AzTrials
AzTrials

Prostate Cancer MetastaticPhase 3ProspectNCT01322490

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

A Phase 3 study testing PROSTVAC-V, PROSTVAC-F and GM-CSF in people with Prostate Cancer Metastatic, run by Bavarian Nordic at 220 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
PROSTVAC-V, PROSTVAC-F and GM-CSF
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,297 participants
Where
220 sitesin 16 countries
Study dates
28 Nov 2011to 15 Dec 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • OR
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

220 sites in 16 countries.

220 sites in 16 countries

United States84 sites

  • Alaska Clinical Research Center, Llc

    Anchorage, Alaska, 99508

  • University of Colorado

    Aurora, Colorado, 80045

  • South Florida Medical Research

    Aventura, Florida, 33180

  • Urologic Consultants of Southeaster PA LLP

    Bala-Cynwyd, Pennsylvania, 19004

  • Maryland Prostate Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Alta Bates Summit Medical Center

    Berkeley, California, 94704

  • Walter Reed Army Medical Center

    Bethesda, Maryland, 20889

  • National Cancer Institute - Center for Cancer Research

    Bethesda, Maryland, 20892

  • St. Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Manatee Medical Research Institute, LLC

    Bradenton, Florida, 34205

  • Brooklyn Urology Research Group

    Brooklyn, New York, 11215

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Ralph H Johnson VAMC

    Charleston, South Carolina, 29401

  • Presbyterian Hospital Center for Cancer Research

    Charlotte, North Carolina, 28204

  • Jesse Brown VA

    Chicago, Illinois, 60612

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • North Idaho Urology

    Coeur d'Alene, Idaho, 83814

  • WJB Dorn VA Medical Center

    Columbia, South Carolina, 29209

  • Columbus Urology Research

    Columbus, Ohio, 43221

  • Northeast Urology Research

    Concord, North Carolina, 28025

  • Urology Clinics of North Texas

    Dallas, Texas, 75225

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75230

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Regional Cancer Care PA

    Durham, North Carolina, 27704

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • Florida Urology Physicians

    Fort Myers, Florida, 33908

  • Myron Murdock M.D. LLC

    Greenbelt, Maryland, 20770

  • Greenville Hospital System

    Greenville, South Carolina, 29605

  • First Urology PSC

    Jeffersonville, Indiana, 47130

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

  • University of TN Medical Center

    Knoxville, Tennessee, 37920

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Urological Associates Of Lancaster

    Lancaster, Pennsylvania, 17604

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Prostate Oncology Specialists, Inc.

    Marina del Rey, California, 90292

  • The West Clinic, P.C.

    Memphis, Tennessee, 38120

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Delaware Valley Urology LLC - Westhampton

    Mount Laurel, New Jersey, 08054

  • James H. Quillen Veterans Affairs Medical Center

    Mountain Home, Tennessee, 37684

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates, PC

    Nashville, Tennessee, 37209

  • The Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Tulane University

    New Orleans, Louisiana, 70112

  • Ochsner Cancer Institute

    New Orleans, Louisiana, 70121

  • University Urology Associates

    New York, New York, 10016

  • Virginia Oncology Associates PC

    Norfolk, Virginia, 23502

  • GU Research Network, LLC

    Omaha, Nebraska, 68130

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • UPMC Cancer Pavillion

    Pittsburgh, Pennsylvania, 15232

  • Hudson Valley Urology, P.C.

    Poughkeepsie, New York, 12601

  • Desert Hematology-Oncology

    Rancho Mirage, California, 92270

  • VA Sierra Nevada HealthCare System

    Reno, Nevada, 89502

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • W.G. (Bill) Hefner VA Medical Center

    Salisbury, North Carolina, 28144

  • Salt Lake Research

    Salt Lake City, Utah, 84107

  • University of Utah

    Salt Lake City, Utah, 84132

  • San Bernardino Urological Associates

    San Bernardino, California, 92404

  • San Diego Clinical Trials

    San Diego, California, 92120

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • VA San Diego Healthcare System

    San Diego, California, 92161

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85258

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Willamette Valley Cancer Center

    Springfield, Oregon, 97477

  • Pinellas Urology, Inc.

    St. Petersburg, Florida, 33710

  • Stanford Advanced Medical Center

    Stanford, California, 94305

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16801

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • James A Haley Veteran Affairs Medical Center

    Tampa, Florida, 33612

  • Central Texas Veterans Health Care System

    Temple, Texas, 76504

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

  • The Iowa Clinic, PC Iowa Urology

    West Des Moines, Iowa, 50266

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • The Schiffler Cancer Center

    Wheeling, West Virginia, 26003

  • White River Junction Veterans Affairs Medical Center

    White River Junction, Vermont, 05009

Other trials in United States

Spain23 sites

  • Hospital Nuestra Señora de Sonsoles

    Ávila, 05004

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Vall D´Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, 03203

  • Hospital 12 de Octubre

    Madrid, Madrid, Communidad de, 28041

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • MD Anderson International Espana

    Madrid, 28033

  • Centro Integral Oncológico Clara Campal

    Madrid, 28050

  • Hospital Universitario Fundación Alcorcón

    Madrid, 28922

  • Hospital Universitario Puerta de Hierro

    Majadahonda, 28222

  • Hospital General Carlos Haya

    Málaga, 29010

  • Althaia: Xarxa Assistencial de Manresa

    Manresa, 08243

  • Hospital Son Espases

    Palma de Mallorca, 07010

  • Fundación Hospital Manacor

    Palma de Mallorca, 07198

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Corporació Sanitaria Parc Taulí

    Sabadell, 08208

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, Galicia, 15706

  • Hospital Virgen del Rocio

    Seville, 41013

  • Hospital Mutua de Terrassa

    Terrassa, 08221

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Russia15 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, 163045

  • Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, 454087

  • Kazan State Medical University

    Kazan', 420111

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

    Moscow, 125248

  • Clinical Oncology Dispensary

    Omsk, 644013

  • Orenburg Regional Clinical Oncology Center

    Orenburg, 460021

  • Orel Oncology Center

    Oryol, 302020

  • St. Petersburg Medical Academy of Postgraduate Education

    Saint Petersburg, 191015

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

    Saint Petersburg, 197022

  • "Clinic Andros" LLC

    Saint Petersburg, 197136

  • City Hospital #15

    Saint Petersburg, 198205

  • "Orkli" LLC

    Saint Petersburg, 199178

  • Stavropol Regional Clinical Oncology Dispensary

    Stavropol, 355047

  • Regional Clinical Oncology Center

    Vladimir, 600020

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150040

Other trials in Russia

Germany14 sites

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Universitätsklinikum Essen

    Essen, 45147

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

    Frankfurt, 60590

  • Chirurgische Universitätsklinik Freiburg

    Freiburg im Breisgau, 79106

  • Martini-Klinik am UKE GmbH

    Hamburg, 20246

  • Klinikum der Friedrich-Schiller-Universität Jena

    Jena, 07743

  • Universitätsmedizin der JGU Mainz

    Mainz, 55131

  • Klinikum der Philipps-Universität Marburg

    Marburg, 35043

  • Stadtisches Klinikum Muchen GmbH

    Munich, Bavaria, 81737

  • Studienpraxis Urologie

    Reutlingen, 72766

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitatsklinikum Ulm

    Ulm, 89075

  • Universitätsklinikum Ulm

    Ulm, 89075

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

United Kingdom14 sites

  • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Bristol Haematology & Oncology Centre

    Bristol, UK, BS2 8ED

  • Velindre Hospital

    Cardiff, CF14 2TL

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • University of Surrey

    Guildford, GU2 7XP

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

    Leeds, LS9 7TF

  • St Bartholomews Hospital

    London, EC1M 6BQ

  • The Royal Marsden

    London, SW3 6JJ

  • St Mary's Hospital

    London, W2 1NY

  • Christie Hospital

    Manchester, M20 4BX

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral, CH63 4JY

  • Plymouth Hospitals NHS Trust, Derriford Hospital

    Plymouth, PL6 8DH

  • University of Southampton

    Southampton, SO16 6YD

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

France13 sites

  • Centre Paul Papin

    Angers, 49933

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

    La Roche-sur-Yon, 85925

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

    Lyon, 69373

  • Centre d'Oncologie de Gentilly

    Nancy, 54000

  • HIA du Val de Grâce

    Paris, 75005

  • Institut Curie

    Paris, 75005

  • Fondation Hôpital Saint-Joseph

    Paris, 75014

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Institut Jean Godinot - Centre de lutte contre le cancer

    Reims, 51056

  • Clinique Armoricaine de Radiologie

    Saint-Brieuc, 22000

  • Hôpital Bretonneau

    Tours, 37044

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

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Canada11 sites

  • Brantford Urology Research

    Brantford, Ontario, N3S 6T6

  • Cambridge Memorial Hospital

    Cambridge, Ontario, N1R3G2

  • Capital District Health Authority

    Halifax, Nova Scotia, B3H 2Y9

  • St. Josephs Healthcare Hamilton Research Ethics Board

    Hamilton, Ontario, L8N 4A6

  • Southern Interior Medical Research Inc.

    Kelowna, British Columbia, V1Y 2H4

  • Queen's University at Kingston

    Kingston, Ontario, K7L3J7

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L 4M1

  • The Female/Male Health Centres

    Oakville, Ontario, L6H 3P1

  • Centre Hospitalier Universitaire de Quebec Hotel Dieu

    Québec, G1R 2J6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Australia10 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Medical Centre - Moorabbin Campus

    Bentleigh East, 3165

  • Barwon Health

    Geelong, 3220

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Redcliffe Hospital

    Redcliffe, Queensland, 4020

  • Sydney Haematology and Oncology Clinic

    St Leonards, New South Wales, 2065

  • St John of God Hospital

    Subiaco, 6008

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Border Medical Oncology

    Wodonga, 3690

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Denmark7 sites

  • Aalborg Sygehus

    Aalborg, 9100

  • Skejby Sygehus

    Århus N, DK-8200

  • Rigshospitalet

    Copenhagen, 2200

  • Frederiksberg Hospital

    Frederiksberg, DK-2000

  • Herlev Hospital

    Herlev, 2730

  • Holstebro Sygehus

    Holstebro, 7500

  • Storstrømmens Sygehus Næstved

    Næstved, DK-4700

Other trials in Denmark

Israel7 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • Bnei Zion Medical Center

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 31096

  • Edith Wolfson Medical Center

    Holon, 58100

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 91120

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Assaf Harofe Medical Center

    Tzrifin, 70300

Other trials in Israel

Belgium6 sites

  • Ziekenhuisnetwerk Antwerpen - AZ Middelheim

    Antwerp, 2020

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • AZ Maria Middelares

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • H.-Hartziekenhuis Roeselare-Menen vzw

    Roeselare, 8800

Other trials in Belgium

Netherlands5 sites

  • NKI-AVL

    Amsterdam, 1066 CX

  • VUMC

    Amsterdam, 1081 HV

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6229 HX

  • Radboudumc

    Nijmegen, 6525 GA

  • Erasmus MC

    Rotterdam, 3015CE

Other trials in Netherlands

Poland5 sites

  • AMEDS CENTRUM Sp. z o.o.

    Grodzisk Mazowiecki, 05-827

  • Urologica Praktyka Lekarska Adam Marcheluk

    Siedlce, 08-110

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

    Warsaw, 02-616

  • Miedzyleski Szpital Specjalistyczny w Warszawie

    Warsaw, 04-749

  • Klinika Urologii i Onkologii Urologicznej, Uniwersytecki Szpital Kliniczny we Wrocławiu

    Wroclaw, 50-556

Other trials in Poland

Estonia3 sites

  • East Tallinn Central Hospital

    Tallinn, EE-10138

  • North Estonia Medical Centre Foundation

    Tallinn, EE-13419

  • Tartu University Hospital

    Tartu, EE-51014

Other trials in Estonia

Puerto Rico2 sites

  • Ponce School of Medicine

    Ponce, 00716

  • Alliance for Research and Knowledge

    San Juan, 00910

Other trials in Puerto Rico

Iceland1 site

  • Landspitali University Hospital

    Reykjavik, IS-101

Other trials in Iceland

About this study

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.

Read the 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
Being tested
PROSTVAC-V, PROSTVAC-F, GM-CSF, GM-CSF Placebo, Placebo
Keywords
PROSTVAC, metastatic, prostate cancer, castrate-resistant, vaccine, immunotherapy, Phase 3
Medical subject headings
Neoplasm Metastasis, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROSTVAC-VBiological

  • PROSTVAC-FBiological

  • GM-CSFDrug

  • GM-CSF PlaceboOther

  • PlaceboBiological

    PROSTVAC V/F Placebo

Study groups in NCT01322490
Study groupRoleWhat they receive
PROSTVAC-V/F-TRICOM + GM-CSFExperimental* PROSTVAC-V-TRICOM * PROSTVAC-F-TRICOM * GM-CSF
Receives: Biological: PROSTVAC-V; Biological: PROSTVAC-F; Drug: GM-CSF
PROSTVAC-V/F-TRICOM + GM-CSF placeboExperimental* PROSTVAC-V-TRICOM * PROSTVAC-F-TRICOM * GM-CSF placebo
Receives: Biological: PROSTVAC-V; Biological: PROSTVAC-F; Other: GM-CSF Placebo
Placebo ControlPlacebo comparatorPROSTVAC V/F Placebo + GM-CSF Placebo
Receives: Other: GM-CSF Placebo; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: Randomization through Week 25/End of Treatment visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2011 (estimated)
  2. Study start28 Nov 2011
  3. Primary completion25 Sep 2017
  4. Study completion15 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01322490
Sponsor's protocol ID
BNIT-PRV-301
Acronym
Prospect
Status last verified
Aug 2019
First submitted
23 Mar 2011
Last updated
4 Sep 2019
Data monitoring committee
Yes

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.

    PubMed 30817251

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PROSTVAC-V, PROSTVAC-F and GM-CSF in people with Prostate Cancer Metastatic, run by Bavarian Nordic at 220 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 220 sites in United States, Spain, Russia, Germany, United Kingdom and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01322490, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.

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