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 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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer Metastatic
• Intervention / Treatment: Drug: GM-CSF; Biological: PROSTVAC-V; Biological: PROSTVAC-F; 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

• Study Type: Interventional
• Enrollment (Actual): 1297
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

   OR

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PROSTVAC-V/F-TRICOM + GM-CSF; PROSTVAC-V-TRICOM; PROSTVAC-F-TRICOM; GM-CSF	Drug: GM-CSF; Biological: PROSTVAC-V; Biological: PROSTVAC-F
EXPERIMENTAL: PROSTVAC-V/F-TRICOM + GM-CSF placebo; PROSTVAC-V-TRICOM; PROSTVAC-F-TRICOM; 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; PROSTVAC V/F Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Alive Without Event at 6 Months	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.	Randomization through Week 25/End of Treatment visit.

Collaborators and Investigators

• Sponsor: Bavarian Nordic
• Investigators: Principal Investigator: James L. Gulley, MD, National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 28, 2011
• Primary Completion (ACTUAL): September 25, 2017
• Study Completion (ACTUAL): December 15, 2017

Study Registration Dates

• First Submitted: March 23, 2011
• First Submitted That Met QC Criteria: March 23, 2011
• First Posted (ESTIMATE): March 24, 2011

Study Record Updates

• Last Update Posted (ACTUAL): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: immunotherapy; prostate cancer; vaccine; metastatic; Phase 3; PROSTVAC; castrate-resistant
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Sargramostim; Molgramostim
• Other Study ID Numbers: BNIT-PRV-301