout table for investigator information
Principal Investigator: James L. Gulley, MD National Cancer Institute (NCI)
Principal Investigator: Philip Kantoff, MD Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by Bavarian Nordic:
Statistical Analysis Plan  [PDF] June 29, 2015
Study Protocol  [PDF] February 8, 2017

Layout table for additonal information
Responsible Party: Bavarian Nordic Identifier: NCT01322490     History of Changes
Other Study ID Numbers: BNIT-PRV-301
First Posted: March 24, 2011    Key Record Dates
Results First Posted: August 8, 2019
Last Update Posted: September 4, 2019
Last Verified: August 2019
Keywords provided by Bavarian Nordic:
prostate cancer
Phase 3
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Immunologic Factors
Physiological Effects of Drugs