search
Back to results

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

Primary Purpose

Metastatic Castration-resistant Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DCVAC/PCa
Placebo
Sponsored by
SOTIO a.s.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer focused on measuring Immunotherapy, Metastatic, Castration-resistant, Prostate cancer, Biological, Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion criteria:

  • 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

  • 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.

Exclusion criteria:

  • 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.
    • 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.

Sites / Locations

  • University of South Alabama Mitchell Cancer Institute
  • Ironwood Cancer & Research Centers
  • Mayo Clinic
  • Compassionate Care Research Group, Inc.
  • California Cancer Associates for Research and Excellence
  • Compassionate Care Research Group, Inc.
  • St. Joseph Heritage Healthcare
  • Hao Wei Zhang, MD, LLC
  • Desert Hematology Oncology Medical Group
  • Compassionate Care Research Group, Inc.
  • Sharp Clinical Oncology Research
  • Oncology Institute of Hope and Innovation
  • Rocky Mountain Cancer Centers
  • University of Colorado
  • Yale Cancer Center
  • Eastern CT Hematology and Oncololgy Associates
  • Medstar Georgetown University Hospital
  • Univ. of Miami, Sylvester Comprehensive Cancer Center
  • Winship Cancer Institute of Emory University
  • Saint Luke's Cancer Institute
  • University of Kansas Cancer Center & Medical Pavilion
  • Tulane University
  • University of Maryland Greenebaum Cancer Center
  • Associates In Oncology/Hematology,P.C
  • Dana-Farber Cancer Institute
  • Umass Memorial Medical Center
  • Henry Ford Health System
  • Karmanos Cancer Center
  • Minnesota Oncology Hematology, P.A.
  • GU Research Network
  • Nebraska Cancer Specialists
  • Comprehensive Cancer Research Centers of Nevada
  • New Jersey Hematology Oncology Associates
  • Premier Urology Associates, LLC / AdvanceMed Research
  • Cancer Institute of New Jersey
  • Montefiore Medical Center
  • Mount Sinai Medical Center
  • SUNY Upstate Medical University
  • UC Health University of Cincinnati
  • Oregon Health & Science University
  • Northwest Cancer Specialists, P.C.
  • Urologic Consultants of Southeastern Pennsylvania
  • Cancer Care Associates St. Luke's University and Health Network
  • Fox Chase Cancer Center
  • UPMC Cancer Center
  • Carolina Urologic Research Center
  • Associates in Oncology & Hematology
  • Arlington Cancer Center
  • UT Health, Internal Medicine, Division of Oncology
  • Texas Health Physicians Group
  • Cancer Care Network of South Texas
  • Tyler Hematology Oncology
  • Utah Cancer Specialists
  • Fort Belvoir Community Hospital
  • Virginia Oncology Associates
  • Virginia Mason Medical Center
  • Northwest Medical Specialties, PLLC
  • West Virginia University Mary Babb Randolph Cancer Center
  • Universitatsklinikum fur Urologie und Andrologie
  • Krankenhaus Barmherzige Brueder
  • AKH Universitatskrankenhaus Wien
  • N.N. Alexandrov National Research Center
  • Minsk City Oncological Hospital
  • Clinique d'Oncologie Medicale Institut Jules Bordet
  • Erasme Hospital- Urologie
  • Cliniques Universitaires Saint Luc- Urologie
  • Urologie UZ Gent
  • Urology Department St. Elizabeth Ziekenhuis
  • Specialized Hospital for Active treatment in Oncology
  • Central Oncology Hospital
  • Complex Oncology Center
  • Multifunctional Hospital for Active Treatment Serdika
  • Specialized Hospital for Active Treatment of Oncology Diseases
  • General Hospital Varazdin
  • Clinical Hospital Center Zagreb
  • University Hospital Center Sisters of Charity
  • Onkologicke centrum, Nemocnice Chomutov
  • Klinika onkologie a radioterapie, Fakultni nemocnice
  • Nemocnice Jihlava, urologicke oddeleni
  • Urologicke oddeleni, Krajska nemocnice
  • Onkologicka klinika, Fakultni nemocnice
  • Klinika onkologicka, Fakultni nemocnice
  • Fakultni nemocnice Kralovske Vinohrady
  • Vseobecna fakultni nemocnice v Praze
  • Thomayerova nemocnice
  • Fakultni nemocnice v Motole
  • Krajska zdravotni, urologicke oddeleni
  • Rigshospitalet
  • HEGP medical oncology
  • St-Louis IDF Medical Oncology
  • Hopital St. Joseph
  • Hospital Cochin, Service de Urologie
  • HIA Begin
  • Hospital Civil de Strasbourg
  • Charite Universitatsklinikum Berlin
  • Stadtisches Klinikum Braunschweig
  • Universtatsklinikum Carl Gustav Carus
  • Waldkrankenhaus St. Marien
  • Krankenhaus Nordwest
  • Universitatsklinikum Halle (Saale)
  • Asklepios-Klinik Hamburg-Altona
  • Vinzenkrankenhaus Hannover
  • Medizinische hochschule Hannover
  • Universitatskinikum Jena
  • Klinik und Poliklinik Urologie
  • Universitatsmedizin Mannheim
  • Universtatsklinikum Munster
  • Studienpraxis Urologie
  • Klinikum Oldenburg AOR
  • Universitastsklinikum Tubingen
  • Universitatsklinikum Ulm
  • Ammerland Klinik fur Urologie
  • Praxigemeinschaft fur Onkologie und Urologie
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeszet
  • Bajcsy-Zsilinsky Korhaz
  • Jasz-Nagykun-Szolnok Megyei
  • CRO Aviano
  • A.O.U. Policlinico Vittorio Emanuele
  • A.O. Istituti Ospitalieri di Cremona
  • A.O. Santa Croce e Carle Oespedale
  • Universita di Roma Sapienza
  • Azienda Ospedialiera Universitaria Senese
  • Oncologia medica Ospedale S. Vincenzo
  • Paula Stradina Kliniska Universitates slimnica
  • Lithuanian University of Health Science Oncology Institute
  • Klaipeda University Hospital
  • Vilnius University Hospital
  • National Cancer Institute
  • VU medical Center
  • Wilhemina Ziekenhuis
  • Tergooi Ziekenhuizen
  • Spaarne Gasthuis
  • Oncology Medisch Centrum
  • UMC St.Radboud
  • Oncology Maasstad Ziekenhuis
  • Przychodnia Lekarska (KOMED)
  • Szpital im M.Kopernika
  • INSTYTUT im. Marii Sklodowskiej-Curie
  • Centrum Medyczne Ostrobramska
  • Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
  • Hospital da Luz
  • Centro Hospitalar de Lisboa Norte, E.P.E - Hospital de Santa Maria
  • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E
  • CHC Zemun
  • Clinical Center of Serbia
  • Institute of Oncology and Radiology of Serbia
  • KBC Bezanijska Kosa
  • J.Breza MEDICAL s.r.o.
  • Urologicka ambulancia CUIMED s.r.o.
  • Univerzitna nemocnica Martin
  • Urologicka ambulancia Uroexam, spol. s r.o.
  • UROX s.r.o.
  • Urocentrum MILAB s.r.o.
  • Privatna urologicka ambulancia
  • Fakultna nemocnica s poliklinikou Zilina
  • Hospital Universitario Príncipe de Asturias
  • Hospital Clinic I Provincial de Barcelona
  • Hospital General Universitario Gregorio Maranón
  • Hosp. Clinico Univ. San Carlos
  • Instituto de Investigaciones Sanitarias (IIS), Fundacíon Jimenez Díaz (FJD)
  • Hospital Universitario 12 de Octubre
  • Centro Integral Oncológico Clara Campal (CIOCC)
  • Hospital Universitario Puerta de Hierro de Majadahonda
  • Hospital Carlos Haya
  • Hospital Universitario Quiron Madrid
  • University Hospital Umeå, Dept Oncology
  • Örebro University Hospital
  • The Clatterbridge Cancer Centre
  • University Hospitals Birmingham NHS Foundation Trust
  • Bristol Haematology and Oncology Centre
  • Cambridge University Hospitals NHS Foundation Trust
  • St. Luke's Cancer Centre Royal Surrey County Hospital NHS Foundation Trust
  • Royal Free Hospital
  • The Royal Marsden NHS Foundation Trust
  • The Christie NHS Foundation Trust
  • Northern Centre for Cancer Care, Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DCVAC/PCa with standard of care chemotherapy

Placebo with standard of care chemotherapy

Arm Description

Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)

Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator

Outcomes

Primary Outcome Measures

Overall Survival, Intention-to-treat Population
Overall survival is defined as the time from randomization until death due to any cause.

Secondary Outcome Measures

Overall Survival, Per Protocol Population
Overall survival is defined as the time from randomization until death due to any cause.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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

Full Information

First Posted
April 9, 2014
Last Updated
March 10, 2021
Sponsor
SOTIO a.s.
search

1. Study Identification

Unique Protocol Identification Number
NCT02111577
Brief Title
Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Acronym
VIABLE
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 26, 2014 (Actual)
Primary Completion Date
January 28, 2020 (Actual)
Study Completion Date
January 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOTIO a.s.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-resistant Prostate Cancer
Keywords
Immunotherapy, Metastatic, Castration-resistant, Prostate cancer, Biological, Vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DCVAC/PCa with standard of care chemotherapy
Arm Type
Experimental
Arm Description
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Arm Title
Placebo with standard of care chemotherapy
Arm Type
Placebo Comparator
Arm Description
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Intervention Type
Biological
Intervention Name(s)
DCVAC/PCa
Other Intervention Name(s)
Stapuldencel
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival, Intention-to-treat Population
Description
Overall survival is defined as the time from randomization until death due to any cause.
Time Frame
From randomization to death due to any cause, up to 58 months
Secondary Outcome Measure Information:
Title
Overall Survival, Per Protocol Population
Description
Overall survival is defined as the time from randomization until death due to any cause.
Time Frame
From randomization to death due to any cause, up to 58 months
Title
Overall Survival, Intention-to-treat Population, Abiraterone as Prior Therapy
Description
Overall survival is defined as the time from randomization until death due to any cause.
Time Frame
From randomization to death due to any cause, up to 58 months
Title
Overall Survival, Intention-to-treat Population, Enzalutamide as Prior Therapy
Description
Overall survival is defined as the time from randomization until death due to any cause.
Time Frame
From randomization to death due to any cause, up to 58 months
Title
Overall Survival, Intention-to-treat Population, no Prior Abiraterone or Enzalutamide
Description
Overall survival is defined as the time from randomization until death due to any cause.
Time Frame
From randomization to death due to any cause, up to 58 months
Title
Radiological Progression-free Survival, Intention-to-treat Population
Description
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.
Time Frame
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
Title
Radiological Progression-free Survival, Per Protocol Population
Description
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.
Time Frame
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
Title
Time to PSA Progression, Intention-to-treat Population
Description
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.
Time Frame
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
Title
Time to PSA Progression, Per Protocol Population
Description
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.
Time Frame
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
Title
Time to First Skeletal-related Event, Intention-to-treat Population
Description
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
Time Frame
Time from randomization to the date of the first skeletal-related event, up to 58 months
Title
Time to First Skeletal-related Event, Per Protocol Population
Description
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
Time Frame
Time from randomization to the date of the first skeletal-related event, up to 58 months
Title
Time to Radiological Progression or Skeletal-related Event, Intention-to-treat Population
Description
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
Time Frame
Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months
Title
Time to Radiological Progression or Skeletal-related Event, Per Protocol Population
Description
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
Time Frame
Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months
Title
Proportion of Patients With Skeletal-related Events, Intention-to-treat Population
Description
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
Time Frame
From randomization to the end of the study, up to 57 months
Title
Proportion of Patients With Skeletal-related Events, Per Protocol Population
Description
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
Time Frame
From randomization to the end of the study, up to 57 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 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. Exclusion criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas J. Vogelzang
Organizational Affiliation
US Oncology Research/Comprehensive Cancer Centers of Nevada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Ironwood Cancer & Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Compassionate Care Research Group, Inc.
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
California Cancer Associates for Research and Excellence
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Compassionate Care Research Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Hao Wei Zhang, MD, LLC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Desert Hematology Oncology Medical Group
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Compassionate Care Research Group, Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Eastern CT Hematology and Oncololgy Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Univ. of Miami, Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Saint Luke's Cancer Institute
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64111
Country
United States
Facility Name
University of Kansas Cancer Center & Medical Pavilion
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Associates In Oncology/Hematology,P.C
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Umass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Oncology Hematology, P.A.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
GU Research Network
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Research Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
New Jersey Hematology Oncology Associates
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Premier Urology Associates, LLC / AdvanceMed Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
UC Health University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Northwest Cancer Specialists, P.C.
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Urologic Consultants of Southeastern Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Cancer Care Associates St. Luke's University and Health Network
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Associates in Oncology & Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
UT Health, Internal Medicine, Division of Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Health Physicians Group
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Cancer Care Network of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Tyler Hematology Oncology
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98012
Country
United States
Facility Name
Northwest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
West Virginia University Mary Babb Randolph Cancer Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Universitatsklinikum fur Urologie und Andrologie
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Krankenhaus Barmherzige Brueder
City
Wien
ZIP/Postal Code
1020
Country
Austria
Facility Name
AKH Universitatskrankenhaus Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
N.N. Alexandrov National Research Center
City
Lesnoy
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Minsk City Oncological Hospital
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Facility Name
Clinique d'Oncologie Medicale Institut Jules Bordet
City
Brussels
ZIP/Postal Code
01000
Country
Belgium
Facility Name
Erasme Hospital- Urologie
City
Brussels
ZIP/Postal Code
01070
Country
Belgium
Facility Name
Cliniques Universitaires Saint Luc- Urologie
City
Brussels
ZIP/Postal Code
01200
Country
Belgium
Facility Name
Urologie UZ Gent
City
Gent
ZIP/Postal Code
09000
Country
Belgium
Facility Name
Urology Department St. Elizabeth Ziekenhuis
City
Turnhout
ZIP/Postal Code
02300
Country
Belgium
Facility Name
Specialized Hospital for Active treatment in Oncology
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
Central Oncology Hospital
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Complex Oncology Center
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Multifunctional Hospital for Active Treatment Serdika
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Oncology Diseases
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
General Hospital Varazdin
City
Varaždin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
Clinical Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Center Sisters of Charity
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Onkologicke centrum, Nemocnice Chomutov
City
Chomutov
ZIP/Postal Code
430 12
Country
Czechia
Facility Name
Klinika onkologie a radioterapie, Fakultni nemocnice
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Nemocnice Jihlava, urologicke oddeleni
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Urologicke oddeleni, Krajska nemocnice
City
Liberec
ZIP/Postal Code
46003
Country
Czechia
Facility Name
Onkologicka klinika, Fakultni nemocnice
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Klinika onkologicka, Fakultni nemocnice
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Prague
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Prague
ZIP/Postal Code
12 808
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Prague
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Krajska zdravotni, urologicke oddeleni
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
02100
Country
Denmark
Facility Name
HEGP medical oncology
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
St-Louis IDF Medical Oncology
City
Paris
ZIP/Postal Code
75 010
Country
France
Facility Name
Hopital St. Joseph
City
Paris
ZIP/Postal Code
75 014
Country
France
Facility Name
Hospital Cochin, Service de Urologie
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
HIA Begin
City
Saint Mandé
ZIP/Postal Code
94160
Country
France
Facility Name
Hospital Civil de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Charite Universitatsklinikum Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Stadtisches Klinikum Braunschweig
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Universtatsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Waldkrankenhaus St. Marien
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Krankenhaus Nordwest
City
Frankfurt
ZIP/Postal Code
60 439
Country
Germany
Facility Name
Universitatsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Asklepios-Klinik Hamburg-Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Vinzenkrankenhaus Hannover
City
Hannover
ZIP/Postal Code
30 559
Country
Germany
Facility Name
Medizinische hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitatskinikum Jena
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Klinik und Poliklinik Urologie
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitatsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universtatsklinikum Munster
City
Münster
ZIP/Postal Code
48 149
Country
Germany
Facility Name
Studienpraxis Urologie
City
Nürtingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Klinikum Oldenburg AOR
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Universitastsklinikum Tubingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Ammerland Klinik fur Urologie
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Praxigemeinschaft fur Onkologie und Urologie
City
Wilhelmshaven
ZIP/Postal Code
26389
Country
Germany
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
H-1062
Country
Hungary
Facility Name
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeszet
City
Budapest
ZIP/Postal Code
H-1097
Country
Hungary
Facility Name
Bajcsy-Zsilinsky Korhaz
City
Budapest
ZIP/Postal Code
H-1106
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei
City
Szolnok
ZIP/Postal Code
H-5004
Country
Hungary
Facility Name
CRO Aviano
City
Aviano
Country
Italy
Facility Name
A.O.U. Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
A.O. Istituti Ospitalieri di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
A.O. Santa Croce e Carle Oespedale
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Universita di Roma Sapienza
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedialiera Universitaria Senese
City
Sienna
ZIP/Postal Code
53100
Country
Italy
Facility Name
Oncologia medica Ospedale S. Vincenzo
City
Taormina
ZIP/Postal Code
98039
Country
Italy
Facility Name
Paula Stradina Kliniska Universitates slimnica
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Lithuanian University of Health Science Oncology Institute
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Klaipeda University Hospital
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Vilnius University Hospital
City
Vilnius
ZIP/Postal Code
08 661
Country
Lithuania
Facility Name
National Cancer Institute
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
Facility Name
VU medical Center
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
Facility Name
Wilhemina Ziekenhuis
City
Assen
ZIP/Postal Code
9401 RK
Country
Netherlands
Facility Name
Tergooi Ziekenhuizen
City
Hilversum
ZIP/Postal Code
1213 XZ
Country
Netherlands
Facility Name
Spaarne Gasthuis
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Oncology Medisch Centrum
City
Leeuwarden
ZIP/Postal Code
08934
Country
Netherlands
Facility Name
UMC St.Radboud
City
Nijmegen
ZIP/Postal Code
06525
Country
Netherlands
Facility Name
Oncology Maasstad Ziekenhuis
City
Rotterdam
ZIP/Postal Code
03079
Country
Netherlands
Facility Name
Przychodnia Lekarska (KOMED)
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Szpital im M.Kopernika
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
INSTYTUT im. Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Centrum Medyczne Ostrobramska
City
Warszawa
ZIP/Postal Code
04-125
Country
Poland
Facility Name
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Hospital da Luz
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte, E.P.E - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1645-039
Country
Portugal
Facility Name
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
CHC Zemun
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Oncology and Radiology of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
KBC Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
J.Breza MEDICAL s.r.o.
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
Urologicka ambulancia CUIMED s.r.o.
City
Bratislava
ZIP/Postal Code
851 05
Country
Slovakia
Facility Name
Univerzitna nemocnica Martin
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Urologicka ambulancia Uroexam, spol. s r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
UROX s.r.o.
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
Urocentrum MILAB s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Privatna urologicka ambulancia
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou Zilina
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Hospital Universitario Príncipe de Asturias
City
Alcalá de Henares
ZIP/Postal Code
28805
Country
Spain
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hosp. Clinico Univ. San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Instituto de Investigaciones Sanitarias (IIS), Fundacíon Jimenez Díaz (FJD)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro Integral Oncológico Clara Campal (CIOCC)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro de Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Quiron Madrid
City
Pozuelo de Alarcón
ZIP/Postal Code
28223
Country
Spain
Facility Name
University Hospital Umeå, Dept Oncology
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebrö
ZIP/Postal Code
SE-701 85
Country
Sweden
Facility Name
The Clatterbridge Cancer Centre
City
Bebington
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre Royal Surrey County Hospital NHS Foundation Trust
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Northern Centre for Cancer Care, Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35898703
Citation
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.
Results Reference
derived
PubMed Identifier
35142815
Citation
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.
Results Reference
derived
Links:
URL
http://www.viablestudy.com
Description
Click here for more information about this study: Phase III Study of DCVAC Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (VIABLE)

Learn more about this trial

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

We'll reach out to this number within 24 hrs