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

NCT ID: NCT01322490

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1297 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-28
• Study Completion Date: 2017-12-15

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.

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

Conditions

Prostate Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PROSTVAC-V/F-TRICOM + GM-CSF

• PROSTVAC-V-TRICOM
• PROSTVAC-F-TRICOM
• GM-CSF

Group Type: EXPERIMENTAL

PROSTVAC-V

Intervention Type: BIOLOGICAL

PROSTVAC-F

Intervention Type: BIOLOGICAL

GM-CSF

Intervention Type: DRUG

PROSTVAC-V/F-TRICOM + GM-CSF placebo

• PROSTVAC-V-TRICOM
• PROSTVAC-F-TRICOM
• GM-CSF placebo

Group Type: EXPERIMENTAL

PROSTVAC-V

Intervention Type: BIOLOGICAL

PROSTVAC-F

Intervention Type: BIOLOGICAL

GM-CSF Placebo

Intervention Type: OTHER

Placebo Control

PROSTVAC V/F Placebo + GM-CSF Placebo

Group Type: PLACEBO_COMPARATOR

GM-CSF Placebo

Intervention Type: OTHER

Placebo

Intervention Type: BIOLOGICAL

PROSTVAC V/F Placebo

Interventions

PROSTVAC-V

Intervention Type: BIOLOGICAL

PROSTVAC-F

Intervention Type: BIOLOGICAL

GM-CSF

Intervention Type: DRUG

GM-CSF Placebo

Intervention Type: OTHER

Placebo

PROSTVAC V/F Placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bavarian Nordic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James L. Gulley, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Philip Kantoff, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Alaska Clinical Research Center, Llc

Anchorage, Alaska, United States

Scottsdale Healthcare

Scottsdale, Arizona, United States

Alta Bates Summit Medical Center

Berkeley, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Prostate Oncology Specialists, Inc.

Marina del Rey, California, United States

Desert Hematology-Oncology

Rancho Mirage, California, United States

San Bernardino Urological Associates

San Bernardino, California, United States

San Diego Clinical Trials

San Diego, California, United States

Sharp Memorial Hospital

San Diego, California, United States

VA San Diego Healthcare System

San Diego, California, United States

Stanford Advanced Medical Center

Stanford, California, United States

University of Colorado

Aurora, Colorado, United States

The Urology Center of Colorado

Denver, Colorado, United States

Washington Cancer Institute

Washington D.C., District of Columbia, United States

South Florida Medical Research

Aventura, Florida, United States

Manatee Medical Research Institute, LLC

Bradenton, Florida, United States

Florida Urology Physicians

Fort Myers, Florida, United States

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Pinellas Urology, Inc.

St. Petersburg, Florida, United States

James A Haley Veteran Affairs Medical Center

Tampa, Florida, United States

Palm Beach Cancer Institute

West Palm Beach, Florida, United States

North Idaho Urology

Coeur d'Alene, Idaho, United States

Jesse Brown VA

Chicago, Illinois, United States

First Urology PSC

Jeffersonville, Indiana, United States

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

The Iowa Clinic, PC Iowa Urology

West Des Moines, Iowa, United States

Tulane University

New Orleans, Louisiana, United States

Ochsner Cancer Institute

New Orleans, Louisiana, United States

Maryland Prostate Center

Baltimore, Maryland, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Union Memorial Hospital

Baltimore, Maryland, United States

Walter Reed Army Medical Center

Bethesda, Maryland, United States

National Cancer Institute - Center for Cancer Research

Bethesda, Maryland, United States

Myron Murdock M.D. LLC

Greenbelt, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

GU Research Network, LLC

Omaha, Nebraska, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

VA Sierra Nevada HealthCare System

Reno, Nevada, United States

Delaware Valley Urology LLC - Westhampton

Mount Laurel, New Jersey, United States

The Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Brooklyn Urology Research Group

Brooklyn, New York, United States

University Urology Associates

New York, New York, United States

Hudson Valley Urology, P.C.

Poughkeepsie, New York, United States

Presbyterian Hospital Center for Cancer Research

Charlotte, North Carolina, United States

Northeast Urology Research

Concord, North Carolina, United States

Regional Cancer Care PA

Durham, North Carolina, United States

Durham VA Medical Center

Durham, North Carolina, United States

W.G. (Bill) Hefner VA Medical Center

Salisbury, North Carolina, United States

St. Alexius Medical Center

Bismarck, North Dakota, United States

Gabrail Cancer Center

Canton, Ohio, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Columbus Urology Research

Columbus, Ohio, United States

Willamette Valley Cancer Center

Springfield, Oregon, United States

Urologic Consultants of Southeaster PA LLP

Bala-Cynwyd, Pennsylvania, United States

Urological Associates Of Lancaster

Lancaster, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

UPMC Cancer Pavillion

Pittsburgh, Pennsylvania, United States

Mount Nittany Medical Center

State College, Pennsylvania, United States

Ralph H Johnson VAMC

Charleston, South Carolina, United States

WJB Dorn VA Medical Center

Columbia, South Carolina, United States

Greenville Hospital System

Greenville, South Carolina, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

University of TN Medical Center

Knoxville, Tennessee, United States

The West Clinic, P.C.

Memphis, Tennessee, United States

James H. Quillen Veterans Affairs Medical Center

Mountain Home, Tennessee, United States

Urology Associates, PC

Nashville, Tennessee, United States

Urology Clinics of North Texas

Dallas, Texas, United States

Mary Crowley Cancer Research Center

Dallas, Texas, United States

Central Texas Veterans Health Care System

Temple, Texas, United States

Scott and White Memorial Hospital

Temple, Texas, United States

Salt Lake Research

Salt Lake City, Utah, United States

University of Utah

Salt Lake City, Utah, United States

White River Junction Veterans Affairs Medical Center

White River Junction, Vermont, United States

Virginia Oncology Associates PC

Norfolk, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Madigan Army Medical Center

Tacoma, Washington, United States

The Schiffler Cancer Center

Wheeling, West Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Sydney Haematology and Oncology Clinic

St Leonards, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Redcliffe Hospital

Redcliffe, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Monash Medical Centre - Moorabbin Campus

Bentleigh East, , Australia

Barwon Health

Geelong, , Australia

St John of God Hospital

Subiaco, , Australia

Border Medical Oncology

Wodonga, , Australia

Princess Alexandra Hospital

Woolloongabba, , Australia

Ziekenhuisnetwerk Antwerpen - AZ Middelheim

Antwerp, , Belgium

Institut Jules Bordet

Brussels, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

AZ Maria Middelares

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

H.-Hartziekenhuis Roeselare-Menen vzw

Roeselare, , Belgium

Southern Interior Medical Research Inc.

Kelowna, British Columbia, Canada

Capital District Health Authority

Halifax, Nova Scotia, Canada

Brantford Urology Research

Brantford, Ontario, Canada

Cambridge Memorial Hospital

Cambridge, Ontario, Canada

St. Josephs Healthcare Hamilton Research Ethics Board

Hamilton, Ontario, Canada

Queen's University at Kingston

Kingston, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Female/Male Health Centres

Oakville, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec Hotel Dieu

Québec, , Canada

Aalborg Sygehus

Aalborg, , Denmark

Skejby Sygehus

Århus N, , Denmark

Rigshospitalet

Copenhagen, , Denmark

Frederiksberg Hospital

Frederiksberg, , Denmark

Herlev Hospital

Herlev, , Denmark

Holstebro Sygehus

Holstebro, , Denmark

Storstrømmens Sygehus Næstved

Næstved, , Denmark

East Tallinn Central Hospital

Tallinn, , Estonia

North Estonia Medical Centre Foundation

Tallinn, , Estonia

Tartu University Hospital

Tartu, , Estonia

Centre Paul Papin

Angers, , France

Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries

La Roche-sur-Yon, , France

Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes

Lyon, , France

Centre d'Oncologie de Gentilly

Nancy, , France

HIA du Val de Grâce

Paris, , France

Institut Curie

Paris, , France

Fondation Hôpital Saint-Joseph

Paris, , France

Institut Mutualiste Montsouris

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Institut Jean Godinot - Centre de lutte contre le cancer

Reims, , France

Clinique Armoricaine de Radiologie

Saint-Brieuc, , France

Hôpital Bretonneau

Tours, , France

Centre Alexis Vautrin - Centre Régional de lutte contre le cancer de Lorraine

Vandœuvre-lès-Nancy, , France

Stadtisches Klinikum Muchen GmbH

Munich, Bavaria, Germany

Universitätsklinikum Bonn

Bonn, , Germany

Universitätsklinikum Essen

Essen, , Germany

Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt am Main

Frankfurt, , Germany

Chirurgische Universitätsklinik Freiburg

Freiburg im Breisgau, , Germany

Martini-Klinik am UKE GmbH

Hamburg, , Germany

Klinikum der Friedrich-Schiller-Universität Jena

Jena, , Germany

Universitätsmedizin der JGU Mainz

Mainz, , Germany

Klinikum der Philipps-Universität Marburg

Marburg, , Germany

Studienpraxis Urologie

Reutlingen, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

Universitatsklinikum Ulm

Ulm, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Landspitali University Hospital

Reykjavik, , Iceland

Soroka University Medical Center

Beersheba, , Israel

Bnei Zion Medical Center

Haifa, , Israel

Rambam Medical Center

Haifa, , Israel

Edith Wolfson Medical Center

Holon, , Israel

Hadassah University Hospital Ein Kerem

Jerusalem, , Israel

The Chaim Sheba Medical Center

Ramat Gan, , Israel

Assaf Harofe Medical Center

Tzrifin, , Israel

NKI-AVL

Amsterdam, , Netherlands

VUMC

Amsterdam, , Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Radboudumc

Nijmegen, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

AMEDS CENTRUM Sp. z o.o.

Grodzisk Mazowiecki, , Poland

Urologica Praktyka Lekarska Adam Marcheluk

Siedlce, , Poland

Szpital sw Elzbiety - Mokotowskie Centrum Medyczne Sp. z o. o.

Warsaw, , Poland

Miedzyleski Szpital Specjalistyczny w Warszawie

Warsaw, , Poland

Klinika Urologii i Onkologii Urologicznej, Uniwersytecki Szpital Kliniczny we Wrocławiu

Wroclaw, , Poland

Ponce School of Medicine

Ponce, , Puerto Rico

Alliance for Research and Knowledge

San Juan, , Puerto Rico

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, , Russia

Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, , Russia

Kazan State Medical University

Kazan', , Russia

Moscow Research Oncology Institute n.a. P.A.Gertsen

Moscow, , Russia

Clinical Oncology Dispensary

Omsk, , Russia

Orenburg Regional Clinical Oncology Center

Orenburg, , Russia

Orel Oncology Center

Oryol, , Russia

St. Petersburg Medical Academy of Postgraduate Education

Saint Petersburg, , Russia

St. Petersburg State Medical University n.a. I.P. Pavlov

Saint Petersburg, , Russia

"Clinic Andros" LLC

Saint Petersburg, , Russia

City Hospital #15

Saint Petersburg, , Russia

"Orkli" LLC

Saint Petersburg, , Russia

Stavropol Regional Clinical Oncology Dispensary

Stavropol, , Russia

Regional Clinical Oncology Center

Vladimir, , Russia

Regional Clinical Oncology Hospital

Yaroslavl, , Russia

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Galicia, Spain

Hospital 12 de Octubre

Madrid, Madrid, Communidad de, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital Nuestra Señora de Sonsoles

Ávila, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Vall D´Hebron

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital General Universitario de Elche

Elche, , Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

MD Anderson International Espana

Madrid, , Spain

Centro Integral Oncológico Clara Campal

Madrid, , Spain

Hospital Universitario Fundación Alcorcón

Madrid, , Spain

Hospital Universitario Puerta de Hierro

Majadahonda, , Spain

Althaia: Xarxa Assistencial de Manresa

Manresa, , Spain

Hospital General Carlos Haya

Málaga, , Spain

Hospital Son Espases

Palma de Mallorca, , Spain

Fundación Hospital Manacor

Palma de Mallorca, , Spain

Clinica Universitaria de Navarra

Pamplona, , Spain

Corporació Sanitaria Parc Taulí

Sabadell, , Spain

Hospital Virgen del Rocio

Seville, , Spain

Hospital Mutua de Terrassa

Terrassa, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Bristol Haematology & Oncology Centre

Bristol, UK, United Kingdom

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

Birmingham, , United Kingdom

Velindre Hospital

Cardiff, , United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

University of Surrey

Guildford, , United Kingdom

Leeds Teaching Hospitals NHS Trust, St James's University Hospital

Leeds, , United Kingdom

St Bartholomews Hospital

London, , United Kingdom

The Royal Marsden

London, , United Kingdom

St Mary's Hospital

London, , United Kingdom

Christie Hospital

Manchester, , United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, , United Kingdom

Plymouth Hospitals NHS Trust, Derriford Hospital

Plymouth, , United Kingdom

University of Southampton

Southampton, , United Kingdom

Royal Marsden Hospital

Sutton, , United Kingdom

Countries

United States; Australia; Belgium; Canada; Denmark; Estonia; France; Germany; Iceland; Israel; Netherlands; Poland; Puerto Rico; Russia; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30817251 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

BNIT-PRV-301

Identifier Type: -

Identifier Source: org_study_id