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

May 23, 2017 updated by: SOTIO a.s.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate
Time Frame: 135 weeks
135 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiographic Progression Free Survival
Time Frame: 135 weeks
135 weeks
Duration to Prostate Specific Antigen (PSA) Progression
Time Frame: 135 weeks
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
0, 10, 22, 37, 53, 65 weeks
Changes in Pain assessed by EORTC QLQ-C30
Time Frame: 0, 10, 22, 37, 53, 65 weeks
0, 10, 22, 37, 53, 65 weeks
Incidence of Adverse Events
Time Frame: 135 weeks
135 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOTIO a.s.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

February 20, 2017

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP001
  • 2011-004735-32 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

possibly shared on EMA website

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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