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Phase II Study of DCVAC/PCa After Primary Radiotherapy for Patients With High Risk Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02107430
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
SOTIO Biotech ( SOTIO a.s. )

Study Description
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Brief Summary:
The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA progression times within 5 years for patients with high risk localized Prostate Cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Dendritic Cells DCVAC/PCa Radiation: Standard radiotherapy Phase 2

Detailed Description:
Treatment post radical primary prostatectomy Treatment post standard radiotherapy
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Localized High-risk Prostate Cancer After Primary Radiotherapy
Study Start Date : March 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: DCVAC/PCa arm post radiotherapy
Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy
 Biological: Dendritic Cells DCVAC/PCa
DCVAC/PCa arm post radiotherapy
Active Comparator: Standard radiotherapy
Standard care
 Biological: Dendritic Cells DCVAC/PCa
DCVAC/PCa arm post radiotherapy

Radiation: Standard radiotherapy
radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Number of Prostate Specific Antigen (PSA) failures in 5 years [ Time Frame: Enrollment up to 260 weeks ]
    PSA failure per Phoenix criteria of increase of 2ng/mL over nadir


Secondary Outcome Measures :
  1. Proportion of Patients without use of salvage therapy within 5 years [ Time Frame: Enrollment up to 260 weeks ]
    Calculation of the proportion of patients without use of salvage therapy within 5 years

  2. Frequency of Adverse Events [ Time Frame: enrollment up to 260 weeks ]
    Safety profile as defined by the nature, incidence, duration, severity and outcome of adverse events

  3. Proportion of Patients without Objective disease progression within 5 years [ Time Frame: Enrollment up to 260 weeks ]
    Proportion of patients who do not have a >2ng/mL elevation in PSA or require salvage therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male 18 years and older
  • Histologically confirmed localized prostate cancer of high risk or very high risk fulfilling at least one of the following: T3-T4 stage or Gleason Score 8-10 or PSA level above 20 ng/ml
  • Indication for prostate cancer radical radiotherapy
  • Neo-adjuvant androgen androgen-deprivation therapy due to prostate cancer using Luteinizing-hormone-releasing hormone (LHRH) analogues ongoing for at least two months and not longer than 12 months prior randomization
  • Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

  • Primary surgical treatment of prostate cancer
  • Prior or ongoing chemotherapy for prostate cancer
  • Participation in other clinical study or administration of other evaluated drug within 30 day prior screening
  • Unresolved lasting obstruction of urinary system
  • Other uncontrolled inter-current illness
  • Treatment with immunotherapy against Prostate Cancer
  • Clinically significant cardiovascular disease
  • History of primary immunodeficiency
  • Active autoimmune disease requiring treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107430


Locations
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Czechia
Nemocnice Jihlava,Urologické oddělení,
Jihlava, Czechia, 586 33
Fakultní nemocnice Olomouc
Olomouc, Czechia, 775 20
FN Ostrava, Onkologická klinika
Ostrava, Czechia, 708 52
FNKV Klinika radiologie a onkologie
Praha 10, Czechia, 100 34
FN Motol
Praha 5, Czechia, 150 06
Nemocnice Na Bulovce
Praha 8, Czechia, 180 00
Sponsors and Collaborators
SOTIO a.s.
Investigators
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Study Director: Tomas Scheiner SOTIO Biotech
More Information
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Responsible Party: SOTIO a.s.
ClinicalTrials.gov Identifier: NCT02107430    
Other Study ID Numbers: SP004
2011-004967-65 ( EudraCT Number )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Clinical trial results will be reported as required by European legislation in clinicaltrialsregister.eu.
Time Frame: Data will be available 12 months after study completion.
Access Criteria: No specific access criteria are required
URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=SP004
Keywords provided by SOTIO Biotech ( SOTIO a.s. ):
Immunotherapy
Prostate Cancer
Biological, Vaccine
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases