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
1 other identifier
interventional
1,297
15 countries
217
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2011
Longer than P75 for phase_3
217 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2011
CompletedFirst Posted
Study publicly available on registry
March 24, 2011
CompletedStudy Start
First participant enrolled
November 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2017
CompletedResults Posted
Study results publicly available
August 8, 2019
CompletedSeptember 4, 2019
August 1, 2019
5.8 years
March 23, 2011
July 16, 2019
August 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
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.
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.
Secondary Outcomes (1)
Number of Subjects Alive Without Event at 6 Months
Randomization through Week 25/End of Treatment visit.
Study Arms (3)
PROSTVAC-V/F-TRICOM + GM-CSF
EXPERIMENTAL* PROSTVAC-V-TRICOM * PROSTVAC-F-TRICOM * GM-CSF
PROSTVAC-V/F-TRICOM + GM-CSF placebo
EXPERIMENTAL* PROSTVAC-V-TRICOM * PROSTVAC-F-TRICOM * GM-CSF placebo
Placebo Control
PLACEBO COMPARATORPROSTVAC V/F Placebo + GM-CSF Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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).
- Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer.
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bavarian Nordiclead
Study Sites (220)
Alaska Clinical Research Center, Llc
Anchorage, Alaska, 99508, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
Alta Bates Summit Medical Center
Berkeley, California, 94704, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Prostate Oncology Specialists, Inc.
Marina del Rey, California, 90292, United States
Desert Hematology-Oncology
Rancho Mirage, California, 92270, United States
San Bernardino Urological Associates
San Bernardino, California, 92404, United States
San Diego Clinical Trials
San Diego, California, 92120, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
VA San Diego Healthcare System
San Diego, California, 92161, United States
Stanford Advanced Medical Center
Stanford, California, 94305, United States
University of Colorado
Aurora, Colorado, 80045, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Manatee Medical Research Institute, LLC
Bradenton, Florida, 34205, United States
Florida Urology Physicians
Fort Myers, Florida, 33908, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Pinellas Urology, Inc.
St. Petersburg, Florida, 33710, United States
James A Haley Veteran Affairs Medical Center
Tampa, Florida, 33612, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
North Idaho Urology
Coeur d'Alene, Idaho, 83814, United States
Jesse Brown VA
Chicago, Illinois, 60612, United States
First Urology PSC
Jeffersonville, Indiana, 47130, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
The Iowa Clinic, PC Iowa Urology
West Des Moines, Iowa, 50266, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Ochsner Cancer Institute
New Orleans, Louisiana, 70121, United States
Maryland Prostate Center
Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Walter Reed Army Medical Center
Bethesda, Maryland, 20889, United States
National Cancer Institute - Center for Cancer Research
Bethesda, Maryland, 20892, United States
Myron Murdock M.D. LLC
Greenbelt, Maryland, 20770, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
GU Research Network, LLC
Omaha, Nebraska, 68130, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
VA Sierra Nevada HealthCare System
Reno, Nevada, 89502, United States
Delaware Valley Urology LLC - Westhampton
Mount Laurel, New Jersey, 08054, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Brooklyn Urology Research Group
Brooklyn, New York, 11215, United States
University Urology Associates
New York, New York, 10016, United States
Hudson Valley Urology, P.C.
Poughkeepsie, New York, 12601, United States
Presbyterian Hospital Center for Cancer Research
Charlotte, North Carolina, 28204, United States
Northeast Urology Research
Concord, North Carolina, 28025, United States
Regional Cancer Care PA
Durham, North Carolina, 27704, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
W.G. (Bill) Hefner VA Medical Center
Salisbury, North Carolina, 28144, United States
St. Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Columbus Urology Research
Columbus, Ohio, 43221, United States
Willamette Valley Cancer Center
Springfield, Oregon, 97477, United States
Urologic Consultants of Southeaster PA LLP
Bala-Cynwyd, Pennsylvania, 19004, United States
Urological Associates Of Lancaster
Lancaster, Pennsylvania, 17604, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, 15232, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16801, United States
Ralph H Johnson VAMC
Charleston, South Carolina, 29401, United States
WJB Dorn VA Medical Center
Columbia, South Carolina, 29209, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
University of TN Medical Center
Knoxville, Tennessee, 37920, United States
The West Clinic, P.C.
Memphis, Tennessee, 38120, United States
James H. Quillen Veterans Affairs Medical Center
Mountain Home, Tennessee, 37684, United States
Urology Associates, PC
Nashville, Tennessee, 37209, United States
Urology Clinics of North Texas
Dallas, Texas, 75225, United States
Mary Crowley Cancer Research Center
Dallas, Texas, 75230, United States
Central Texas Veterans Health Care System
Temple, Texas, 76504, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Salt Lake Research
Salt Lake City, Utah, 84107, United States
University of Utah
Salt Lake City, Utah, 84132, United States
White River Junction Veterans Affairs Medical Center
White River Junction, Vermont, 05009, United States
Virginia Oncology Associates PC
Norfolk, Virginia, 23502, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
The Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Sydney Haematology and Oncology Clinic
St Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Redcliffe Hospital
Redcliffe, Queensland, 4020, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Monash Medical Centre - Moorabbin Campus
Bentleigh East, 3165, Australia
Barwon Health
Geelong, 3220, Australia
St John of God Hospital
Subiaco, 6008, Australia
Border Medical Oncology
Wodonga, 3690, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Ziekenhuisnetwerk Antwerpen - AZ Middelheim
Antwerp, 2020, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
H.-Hartziekenhuis Roeselare-Menen vzw
Roeselare, 8800, Belgium
Southern Interior Medical Research Inc.
Kelowna, British Columbia, V1Y 2H4, Canada
Capital District Health Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
Brantford Urology Research
Brantford, Ontario, N3S 6T6, Canada
Cambridge Memorial Hospital
Cambridge, Ontario, N1R3G2, Canada
St. Josephs Healthcare Hamilton Research Ethics Board
Hamilton, Ontario, L8N 4A6, Canada
Queen's University at Kingston
Kingston, Ontario, K7L3J7, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
The Female/Male Health Centres
Oakville, Ontario, L6H 3P1, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L 4M1, Canada
Centre Hospitalier Universitaire de Quebec Hotel Dieu
Québec, G1R 2J6, Canada
Aalborg Sygehus
Aalborg, 9100, Denmark
Skejby Sygehus
Århus N, DK-8200, Denmark
Rigshospitalet
Copenhagen, 2200, Denmark
Frederiksberg Hospital
Frederiksberg, DK-2000, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Holstebro Sygehus
Holstebro, 7500, Denmark
Storstrømmens Sygehus Næstved
Næstved, DK-4700, Denmark
East Tallinn Central Hospital
Tallinn, EE-10138, Estonia
North Estonia Medical Centre Foundation
Tallinn, EE-13419, Estonia
Tartu University Hospital
Tartu, EE-51014, Estonia
Centre Paul Papin
Angers, 49933, France
Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries
La Roche-sur-Yon, 85925, France
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
Lyon, 69373, France
Centre d'Oncologie de Gentilly
Nancy, 54000, France
HIA du Val de Grâce
Paris, 75005, France
Institut Curie
Paris, 75005, France
Fondation Hôpital Saint-Joseph
Paris, 75014, France
Institut Mutualiste Montsouris
Paris, 75014, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Institut Jean Godinot - Centre de lutte contre le cancer
Reims, 51056, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22000, France
Hôpital Bretonneau
Tours, 37044, France
Centre Alexis Vautrin - Centre Régional de lutte contre le cancer de Lorraine
Vandœuvre-lès-Nancy, 54511, France
Stadtisches Klinikum Muchen GmbH
Munich, Bavaria, 81737, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
Frankfurt, 60590, Germany
Chirurgische Universitätsklinik Freiburg
Freiburg im Breisgau, 79106, Germany
Martini-Klinik am UKE GmbH
Hamburg, 20246, Germany
Klinikum der Friedrich-Schiller-Universität Jena
Jena, 07743, Germany
Universitätsmedizin der JGU Mainz
Mainz, 55131, Germany
Klinikum der Philipps-Universität Marburg
Marburg, 35043, Germany
Studienpraxis Urologie
Reutlingen, 72766, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Universitatsklinikum Ulm
Ulm, 89075, Germany
Universitätsklinikum Ulm
Ulm, 89075, Germany
Universitätsklinikum Würzburg
Würzburg, 97080, Germany
Landspitali University Hospital
Reykjavik, IS-101, Iceland
Soroka University Medical Center
Beersheba, 84101, Israel
Bnei Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Center
Haifa, 31096, Israel
Edith Wolfson Medical Center
Holon, 58100, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, 91120, Israel
The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Assaf Harofe Medical Center
Tzrifin, 70300, Israel
NKI-AVL
Amsterdam, 1066 CX, Netherlands
VUMC
Amsterdam, 1081 HV, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, 6229 HX, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
Erasmus MC
Rotterdam, 3015CE, Netherlands
AMEDS CENTRUM Sp. z o.o.
Grodzisk Mazowiecki, 05-827, Poland
Urologica Praktyka Lekarska Adam Marcheluk
Siedlce, 08-110, Poland
Szpital sw Elzbiety - Mokotowskie Centrum Medyczne Sp. z o. o.
Warsaw, 02-616, Poland
Miedzyleski Szpital Specjalistyczny w Warszawie
Warsaw, 04-749, Poland
Klinika Urologii i Onkologii Urologicznej, Uniwersytecki Szpital Kliniczny we Wrocławiu
Wroclaw, 50-556, Poland
Ponce School of Medicine
Ponce, 00716, Puerto Rico
Alliance for Research and Knowledge
San Juan, 00910, Puerto Rico
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, 163045, Russia
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, 454087, Russia
Kazan State Medical University
Kazan', 420111, Russia
Moscow Research Oncology Institute n.a. P.A.Gertsen
Moscow, 125248, Russia
Clinical Oncology Dispensary
Omsk, 644013, Russia
Orenburg Regional Clinical Oncology Center
Orenburg, 460021, Russia
Orel Oncology Center
Oryol, 302020, Russia
St. Petersburg Medical Academy of Postgraduate Education
Saint Petersburg, 191015, Russia
St. Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg, 197022, Russia
"Clinic Andros" LLC
Saint Petersburg, 197136, Russia
City Hospital #15
Saint Petersburg, 198205, Russia
"Orkli" LLC
Saint Petersburg, 199178, Russia
Stavropol Regional Clinical Oncology Dispensary
Stavropol, 355047, Russia
Regional Clinical Oncology Center
Vladimir, 600020, Russia
Regional Clinical Oncology Hospital
Yaroslavl, 150040, Russia
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, 15706, Spain
Hospital 12 de Octubre
Madrid, Madrid, Communidad de, 28041, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Nuestra Señora de Sonsoles
Ávila, 05004, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Vall D´Hebron
Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital General Universitario de Elche
Elche, 03203, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
MD Anderson International Espana
Madrid, 28033, Spain
Centro Integral Oncológico Clara Campal
Madrid, 28050, Spain
Hospital Universitario Fundación Alcorcón
Madrid, 28922, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, 28222, Spain
Althaia: Xarxa Assistencial de Manresa
Manresa, 08243, Spain
Hospital General Carlos Haya
Málaga, 29010, Spain
Hospital Son Espases
Palma de Mallorca, 07010, Spain
Fundación Hospital Manacor
Palma de Mallorca, 07198, Spain
Clinica Universitaria de Navarra
Pamplona, 31008, Spain
Corporació Sanitaria Parc Taulí
Sabadell, 08208, Spain
Hospital Virgen del Rocio
Seville, 41013, Spain
Hospital Mutua de Terrassa
Terrassa, 08221, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Bristol Haematology & Oncology Centre
Bristol, UK, BS2 8ED, United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
Velindre Hospital
Cardiff, CF14 2TL, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
University of Surrey
Guildford, GU2 7XP, United Kingdom
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds, LS9 7TF, United Kingdom
St Bartholomews Hospital
London, EC1M 6BQ, United Kingdom
The Royal Marsden
London, SW3 6JJ, United Kingdom
St Mary's Hospital
London, W2 1NY, United Kingdom
Christie Hospital
Manchester, M20 4BX, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Plymouth Hospitals NHS Trust, Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
University of Southampton
Southampton, SO16 6YD, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Carles J, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2019 May 1;37(13):1051-1061. doi: 10.1200/JCO.18.02031. Epub 2019 Feb 28.
PMID: 30817251DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Program Lead, Clinical Operations
- Organization
- Bavarian Nordic A/S
Study Officials
- PRINCIPAL INVESTIGATOR
James L. Gulley, MD
National Cancer Institute (NCI)
- PRINCIPAL INVESTIGATOR
Philip Kantoff, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2011
First Posted
March 24, 2011
Study Start
November 28, 2011
Primary Completion
September 25, 2017
Study Completion
December 15, 2017
Last Updated
September 4, 2019
Results First Posted
August 8, 2019
Record last verified: 2019-08