We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 Biotech ( SOTIO a.s. )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Cancer Metastatic Biological: Dendritic Cells DCVAC/PCa Drug: Docetaxel Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 Castrate-resistant Prostate Cancer
Actual Study Start Date : February 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : February 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: DCVAC/PCa add on to Standard of Care
Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care
 Biological: Dendritic Cells DCVAC/PCa
DCVAC/PCa is the experimental therapy added on to Docetaxel
Active Comparator: Standard of Care
Docetaxel as an Active Comparator
 Drug: Docetaxel
Docetaxel is Standard of Care First Line Chemotherapy
Other Name: taxotere


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Survival rate [ Time Frame: 135 weeks ]

Secondary Outcome Measures :
  1. Radiographic Progression Free Survival [ Time Frame: 135 weeks ]
  2. Duration to Prostate Specific Antigen (PSA) Progression [ Time Frame: 135 weeks ]
  3. 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 ]
  4. Changes in Pain assessed by EORTC QLQ-C30 [ Time Frame: 0, 10, 22, 37, 53, 65 weeks ]
  5. Incidence of Adverse Events [ Time Frame: 135 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02105675


Locations
Layout table for location information
Czechia
Brno, Czechia
Hradec Kralove, Czechia
Jihlava, Czechia
Liberec, Czechia
Nova Ves pod Plesi, Czechia
Olomouc, Czechia
Ostrava, Czechia
Praha 10, Czechia
Praha 4, Czechia
Praha 5, Czechia
Praha 8, Czechia
Usti nad Labem, Czechia
Zlin, Czechia
Sponsors and Collaborators
SOTIO a.s.
Investigators
Layout table for investigator information
Study Director: Tomas Scheiner, PhD SOTIO Biotech
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: SOTIO a.s.
ClinicalTrials.gov Identifier: NCT02105675    
Other Study ID Numbers: SP001
2011-004735-32 ( EudraCT Number )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: possibly shared on EMA website
Keywords provided by SOTIO Biotech ( SOTIO a.s. ):
Immunotherapy
Metastatic
Castrate Resistant
 Prostate Cancer
Biological
Vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
 Prostatic Diseases
Male Urogenital Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action