AzTrials
AzTrials

Metastatic Castration-resistant Prostate CancerPhase 3VIABLENCT02111577

Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

A Phase 3 study testing DCVAC/PCa in people with Metastatic Castration-resistant Prostate Cancer, run by SOTIO a.s. at 177 sites in 22 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 VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
DCVAC/PCa
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,182 participants
Where
177 sitesin 22 countries
Study dates
26 May 2014to 28 Jan 2020
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

  • Male 18 years and older.
  • Histologically or cytologically confirmed prostate adenocarcinoma.
  • Presence of skeletal, or soft-tissue/visceral/nodal metastases according to one of the following criteria:
  • Confirmed pathological fracture related to the disease OR
  • Confirmation of distant bone and/or soft-tissue and/or visceral metastases on CT or MRI scan or bone scintigraphy OR
  • Positive pathology report of metastatic lesion
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  • Disease progression despite androgen-deprivation therapy (ADT) as indicated by:
  • Prostate-specific antigen (PSA) increase that is ≥ 2 ng/mL and ≥ 25% above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed and which is confirmed by a second value 1 or more weeks later OR
  • Progression of measurable lymph nodes (short axis ≥ 15 mm) or visceral lesion measurable per RECIST v1.1 criteria, confirmation by an independent review facility (IRF) required OR
  • Two or more new lesions appearing on bone scan/imaging compared with a previous scan (confirmation by IRF required)
  • Maintenance of castrate conditions: patients, who have not had a surgical orchiectomy, must continue with hormone therapy with gonadotropin releasing hormone/ luteinizing hormone-releasing hormone (GnRH/LHRH) agonists or antagonists to reach levels of serum testosterone of ≤ 1.7 nmol/L (50 ng/dL). The duration of the castration period must be at least 4 months before screening as evidenced by combination of clinical/laboratory data (see section 6.8.1).
  • Laboratory criteria:
  • White blood cells (WBC) greater than 4,000/mm3 (4.0 x109/L)
  • Neutrophil count greater than 1,500/mm3 (1.5 x109/L).
  • Hemoglobin of at least 10 g/dL (100 g/L).
  • Platelet count of at least 100,000/mm3 (100 x 109/L).
  • Total bilirubin within normal limits (benign hereditary hyperbilirubinemias, e.g. Gilbert's syndrome, are permitted).
  • Serum alanine aminotransferase, aspartate aminotransferase, and creatinine < 1.5x times the upper limit of normal (ULN).
  • Life expectancy of at least 6 months based on Investigator's judgment.
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
  • At least 4 weeks after surgery or radiotherapy before randomization.
  • A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy before randomization.
  • Recovery from primary local surgical treatment, radiotherapy or orchiectomy before randomization.
  • Signed informed consent including patient's ability to comprehend its contents.

Who cannot join

  • Confirmed brain and/or leptomeningeal metastases (other visceral metastases are acceptable).
  • Current symptomatic spinal cord compression requiring surgery or radiation therapy.
  • Prior chemotherapy for prostate cancer.
  • Patient co-morbidities:
  • Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone).
  • HIV positive, human T-lymphotropic virus positive.
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  • Active hepatitis B (active hepatitis B), active hepatitis C (HCV), active syphilis.
  • Evidence of active bacterial, viral or fungal infection requiring systemic treatment.
  • Clinically significant cardiovascular disease including:
  • symptomatic congestive heart failure.
  • unstable angina pectoris.
  • serious cardiac arrhythmia requiring medication.
  • uncontrolled hypertension.
  • myocardial infarction or ventricular arrhythmia or stroke within a 6 months before screening, known left ventricular ejection fraction (LVEF) < 40% or serious cardiac conduction system disorders, if a pacemaker is not present.
  • Pleural and pericardial effusion of any NCI CTCAE grade.
  • Peripheral neuropathy having a NCI CTCAE ≥ grade 2.
  • History of malignant disease (with the exception of non-melanoma skin tumors) in the preceding five years.
  • Active autoimmune disease requiring treatment.
  • History of severe forms of primary immune deficiencies.
  • History of anaphylaxis or other serious reaction following vaccination.
  • Known hypersensitivity to any constituent of the DCVAC/PCa or placebo product.
  • Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator's opinion, would prevent participation in the trial.
  • Systemic corticosteroids at doses greater than 40 mg hydrocortisone daily or equivalent for any reason other than treatment of PCa within 6 months before randomization.
  • Ongoing systemic immunosuppressive therapy for any reason.
  • Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumor-focused treatment performed on the day of randomization (except for GnRH/LHRH agonists or antagonists) to exclude possible anti-androgen withdrawal response. This criterion is not applicable to subjects who have never responded to anti-androgen treatment, as there is no risk of anti-androgen withdrawal response.
  • Treatment with immunotherapy against PCa within 6 months before randomization.
  • Treatment with radiopharmaceutical within 8 weeks before randomization.
  • Participation in a clinical trial using non-immunological experimental therapy within 4 weeks before randomization.
  • Participation in a clinical trial using immunological experimental therapy (e.g., monoclonal antibodies, cytokines or active cellular immunotherapies) within 6 months before randomization.
  • Refusal to sign the informed consent.

Trial locations and contacts

177 sites in 22 countries.

177 sites in 22 countries

United States58 sites

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • University of Colorado

    Aurora, Colorado, 80045

  • Urologic Consultants of Southeastern Pennsylvania

    Bala-Cynwyd, Pennsylvania, 19004

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • New Jersey Hematology Oncology Associates

    Brick, New Jersey, 08724

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

  • Associates in Oncology & Hematology

    Chattanooga, Tennessee, 37421

  • UC Health University of Cincinnati

    Cincinnati, Ohio, 45267

  • Compassionate Care Research Group, Inc.

    Corona, California, 92879

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Karmanos Cancer Center

    Detroit, Michigan, 48202

  • Cancer Care Associates St. Luke's University and Health Network

    Easton, Pennsylvania, 18045

  • California Cancer Associates for Research and Excellence

    Encinitas, California, 92024

  • Fort Belvoir Community Hospital

    Fort Belvoir, Virginia, 22060

  • Compassionate Care Research Group, Inc.

    Fountain Valley, California, 92708

  • St. Joseph Heritage Healthcare

    Fullerton, California, 92835

  • Comprehensive Cancer Research Centers of Nevada

    Henderson, Nevada, 89052

  • UT Health, Internal Medicine, Division of Oncology

    Houston, Texas, 77030

  • Saint Luke's Cancer Institute

    Kansas City, Kansas, 64111

  • Premier Urology Associates, LLC / AdvanceMed Research

    Lawrenceville, New Jersey, 08648

  • Hao Wei Zhang, MD, LLC

    Los Angeles, California, 90033

  • Univ. of Miami, Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • West Virginia University Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26506

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Yale Cancer Center

    New Haven, Connecticut, 06519

  • Tulane University

    New Orleans, Louisiana, 70112

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Eastern CT Hematology and Oncololgy Associates

    Norwich, Connecticut, 06360

  • GU Research Network

    Omaha, Nebraska, 68130

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Texas Health Physicians Group

    Plano, Texas, 75093

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Desert Hematology Oncology Medical Group

    Rancho Mirage, California, 92270

  • Compassionate Care Research Group, Inc.

    Riverside, California, 92501

  • Associates In Oncology/Hematology,P.C

    Rockville, Maryland, 20850

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Cancer Care Network of South Texas

    San Antonio, Texas, 78217

  • Sharp Clinical Oncology Research

    San Diego, California, 92123

  • Mayo Clinic

    Scottsdale, Arizona, 85259-5499

  • Virginia Mason Medical Center

    Seattle, Washington, 98012

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Northwest Cancer Specialists, P.C.

    Tualatin, Oregon, 97062

  • Tyler Hematology Oncology

    Tyler, Texas, 75701

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • University of Kansas Cancer Center & Medical Pavilion

    Westwood, Kansas, 66205

  • Oncology Institute of Hope and Innovation

    Whittier, California, 90603

  • Umass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Germany19 sites

  • Charite Universitatsklinikum Berlin

    Berlin, 12200

  • Stadtisches Klinikum Braunschweig

    Braunschweig, 38126

  • Klinik und Poliklinik Urologie

    Cologne, 50937

  • Universtatsklinikum Carl Gustav Carus

    Dresden, 01307

  • Waldkrankenhaus St. Marien

    Erlangen, 91054

  • Krankenhaus Nordwest

    Frankfurt, 60 439

  • Universitatsklinikum Halle (Saale)

    Halle, 06120

  • Asklepios-Klinik Hamburg-Altona

    Hamburg, 22763

  • Vinzenkrankenhaus Hannover

    Hanover, 30 559

  • Medizinische hochschule Hannover

    Hanover, 30625

  • Universitatskinikum Jena

    Jena, 07743

  • Universitatsmedizin Mannheim

    Mannheim, 68167

  • Universtatsklinikum Munster

    Münster, 48 149

  • Studienpraxis Urologie

    Nürtingen, 72622

  • Klinikum Oldenburg AOR

    Oldenburg, 26133

  • Universitastsklinikum Tubingen

    Tübingen, 72076

  • Universitatsklinikum Ulm

    Ulm, 89075

  • Ammerland Klinik fur Urologie

    Westerstede, 26655

  • Praxigemeinschaft fur Onkologie und Urologie

    Wilhelmshaven, 26389

Other trials in Germany

Czechia11 sites

  • Onkologicke centrum, Nemocnice Chomutov

    Chomutov, 430 12

  • Klinika onkologie a radioterapie, Fakultni nemocnice

    Hradec Králové, 500 05

  • Nemocnice Jihlava, urologicke oddeleni

    Jihlava, 586 33

  • Urologicke oddeleni, Krajska nemocnice

    Liberec, 46003

  • Onkologicka klinika, Fakultni nemocnice

    Olomouc, 775 20

  • Klinika onkologicka, Fakultni nemocnice

    Ostrava-Poruba, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12 808

  • Thomayerova nemocnice

    Prague, 140 00

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Krajska zdravotni, urologicke oddeleni

    Ústí nad Labem, 401 13

Other trials in Czechia

Spain10 sites

  • Hospital Universitario Príncipe de Asturias

    Alcalá de Henares, 28805

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08035

  • Hospital General Universitario Gregorio Maranón

    Madrid, 28007

  • Hosp. Clinico Univ. San Carlos

    Madrid, 28040

  • Instituto de Investigaciones Sanitarias (IIS), Fundacíon Jimenez Díaz (FJD)

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncológico Clara Campal (CIOCC)

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Madrid, 28222

  • Hospital Carlos Haya

    Málaga, 29010

  • Hospital Universitario Quiron Madrid

    Pozuelo de Alarcón, 28223

Other trials in Spain

United Kingdom9 sites

  • The Clatterbridge Cancer Centre

    Bebington, CH63 4JY

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • St. Luke's Cancer Centre Royal Surrey County Hospital NHS Foundation Trust

    Guildford, GU2 7XX

  • Royal Free Hospital

    London, NW3 2QG

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Northern Centre for Cancer Care, Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Slovakia8 sites

  • J.Breza MEDICAL s.r.o.

    Bratislava, 851 01

  • Urologicka ambulancia CUIMED s.r.o.

    Bratislava, 851 05

  • Univerzitna nemocnica Martin

    Martin, 036 59

  • Urologicka ambulancia Uroexam, spol. s r.o.

    Nitra, 949 01

  • UROX s.r.o.

    Piešťany, 921 01

  • Urocentrum MILAB s.r.o.

    Prešov, 080 01

  • Privatna urologicka ambulancia

    Trenčín, 911 01

  • Fakultna nemocnica s poliklinikou Zilina

    Žilina, 012 07

Other trials in Slovakia

Italy7 sites

  • CRO Aviano

    Aviano

  • A.O.U. Policlinico Vittorio Emanuele

    Catania, 95123

  • A.O. Istituti Ospitalieri di Cremona

    Cremona, 26100

  • A.O. Santa Croce e Carle Oespedale

    Cuneo, 12100

  • Universita di Roma Sapienza

    Rome, 00161

  • Azienda Ospedialiera Universitaria Senese

    Siena, 53100

  • Oncologia medica Ospedale S. Vincenzo

    Taormina, 98039

Other trials in Italy

Netherlands7 sites

  • VU medical Center

    Amsterdam, 1007 MB

  • Wilhemina Ziekenhuis

    Assen, 9401 RK

  • Tergooi Ziekenhuizen

    Hilversum, 1213 XZ

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM

  • Oncology Medisch Centrum

    Leeuwarden, 08934

  • UMC St.Radboud

    Nijmegen, 06525

  • Oncology Maasstad Ziekenhuis

    Rotterdam, 03079

Other trials in Netherlands

France6 sites

  • St-Louis IDF Medical Oncology

    Paris, 75 010

  • Hopital St. Joseph

    Paris, 75 014

  • Hospital Cochin, Service de Urologie

    Paris, 75014

  • HEGP medical oncology

    Paris, 75908

  • HIA Begin

    Saint-Mandé, 94160

  • Hospital Civil de Strasbourg

    Strasbourg, 67091

Other trials in France

Belgium5 sites

  • Clinique d'Oncologie Medicale Institut Jules Bordet

    Brussels, 01000

  • Erasme Hospital- Urologie

    Brussels, 01070

  • Cliniques Universitaires Saint Luc- Urologie

    Brussels, 01200

  • Urologie UZ Gent

    Ghent, 09000

  • Urology Department St. Elizabeth Ziekenhuis

    Turnhout, 02300

Other trials in Belgium

Bulgaria5 sites

  • Specialized Hospital for Active treatment in Oncology

    Haskovo, 6300

  • Central Oncology Hospital

    Plovdiv, 4000

  • Complex Oncology Center

    Plovdiv, 4000

  • Multifunctional Hospital for Active Treatment Serdika

    Sofia, 1303

  • Specialized Hospital for Active Treatment of Oncology Diseases

    Sofia, 1784

Other trials in Bulgaria

Poland5 sites

  • Przychodnia Lekarska (KOMED)

    Konin, 62-500

  • Szpital im M.Kopernika

    Lodz, 93-513

  • INSTYTUT im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

  • Centrum Medyczne Ostrobramska

    Warsaw, 04-125

  • Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

    Wroclaw, 50-556

Other trials in Poland

Hungary4 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, H-1062

  • Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeszet

    Budapest, H-1097

  • Bajcsy-Zsilinsky Korhaz

    Budapest, H-1106

  • Jasz-Nagykun-Szolnok Megyei

    Szolnok, H-5004

Other trials in Hungary

Lithuania4 sites

  • Lithuanian University of Health Science Oncology Institute

    Kaunas, 50009

  • Klaipeda University Hospital

    Klaipėda, 92288

  • Vilnius University Hospital

    Vilnius, 08 661

  • National Cancer Institute

    Vilnius, 08660

Other trials in Lithuania

Serbia4 sites

  • CHC Zemun

    Belgrade, 11000

  • Clinical Center of Serbia

    Belgrade, 11000

  • Institute of Oncology and Radiology of Serbia

    Belgrade, 11000

  • KBC Bezanijska Kosa

    Belgrade, 11080

Other trials in Serbia

Austria3 sites

  • Universitatsklinikum fur Urologie und Andrologie

    Salzburg, 5020

  • Krankenhaus Barmherzige Brueder

    Vienna, 1020

  • AKH Universitatskrankenhaus Wien

    Vienna, 1090

Other trials in Austria

Croatia3 sites

  • General Hospital Varazdin

    Varaždin, 42000

  • Clinical Hospital Center Zagreb

    Zagreb, 10000

  • University Hospital Center Sisters of Charity

    Zagreb, 10000

Other trials in Croatia

Portugal3 sites

  • Hospital da Luz

    Lisbon, 1500-650

  • Centro Hospitalar de Lisboa Norte, E.P.E - Hospital de Santa Maria

    Lisbon, 1645-039

  • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E

    Porto, 4200-319

Other trials in Portugal

Belarus2 sites

  • N.N. Alexandrov National Research Center

    Lesnoy, 223040

  • Minsk City Oncological Hospital

    Minsk, 220013

Other trials in Belarus

Sweden2 sites

  • Örebro University Hospital

    Örebrö, SE-701 85

  • University Hospital Umeå, Dept Oncology

    Umeå, 901 85

Other trials in Sweden

Denmark1 site

  • Rigshospitalet

    Copenhagen, 02100

Other trials in Denmark

Latvia1 site

  • Paula Stradina Kliniska Universitates slimnica

    Riga, LV-1079

Other trials in Latvia

About this study

Official title: A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men With Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.

Read the detailed description

This was a randomized, double blind, placebo-controlled, multicenter, international, parallel-group phase III study. Patients with metastatic castration-resistant prostate cancer who were candidates to receive standard of care first-line chemotherapy with docetaxel plus prednisone were randomized 2:1 into one of two arms: an investigational arm (DCVAC/PCa) and a control arm (placebo) in addition to chemotherapy (docetaxel plus prednisone).

Being tested
DCVAC/PCa, Placebo
Keywords
Immunotherapy, Metastatic, Castration-resistant, Prostate cancer, Biological, Vaccine
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.

  • DCVAC/PCaBiological

    Also called Stapuldencel

    DCVAC/PCa concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). DCVAC/PCa was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of DCVAC/PCa was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.

  • PlaceboBiological

    Placebo concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). Placebo was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of placebo was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.

Study groups in NCT02111577
Study groupRoleWhat they receive
DCVAC/PCa with standard of care chemotherapyExperimentalCombination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Receives: Biological: DCVAC/PCa
Placebo with standard of care chemotherapyPlacebo comparatorCombination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Receives: Biological: Placebo

What is being measured

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

  1. Overall Survival, Intention-to-treat Population

    Overall survival is defined as the time from randomization until death due to any cause.

    Measured: From randomization to death due to any cause, up to 58 months

Secondary outcomes (14)

  1. Overall Survival, Per Protocol Population

    Overall survival is defined as the time from randomization until death due to any cause.

    Measured: From randomization to death due to any cause, up to 58 months

  2. Overall Survival, Intention-to-treat Population, Abiraterone as Prior Therapy

    Overall survival is defined as the time from randomization until death due to any cause.

    Measured: From randomization to death due to any cause, up to 58 months

  3. Overall Survival, Intention-to-treat Population, Enzalutamide as Prior Therapy

    Overall survival is defined as the time from randomization until death due to any cause.

    Measured: From randomization to death due to any cause, up to 58 months

  4. Overall Survival, Intention-to-treat Population, no Prior Abiraterone or Enzalutamide

    Overall survival is defined as the time from randomization until death due to any cause.

    Measured: From randomization to death due to any cause, up to 58 months

  5. Radiological Progression-free Survival, Intention-to-treat Population

    Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.

    Measured: Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months

  6. Radiological Progression-free Survival, Per Protocol Population

    Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.

    Measured: Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months

  7. Time to PSA Progression, Intention-to-treat Population

    The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.

    Measured: Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months

  8. Time to PSA Progression, Per Protocol Population

    The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.

    Measured: Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months

  9. Time to First Skeletal-related Event, Intention-to-treat Population

    Skeletal-related events included:

    • Radiation therapy to bone
    • Pathologic bone fracture
    • Spinal cord compression
    • Surgery to bone
    • Change in antineoplastic therapy to treat bone pain

    Measured: Time from randomization to the date of the first skeletal-related event, up to 58 months

  10. Time to First Skeletal-related Event, Per Protocol Population

    Skeletal-related events included:

    • Radiation therapy to bone
    • Pathologic bone fracture
    • Spinal cord compression
    • Surgery to bone
    • Change in antineoplastic therapy to treat bone pain

    Measured: Time from randomization to the date of the first skeletal-related event, up to 58 months

  11. Time to Radiological Progression or Skeletal-related Event, Intention-to-treat Population

    Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.

    Skeletal-related events included:

    • Radiation therapy to bone
    • Pathologic bone fracture
    • Spinal cord compression
    • Surgery to bone
    • Change in antineoplastic therapy to treat bone pain

    Measured: Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months

  12. Time to Radiological Progression or Skeletal-related Event, Per Protocol Population

    Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.

    Skeletal-related events included:

    • Radiation therapy to bone
    • Pathologic bone fracture
    • Spinal cord compression
    • Surgery to bone
    • Change in antineoplastic therapy to treat bone pain

    Measured: Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months

  13. Proportion of Patients With Skeletal-related Events, Intention-to-treat Population

    Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.

    Skeletal-related events included:

    • Radiation therapy to bone
    • Pathologic bone fracture
    • Spinal cord compression
    • Surgery to bone
    • Change in antineoplastic therapy to treat bone pain

    Measured: From randomization to the end of the study, up to 57 months

  14. Proportion of Patients With Skeletal-related Events, Per Protocol Population

    Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.

    Skeletal-related events included:

    • Radiation therapy to bone
    • Pathologic bone fracture
    • Spinal cord compression
    • Surgery to bone
    • Change in antineoplastic therapy to treat bone pain

    Measured: From randomization to the end of the study, up to 57 months

Timeline

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

  1. First posted11 Apr 2014 (estimated)
  2. Study start26 May 2014
  3. Primary completion28 Jan 2020
  4. Study completion28 Jan 2020

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02111577
Sponsor's protocol ID
SP005
Other IDs
2012-002814-38
Acronym
VIABLE
Status last verified
Mar 2021
First submitted
9 Apr 2014
Last updated
6 Apr 2021
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Hensler M, Rakova J, Kasikova L, Lanickova T, Pasulka J, Holicek P, Hraska M, Hrnciarova T, Kadlecova P, Schoenenberger A, Sochorova K, Rozkova D, Sojka L, Drozenova J, Laco J, Horvath R, Podrazil M, Hongyan G, Brtnicky T, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Garg AD, Cibula D, Bartunkova J, Spisek R, Fucikova J. Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines. Oncoimmunology. 2022 Jul 22;11(1):2101596. doi: 10.1080/2162402X.2022.2101596. eCollection 2022.

    PubMed 35898703

  • Vogelzang NJ, Beer TM, Gerritsen W, Oudard S, Wiechno P, Kukielka-Budny B, Samal V, Hajek J, Feyerabend S, Khoo V, Stenzl A, Csoszi T, Filipovic Z, Goncalves F, Prokhorov A, Cheung E, Hussain A, Sousa N, Bahl A, Hussain S, Fricke H, Kadlecova P, Scheiner T, Korolkiewicz RP, Bartunkova J, Spisek R; VIABLE Investigators. Efficacy and Safety of Autologous Dendritic Cell-Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer: The VIABLE Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):546-552. doi: 10.1001/jamaoncol.2021.7298.

    PubMed 35142815

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DCVAC/PCa in people with Metastatic Castration-resistant Prostate Cancer, run by SOTIO a.s. at 177 sites in 22 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 24 inclusion and 30 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 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, Germany, Czechia, Spain, United Kingdom and 17 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 6 Apr 2021). 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, Intention-to-treat Population (time frame: From randomization to death due to any cause, up to 58 months). 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 NCT02111577, which also lists 2 linked publications.

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 6 Apr 2021.

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