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Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant 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: NCT02105675
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Sotio a.s.

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE April 7, 2014
Last Update Posted Date May 24, 2017
Actual Study Start Date  ICMJE February 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
Survival rate [ Time Frame: 135 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
Overall survival (all cause mortality) [ Time Frame: 135 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
  • Radiographic Progression Free Survival [ Time Frame: 135 weeks ]
  • Duration to Prostate Specific Antigen (PSA) Progression [ Time Frame: 135 weeks ]
  • Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 [ Time Frame: 0, 10, 22, 37, 53, 65 weeks ]
  • Changes in Pain assessed by EORTC QLQ-C30 [ Time Frame: 0, 10, 22, 37, 53, 65 weeks ]
  • Incidence of Adverse Events [ Time Frame: 135 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
  • Radiographic Progression Free Survival [ Time Frame: 135 weeks ]
  • Duration to Prostate Specific Antigen (PSA) Progression [ Time Frame: 135 weeks ]
  • Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 [ Time Frame: 0, 10, 22, 37, 53, 65 weeks ]
  • Changes in Pain assessed by EORTC QLQ-C30 [ Time Frame: 0, 10, 22, 37, 53, 65 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Official Title  ICMJE Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer
Brief Summary The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Prostate Cancer Metastatic
Intervention  ICMJE
  • Biological: Dendritic Cells DCVAC/PCa
    DCVAC/PCa is the experimental therapy added on to Docetaxel
  • Drug: Docetaxel
    Docetaxel is Standard of Care First Line Chemotherapy
    Other Name: taxotere
Study Arms  ICMJE
  • Experimental: DCVAC/PCa add on to Standard of Care
    Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care
    Intervention: Biological: Dendritic Cells DCVAC/PCa
  • Active Comparator: Standard of Care
    Docetaxel as an Active Comparator
    Intervention: Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 2, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 20, 2017
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men aged ≥ 18 years
  • Histologically confirmed prostate cancer
  • Presence of skeletal metastasis (by CT or PET or MRI)
  • Disease progression documented by increasing PSA or two new lesions
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

Exclusion Criteria:

  • Confirmed brain and/or leptomeningeal metastases
  • Prior chemotherapy for prostate cancer
  • Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
  • Other uncontrolled intercurrent illness
  • Treatment with immunotherapy against PCa
  • Clinically significant cardiovascular disease
  • Active autoimmune disease requiring treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02105675
Other Study ID Numbers  ICMJE SP001
2011-004735-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: possibly shared on EMA website
Responsible Party Sotio a.s.
Study Sponsor  ICMJE Sotio a.s.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tomas Scheiner, PhD Sotio a.s.
PRS Account Sotio a.s.
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP